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NCT ID: NCT01117233 Completed - Healthy Clinical Trials

Study In Healthy Adult Volunteers To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429

Start date: May 2010
Phase: Phase 1
Study type: Interventional

The purpose is to study the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04427429 administered intravenously to healthy adult volunteers

NCT ID: NCT01116804 Completed - Clinical trials for Primary Liver Cancer

Role PET Imaging in Response Assessment for Hepatocellular Carcinoma (HCC)

Start date: June 16, 2010
Phase: Phase 1
Study type: Interventional

Present imaging modalities for primary liver cancer (hepatocellular carcinoma or HCC) have several shortcomings. One important shortcoming is the time delay between successful treatment and radiological confirmation of this response. Often it takes several months for anatomical changes to occur and to be appreciated on morphological imaging such as CT or MRI (shrinkage of tumor, absence of contrast enhancement). Functional imaging by means of Fluor-18 deoxyglucose or Fluor-18 Choline (positron emitters, PET-scan) might be an early indicator of response. This "early" information might help to tailor treatment. For instance, if no response is induced, an early switch in therapy can be planned. The present study investigates whether the routine PET-tracer (Fluor-18 deoxyglucose) and the experimental PET-tracer, Fluor-18 Choline help to predict response if a patient with inoperable primary liver cancer is treated (radionuclide therapy, biologicals).

NCT ID: NCT01116323 Completed - Adverse Effects Clinical Trials

Emergency Department Crowding in Relation to In-hospital Adverse Medical Events

Start date: June 2010
Phase:
Study type: Observational

Since the report "To Err is Human" by the Institute of Medicine (IOM) in 1999, attention was brought to the general public that adverse events in medicine are common and are one of the leading causes of morbidity and mortality within the United States. The report estimates that 44,000 - 98,000 patients hospitalized in the United States die each year as a result of medical errors. In spite of the growing patient safety movement worldwide, health care has not become measurably safer. Health care is one of the few risk-prone areas in which public demand limits the use of common-sense safety-enhancing solutions, such as limiting the flow and choosing the type of incoming patients. The latter is especially true for emergency departments (EDs) since they deliver an important public service by providing emergency care 24 hours a day, 365 days per year, without discrimination by social or economic status. One of the key expectations of EDs is the ability to provide immediate access and stabilization for those patients who have an emergency medical condition. However, emergency department (ED) crowding is recognized to be a major, international problem that affects patients and providers. A recent report from the IOM noted that the increasing strain caused by crowding is creating a deficit in quality of emergency care. Crowding has been associated with reduced access to emergency medical services, delays in care for cardiac patients, increased patient mortality, inadequate pain management, increased costs of patient care, and delays in administration of antibiotic therapy. Several issues remain concerning ED crowding and it's relation to adverse events. First, the existing evidence on adverse event occurrence during ED crowding is largely anecdotal and inconclusive. Secondly, although a few studies showed a relationship between ED crowding and mortality, neither of these examined the causes of excess mortality. Finally, although a significant increase in the average length of hospital stay was shown during ED crowding the reasons for this are open to speculation. The purpose of this study therefore is to identify six explicit adverse events and mortality for patients who were admitted through ED and to compare these results in relation to ED crowding. This will provide us novel insight into the reasons for the hypothesized increased mortality during ED crowding.

NCT ID: NCT01114529 Completed - Clinical trials for Renal Transplantation

Efficacy, Safety and Evolution of Cardiovascular Parameters in Renal Transplant Recipients

ELEVATE
Start date: August 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether an early Calcineurin Inhibitor (CNI) to everolimus conversion at 10-14 weeks post transplantation improves renal allograft function without compromising efficacy compared to standard CNI treatment in de novo renal allograft recipients. In addition, the study is designed to evaluate the impact of a CNI-free regimen on evolution of cardiovascular parameters in de novo renal allograft recipients

NCT ID: NCT01112306 Completed - Clinical trials for Pulmonary Arterial Hypertension

ACT-293987 in Pulmonary Arterial Hypertension

Start date: July 7, 2010
Phase: Phase 3
Study type: Interventional

Long-term, single-arm, multicenter, open-label extension, Phase 3 study, to evaluate the safety and tolerability of ACT-293987 in patients with PAH who participated in the double-blind study AC-065A302 (GRIPHON)

NCT ID: NCT01111461 Completed - Endometrial Cancer Clinical Trials

Study of Lenvatinib in Subjects With Advanced Endometrial Cancer and Disease Progression

Start date: March 2010
Phase: Phase 2
Study type: Interventional

To assess the objective response rate (ORR: complete response + partial response [CR+ PR]) of E7080 in subjects with unresectable endometrial cancer and disease progression following platinum-based, first-line chemotherapy. .

NCT ID: NCT01111279 Completed - Clinical trials for Seasonal Allergic Rhinoconjunctivitis

Clinical Safety and Tolerability Study of gpASIT+TM and gpASIT+TM/Immunoregulating Adjuvant to Treat Seasonal Grass Pollen Rhinoconjunctivitis

Start date: March 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of gpASIT+TM administered subcutaneously in absence or in presence of an immunoregulating adjuvant in grass pollen allergic patients.

NCT ID: NCT01110915 Completed - Clinical trials for Magnetic Resonance Imaging

Advisa MRI Clinical Study

Start date: June 2010
Phase: N/A
Study type: Interventional

The purpose of the Advisa MRI System clinical study is to confirm safety and effectiveness in the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI scans up to 2W/kg Specific Absorption Rate (SAR) without positioning restrictions (MRI scans may occur anywhere on the body including the chest).

NCT ID: NCT01110811 Completed - Clinical trials for Gastroesophageal Reflux Disease

Transoral Incisionless Fundoplication (TIF) Versus Sham for Treatment of Gastroesophageal Reflux Disease (GERD)

Start date: April 2010
Phase: N/A
Study type: Interventional

The study objective is to evaluate the relative merits, safety and effectiveness of transoral incisionless fundoplication (TIF) in proton pump inhibitor (PPI) dependent GERD patients compared with sham procedure.

NCT ID: NCT01109823 Completed - Infection Clinical Trials

Pharmacokinetic Evaluation of Fluoroquinolone Antibiotics Administered Intravenously in Intensive Care Patients With Normal Renal Function and With Renal Hyperfiltration

Start date: May 19, 2010
Phase: Phase 3
Study type: Interventional

At the intensive care unit (ICU) fluoroquinolone antibiotics, like levofloxacin, are frequently used for the treatment of infections. Adequate blood levels are required for a good efficacy of the antibiotic. Due to the fact that levofloxacin is almost completely eliminated renally, the blood levels for this antibiotic are strongly influenced by the renal function. Therefore, this study aims to evaluate the pharmacokinetics of levofloxacin in patients with hyperfiltration, in comparison with critically ill patients with normal renal function.