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NCT ID: NCT01428765 Completed - Atrial Fibrillation Clinical Trials

GLORIA-AF Registry Program (Phase I)

Start date: May 2011
Phase: N/A
Study type: Observational

This study constitutes Phase I of the Registry Program. The main objective of this study is to characterize the newly diagnosed non-valvular AF patient population at risk for stroke and the selection of antithrombotic treatment for stroke prevention in a real-world setting before dabigatran etexilate is approved for the prevention of strokes and systemic emboli in patients with non-valvular AF in different regions of the world.

NCT ID: NCT01428297 Completed - Healthy Volunteers Clinical Trials

A Study Evaluating the Safety and Efficacy of Topical BPR277 for the Treatment of Atopic Dermatitis and Netherton Syndrome

3
Start date: May 2011
Phase: Phase 1
Study type: Interventional

The study is divided in 3 parts, starting with the safety assessment of BPR277 ointment in Healthy volunteers (Part 1). If found to be well tolerated in Part 1, BPR277 ointment will be assessed in two different patients groups to evaluate safety and efficacy in atopic dermatitis (Part 2) and in Netherton syndrome (Part 3).

NCT ID: NCT01427231 Completed - Mental Health Clinical Trials

Short-term Effect of Glucose and Sacharose Ingestion on Cognitive Performance and Mood in Elderly

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

The objective of the current study is to determine the acute effect of a glucose drink and a sacharose drink compared to a placebo on cognitive performance in elderly with light memory complaints. The investigators expect that the sugar containing drinks will improve memory and attentional functions. Furthermore, blood glucose response will be measured.

NCT ID: NCT01427049 Completed - Hypertension Clinical Trials

The Effect of Renal Denervation on Biological Variables

Start date: August 2011
Phase: N/A
Study type: Observational

Hypertension is a major and growing public health concern. Chronic elevation of sympathetic nervous system (SNS) activity has been identified as a major contributor to the complex pathophysiology of (essential) hypertension. The renal sympathetic nerves play a major role in the elevation of the SNS activity. Therapeutic renal denervation (RD), the deliberate disruption of the nerves connecting the kidneys with the central nervous system, has been shown to be an effective means of modulating elevated SNS activity - both by reducing the sympathetic modulation of renal function (renin release, sodium excretion and renal blood flow) and by removing the renal afferent sympathetic contribution to central blood pressure elevation. This current study is an observational exploratory study. The main objective of this study is to learn more on the effects of RD. We wish to do that by quantifying the effects of RD on various biological variables. Those variables are studied in four sets of investigations: a radiological set, a laboratorial set, a set of blood pressure measurements and a set of investigations in the vascular laboratory. The radiological set consists of imaging of the heart and kidney function (renal perfusion) and structure (renal arteries), the laboratorial set of serum and urine tests, 24 h- home- and office- blood pressure measurements will be taken and finally the set of vascular tests contains investigations on pulse wave velocity(PWV) and heart rate variability(HRV). The data will most likely help us to define future studies, to describe the mode of action and the effects of RD on various organs and systems in more detail, and finally to define in more detail which type of hypertensive patients is especially likely to benefit of the procedure. Hypothesis: - We hypothesize that LV mass will decrease after RD. Because all patients have severe hypertension, it is likely that a substantial percentage will have increased LV mass. - We hypothesize that renal perfusion and renal oxygenation increase after RD. - We hypothesize that there will be no complications related to the device or procedure. - We hypothesize that renal denervation has a beneficial effect on insulin resistance - We hypothesize that renal denervation will decrease the blood pressure(office and 24-hour-measurements) - We hypothesize that RD has a beneficial effect on PWV and HRV.

NCT ID: NCT01426022 Completed - Mood Swings Clinical Trials

Effect of Moderate Alcohol Consumption on Postprandial Mood

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

Rationale: Food choice is influenced by postprandial mood; the feelings of well-being after a meal. Postprandial mood can be measured by subjective responses. Physiological responses may play an important role in the generation of postprandial mood. However, the relationship between subjective and physiological responses after a meal is not clear yet. To investigate this relationship, moderate alcohol consumption will be used as a mood modulator, because of its well-studied effects on mood. Postprandial mood depends on the current mood state. Therefore the investigators will manipulate the current mood state by changing the ambiance to measure the influence of moderate alcohol consumption with a meal on postprandial mood in a pleasant or unpleasant ambiance. Objective: To determine whether moderate alcohol consumption with a meal in different ambiances affects postprandial mood, evaluated by subjective and physiological parameters. Study design: Randomized, placebo-controlled, single-blind, cross-over trial Study population: 28 apparently healthy, normal weight (BMI 18.5-27 kg/m2) women (18-45 y), taking oral contraceptives. Intervention: 4 times having dinner at TNO Zeist with either 3 glasses of sparkling white wine (~30g alcohol) or alcohol-free sparkling white wine in either a pleasant or unpleasant meal ambiance. Hypothesis: It is hypothesized that moderate alcohol consumption with a meal in different ambiances changes the response of subjective and physiological parameters of mood. - Ho: there is no effect of alcohol consumption and ambiance on mood - H1: there is an effect of alcohol consumption and ambiance on mood

NCT ID: NCT01425957 Completed - Clinical trials for MILD COGNITIVE IMPAIRMENT

Identification of Biomarkers Sensitive to Disease Progression in Patients With Mild Cognitive Impairment

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

THE STUDY WILL BE A TWO-PART RESEARCH PART A and PART A extended: 1. To implement a "common" MRI acquisition protocol in multiple centers across Europe (Pharma-COG partners). 2. Apply the common MRI protocol on phantoms and human subjects to characterize, compare and minimize test-retest variability across the MR sites of WP5 for all the quantitative metrics that will be later assessed on patients. PART B: By collecting clinical, biochemical, neuroimaging, neuropsychological and neurophysiological data in Mild Cognitive Impairment patient, we aim to: 1. To develop a biomarker MATRIX (made of a combination of biological secondary endpoints) which is more sensitive than the changes observed in the loss of hippocampal volume (primary endpoint) and correlate with the neuropsychological progression and conversion (clinical secondary endpoints). 2. To develop a biomarker MATRIX (made of a combination of biological secondary endpoints) at baseline which is more predictive of the loss of hippocampal volume (primary endpoint) and neuropsychological progression (clinical secondary endpoint) in MCI patients. 3. To harmonize the biomarker MATRIX collection and qualify multiple centres across Europe

NCT ID: NCT01425723 Completed - Severe Hemophilia B Clinical Trials

Long-Term Safety and Efficacy of rFIXFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia B

B-YOND
Start date: December 8, 2011
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to evaluate the long-term safety of rFIXFc in participants with hemophilia B. The secondary objective of this study is to evaluate the efficacy of rFIXFc in the prevention and treatment of bleeding episodes.

NCT ID: NCT01425242 Terminated - Hypertension Clinical Trials

Study on Anti-inflammatory Effect of Anti-hypertensive Treatment in Patients With Small AAA's and Mild Hypertension

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

Inflammation of the blood vessel plays an important role in the development and growth of a dilated abdominal aorta. An elevated blood pressure leads to an increase in inflammation, therefore blood pressure lowering is an important part of the treatment of patients with a dilated abdominal aorta who also have an elevated blood pressure. In the investigators study the investigators compare the anti-inflammatory effects of 2 different blood pressure lowering strategies. The investigators hypothesize that both strategies will decrease inflammation, however the investigators believe the total decrease of inflammation depends on the type of blood pressure lowering medication used.

NCT ID: NCT01424267 Terminated - Clinical trials for Abdominal Aortic Aneurysm

Zenith® LP Abdominal Aortic Aneurysm (AAA) Post-Market Registry

Start date: July 2010
Phase: N/A
Study type: Observational

A registry to collect additional prospective intra-operative and follow-up information on physician use of the CE-marked Zenith® Low Profile Abdominal Aortic Aneurysm (AAA) Endovascular Graft under routine clinical care.

NCT ID: NCT01423500 Active, not recruiting - Clinical trials for Lymphoblastic Leukemia, Acute, Childhood;

ALL-SCT BFM International- HSCT in Children and Adolescents With ALL

ALL-SCT-BFMi
Start date: January 2007
Phase: Phase 3
Study type: Interventional

With this protocol the ALL-SCT BFM international study group wants - to evaluate whether hematopoietic stem cell transplantation (HSCT) from matched family or unrelated donors (MD) is equivalent to the HSCT from matched sibling donors (MSD). - to evaluate the efficacy of hematopoietic stem cell transplantation (HSCT)from mismatched family or unrelated donors (MMD) as compared to HSCT from matched sibling donors or matched donors. - to determine whether therapy has been carried out according to the main HSCT protocol recommendations. The standardisation of the treatment options during HSCT from different donor types aims at the achievement of an optimal comparison of survival after HSCT with survival after chemotherapy only. - to prospectively evaluate and compare the incidence of acute and chronic Graft-versus-Host-Disease (GvHD) after HSCT from matched sibling donor (MSD), from matched donor (MD) and from mismatched donor (MMD).