Clinical Trials

A PHASE 2a MULTICENTER, RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED STUDY EVALUATING SAFETY, TOLERABILITY AND EFFICACY OF LIRIS® IN WOMEN WITH INTERSTITIAL CYSTITIS FOLLOWED BY AN OPEN LABEL EXTENSION (Protocol TAR-100-201)

Status: open and enrolling

Approval Date: 1/27/2012

The purpose of this study is to determine if LiRIS®, an investigational drug-delivery system, is safe, tolerable and effective in women with Interstitial Cystitis. LiRIS® is inserted into the bladder via cystoscopy , remains in the bladder for 14 days, and is removed via cystoscopy.

A PHASE III INTERNATIONAL, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF 300 MG OR 600 MG OF INTRAVENOUS ZANAMIVIR TWICE DAILY COMPARED TO 75 MG OF ORAL OSELTAMIVIR TWICE DAILY IN THE TREATMENT OF HOSPITALIZED ADULTS

A Study of Intravenous Zanamivir Versus Oral Oseltamivir in Adults and Adolescents Hospitalized With Influenza. (ZORO)

Status: open and enrolling

Approval Date: 1/23/2012

The purpose of this study is to test the safety and efficacy of zanamivir given intravenously and how well it works at two different doses in hospitalized adolescents and adults with flu. Zanamivir will be compared with oseltamivir, which is used for treating flu.

[Protocol TG-MV-014] A RANDOMIZED, SHAM-CONTROLLED, DOUBLE-MASKED, MULTICENTER TRIAL EVALUATING OCRIPLASMIN TREATMENT FOR SYMPTOMATIC VITREOMACULAR ADHESION INCLUDING MACULAR HOLE (OASIS)

Status: open and enrolling

Approval Date: 1/6/2012

The purpose of this study is to evaluate the treatment of symptomatic vitreomacular adhesion including macular hole with ocriplasmin.

A COMPARISON OF INTRAOCULAR PRESSURES DURING PROLONGED TRENDELENBURG POSITIONING IN MORBIDLY OBESE AND THIN PATIENTS: A PILOT STUDY

Status: open and enrolling

Approval Date: 12/5/2011

The major determinants of intraocular pressure (IOP) are aqueous humor production, aqueous humor outflow, choroidal blood volume, and episcleral venous pressure.  Acute and chronic increased IOP have been demonstrated to be associated with excavation of optic nerve tissue, leading to visual field defects.

Postoperative visual loss is a rare but devastating complication.  The exact causes of postoperative visual loss are still unclear, but intraoperative hypotension, anemia, and positioning have all been implicated as potential risk factors.

When placed in the Trendelenburg position, venous drainage from the head is impaired and presumably a resultant increase in central venous pressure impacts IOP. 

Obesity and increased body mass index (BMI) are associated with a number of physiologic changes, many of which are accentuated in the supine position and during general anesthesia.  Lung functional residual capacity decreases, atelectasis increases, and hypoxemia results.  Mechanical ventilation is more difficult due to increased abdominal mass, and this is accentuated with pneumoperitoneum and body position changes, especially when in steep Trendelenburg position.  Pneumoperitoneum plus Trendelenburg position in the obese results in increased airway pressures (required to inflate the lungs and provide for adequate oxygenation), and progressive difficulty with CO₂ elimination. 

It is unclear if obesity itself is a risk factor for increased IOP, but obese patients in prolonged Trendelenburg position with pneumoperitoneum would seem to be at the highest risk of IOP rise.  We have designed this study to measure rate of rise of IOP and highest achieved IOP in cases of long duration.  We also wish to determine if obese patients have a higher peak IOP increase compared to thin controls.

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.