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NCT ID: NCT01675791 Completed - Clinical trials for Birch Pollen Allergy

A Dose-response Evaluation of ALK (the Sponsor) Tree Allergy Immunotherapy Tablet

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

The primary aim of this trial is to evaluate the dose-response relationship for the ALK tree AIT administered once daily in order to define a dose-range that would be suitable for at-home administration.

NCT ID: NCT01675401 Completed - Obesity Clinical Trials

Body Weight and Vascular Function

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

An increased body mass impairs vascular function (VF), an important characteristic of subjects suffering from type 2 diabetes and a risk marker for cardiovascular diseases. However, a wide variety of in vivo VF markers exists each measuring different aspects of VF. Each of these markers addresses a different aspect of the vasculature. Studies comparing under standardized conditions the differences and relationships of the many different VF measurements in lean and abdominally overweight / obese subjects are missing. Also, there is a great need to know which of these markers are sensitive to dietary challenges. Therefore, it is imperative to conduct an extensive study on dietary effects and interrelationships of a broad spectrum of VF measurements and plasma biomarkers in lean and overweight / obese subjects. Focus will be on FMD, a well accepted biomarker for cardiovascular disease. The investigators propose to examine, in a two-way parallel-randomized human intervention study, the effects of weight-loss in abdominally overweight / obese men on VF markers and plasma biomarkers related to low-grade inflammation and vascular activity during the fasting and both the postprandial and hyperinsulinemic state. Furthermore, differences - and relations between - VF measurements and plasma biomarkers will be compared cross-sectionally between lean and abdominally overweight / obese male subjects.

NCT ID: NCT01675193 Completed - Amblyopia Clinical Trials

Disinvestment Study of Population-Based Vision Screening in Children

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

The purpose of this study is to determine the optimal screening intervals and cost-effectiveness of population-based vision screening in preverbal children in the Netherlands.

NCT ID: NCT01675102 Completed - CLL Clinical Trials

Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in 17p- Chronic Lymphocytic Leukemia (CLL)

17p-CLL
Start date: August 1, 2010
Phase:
Study type: Observational

17p-/p53-mutated chronic lymphocytic leukemia (CLL) is an orphan disease, accounting for approximately 5% of newly diagnosed CLL. This subgroup of patients has a very poor outcome after chemoimmunotherapy. Allogeneic HCT may change the poor prognosis. In a retrospective EBMT-analysis on 44 patients with advanced 17p-CLL 2-year progression-free survival was 45% (95% CI, 30% to 60%) after allogeneic HCT (Allogeneic hematopoietic stem-cell transplantation for chronic lymphocytic leukemia with 17p deletion: a retrospective European Group for Blood and Marrow Transplantation analysis. J Clin Oncol, 2008, 26, 5094-5100). Referring to these favorable results and small additional series, patients with 17p-CLL requiring therapy are considered to have an indication for allogeneic transplantation by many CLL study groups. Several CLL study groups recommend allogeneic HCT in 17p-CLL as part of the first- or second line treatment. The aim is to collect additional evidence on allogeneic HCT in 17p-/p53-mutated CLL in first or second remission by a non-interventional prospective study. Patients shall be registered prior to HCT at the Leiden Office in order to rule out a reporting bias after transplantation.

NCT ID: NCT01674803 Completed - Clinical trials for Coronary Artery Disease

Comparison of BIOdegradable Polymer and DuRablE Polymer Drug-eluting Stents in an All COmeRs PopulaTion (BIO-RESORT)

BIO-RESORT
Start date: December 21, 2012
Phase: N/A
Study type: Interventional

The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity. However, the first generation of these devices had no positive impact on the mortality after PCI (compared to bare metal stents), which was greatly attributed to a somewhat increased incidence of late and very late stent thrombosis. Concerns about the role of durable polymers as a potential trigger of inflammation and finally adverse events also led to the development of DES with biodegradable coatings, which leave after degradation of the coating only a bare metal stent in the vessel wall that does not induce an inflammatory response. While such biodegradable polymer DES are increasingly used in clinical practice, there is no data available from head-to-head comparisons between biodegradable and contemporary third generation durable polymer DES.

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: NCT01673256 Completed - Atrial Fibrillation Clinical Trials

DEtermining Accuracy and TrEnding CharacTerization of AF

Start date: September 2012
Phase:
Study type: Observational

The objective of this study is to assess the atrial fibrillation (AF) episode detection when using the SJM(St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor).

NCT ID: NCT01672853 Completed - Clinical trials for Primary Sclerosing Cholangitis (PSC)

Simtuzumab (GS-6624) in the Prevention of Progression of Liver Fibrosis in Adults With Primary Sclerosing Cholangitis (PSC)

Start date: March 4, 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate whether simtuzumab (GS-6624) is effective at preventing the progression of liver fibrosis in adults with primary sclerosing cholangitis (PSC).