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NCT ID: NCT02029885 Recruiting - Hypertension Clinical Trials

Sham Controlled Study of Renal Denervation for Subjects With Uncontrolled Hypertension

WAVE_IV
Start date: August 2014
Phase: N/A
Study type: Interventional

To demonstrate that non-invasive renal denervation is safe and shows a net difference in blood pressure reduction when compared to sham in subjects with uncontrolled hypertension.

NCT ID: NCT02020044 Recruiting - Clinical trials for Endothelial Dysfunction

Outcome After Descemet Membrane Endothelial Keratoplasty (DMEK) and Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)

Start date: September 2012
Phase: N/A
Study type: Interventional

The purpose of this study is evaluate the outcome after posterior lamellar keratoplasty (DMEK and Ultra-thin DSAEK) for corneal transplantation.

NCT ID: NCT02011984 Recruiting - Clinical trials for Peripheral Artery Disease

Multicentric Non-randomized Investigation of RESISTANT Camouflage Stent-system

RECAM
Start date: December 2013
Phase: N/A
Study type: Observational [Patient Registry]

Non-randomized multicenter post-market study to confirm the long-term safety and effectiveness of the CE-approved Camouflage-coated self-expandable RESISTANT Camouflage stent system for revascularization of de novo stenotic lesions in the superficial femoral artery in 100 compliant patients suitable for stent angioplasty. The CE-approved device will be used according to its intended use. Beyond the standard of care no further interventions are scheduled. Therefore, this trial is subject to the exception to the rule §23b of the German Medical Device Act (MPG), which includes the national implementation of EC directive 93/42/EEC.

NCT ID: NCT02010957 Recruiting - Clinical trials for Adrenal Gland Neoplasms

Combined FDG-PET and 123I-Iodometomidate Imaging for Adrenal Neoplasia

FAMIAN
Start date: August 2015
Phase: Phase 3
Study type: Interventional

Adrenal masses are highly prevalent and detected with high frequency by conventional imaging. Conventional imaging often fails to rule out a malignant lesion. Accordingly, most hormonally inactive adrenal masses removed by surgery are benign adenomas for which surgical removal is unnecessary and poses an avoidable risk to the patients. We hypothesize that the combination of FDG-PET and 123I-Iodometomidate imaging has the potential to noninvasively identify benign adrenocortical adenomas with high accuracy, thereby avoiding unnecessary surgery. Uptake of 123I-Iodometomidate by the adrenal mass demonstrates the presence of CYP 11B enzymes which specifically bind metomidate with high avidity establishing the adrenocortical origin of the lesion, while low uptake of FDG-PET in an adrenocortical lesion establishes its benign nature and excludes the presence of adrenocortical cancer (ACC). The proposed trial will assess the sensitivity, specificity, positive and negative predictive value of the combined imaging for the diagnosis of adrenocortical adenoma. A secondary focus is on the performance of the combined test for differentiating ACC from non-ACC lesions. We expect that the results of our trial will help to greatly reduce the need for surgery in hormonally inactive adrenal masses.

NCT ID: NCT02007811 Recruiting - Multiple Myeloma Clinical Trials

Open-label Clinical Trial to Investigate the Safety and Tolerability of Allogeneic B-cell Concentrates for Immune Reconstitution After Allogeneic Stem Cell Transplantation Measured as Response to a Antedated Single Vaccination

B-cell therapy
Start date: November 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The reconstitution of a functioning immune system after allogeneic stem cell transplantation takes months to years. Particularly memory B-lymphocytes reconstitute poorly with the current conditioning regimes. During the period of intense immune suppression the patients are extremely susceptible to bacterial, fungal and, most importantly, viral infections.The adoptive transfer of B-lymphocytes from the stem-cell donor might significantly enhance humoral immunity for the patient. Aim of the study is to evaluate a new cellular therapy with B-lymphocytes regarding safety. A booster vaccination after B-lymphocyte transfer will evaluate the functionality of the transferred B-lymphocytes in the patient.

NCT ID: NCT02006134 Recruiting - Clinical trials for Microscopic Polyangiitis

Pediatric Vasculitis Initiative

PedVas
Start date: January 2013
Phase:
Study type: Observational [Patient Registry]

Childhood chronic vasculitis describes a group of rare life-threatening diseases that have in common inflammation of blood vessels in vital organs such as kidneys, lungs and brain. Most knowledge about them comes from adult patients. Severe disease requires aggressive life-saving treatments with steroids and some cancer drugs which can themselves cause damage, and increase risks of cancer and severe infections. Conversely, milder disease can be treated with less toxic drugs. Different classification and "scoring tools" are used to define the types and severity of vasculitis and to measure damage caused by disease or drugs. These in turn help direct how aggressively to treat a patient and to measure outcome. None of these tools however have been assessed in children and the best balance of disease and treatment risks against outcome for children is not known. Although causes of these diseases in children and adults are probably the same, the effects of the disease and the response (good and bad) to drugs will differ in growing children. Because specialists may see only one new child with vasculitis each year, obtaining enough information to learn about childhood vasculitis requires cooperation. We will use an international web-based registry to which doctors from 50 or more centers can contribute patient data. We will determine the features which help better classify and diagnose children compared to adults. Through the web we will collect and analyze information on patients similarly classified and "scored" so that most successful treatments can be identified. Children with vasculitis are less likely to have diseases associated with aging, alcohol and smoking etc., and therefore may be a better group in whom to study the underlying biology of vasculitis. We will use this opportunity and collect spit, blood and tissue from registry patients for laboratory study with an aim to find biomarkers to better classify, define and direct optimal treatment and outcomes.

NCT ID: NCT02002481 Recruiting - Cardiac Arrest Clinical Trials

Comparison of the Quality of CPR by Professional Helpers (Emergency Physicians / Paramedics) During Flights

flights
Start date: December 2013
Phase: N/A
Study type: Interventional

Investigation of the influence of narrowness and unusual circumstances on the CPR-quality

NCT ID: NCT02000505 Recruiting - Cardiac Arrest Clinical Trials

Comparison of the Quality of CPR by Lay Rescuers With and Without Feedback Devices

frequenz
Start date: November 2013
Phase: N/A
Study type: Interventional

Comparison of various methods to improve the quality of CPR

NCT ID: NCT01995565 Recruiting - Clinical trials for Critically Ill Patients

Regional Cerebral Hemodynamics Related to Global Hemodynamics

Start date: July 2011
Phase: N/A
Study type: Observational

This prospective investigation studies changes in regional cerebral hemodynamics and oxygenation as a function of cardiac output and blood pressure in intensive care patients.

NCT ID: NCT01992237 Recruiting - Acute Lung Injury Clinical Trials

Measuring Energy Expenditure in ECMO (Extracorporeal Membrane Oxygenation) Patients

MEEP
Start date: October 2013
Phase: N/A
Study type: Observational

With the perception that lung protective ventilation with regard to low tidal volume ventilation and limiting airway pressures improves outcome in ARDS (acute respiratory distress syndrome) and that the development of new technical devices of extracorporeal lung assist systems with lower complication rates support establishment of lung protective ventilation strategies these systems are more and more frequently used. All critically ill patients with and without ECLA (extracorporeal lung assist)/ECMO (extracorporeal membrane oxygenation) treatment are on high risk for muscle wasting, leading to more comorbidity and higher mortality risk. Besides inflammation malnutrition is known as one of the main risk factors. Over and underfeeding should be prevented. However nutritional aspects of patients on extracorporeal lung assist are hardly investigated. Up to now changes in metabolic rates induced by ECLA/ECMO are poorly described. Factors like work of breathing, changes in cardiac output and septic state are influencing energy metabolism but until now there is no tool for measuring energy expenditure in clinical routine for patients on ECLA/ECMO. Indirect calorimetry is a simple device only for patients without ECLA/ECMO system. Oxygenation and CO2 (carbon dioxide) elimination by the lung assist system can be calculated but is not implemented to clinical routine. The combination of indirect calorimetry and calculation of lung assist function at the same time would give us the chance to adapt nutrition rates to energy expenditure. This may prevent muscle wasting and weakness. This pilot study will include 40 participating patients during 8 month investigating nutritional therapy adapted to energy expenditure calculated by O2 and CO2 turnover rates in patients on ECLA or ECMO systems. The investigators aim is to describe a calculation to set nutrition targets in ECMO patients. Second the investigators will describe level of nutritional needs under consideration of different mechanical ventilation states. Third O2 consumption and CO2 elimination will be used to estimate cardiac output.