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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: NCT01674933 Completed - Dental Caries Clinical Trials

Fluoride Varnish For Childsmile Nursery School Attenders

PT@3
Start date: October 2012
Phase: Phase 4
Study type: Interventional

The study will compare the effectiveness of Duraphat® fluoride varnish in preventing any further dental decay among 3-4 year old children in nursery schools. It is important to ascertain the additional preventive value that fluoride varnish may provide when applied in conjunction with other preventive measures which form part of a national dental health improvement programme targeting children at risk from dental decay. 1600 children will be recruited into the study for 2 years.

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: NCT01674257 Completed - Stroke Clinical Trials

Metabolic Imaging in Carotid Atherosclerosis

MICA
Start date: October 10, 2012
Phase:
Study type: Observational

Hardening of the arteries (atherosclerosis) is a common disorder that causes heart attacks and strokes. PET CT and contrast-enhanced MRI scans are two new ways of assessing atherosclerosis. The investigators propose to perform PET CT and MRI scans on patients with hardening of the neck arteries due to undergo surgery to remove the hardened areas. The investigators will then be able to compare the hot spots found on these scans with what the investigators can see in the removed specimens under the microscope in the laboratory. This will give investigators insight into the value of PET CT and MRI as tools for assessing atherosclerosis. It will also provide the investigators with new information relating to the underlying processes that give rise to atherosclerosis and will pave the way for the future development of new treatments.

NCT ID: NCT01673529 Completed - Dermatitis, Atopic Clinical Trials

Investigation of Topical SB705498 on Healthy Volunteers

Start date: July 17, 2012
Phase: Phase 1
Study type: Interventional

A two part, randomized, double-blind, placebo controlled study to investigate the effects of topical doses of SB705498 in healthy volunteers.

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).

NCT ID: NCT01672528 Completed - Cardiac Arrhythmia Clinical Trials

Patient Reported Outcome Measures for Ablation of Cardiac Arrhythmias

Start date: October 2012
Phase:
Study type: Observational

A multicentre, prospective observational study to develop, evaluate and validate Patient Reported Outcome Measures (PROMs) for patients treated with cardiac ablation for symptomatic cardiac arrhythmias

NCT ID: NCT01672073 Completed - Clinical trials for Local Pressure Effects

Analysis of the Arterial Pressure Wave Form Through the Proxima Device

Start date: January 2013
Phase: N/A
Study type: Observational

The purpose of the trial is to confirm that the presence of the Proxima 3 disposable in the arterial line doesn't significantly attenuate the arterial pressure wave form. The principal aim of the trial will be: • To obtain quantitative data allowing investigation of the pressure wave form obtained in a standard arterial line compared to various arterial lines fitted with the Proxima 3.

NCT ID: NCT01671787 Completed - Chronic Hepatitis B Clinical Trials

A Phase 1b Study Assessing GS-7340 in Treatment-Naive Adults With Chronic Hepatitis B

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

This is an open-label study evaluating multiple doses of GS-7340 versus Tenofovir disoproxil fumarate (TDF).