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NCT ID: NCT01432106 Withdrawn - Hypertension Clinical Trials

The Study of Novel Dual Renin Angiotensin Aldosterone System (RAAS) Blockade; Valsartan/Aliskiren in African American Patients With Hypertension and the Metabolic Syndrome

SAAVE
Start date: February 2011
Phase: Phase 1
Study type: Interventional

Study purpose: African Americans with hypertension and markers of metabolic syndrome (small elevations in blood glucose, triglycerides and or weight) are at a high risk of cardiovascular (heart and blood vessel) problems. There is a circulating factor called angiotensin II that increases risk and may be more important in African Americans who have up to 20 times greater risk of losing kidney function and requiring dialysis. Research Investigators, including those at the University of Michigan, found one drug (Ramipril) that blocks angiotensin II effects significantly and improves kidney function in African Americans. The purpose of The SAAVE Study is to determine whether the combination of two new blockers (Valsartan and Aliskiren) of angiotensin II, are better able to lower blood pressure, also improve some of the risk factors for cardiovascular problems and provide greater protection to the heart and kidneys.

NCT ID: NCT01431742 Withdrawn - Pain Clinical Trials

Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Low Back Pain

Start date: July 2012
Phase: Phase 3
Study type: Interventional

This is an open label study of up to approximately 52 weeks duration to assess the safety and effectiveness of BEMA Buprenorphine in the management of moderate to severe chronic low back pain. BEMA Buprenorphine is an oral transmucosal form of the opioid analgesic, buprenorphine hydrochloride, intended for application to the buccal mucosa. Buprenorphine is a synthetic opioid that is classified as a partial μ-receptor agonist and a Schedule III controlled substance in the United States.

NCT ID: NCT01430702 Withdrawn - Clinical trials for Medication Adherence

Feasibility of Using a Telemedicine Medication Delivery Unit for Older Adults

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

Care transition interventions have been successful in reducing medication-related problems and associated rehospitalization primarily by focusing on medication reconciliation conducted by trained healthcare professionals. Programs to improve the medication reconciliation process have largely been effective, but have limitations including the expense associated with recruiting, training, and retaining care transition healthcare professionals (e.g., nurses and nurse practitioners) the ability to provide services within a finite geographic area, and the retrospective nature of the reconciliation process which usually occurs in the home following hospital discharge. Our short-term objective is to use Pennsylvania Department of Aging resources to assess the feasibility of using a telemedicine medication delivery unit for frail older adults that require medication assistance in their home immediately following an acute hospitalization. As part of this feasibility assessment, the investigators will assess (1) recruitment process and procedures, (2) data collection procedures, (3) resource utilization, (4) drop-out rates, (5) acceptability and usability of the EMMA® telemedicine medication delivery unit, (6) medication adherence, and (7) medication-reconciliation errors during transition from hospital to home.

NCT ID: NCT01428648 Withdrawn - Parkinson's Disease Clinical Trials

Impact of Dance Therapy on Parkinson's Disease

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

Parkinson's disease (PD) affects ability of individuals to perform unconscious learned motor tasks, affects quality of life and has been associated with depression. The purpose of this study is to investigate the effect of dance therapy on motor performance, quality of life and depression in PD patients, by comparing certain symptoms between a group of subjects with PD who undergo ballroom dancing classes and a control group of subjects with PD. The investigators will assess mental status, severity of PD, quality of life and depression using rating scales. Subjects will be randomized to intervention and control group. Intervention group will participate in dance therapy for 12 weeks and will be examined at 12 and 20 weeks. Control group will be examined at same time intervals. Classes will follow a curriculum designed by Arthur Murray Dance Studio Staff. The investigators do not anticipate significant risk for participants.

NCT ID: NCT01427465 Withdrawn - Alcohol Abuse Clinical Trials

Brief Integrative Alcohol Interventions for Adolescents

Brief
Start date: September 2007
Phase: N/A
Study type: Interventional

The primary aim of this research is to test the efficacy of innovative, brief alcohol abuse prevention strategies that integrate positive youth development messages and health risk messages for adolescents in high school settings. A secondary aim is to examine these strategies in various combinations as interventions and re-interventions (i.e., boosters) for sustaining or enhancing behavior change over time. These strategies are founded upon an emerging conceptual framework titled the Behavior-Image Model emanating from findings of our recent trials examining multiple behavior health interventions. The long-term objective of this project is to reduce alcohol abuse and problems among older high-risk adolescents for whom alcohol and drug use disparities exist, yet who are often overlooked in prevention research and services.

NCT ID: NCT01427244 Withdrawn - Clinical trials for Paget's Disease of the Vulva

Evaluation of Trastuzumab In Patients With HER2 Positive Persistent Or Recurrent Vulvar Paget's Disease

Start date: August 2011
Phase: Phase 2
Study type: Interventional

This is a phase II open-label study of the activity and safety of trastuzumab in patients with vulvar Paget's disease with overexpression of HER2 on biopsy.

NCT ID: NCT01426724 Withdrawn - Clinical trials for Chronic Kidney Disease

Effects of Vitamin D on Renal Blood Flow, Proteinuria and Inflammation in Patients With Chronic Kidney Disease

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

Active forms of vitamin D and its analogs are used to treat elevated parathyroid hormone levels and bone disease in chronic kidney disease (CKD). More recent animal and human studies suggest that treatment with vitamin D may be associated with reduction of inflammation and urinary protein loss as well as reduction the activity of the renin angiotensin system (RAS) in addition to its effects on the bone metabolism. The investigators of this study have used the new technique of contrast enhanced ultrasound (CEU) to measure the flow of blood to the kidney in other human studies. In this study, the investigators will investigate if 3 month of treatment with an active form of vitamin D in individuals with kidney disease and high parathyroid hormone levels would reduce protein loss in the urine. The investigators will also look at the potential changes in blood flow to the kidney using CEU, kidney function (GFR), inflammation and activity of RAS in response to treatment with active form of vitamin D. Finally, they will examine the association between reduction of protein loss in the urine as shown in other studies with any of the other factors measured (e.g, change in blood flow or inflammation).

NCT ID: NCT01425125 Withdrawn - SIADH Clinical Trials

Fractional Urate Excretion in Nonedematous Hyponatremia

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

Hyponatremia, defined as a serum sodium < 135 mmol/l, in patients without edema has undergone significant changes where it is now evident that even mild hyponatremia should be treated because of its association with symptoms, especially a fourfold increase in falls over the age of 65 years. There is an unresolved controversy over the relative prevalence of the syndrome of inappropriate secretion of antidiuretic hormone (SIADH) and cerebral/renal salt wasting (C/RSW). Resolution of this diagnostic dilemma becomes urgent because of divergent therapeutic goals, to water-restrict in SIADH or to give salt and water supplementation in C/RSW. The dilemma is compounded by recent reports of C/RSW occurring in patients without cerebral disease, thus adding further confusion in defining the relative prevalence of both syndromes. Because of overlapping laboratory and clinical findings in both syndromes, only differences in the state of extracellular volume differentiates one syndrome from the other, being high normal to increased in SIADH and decreased in C/RSW. The investigators have used fractional excretion (FE) of urate to categorize patients with hyponatremia. The increased FEurate that is observed in hyponatremic patients with SIADH and C/RSW can be used to differentiate both syndromes by correcting the hyponatremia and determining whether FEurate normalizes as in SIADH or remains increased in C/RSW. The present studies have been designed to determine total body water by deuterium and extracellular water by sodium bromide in patients with nonedematous hyponatremia with normal and increased FEurate to differentiate more conclusively whether the patient has normal or decreased water volumes. The investigators will also correct serum sodium rapidly with judicious administration of hypertonic saline over approximately three days and determine whether FEurate normalizes as in SIADH or remains increased as in C/RSW. In another group of patients, The investigators have data to suggest that those with normal sodium and increased FEurate is consistent with C/RSW. The investigators intend to do the same water volume studies to determine whether an increased FEurate with normonatremia would have decreased total and extracellular water that these patients have C/RSW without the need to correct a prior hyponatremia.

NCT ID: NCT01424917 Withdrawn - Clinical trials for Cardiac Allograft Vasculopathy

Noninvasive Predictors of Transplant Vasculopathy

CAV
Start date: March 2008
Phase: N/A
Study type: Observational

Post transplant vasculopathy is a major negative outcome in heart transplantation. Current methods of detection are highly invasive and pose a risk to transplant recipients. Noninvasive markers of endothelial function can be used to detect transplant vasculopathy. Endothelial biomarkers such as: endothelial nitric oxide synthase, vascular cellular adhesion molecules, intracellular adhesion molecules, endothelin-1, thromboplastin, circulating endothelial cells, uric acid, and C-reactive play a role in the pathophysiologic mechanism of vasculopathy. Therefore, the investigators would like to assess the association between various endothelial biomarkers and the presence or absence of transplant vasculopathy.

NCT ID: NCT01423539 Withdrawn - Clinical trials for Diffuse Large B-Cell Lymphoma

A Study of Navitoclax in Addition to Bendamustine and Rituximab in Patients With Relapsed Diffuse Large B-Cell Lymphoma (NAVIGATE)

Start date: October 2011
Phase: Phase 2
Study type: Interventional

This randomized, open-label, multicenter study will evaluate the efficacy and safety of navitoclax in addition to bendamustine and rituximab in patients with relapsed diffuse large B-cell lymphoma. Patients will be randomized to receive navitoclax in addition to bendamustine and rituximab or bendamustine and rituximab alone for 6 cycles.