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.
OBJECTIVES Primary: To evaluate efficacy of treatment with anakinra in subjects with CF who are ≥ 12 years of age by means of lung clearance index (LCI). Secondary To evaluate safety and tolerability of treatment with anakinra as well as to investigate further effects of anakinra on lung function and quality of life (QOL) in subjects with CF.
During sleep, the muscle tonus in the oropharyngeal space is lost, the tongue might fall back andthe volume of the pharynx decreases. Air cannot pass through as it would in the awake state and thus airflow limitations occur. The person asleep might compensate the flow limitation by breathing faster, which causes the soft tissue to vibrate (= snoring). Further narrowing of the airways can lead to obstructive apneas (complete airway collapse and stopping of airflow). First line therapy for obstructive sleep apnea (OSA) is positive airway pressure (PAP) that keeps the airways open with a pneumatic splint. Since PAP involves wearing a facial mask that applies air pressure into the airways, some patients cannot tolerate this therapy. These patients might be candidates for an alternative treatment approach with a mandibular advancement device (MAD).
Aim of this study is to conduct longitudinal and cross-sectional analyses about the corneal ectatic disease Keratoconus based on data obtained from Keratoconus patients in the Homburg Keratoconus Center (HKC). The Homburg Keratoconus Center (HKC) was founded in 2010 and, up to now, comprises more than 2.000 Keratoconus patients. Topographic, tomographic and biomechanic characteristics of the disease are being analyzed with the intention to elucidate how the disease begins and develops during lifetime.
Nephropathic Cystinosis (NC) is an orphan inherited autosomal recessive disease characterised as a generalized lysosomal storage disease due to a deficiency of the cystine lysosomal transport protein, cystinosin. Patients with NC usually receive cysteamine. Bone impairment was recently recognized as a late complication of NC, occurring at adolescence or early adulthood. Even though the exact underlying pathophysiology is unclear, at least six hypotheses are discussed, and mainly cysteamine toxicity and/or direct bone effect of the Cystinosin (CTNS) mutation. Because of the potential dramatic impact on quality of life of this novel complication, research should aim to better understand bone disease in NC. The primary objective of this study is to evaluate the action of cysteamine on osteoclastic differentiation and resorption activity of NC patients, depending on the underlying genotype. The Secondary objective is to describe the clinical bone status of NC patients depending on their underlying genotype.
Idiopathic Parkinson's syndrome (IPS) is one of the most common neurodegenerative diseases. The prevalence and significance of this disease is continuously increasing in the course of demographic change. For many decades, the focus of diagnostics and therapy was on the motor symptoms of IPS. Only in recent years, it has been recognized that Parkinson's patients also suffer from a variety of non-motor symptoms. These have a decisive influence on the patient's quality of life. As one of the most common non-motor symptoms, 55 to 80% of IPS patients suffer from urinary dysfunction. This is associated with a very high impairment of quality of life due to a high degree of stigmatization and impairment of social participation. In clinical everyday life, Parkinson's patients regularly report the occurrence of a strong imperative urge to urinate, which occurs suddenly and is usually triggered by a certain external stimuli. Specific cognitive processing and reflection of these external stimuli seems to help overcome the imperative urge to urinate. From this clinical observation, it can be assumed that the imperative urge to urinate is subject to a certain cognitive control in the sense of targeted inhibition. The pharmacological therapy of urinary dysfunction in IPS patients is severely restricted and characterized by insufficient proof of efficacy as well as a high potential for side effects. In clinical practice, alpha-blockers and anticholinergics are frequently used, but the evidence base for IPS is inadequate. In addition, there is a highly relevant risk for Parkinson's patients of specific side effects such as orthostatic dysregulation or deterioration of cognition up to psychoses and hallucinations. This greatly limits their use especially in older IPS patients. While the use of dopaminergic medication is essential for the treatment of motor symptoms in Parkinson's patients, a large number of studies have not confirmed sufficient evidence for the efficacy of dopaminergic medication in urinary dysfunction. In addition, non-pharmacological therapy options, in particular pelvic floor training, are used to treat bladder dysfunction. Due to the lack of risk of side effects, pelvic floor training is currently recommended as a first-line therapy option for IPS patients. Initial studies have shown positive effects, but due to the lack of randomized controlled trials, a sufficient evidence base for this has not yet been established. The aim of the study is to examine whether a purely cognitive therapy approach is suitable to improve subjective and objective symptoms of urinary dysfunction in IPS patients. This therapeutic approach will be compared with the gold standard of pelvic floor training in terms of efficacy.
Investigation of how a single session of an attentional filter exercise of distractor inhibition combined with tDCS modulates cognitive functions like working memory, decision making and attentional control.
Liver resection is the only curative treatment option for primary and secondary liver tumors. For some primary or secondary malignancies (HCC, NET) liver transplantation is a possible treatment option. Unfortunately, the majority of patients show a high hepatic tumor load or adverse intrahepatic distribution, that resection or transplantation at the time of initial diagnosis is not possible. In that case different treatment approaches are possible. For those patients that are very unlikely to ever become resectable, palliative systemic therapy is the preferred treatment option. For those patients that may become resectable after downsizing of the tumors or increase of volume of the future liver remnant secondary resection after induction therapy may be a possibility. Then, an induction treatment that has the most likelihood of causing physical shrinkage of the tumors is usually preferred. One of the approaches to create contralateral hypertrophy to increase future liver remnant is portal vein embolization. However, tumor growth might be stimulated during the phase of hypertrophy. Selective internal radiation therapy (SIRT) with SIR-Spheres Y-90 resin microspheres is an endovascular interventional radio-oncologic procedure treating primary and secondary liver tumors1-3. It offers radiation therapy with yttrium-90, a high-energy beta-emitting isotope, directly in the vascular system of liver tumors. It treats the tumor locally, saves healthy liver tissue and could lead to hypertrophy of this residual healthy liver tissue due to the embolization effect. Therefore secondary liver resection after SIRT might become possible4,5. SIRT could also be an option as bridging-, downsizing- or downstaging-therapy before liver transplantation. Liver resection with local tumor treatment and hypertrophy induction after SIRT seems to be a promising therapy option. Previous reports have shown the feasibility, safety and efficacy of this therapeutic strategy. Aim of the European SIR-Spheres Surgical Registry - ESSURE - is now to further improve the understanding and optimize the process and patient selection of this therapy strategy in its true clinical setting. This registry enables data collection on the real-life clinical application of liver resection/liver transplantation after SIRT.
The aim of the present study is to detect changes in the dopamine system in the brain of patients with schizophrenia, especially when pretreated with antipsychotic medication. Here, the investigators want to find out whether the treatment with these drugs can cause permanent changes in docking points (receptors) of dopamine in the brain. It will be examined whether number and response of dopamine receptors is altered, which are associated with the onset of psychotic symptoms. For this purpose, a single PET/MR measurement will be performed in all participants. In total 140 volunteers, consisting of 30 healthy volunteers, 20 first-episode, drug-naive patients with schizophrenia and 90 pretreated patients with schizophrenia will be included over a time period of three years. In addition, the influence of nicotine consumption on dopamine receptors will be invesitgated by comparing data from smoking and non-smoking patients. In clinical practice, an elevation of dopamine action caused by alterations in receptors in the brain is of most importance. This may be the reason why the treatment with antipsychotic agents does not work in some patients. In addition, a permanent elevation of dopamine action is associated with permanent brain alterations by these drugs. The result can contribute to work out valuable indications, whether it makes sense to continue a long term therapy with antipsychotic drugs in a patient. But also the in-depth understanding of the impact of nicotine on the course of therapy can help to open up possibilities for improved drug treatment.
This trial is being conducted to evaluate the efficacy of Phasix™ Mesh implantation at the time of midline fascial closure compared to primary suture closure in preventing a subsequent incisional hernia in subjects at risk for incisional hernia after open midline laparotomy surgery.
KALIOS is indicated for the surgical treatment of mitral regurgitation by mitral valve repair.It is intended for mitral valve repair using conventional open heart or minimally invasive techniques. The KALIOS device is an adjustable annuloplasty ring, to be implanted by open surgery, having a hollow structure that comprises a flat rigid ring surrounding a deformable cage. The unique feature of KALIOS is that its annular shape and dimension can be finely adjusted percutaneously by an external actuator (three-balloon catheter) independently in the three areas corresponding to P1, P2 and P3 The primary objective of this clinical investigation is to assess the safety and effectiveness of KALIOS for the surgical treatment of Mitral Regurgitation with optional intra-operative and/or post-operative adjustment(s) The secondary objectives are to investigate the effects of KALIOS for the surgical treatment of Mitral Regurgitation on cardiac function and on patient functional status This clinical trial is prospective, non-randomized, single arm, multicentric & international. Up to 100 patients are expected to be enrolled to obtain 62 evaluable patients at one year,presenting with primary (degenerative) or secondary (functional) mitral valve regurgitation and who are candidate to a mitral valve repair.