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NCT ID: NCT01677741 Completed - Neoplasms, Brain Clinical Trials

A Study to Determine Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib In Children and Adolescent Subjects

Start date: May 23, 2013
Phase: Phase 1/Phase 2
Study type: Interventional

This was a 2-part, Phase I/IIa, multi-center, open label, study in pediatric and adolescent patients with advanced BRAF V600 mutation-positive solid tumors. Part 1 was a dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). Part 2 was an expansion study to further evaluate the safety, tolerability, and clinical activity of dabrafenib in 4 tumor-specific pediatric populations. Patients participated in only either part 1 or part 2 of the study.

NCT ID: NCT01677052 Completed - Clinical trials for Symptomatic Atrial Fibrillation

THERMOCOOL® SMARTTOUCHâ„¢ Registry

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

The primary purpose of this registry is to obtain "real world" clinical use of contact force measurements during ablation procedures.

NCT ID: NCT01676727 Completed - Aortic Stenosis Clinical Trials

ADVANCE Direct Aortic Study

Start date: September 2012
Phase:
Study type: Observational

This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve stenosis for which treatment via direct aortic access (DA) is selected.

NCT ID: NCT01676662 Completed - Clinical trials for Stress Urinary Incontinence

Solace European Confirmatory Trial

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

The Solace European Confirmatory (SOLECT) Trial is designed to determine whether the Solace Bladder Control System is safe and effective for the treatment of Stress Urinary Incontinence (SUI) in adult females.

NCT ID: NCT01676519 Completed - Clinical trials for Critical Limb Ischemia

Impact of Critical Limb Ischemia on Long Term Cardiac Mortality in Diabetic Patients Undergoing Percutaneous Coronary Revascularization

Start date: July 2002
Phase: N/A
Study type: Observational

Prospective cohort study of consecutive diabetic patients undergoing percutaneous coronary intervention (PCI) in whom development of critical limb ischemia was prospectively assessed by a dedicated diabetic foot clinic. Cardiac mortality at 4-year follow-up was the primary endpoint of the study.

NCT ID: NCT01675427 Completed - Clinical trials for Hepatitis C, Chronic

A Study on the Correlation Between Interleukin 28B Genotypes With Clinical and Demographic Characteristics in Treatment-Naïve and Treatment-Experienced Patients With Chronic Hepatitis C

Start date: August 2011
Phase: Phase 4
Study type: Interventional

This multicenter study will evaluate the correlation of interleukin 28B (IL28B) genotypes with disease characteristics and demographics in treatment-naïve and treatment-experienced chronic hepatitis C patients, including patients with HIV co-infection. There will be a single study visit for testing.

NCT ID: NCT01674764 Completed - Clinical trials for Acute Spinal Cord Injury of Traumatic Origin (tSCI)

Surgical Treatment for Spinal Cord Injury

SCI-POEM
Start date: November 2012
Phase:
Study type: Observational

Despite many years of research, an incomprehensible amount of scientific efforts worldwide and billions of dollars invested, no effective therapy resulting in major neurological or functional recovery is available to date for traumatic spinal cord injury (tSCI). Although there is increasing experimental evidence from animal models that surgical decompression of the spinal cord improves recovery after tSCI, clinical studies have not shown conclusive data yet. The main explanations for this lack of convincing evidence are relatively small sample sizes in previous studies, their predominantly retrospective nature, suboptimal measurement methods for the assessment of neurological deficits, and inappropriate recording and documentation of potential confounding factors.

NCT ID: NCT01674647 Completed - Atrial Fibrillation Clinical Trials

Explore the Efficacy and Safety of Once-daily Oral Rivaroxaban for the Prevention of Cardiovascular Events in Subjects With Nonvalvular Atrial Fibrillation Scheduled for Cardioversion

X-VERT
Start date: October 2012
Phase: Phase 3
Study type: Interventional

A study for patients with abnormal heart rhythm (atrial fibrillation) who need to undergo cardioversion (procedure to restore normal heart rhythm). The study will compare patients assigned randomly (like flipping a coin) to either Rivaroxaban or vitamin K antagonist (VKA). The study will measure common medical outcomes for this type of patient such as bleeding and stroke.

NCT ID: NCT01673945 Completed - Clinical trials for Solid Lesions of the GI Tract or of Adjacent Organs

FV-EUS Endoscope Versus CLA-EUS for EUS-FNA of Solid Lesions

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

The intent of this study is to compare the performance of the CLA-EUS versus the FV-EUS in the performance of EUS-FNA of patients with solid lesions of the GI tract and of adjacent organs, with the aim of establishing for which lesions and from which location the capability of the FV-EUS will be superior, equal or, inferior to the CLA-EUS

NCT ID: NCT01673906 Completed - Clinical trials for Neuroendocrine Tumours

68-Ga-labeled Octreotide Analogues PET in Duodenal-pancreatic Neuroendocrine Tumours

Start date: August 2012
Phase: Phase 2
Study type: Interventional

The diagnostic work-up of patients suspected of having neuroendocrine tumours (NETs) has traditionally been a challenging issue. The last two decades have been marked by the application to use in the diagnosis of NETs of 3 newly available diagnostic techniques: endoscopic ultrasonography (EUS), multidetector CT (MDCT), and more recently, positron emission tomography using 68Ga-labelled octreotide analogues (PET). In a prospective study conducted at a single referral centre that compared PET with conventional somatostatin receptor scintigraphy and MDCT in diagnosis, staging and follow-up of patients affected by NET, PET detected more primary and secondary lesions than other methods. Recent studies investigated the clinical impact of PET in the management of patients affected by NET, previously studied by MDCT. The investigators recently reported the results of the investigation of 19 patients suspected of having primary pancreatic NET and studied by PET, MDCT and EUS. The investigators preliminary data suggest that PET may be slightly more sensitive than MDCT in detecting small (<2cm) pancreatic lesions; accuracy of PET and EUS is probably similar. No prospective study has yet been devoted to evaluate the accuracy of PET in the diagnosis and staging of primary duodenal-pancreatic NETs. Furthermore, the clinical impact of the adjunct of PET to the traditional protocols of diagnosis and staging of these tumours waits to be thoroughly evaluated. Thus the appropriate place of PET in the diagnostic algorithm of patients suspected of having duodenal-pancreatic NET remains undefined. The main aim of this project is to prospectively compare the accuracy of PET and MDCT in the diagnosis and staging of patients suspected of having duodenal-pancreatic NETs. The investigators hypothesised that PET is superior to MDCT in the diagnosis of these neoplasm (the dimension of the study sample is estimated in order to detect a 10% difference). The impact of PET on management plan of affected patients will also be evaluated. As a secondary endpoint of the study, the investigators will compare EUS, PET and MDCT in the diagnosis of primary duodenal-pancreatic NET. The study is designed as a multicentre, prospective, non-randomised clinical trial. All patients will undergo MDCT, PET and EUS in this fixed order.