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NCT ID: NCT02585128 Completed - Clinical trials for Postoperative Delirium

Predictors of Postoperative Delirium After Transcatheter Aortic Valve Implantation

Start date: September 2015
Phase: N/A
Study type: Interventional

Patients undergoing transcatheter aortic valve implantation (TAVI) have distinctive characteristics: they are old, frail, with several co-morbidities and take multiple medications. Hemodynamic instability, cerebral embolism, sedation, general anesthesia and hospitalization in intensive care expose those patients to postprocedural delirium. Acute neurocognitive dysfunctions are associated with adverse outcomes in these population. The objective of this study is to determine the incidence of delirium and neurocognitive disorders in elderly patients after TAVI.

NCT ID: NCT02584842 Completed - Bleeding Clinical Trials

Rivaroxaban in Endovenous Laser Ablation With and Without Miniphlebectomy

RITE
Start date: January 2012
Phase: N/A
Study type: Observational

The purpose of this study is to determine retrospectively if the application of rivaroxaban after endovenous laser ablation with and without miniphlebectomy is safe and if it lowers the risk of venous thrombosis.

NCT ID: NCT02582866 Completed - Epilepsy Clinical Trials

A Clinical Study to Investigate the Long-term Use of Lacosamide as Monotherapy in Subjects Who Completed Study SP0994

Start date: January 2016
Phase: Phase 3
Study type: Interventional

Study is conducted to evaluate the long-term safety and tolerability of lacosamide (LCM) in patients receiving LCM in SP0994 [NCT01465997]. The study will enable collection of additional monotherapy safety data, and will facilitate access to treatment until commercial availability for monotherapy use.

NCT ID: NCT02581995 Completed - Macular Edema Clinical Trials

Investigation of the Change of Vision-related Quality of Life in Subjects Treated With Aflibercept According to EU Label for DME.

AQUA
Start date: November 19, 2015
Phase: Phase 4
Study type: Interventional

To evaluate the change in quality of life (NEI VFQ 25) in subjects with DME during the first year of treatment with aflibercept according to the EU Label.

NCT ID: NCT02580058 Completed - Ovarian Cancer Clinical Trials

A Study Of Avelumab Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer (JAVELIN Ovarian 200)

Start date: December 21, 2015
Phase: Phase 3
Study type: Interventional

A Phase 3 global study comparing avelumab alone to avelumab plus PLD and to PLD alone to demonstrate that avelumab given alone or in combination with PLD is superior to PLD alone in prolonging Overall Survival in patients with platinum resistant/platinum refractory ovarian cancer.

NCT ID: NCT02579525 Completed - Critical Illness Clinical Trials

Targeted Tissue Perfusion Versus Macrocirculatory-guided Standard Care in Patients With Septic Shock

TARTARE-2S
Start date: May 2016
Phase: N/A
Study type: Interventional

Background: The recommended monitoring and target levels in septic shock (SSC Guidelines 2012) including mean arterial pressure (MAP) target are not based on robust clinical data. Objective: To test, if in patients with septic shock, tissue perfusion guided (TPG) treatment strategy leads to a faster resolution of hypoperfusion than the macrocirculatory target guided standard care. Design: A prospective phase II two-parallel-group open-label randomized controlled trial Interventions: 1. Intervention group- Targeted tissue perfusion guided (TTP) - care. 2. Control group - Macrocirculatory - guided (MCG) care. Randomization: 1:1 stratified according to the site and presence or absence of known hypertension. Trial size: 200 randomised patients in 4 ICUs.

NCT ID: NCT02579330 Not yet recruiting - Hemorrhoids Clinical Trials

Trial on Use of Coloshield in Transanal and Anal Surgery

Start date: December 2015
Phase: N/A
Study type: Interventional

In various transanal and anal procedures it is desirable to clean the operating field from stool contamination. Thus mechanical bowel preparation is not well tolerated by patients. Enema does not provide sufficient effect. By the use of Coloshield a rectal washout might be performed and enable a clean operating field. In this randomized controlled trial the macroscopic contamination of the rectum with and without Coloshield is compared using the Boston Bowel Preparation Score (0-3).

NCT ID: NCT02579031 Completed - Clinical trials for Coronary Artery Disease

A Comparison of an Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent With a Durable Polymer Everolimus-Eluting Stent for Patients With Acute ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

BIOSTEMI
Start date: April 2016
Phase: N/A
Study type: Interventional

PCI is considered as the reperfusion strategy of choice for patients with acute STEMI. Data from RCTs and meta-analyses demonstrate a consistent and strong signal towards a significant reduction in MACE among patients with STEMI undergoing primary PCI with newer generation stents with enhanced biocompatibility. The present trial aims at filling the current gap of evidence by providing randomized data to establish the superior clinical outcome with an ultrathin strut third-generation DES with biodegradable polymer designed to improve vascular healing in patients with STEMI undergoing primary PCI, compared to the current state-of-the art second-generation DES with permanent polymer.

NCT ID: NCT02578784 Recruiting - Renal Insufficiency Clinical Trials

DEB-after-Cutting Balloon-PTA in Dialysis Fistula Stenosis

DEB-after-CB
Start date: October 2015
Phase: N/A
Study type: Interventional

The incidence of hemodynamically relevant dialysis fistula stenoses/obstructions after 1 year is between 60-90% (from 62.5 to 91% radiocephalic, brachiocephalic 70-84%, PTFE shunts 62-87%), necessitating a therapeutic measure to preserve dialysis access during this period in 1/3 of the patients. This therapeutic measure is a dilatation of the stenosis using a standard PTA balloon (POBA, plain old balloon angioplasty with a primary technical success rate of 50-79% [2-4].In turn, in 21-50% of the cases an insufficient PTA result is obtained (so-called POBA-resistant stenosis). In these cases, predilatation with a so-called cutting balloon (carrying with small knives on its surface) is performed, leading to a success rate of 89%. However, a problem is the high incidence of restenosis, which is about 40% for recurrent stenosis and over 10% in de novo stenosis. The use of drug-coated balloon (DCB) in non-POBA resistant stenoses lead to a reduction in the restenosis rate of 35% to 5%. However, the effect of DCB in POBA resistant stenoses is unknown. Therefore, the aim of this study is to evaluate the clinical benefit of the combined use of a cutting balloon and a drug-coated balloon in POBA resistant dialysis fistula stenoses compared to the sole use of a cutting balloon.

NCT ID: NCT02578420 Completed - Pain Clinical Trials

Back to Basics - Effects, Narratives and Routes of Administration of Open-label Placebo

Start date: January 2016
Phase: N/A
Study type: Interventional

To date, very little is known about the mechanisms of open-label placebo treatment and there is a lack in highly controlled experimental designs. Therefore, the planned project will test well-established explanatory models of (deceptive) placebo, i.e., (1) expectancy, (2) meaning response, in an open-label placebo design, investigating their influence on placebo analgesia.