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NCT ID: NCT01667419 Completed - Melanoma Clinical Trials

A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma

BRIM8
Start date: September 24, 2012
Phase: Phase 3
Study type: Interventional

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of vemurafenib in participants with completely resected, cutaneous BRAF mutation-positive melanoma at high risk for recurrence. Participants will be enrolled in two separate cohorts: Cohort 1 will include participants with completely resected Stage IIC, IIIA (participants with one or more nodal metastasis greater than [>] 1 millimeter [mm] in diameter), or IIIB cutaneous melanoma, as defined by the American Joint Committee on Cancer (AJCC) Classification, Version 7; Cohort 2 will include participants with Stage IIIC cutaneous melanoma, as defined by this classification scheme. Within each cohort, participants will be randomized (1:1 ratio) to receive vemurafenib or matching placebo over a 52-week period.

NCT ID: NCT01666483 Completed - Pain, Postoperative Clinical Trials

Micro-laparoscopy and Single-port Hysterectomy

MLPS/LESS
Start date: May 2011
Phase: N/A
Study type: Interventional

A total of 86 patients underwent total hysterectomy. Three of them refused randomization, 34 were randomly assigned to undergo to laparoendoscopic single-site surgery (LESS) and 34 to undergo micro-laparoscopy (M-LPS).Laparoscopic hysterectomy can be safely performed by M-LPS and LESS.

NCT ID: NCT01666106 Completed - Clinical trials for Osteonecrosis of the Jaw

Osteonecrosis of the Jaw (ONJ) Case Registry

Start date: October 1, 2012
Phase:
Study type: Observational

Osteonecrosis of the Jaw (ONJ) Case Registry

NCT ID: NCT01665391 Completed - Clinical trials for Primary Focal Segmental Glomerulosclerosis

A Study of Fresolimumab in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis (FSGS)

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

The primary objectives of this trial are as follows: - to compare the achievement of a partial remission (PR) or complete remission (CR) in urinary protein: creatinine ratio (Up/c ratio) in patients treated with fresolimumab versus placebo - to compare the safety profile of patients treated with fresolimumab versus placebo The secondary objectives are as follows: - To compare the reduction in proteinuria in patients treated with fresolimumab versus placebo - To evaluate fresolimumab dose-dependent reduction in proteinuria - To compare the change in renal function (estimated glomerular filtration rate [eGFR]) in patients treated with fresolimumab versus placebo - To evaluate the multiple-dose pharmacokinetics of fresolimumab

NCT ID: NCT01665144 Completed - Clinical trials for Secondary Progressive Multiple Sclerosis

Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND)

Start date: December 20, 2012
Phase: Phase 3
Study type: Interventional

Evaluate the safety and efficacy of Siponimod (BAF312) versus placebo in a variable treatment duration in patients with secondary progressive multiple sclerosis (Core Part) followed by extended treatment with open-label BAF312 to obtain data on long-term safety, tolerability and efficacy (Extension Part).

NCT ID: NCT01665066 Completed - Tobacco Abuse Smoke Clinical Trials

Pharmacokinetic Profile of Toxic Substances and Nicotine in Electronic Cigarettes

KINECIG
Start date: May 2012
Phase: N/A
Study type: Interventional

The aim of the present study is to compare serum nicotine levels of different e-Cigarette strength with usual cigarettes. Serum levels of carcinogenic and toxic substances will be also compared.

NCT ID: NCT01665053 Completed - Clinical trials for Coronary Artery Disease

The EVOLVE II Clinical Trial To Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion(s)

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

The purpose of this study is to assess the safety and effectiveness of the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) ≤ 34 mm in length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate).

NCT ID: NCT01664949 Completed - Dry Eye Disease Clinical Trials

A Study to Compare the Safety and Efficacy of A New Eye Drop Formulation With OPTIVE™ in Subjects With Dry Eye Disease

Start date: January 2013
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and efficacy of a carboxymethylcellulose based eye drop formulation compared with carboxymethylcellulose based preservative-free lubricant eye drops (OPTIVE™) in subjects with dry eye disease.

NCT ID: NCT01664767 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Effects of Sulfur Thermal Water Inhalation on Airway Oxidative Stress in COPD Patients

Start date: November 2011
Phase: N/A
Study type: Interventional

The chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease of the airways characterized by fixed airflow obstruction, with important systemic co-morbidities. The obstruction is usually progressive and irreversible despite chronic therapy. Cigarette smoking is the major cause of this disease. COPD is an important cause of morbidity and mortality worldwide. Numerous studies have shown that oxidative stress plays a key role in the pathogenesis of COPD. In particular, the active metabolites of oxygen such as superoxide anion and the hydroxyl radical are unstable molecules that can trigger significant oxidative processes at the cellular level. These molecules can alter the extracellular matrix remodeling, cell respiration, cell proliferation, cellular repair and the immune response in the lung. All these events are key elements in the pathogenesis of COPD. Currently available treatments for COPD (i.e. long-acting bronchodilators and inhaled corticosteroids) have not demonstrated a significant in vivo antioxidant effect. The thermal inhalation treatments are a therapeutic strategy used since many years in an empirical way in patients with COPD. Indeed, the evidence of effectiveness of spa treatment in patients with COPD are very limited. The aim of this in vivo study is to evaluate the modulatory effects of sulfur thermal water inhalation on oxidant stress in the airways of stable COPD patients.

NCT ID: NCT01664650 Completed - Metabolic Syndrome Clinical Trials

Effects of Genistein in Postmenopausal Women With Metabolic Syndrome

Start date: September 2008
Phase: Phase 2/Phase 3
Study type: Interventional

The 15-25% of the population of developed countries suffers for metabolic syndrome. It is associated with a 2-4 fold increase in cardiovascular morbility and mortality and with a 5- 9 fold increase in developing type II diabetes. MS prevalence increases after the onset of menopause, because of estrogen deficiency. It is still not clear if menopause itself increases the risk of cardiovascular diseases in al women or only in those that develop MS. Many MS patients that show slight modification in cardiovascular and metabolic parameters are not generally pharmacologically treated since diabetes or alteration in the lipid profile are not evidenced. In this respect it is of importance to develop new therapeutic strategies to prevent and treat MS. Genistein (4,5,7-trihydroxyisoflavone), shown a potentially preventive role on the cardiovascular apparatus in post-menopausal women, may be termed as selective ER modulator (SERM), since it reveals both ER-alpha full agonist and ER-beta partial agonist activity.