Clinical Trials

A post marketing observational study to assess respiratory tract adverse events in pulmonary arterial hypertension patients treated with Tyvaso inhalation solution

Status: open and enrolling

Approval Date: 10/19/2011

Tyvaso is an inhaled drug recently approved in the United States for treatment of pulmonary arterial hypertension (PAH).  Researchers want to better understand the long-term safety of this drug compared to other therapies for PAH.  Information about your current drug treatment as normally prescribed by your doctor and certain reactions to the drug treatments will be recorded into the registry.  The objective of this study is to describe the type and frequency of pulmonary adverse events that may be associated with certain treatments for PAH.

Pulmonary Arterial Hypertension (PAH) Quality Enhancement Research Initiative Extension Program

Status: open and enrolling

Approval Date: 10/13/2011

To improve the management of PAH patients through evidence-based approach aimed at achieving optimal WHO functional class.  This study is seeking patients with a specific condition, pulmonary arterial hypertension.

CANARY: Coronary Assessment by Near-infrared of Atherosclerotic Rupture-prone Yellow Randomized Pilot Trial of the Use of the Distal Protection Device to Prevent Periprocedural MI During Dilation of Coronary Stenosis Caused by Plaques with Large Lipid Cor

Status: open and enrolling

Approval Date: 8/18/2011

Assessment by Near-infrared of Atherosclerotic Rupture-prone Yellow) Study is a pivotal trial to evaluate criteria for defining a Lipid Core Plaque (LCP) that is at high risk of rupturing during standard of care therapy and causing intra-procedural complications. If plaques that require treatment are at higher than normal risk of causing intra-procedural complications, some life threatening, the treating physician is better informed and may opt to take precautionary measures to mitigate the risk or result of a complication. The CANARY Study is also designed to evaluate the feasibility of using a distal embolization protection device (EPD) as a means to prevent heart attacks triggered by the embolization of plaque during standard care therapy. It is thought that the EPD will prevent plaque from going downstream during treatment and obstructing other heart vessels. These obstructions could cause heart attacks by preventing blood from reaching heart muscle tissue.

Phase III Double Blind Randomized Study to Evaluate Safety and Efficacy of Isavuconazole (BAL8557) versus ACASPOFUNGIN Followed by VORCONAZOLE Regimen in the Treatment of Candidemia and Other Invasive Candida Infections

savuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections

Status: open and enrolling

Approval Date: 8/1/2011

The purpose of the study is to compare the safety and efficacy of Isavuconazole versus caspofungin followed by voriconazole in the treatment of candidemia and other invasive Candida infections.

A Prospective Trial Comparing The Response To Hyperbaric Oxygen Treatment In Patients With Ulcerative And Non-Ulcerative Interstitial Cystitis

Status: open and enrolling

Approval Date: 1/20/2011

This 18-month study will evaluate the use of hyperbaric oxygen in patients with interstitial cystitis.

Hyperbaric oxygen therapy uses 100 percent oxygen at increased pressure to stimulate healing. Breathing oxygen at higher pressures will increase the body’s ability to carry oxygen-rich blood to tissues. This improves the ability to heal by growing new blood vessels. In order to achieve this benefit, treatment must be given inside a pressurized chamber.

The study will consist of an enrollment visit at the clinic, then 30 consecutive (Monday through Friday) visits during a six-week course of hyperbaric oxygen treatments at the Beaumont Health Center. During the treatment phase of the study, patients will be required to come to the clinic three times. The patients would then have three additional clinic visits after treatments are complete – at 3, 6 and 12 months.