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NCT ID: NCT01015287 Completed - Clinical trials for Acute Coronary Syndromes

A Comparison of Prasugrel at PCI or Time of Diagnosis of Non-ST Elevation Myocardial Infarction

ACCOAST
Start date: December 2009
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to investigate the potential benefits/risks regarding pretreatment with prasugrel in non-ST-elevation myocardial infarction (NSTEMI) participants with elevated troponin scheduled for coronary angiography/percutaneous coronary intervention (PCI).

NCT ID: NCT01015118 Completed - Ovarian Neoplasms Clinical Trials

LUME-Ovar 1: Nintedanib (BIBF 1120) or Placebo in Combination With Paclitaxel and Carboplatin in First Line Treatment of Ovarian Cancer

Start date: November 17, 2009
Phase: Phase 3
Study type: Interventional

The trial will be performed to evaluate if BIBF 1120 in combination with paclitaxel and carboplatin is more effective than placebo in combination with paclitaxel and carboplatin in first-line treatment of patients with advanced ovarian cancer. Safety information about BIBF1120/paclitaxel/carboplatin will be obtained.

NCT ID: NCT01014949 Completed - Diabetes Clinical Trials

Microcirculation Assessment in Diabetes and Metabolic Syndrome

MADAME
Start date: July 2008
Phase: N/A
Study type: Interventional

Abnormal coronary microvascular vasodilation has been demonstrated in patients with diabetes and metabolic syndrome, but the role of insulin resistance in its pathogenesis is not clear. The aim of this study is to invasively assess coronary microcirculation and to investigate the relationship of insulin resistance with coronary microvascular dysfunction. A pressure temperature-sensor-tipped coronary wire will be advanced in coronary arteries without significant lumen reduction. Thermodilution-derived coronary flow reserve (CFR) will be calculated as resting mean transit time (Tmn) divided by hyperemic Tmn (obtained with a 5-min i.v. infusion of adenosine 140 mg/kg/min). An index of microvascular resistance (IMR) will be calculated as the distal coronary pressure at maximal hyperemia divided by the inverse of the hyperemic Tmn. FFR will be calculated by the ratio of Pd/Pa at maximal hyperemia. Insulin resistance (IR) will be assess by the homeostasis model assessment (HOMA) index and plasma IL-6 and TNF-alpha levels will be measured in addition to routine blood examinations before the procedure.

NCT ID: NCT01014689 Completed - Acne Vulgaris Clinical Trials

Comparison of Epiduo Associated With Lymecycline Versus Epiduo Vehicle Associated With Lymecycline in Acne Vulgaris

TEAM
Start date: August 2009
Phase: Phase 3
Study type: Interventional

Randomized, controlled, multi-center, double-blind, parallel-group comparison study in Subjects with moderate to severe acne vulgaris on the face. The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide (BPO) 2.5% Gel associated with Lymecycline 300mg Capsules compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Lymecycline 300mg Capsules, in the treatment of moderate to severe acne vulgaris. The safety of the two treatment regimens will also be evaluated.

NCT ID: NCT01014390 Completed - Biliary Stricture Clinical Trials

WallFlex Biliary Fully Covered (FC) Benign Stricture Study

Start date: December 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and performance of the WallFlex® Biliary RX Fully Covered Stent as a treatment of biliary obstruction resulting from benign bile duct strictures.

NCT ID: NCT01014234 Completed - Clinical trials for Kidney Transplantation

Rapamycin and Regulatory T Cells in Kidney Transplantation

Start date: July 2008
Phase: Phase 2
Study type: Interventional

The immune system response is mediated by the interaction between the antigen presenting cell (APC), CD4+ T helper cells (Th) and CD4+ CD25+ regulatory T cells, a subgroup of CD4+ T cell which express IL-2 receptor (CD25) and the transcriptional factor foxp3. Regulatory T cell may contribute to the maintenance of tolerance by suppressing the immune response to normal or tumor associated antigens. Regulatory T cell emerge from the thymus during ontogenesis and they represent about 10 % of the peripheral Cd4+ t cells. Rapamycin is one the most use treatment to prevent renal allograft failure. Differently from calcineurin inhibitors (cyclosporine and tacrolimus), that inhibit T-cell activation through the inhibition of calcineurin activation, rapamycin inhibits cellular proliferation by impairing the progression of the cellular cycle, in particular by interaction with mTOR. Recently Battaglia et al. have demonstrated a Treg amplification in murine CD4+ lymphocytes treated with rapamycin in vitro. Aim of the study is to evaluate the effect of different immunosuppressive regimens on regulatory T cell and to verify the hypothesis that rapamycin may induce tolerance in kidney transplanted patients, more than cyclosporine treatment.

NCT ID: NCT01013194 Completed - Liver Cirrhosis Clinical Trials

Human Fetal Liver Cell Transplantation in Chronic Liver Failure

hFLCTx
Start date: February 2007
Phase: Phase 1/Phase 2
Study type: Interventional

The herein study consists in the transplantation of liver progenitor cells isolated from human fetal liver tissue with the aim of improving conventional liver therapy and broadening therapeutical options other than liver transplantation.

NCT ID: NCT01012973 Completed - Clinical trials for Retinal Vein Occlusion

Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO)

GALILEO
Start date: October 2009
Phase: Phase 3
Study type: Interventional

To determine the efficacy of vascular endothelial growth factor (VEGF) Trap-Eye injected into the eye on vision function in subjects with macular edema as a consequence of central retinal vein occlusion

NCT ID: NCT01012921 Completed - Degeneration; Bone Clinical Trials

Comparison of a PEG Membrane and a Collagen Membrane for the Treatment of Bone Dehiscence Defects at Bone Level Implants

Start date: September 2009
Phase: N/A
Study type: Interventional

The aim of the study is to test in a randomized comparative study the performance of Straumann® MembraGel (PEG Membrane) to act as a barrier for guided bone regeneration compared to that of a standard collagen membrane (BioGide®) in the bone regeneration around Straumann® SLActive bone level titanium implants. Furthermore the clinical evaluation and comparison of complementary parameters describing the bony and soft tissue environments at the surgical sites during the study period to evaluate effectiveness and performance of the membranes.

NCT ID: NCT01012037 Completed - Clinical trials for Diabetes Mellitus, Type 2

Linagliptin 2.5 mg Twice Daily Versus 5 mg Once Daily as add-on Therapy to Twice Daily Metformin in Type 2 Diabetes

Start date: November 2009
Phase: Phase 2
Study type: Interventional

The objective of the study is to investigate the efficacy and safety of linagliptin 2.5 mg twice daily compared to 5 mg once daily compared to placebo given orally for 12 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control. It is planned to show non-inferiority of linagliptin 2.5 mg twice daily compared to 5 mg once daily and each treatment's superiority over placebo.