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NCT ID: NCT01071785 Completed - Metabolic Syndrome Clinical Trials

Dietetic Intervention With Soluble Fiber in Type 2 Diabetes Mellitus (DM) Patients With Metabolic Syndrome (MS)

Start date: June 2007
Phase: N/A
Study type: Interventional

Metabolic Syndrome (MS) is an clinical condition with high cardiovascular risk. More than 80% of DM patients had MS. Dietary factors can be associated to both, DM and MS. Therefore the aim of this study is to evaluate the effects of add soluble fiber (goma-guar) in the usual diet of type 2 DM with MS and compare this intervention with an usual diet without this supplement.

NCT ID: NCT01071005 Completed - Healthy Clinical Trials

Pharmacodynamics of Lorelin Depot (Leuprorelin Acetate - Bergamo) Compared to Lupron Depot ® (Leuprorelin Acetate - Abbot)

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

The primary objective of this study is to examine, in healthy subjects, the comparative pharmacodynamics of Lorelin Depot (leuprorelin), manufactured by the Chemical Pharmaceutical Laboratory Bergamo Ltda with the product Lupron Depot ® (leuprorelin), manufactured by Abbott Laboratories Ltd, through the strength of biological markers follicle stimulating hormone (FSH), luteinizing hormone (LH) and total testosterone, associated with the activity of the substance. Secondarily be observed safety (tolerability) of subjects in clinical research through the comparison of clinical and laboratory parameters pre-and post-study, and incidence of adverse events.

NCT ID: NCT01070550 Completed - Clinical trials for Hepatitis C, Chronic

PROPHESYS 1: An Observational Study on Predictors of Response in Treatment-naïve Patients With Chronic Hepatitis C Treated With Pegasys (Peginterferon Alfa-2a)

Start date: June 2007
Phase: N/A
Study type: Observational

This observational study will assess predictors of early on-treatment and sustained virological response in treatment-naïve patients with chronic hepatitis C initiated on treatment with Pegasys (peginterferon alfa-2a) and ribavirin. Data will be collected during the treatment period (24 or 48 weeks) and 12 and 24 weeks after the end of treatment. Target sample size is <5000.

NCT ID: NCT01068561 Completed - Clinical trials for Retinitis Pigmentosa

Autologous Bone Marrow-Derived Stem Cells Transplantation For Retinitis Pigmentosa

Start date: May 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the short-term safety of a single intravitreal injection of autologous bone marrow stem cells in patients with retinitis pigmentosa.

NCT ID: NCT01067976 Completed - Breast Cancer Clinical Trials

Efficacy and Safety of Gadobutrol 1.0 Molar (Gadovist) for Breast MRI

Start date: February 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to look at the efficacy (how does it work) and safety of gadobutrol when used for obtaining MR images of both breasts.Women with a recent diagnosis of breast cancer by mammogram (X-ray examination of the breasts) may benefit from MRI of the breasts as MRI may detect additional breast cancers.

NCT ID: NCT01067950 Recruiting - Type 1 Diabetes Clinical Trials

Pancreas Allotransplantation for Diabetic Nephropathy and Mild Chronic REnal fAilure Stage Study

PANCREAS
Start date: March 2010
Phase: Phase 3
Study type: Interventional

Current medical therapies are not able to prevent progression of established macroproteinuira (i.e. diabetic nephropathy) to end-stage renal failure in type 1 (insulin dependent) diabetic patients. In this setting, proteinuria is a major risk factor for mortality. Pancreas transplantation, on the contrary, can revert diabetic nephropathy and thereby prevent end-stage chronic renal failure, with theoretically lower risk of death as compared to current medical therapies.The main objective of this study is to assess superiority of isolated pancreas transplantation versus intensive exogenous insulin therapy in type 1 diabetic patients with overt diabetic nephropathy and mildly reduced renal function. The primary endpoint is a composite efficacy/failure end-point including: patient mortality and renal function impairment during 5 years in patients with badly controlled diabetes and nephropathy resisting to up-to-date nephroprotective therapies.Main secondary objectives are safety and efficacy of both regimens, including proteinuria and renal histology evaluation, metabolic control and quality of life, acute and chronic extrarenal complications of diabetes, pancreas survival and all risks related to the transplant procedure (anaesthesia, surgery and immunosuppression side-effects) and to the intensive insulin therapy management.

NCT ID: NCT01067820 Completed - Clinical trials for Coronary Artery Disease

ApoA-I Synthesis Stimulation and Intravascular Ultrasound for Coronary Atheroma Regression Evaluation

ASSURE I
Start date: September 2011
Phase: Phase 2
Study type: Interventional

This study is designed to characterize the early effects of ApoA-I synthesis with RVX000222 on coronary atherosclerotic disease when administered to patients with coronary artery disease and have a low HDL-C level, as assessed by Intravascular Ultrasound (IVUS) in addition to standard background therapy.

NCT ID: NCT01066026 Completed - Wrinkles Clinical Trials

Safety and Efficacy of a Metallic Cannula Versus A Standard Needle for Soft Tissue Augmentation of the Nasolabial Folds

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

The purpose of this study was to assess the safety and efficacy of a new metallic cannula to inject hyaluronic acid for dermal augmentation in the nasolabial folds compared to standard needle.

NCT ID: NCT01065649 Completed - Clinical trials for Gastroesophageal Reflux Disease

Effect of Nortriptyline in Cortical Representation of Heartburn in Nonerosive Reflux Disease (NERD) Patients

NORGERD
Start date: January 2010
Phase: Phase 3
Study type: Interventional

Patients with nonerosive reflux disease (NERD) are less responsive to standard treatment with proton pump inhibitors. The hypothesis of this study was that nortriptyline in analgesic doses may decrease heartburn perception and its corresponding cortical activity measured by magnetic resonance image. Therefore, the aim of this study was to assess the cortical representation of heartburn in patients with NERD under treatment with nortriptyline and placebo.

NCT ID: NCT01065064 Completed - Clinical trials for Refractive Assessment

Visual Performance After RESTOR Implantation

Start date: January 2009
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the distance, intermediate, and near vision after aspheric multifocal diffractive AcrySof® ReSTOR SN6AD1 intraocular lens (IOL) implantation.