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NCT ID: NCT01575041 Completed - Hypertension Clinical Trials

The Effects of Sodium and Potassium on Blood Pressure, Vascular Function and Renal Function

KaNa
Start date: January 2012
Phase: N/A
Study type: Interventional

To determine the effect of (1) increased sodium intake and (2) increased potassium intake on blood pressure, vascular function and renal function in untreated (pre)hypertensive subjects.

NCT ID: NCT01574716 Completed - Clinical trials for Metastatic Soft Tissue Sarcoma

Sarcoma Study of MORAb-004 Utilization: Research and Clinical Evaluation

SOURCE
Start date: August 7, 2012
Phase: Phase 2
Study type: Interventional

This study is being done to see if MORAb-004 increases the effectiveness of the chemotherapies gemcitabine and docetaxel in people with metastatic Soft Tissue Sarcoma.

NCT ID: NCT01574456 Completed - Alzheimer's Disease Clinical Trials

Blood-brain Barrier Permeability in Alzheimer's Disease

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

The main aim of the present study is to improve our understanding of the role of blood-brain barrier function in dementia of the Alzheimer's type. The investigators hypothesize that microvascular dysfunction - more specifically "cerebral perfusion and blood-brain barrier leakage" - is a determinant of cognitive decline and cortical atrophy in Alzheimer's disease.

NCT ID: NCT01574417 Completed - Clinical trials for Hypercholesterolemia

Plant Stanols and Gene Expression Profile

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

Plant sterols and stanols are dietary components that are naturally present in plants. Their biological function in plants is comparable with these of cholesterol in animals. They are structurally related to cholesterol, but are absorbed by enterocytes to a much lesser extent. It is generally accepted that they inhibit intestinal cholesterol absorption and consequently lower serum low-density lipoprotein (LDL) cholesterol concentrations up to 10% at daily intakes of 2.5 g. The exact underlying mechanism of the plant sterol/stanol mediated reduction in intestinal cholesterol absorption is still unknown. It has been suggested that they lower the activity of sterol uptake transporters like Niemann-Pick C1 like 1 protein (NPC1L1) in enterocytes, otherwise several studies indicated that these compounds could activate the liver X receptor (LXR) in enterocytes, thereby activating the ABC transporters involved in the intestinal cholesterol metabolism, whereas recently suggestions have been made that plant sterols and stanols activate transintestinal cholesterol excretion (TICE). This is the direct cholesterol secretion from the blood into the intestinal lumen, in which the enterocytes play a central role. None of these assumptions have so far been evaluated in humans. Objective: The major objective of the present study is to examine the acute effects of dietary plant stanol esters on the intestinal mucosal gene expression profiles in intestinal biopsies in healthy volunteers. The minor objective is to investigate whether semi-long-term use (3 weeks) of plant stanol esters have an effect on microbiota composition.

NCT ID: NCT01574339 Active, not recruiting - Clinical trials for Gastroesophageal Reflux Disease

Effect of Long-Term Electrical Stimulation on LES Pressure and Esophageal Acid Exposure in Patients With GERD

Start date: August 2011
Phase: Phase 3
Study type: Interventional

The EndoStim LES Stimulation System is an investigational device intended to improve the LES pressure and restore Lower Esophageal Sphincter (LES) function in individuals suffering from Gastroesophageal Reflux Disease (GERD).

NCT ID: NCT01574053 Recruiting - Clinical trials for Huntington's Disease

Enroll -HD: A Prospective Registry Study in a Global Huntington's Disease Cohort

Start date: July 2012
Phase:
Study type: Observational [Patient Registry]

Enroll-HD is a longitudinal, observational, multinational study that integrates two former Huntington's disease (HD) registries-REGISTRY in Europe, and COHORT in North America and Australasia-while also expanding to include sites in Latin America. More than 30,000 participants have now enrolled into the study. With annual assessments and no end date, Enroll-HD has built a large and rich database of longitudinal clinical data and biospecimens that form the basis for studies developing tools and biomarkers for progression and prognosis, identifying clinically-relevant phenotypic characteristics, and establishing clearly defined endpoints for interventional studies. Periodic cuts of the database are now available to any interested researcher to use in their research - visit www.enroll-hd.org/for-researchers/access-data/ to learn more.

NCT ID: NCT01574040 Active, not recruiting - Healthy Clinical Trials

The Lifestyle moDIfCation Study

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

Rationale: Lifestyle modifications, such as increasing physical exercise and reducing dietary salt and saturated fat intake contribute to prevention of cardiovascular morbidity and mortality. Relevant improvements can already be achieved by small adaptations in everyday life. It is unclear whether simple low-cost interventions in the working environment can promote such healthy lifestyle adaptations. Objective: To study the effect of low-cost interventions for promoting healthy lifestyle modifications. Study design: Before-and-after intervention study. The study period will be subdivided in four parts of 2 weeks each: a run-in period, a before-measurement period, an intervention-period, and an after measurement period. Study population: Staff and visitors of the University Medical Center Utrecht. Study interventions: - Promotion of stair climbing. - Promotion of a low-salt soup alternative for the 'soup of the day'. - Promotion of a low-fat alternative for the butter croissants. - Exchange of the basket positions of butter and margarine between convenient and harder to reach locations. Outcome measures: - Number of passages through each part of the stair cases. - Number of low-salt cream soup and normal clear soup cups sold in the hospital restaurant and ratio between them. - Number of low-fat and normal croissants sold in the hospital restaurant and the ratio between them. - Number of low-fat margarine servings and butter servings sold in the hospital restaurant and the ratio between them.

NCT ID: NCT01573819 Completed - Huntington Disease Clinical Trials

A Repeat Dose Study in Healthy Volunteers Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK356278

Start date: November 24, 2011
Phase: Phase 1
Study type: Interventional

The study drug, GSK356278, is a possible new medicine for the treatment of Huntington's disease. Huntington's disease, which is often called HD, is caused by a faulty gene that is passed down through families. HD causes damage to nerve cells in the brain which causes them to waste away. As the damage progresses patients develop symptoms that affect every aspect of life. HD reduces people's ability to walk, talk, think, communicate and causes uncontrolled movements. GSK356278 may slow down the progression of damage to nerve cells in people with HD and help with their ability to think. GSK356278 was well tolerated when it was given as a single dose to healthy people. In this study we want to see what effects, both good and bad, GSK356278 has in people when it is taken every day. During the study we will look at about 3 different doses of GSK356278 in about 36 healthy people. The study will also look at how GSK356278 tablets behave in the body after it is swallowed (this is called pharmacokinetics). The study will also look at effects of GSK356278 on the body (this is called pharmacodynamics). The study will help to design future clinical studies with GSK356278.

NCT ID: NCT01573351 Completed - Hepatitis C Virus Clinical Trials

Phase III Hallmark QUAD: ASV+DCV+Peg+Rib (Nulls/Partials)

Hallmark QUAD
Start date: May 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess efficacy, as determined by the proportion of subjects with Sustained Virologic Response at Post-Treatment Week 12 (SVR12), defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) < Limit of quantitation (LOQ) at post-treatment Week 12.

NCT ID: NCT01572727 Completed - Breast Cancer Clinical Trials

A Study of the Experimental Drug BKM120 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Activation

BELLE-4
Start date: August 2012
Phase: Phase 2/Phase 3
Study type: Interventional

This study will evaluate whether the addition of daily BKM120 to weekly paclitaxel is effective and safe in treating patients with HER2- locally advanced or metastatic breast cancer.