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NCT ID: NCT01628913 Completed - Clinical trials for Pancreatic Neuroendocrine Tumors (pNET)

Efficacy and Safety of BEZ235 Compared to Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumors

MACS1938
Start date: October 2012
Phase: Phase 2
Study type: Interventional

This study will estimate the treatment effect of BEZ235 relative to everolimus on progression-free survival (PFS) in patients with advanced progressive pancreatic neuroendocrine tumors.

NCT ID: NCT01628484 Completed - Clinical trials for Birch Pollen Allergy

Physiological Study to Determine the Allergic Skin Activity After Different Skin Preparation

Start date: July 2012
Phase: Phase 1
Study type: Interventional

The objectives of this monocentric investigator initiated exploratory clinical trial is to optimize allergen delivery across the epidermal barrier. The cornified outer epidermal layers represent the main barrier towards entry into the viable epidermal layers. In the latter we aim to target the allergen for uptake by professional antigen presenting cells, called Langerhans cells. At the same time as little allergen as possible should be delivered to the dermis. The latter contains a high density of sensitized mast cells eliciting local reactions and also a high density of blood vessels which could lead to systemic distribution of allergen and therefore to systemic allergic reactions. In birch pollen allergic individuals we will compare different methods of preparing the skin before application of the allergen. We will subsequently apply titrated allergen doses to the prepared skin areas to determine at which dose we start observing mast cell degranulation manifesting as hives. This will allow for determination of the maximal tolerated allergen dose for each skin preparation method. The skin preparation methods compared will be: - Single pricking with prick lancet (Entaco LTD., Redditch, Worcestershire, UK, distributed by Stallergenes®). - Tape stripping with conventional adhesive Tape (Tesa-film®). - Microchanneling with Micro Needle Patch (Micro Skin System, 3M®). The methods are strongly connected to routine diagnostics of allergies with low risk associated. The clinical trial protocol has been submitted to the local Ethics Committee. This comparison of skin preparation methods and the determination of the maximal tolerated allergen dose will help us to further improve epicutaneous allergen immunotherapy, which has the potential to make allergen specific immunotherapy not only considerably shorter and safer, but also more convenient for patients. Skin preparation by microneedle patches is significantly less painful than conventional injection and can be self administered. This should help improve the acceptance of allergen specific immunotherapy, as well as treatment compliance.

NCT ID: NCT01628406 Enrolling by invitation - Clinical trials for Patients Treated at the Neurosurgery Department

Patient Registry of the Neurosurgery Department

patregNCH
Start date: June 2012
Phase:
Study type: Observational [Patient Registry]

The investigators record all indications, treatments and outcomes from patients treated at the Neurosurgery Department. - Trial with surgical intervention

NCT ID: NCT01628159 Completed - Clinical trials for Peripheral Artery Disease

LEVANT 2 Continuation Registry of the Lutonix® Drug Coated Balloon (DCB)

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

The purpose of the study is to collect additional safety and efficacy information on the Lutonix (formerly Moxy) Drug Coated Balloon for treatment of stenosis or occlusion of the femoral and popliteal arteries.

NCT ID: NCT01627691 Completed - Clinical trials for Transcatheter Aortic Valve Replacement

REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System

Start date: October 8, 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and performance of the Lotus™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with severe calcific aortic stenosis who are considered high risk for surgical valve replacement.

NCT ID: NCT01627652 Recruiting - Hypoxia Clinical Trials

Human Adaptation to High Altitude

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

This scientific study aims at studying human adaptations to high altitude and the studies will be conducted at the University of Zürich and during a 4 week high altitude "expedition" to the Jungfraujoch research station at 3450 m altitude. The proposal is made up of several independent biological research projects to be conducted in the same healthy volunteers participating in the study. Thus, the subjects will be studied at sea level, and then during 4 weeks of acclimatization to high altitude, and for some experimental purposes all subjects will also be studied one and two weeks after return to sea level.

NCT ID: NCT01625975 Completed - Clinical trials for Leg Length Discrepancy

Retrospective Eight Plate Study

Start date: July 2012
Phase:
Study type: Observational

Understanding bone growth and achieving bone deformity corrections re-mains one of the oldest challenges in paediatric orthopaedics. The purpose of this study is to investigate the clinical and biomechanical effects of implants for growth modulation in pediatric patients undergoing correction of leg length or deformities of the knee. The primary aim of the study is to assess outcome after growth modulation using the Eight plate (Orthofix) at the time of implant removal with regard to any Adverse Events (AE) related to the growth plates or implants under investigation. The secondary aims are to assess if the planned correction was achieved and if the achieved correction was maintained after implant removal. Furthermore, secondary aims include investigation of the number and type of revision surgeries, the proportions of any other local AE as well as any influencing factors for growth modulation.

NCT ID: NCT01625858 Completed - Clinical trials for Evaluation of Success Rate

Evaluation of Supraglottic Airway Devices in Children and Comparison to Historic Control

Start date: May 2012
Phase: N/A
Study type: Observational

The supraglottic airway device LMA Supreme has recently been introduced for pediatric patients. The investigators will prospectively evaluate success rate and airway leak pressure in everyday's clinical pediatric anesthesia practice. Primary hypothesis is that the LMA Supreme has a leak pressure with a 95% confidence interval of 18-22cmH2O. Leak pressures will be compared to results from other pediatric supraglottic airway devices previously studied by the investigators group. Secondary Hypothesis: The primary success rate of the LMA-S is higher than 90%; therefore, performance is similar to the performance of the Ambu Aura Once™ and of the i-gel™. Study design: Prospective controlled observational cohort study. In a second step, we will include more pediatric supraglottic airway devices. Each new arm will be handled exactly the same, assuming the same hypothesis being justified.

NCT ID: NCT01625832 Completed - Clinical trials for Coronary Artery Disease

Effects of Coronary Sinus Occlusion on Myocardial Ischemia (Pilot Study)

Start date: September 2011
Phase: N/A
Study type: Interventional

Coronary artery disease (CAD) is the leading cause of morbidity and mortality in industrialized countries despite advances in medical, interventional, and surgical revascularization therapies. In both, acute myocardial infarction (AMI) and chronic stable disease, standard therapeutic approaches may fail to restore tissue perfusion. Indeed, a substantial number of chronic CAD patients may not be amenable to standard revascularization therapies or percutaneous coronary intervention (PCI) may fail to restore coronary artery patency following an acute vessel occlusion (no-reflow phenomenon, microvascular obstruction). As a consequence, the long pursued strategy of augmenting myocardial perfusion by diverting blood from the coronary venous system to an ischemic region (venous retroperfusion) has again gained attention during recent years. Occlusion of the coronary sinus (CSO) was introduced to provide retroperfusion by transient augmentation of coronary venous pressure. Different devices using CSO have been invented and evaluated in animal models and small clinical trials, e.g. intermittent CSO (ICSO) and pressure-controlled intermittent CSO (PICSO) which seem to be effective for myocardial salvage. However, they are not yet employed in clinical routine, and importantly, the exact underlying mechanisms by which retroperfusion due to CSO may reduce myocardial ischemia are not yet understood. As "natural bypasses", coronary collaterals are anastomoses without an intervening capillary bed between portions of the same coronary artery or between different coronary arteries that represent an alternative source of blood supply to a myocardial area jeopardized by ischemia. Collaterals of the heart can be assessed quantitatively by coronary pressure measurements, which have become the gold standard (collateral flow index, CFI=[Poccl-CVP]/[Pao-CVP]). Theoretically, augmentation of coronary sinus pressure by CSO with an increase of venous backflow reaches the upstream collateral circulation, which in turn could lead to improved collateral flow from non-ischemic area(s) to an occluded, ischemic myocardial region by upstream flow diversion. On the other hand, when considering the formula to calculate pressure-derived CFI, it seems that augmentation of coronary back pressure would rather impair collateral flow (since central venous pressure is coronary sinus pressure). However, the regional effect of a global increase in coronary sinus pressure is unlikely to be as uniform as the above formula implies, i.e., the response is more pronounced in some than in other vascular territories. In experimental studies using dogs (with abundant collaterals), elevation of coronary sinus pressure caused an augmentation of regional myocardial blood flow in the collateralized area. In contrast, when ICSO was performed in pigs (which possess no preformed collaterals), it increased the pressure distal of an occluded LAD but did not improve blood flow or left ventricular function. In conclusion, experimental studies and pathophysiologic considerations suggest a necessary role of the collateral circulation for the beneficial effects of coronary sinus occlusion (CSO) observed in animals and humans; however, no clinical data are available so far on the effect of CSO on myocardial ischemia in the presence of varying collateral flow. Study hypotheses 1. CSO decreases intra-coronary ECG ST-segment elevation during a 2-minute coronary occlusion. 2. The decrease in occlusive intra-coronary ECG ST elevation during CSO is directly proportional to CFI. 3. Coronary sinus oxygen saturation during coronary occlusion with CSO is directly proportional to CFI.

NCT ID: NCT01624545 Completed - Clinical trials for Chronic Subdural Hematoma

To Scan or Not to Scan: The Role of Follow-up CT Scanning for Management of Chronic Subdural Hematoma After Neurosurgical Evacuation

TOSCAN
Start date: June 1, 2012
Phase: N/A
Study type: Interventional

Chronic subdural hematoma (CSH) is one of the most common bleedings of the head. These hematomas develop after minor head trauma and increase in size over weeks. Patients usually present with headaches, gait disturbances, language problems or confusion. The state of the art treatment of a symptomatic chronic subdural hematoma is to remove the hematoma by burr hole trepanation. The optimal follow-up for operated patients remains controversial. Due to the known high rate of a second hematoma at the same place (usually within weeks), one strategy is to perform serial computer tomography scans in order to identify recurrent hematomas early. The radiologic evidence of a second hematoma often leads to reoperation, even if the patient has no, or just slight symptoms. Another strategy after surgical hematoma evacuation is to closely follow the patient with neurological examinations and perform neuroimaging only in case of new symptoms. Advocators of this strategy argue that a follow-up with routine CT scans may be harmful due to additional and maybe unnecessary surgeries and hospital days in a patient population marked by advanced age and fragility. The aim of the current study is to evaluate the role of computer tomography scanning in the postoperative follow-up after removal of a chronic subdural hematoma. Participants of this study will be allocated by chance to one of two study groups: Patients allocated to group A will receive a computer tomography scan on day 2 and again on day 30 after surgery in addition to a clinical examination. Patients allocated to group B will be examined clinically on day 2 and day 30 without computer tomography. All patients will undergo a final clinical examination after 6 months. The study will recruit 400 patients.