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NCT ID: NCT01617824 Completed - Type 2 Diabetes Clinical Trials

Rapid Effects Linagliptin on Monocyte Polarization and Endothelial Progenitor Cells in Type 2 Diabetes

Start date: September 2012
Phase: Phase 4
Study type: Interventional

Diabetes mellitus is characterized by chronic low grade inflammation, which is worsened by the co-existence of renal failure. One key aspect of chronic inflammatory diseases is the alteration in the polarization profile of circulating monocyte-macrophage cells. Namely, monocytes-macrophages can exist in a pro-inflammatory (M1) polarized form or an anti-inflammatory (M2) polarized state. Alterations in the M1/M2 balance is thought to contribute to inflammation within atherosclerotic lesions and visceral adipose tissue which, in turn, can worsen cardiovascular disease and metabolic features in type 2 diabetic patients. M1 and M2 are regulated by a complex interplay of soluble signaling molecules, many of which are substrate of the enzyme DPP-4 (dipeptidyl peptidase-4). Therefore, inhibition of DPP-4 can affect the M1/M2 polarization balance. In this clinical trial, the investigators will test whether the DPP-4 inhibitor Linagliptin, compared to placebo, modifies the M1/M2 balance in type 2 diabetic patients with and without chronic renal failure. In addition, we will test whether DPP-4 inhibition with Linagliptin acutely affects endothelial progenitor cells (EPCs), which are vasculoprotective cells implicated in the pathobiology of diabetic complications.

NCT ID: NCT01617720 Completed - Clinical trials for Mitral Regurgitation

MITRAFIT- Cardinal Adjustable Mitral Repair Follow-up International Postmarketing Surveillance (PMS)

MITRAFIT
Start date: May 2012
Phase:
Study type: Observational

This Study is designed to observe the clinical outcomes of patients requiring mitral repair that were treated with the CE certified Cardinal System.

NCT ID: NCT01617681 Completed - Clinical trials for Pediatric Hypertension With or Without CKD

Efficacy, Safety and Tolerability of Multiple Doses of Valsartan in Children With Hypertension With or Without CKD

Start date: November 8, 2012
Phase: Phase 3
Study type: Interventional

To assess efficacy, safety and tolerability of valsartan when comparing two doses of valsartan in reducing and controlling blood pressure in children with hypertension with or without CKD.

NCT ID: NCT01617668 Completed - Breast Cancer Clinical Trials

A Randomized, Phase 2, Neoadjuvant Study of Weekly Paclitaxel With LCL161 in Patients With Triple Negative Breast Cancer

Start date: August 2012
Phase: Phase 2
Study type: Interventional

To assess whether adding LCL161 to weekly paclitaxel enhances the efficacy of paclitaxel in women with triple negative breast cancer whose tumors are positive for a defined pattern of gene expression

NCT ID: NCT01616524 Completed - Clinical trials for Hepatitis C Virus (HCV)

Safety and Efficacy Study of Pegylated Interferon Lambda With and Without Daclatasvir, Compared to Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C Genotype 2 and 3

PRINCIPAL
Start date: July 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if 24 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and 12 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and Daclatasvir will be safe and effective for treatment of hepatitis C compared to 24 weeks of treatment with Pegylated Interferon Alfa-2a plus Ribavirin

NCT ID: NCT01614665 Completed - Clinical trials for Kidney Transplantation

A Study to Compare How the Body Absorbs and Processes Two Different Formulations of the Anti-rejection Medication Tacrolimus (Advagraf® or Prograf®) in Children Receiving an Organ Transplant, and How Safe and Effective They Are Over a Longer Period of Time

Start date: April 3, 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to compare how the body absorbs and processes two different formulations of the anti-rejection medication tacrolimus (Advagraf® or Prograf®) in children receiving an organ transplant, and how safe and effective they are over a longer period of time. This study is for children less than 16 years old. No minimum age has been set, however, to be included in this study participants must able to swallow the medication capsules intact.

NCT ID: NCT01613144 Completed - Osteoporosis Clinical Trials

OsseoScrew Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate

EVOLVE
Start date: May 2012
Phase:
Study type: Observational

The purpose of this clinical investigation was to collect clinical evidence of the safety and efficacy of the OsseoScrew System. The OsseoScrew System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The study was designed to compare the safety and efficacy of OsseoScrew compared to any other commercially available fenestrated pedicle screw system augmented with PMMA for posterior spinal fixation after surgical correction of spinal deformity or pathology.

NCT ID: NCT01613118 Completed - Clinical trials for Focal Segmental Glomerulosclerosis

Randomized, Double-Blind, Safety and Efficacy Study of RE-021 (Sparsentan) in Focal Segmental Glomerulosclerosis

DUET
Start date: March 2014
Phase: Phase 2
Study type: Interventional

This study will investigate whether RE-021 (Sparsentan), a selective dual-acting receptor antagonist with affinity for endothelin (A type) and angiotensin II receptors (Type 1), is safe and effective in treating patients with focal segmental glomerulosclerosis (FSGS).

NCT ID: NCT01611649 Completed - Infant Development Clinical Trials

Effect of a Mix of Dairy Lipids and Plant Oils in Infant Formula on Omega-3 Fatty Acid in Red Blood Cells

REBECA
Start date: March 2012
Phase: Phase 2
Study type: Interventional

The objective of this study is to determine whether the use of a mix of dairy lipids and plant oils in infant formula can increase the sum of omega-3 fatty acids levels in membrane phospholipids of red blood cells (RBC) in 4 month-old infants compared with a formula containing only lipids of plant origin.

NCT ID: NCT01611324 Completed - Pain Clinical Trials

Painless Local Infiltration Anesthesia

EASE
Start date: May 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess if a dilution with 1.4% sodium bicarbonate of a 2% mepivacaine+epinephrine solution, can be effective in reducing the pain associated with local infiltration anesthesia, during ambulatory phlebectomy procedures.