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NCT ID: NCT01539681 Completed - Clinical trials for Hepatocellular Carcinoma

Sorafenib in Hepatocellular Carcinoma Clinical Practice in Italy

STELLA
Start date: February 2012
Phase: N/A
Study type: Observational

Prospective, non-interventional, multi-center study. Patients affected by Hepatocellular Carcinoma (HCC) who are candidates for systemic therapy and in whom a decision to treat with sorafenib has been made. Aim of this non-interventional, post-marketing study is to evaluate the efficacy of sorafenib in terms of overall survival rate at 12 months in patients with HCC under daily-life treatment conditions.

NCT ID: NCT01539512 Completed - Clinical trials for Chronic Lymphocytic Leukemia

A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)

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

This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of idelalisib in combination with rituximab on the onset, magnitude, and duration of tumor control in participants previously treated for chronic lymphocytic leukemia (CLL). Eligible patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either idelalisib plus rituximab or placebo plus rituximab. Participants who are tolerating primary study therapy but experience definitive CLL progression are eligible to receive active idelalisib therapy in the extension study, GS-US-312-0117.

NCT ID: NCT01539239 Completed - Clinical trials for Primary Open Angle Glaucoma

Safety & Effectiveness Study of the Hydrus Microstent for Lowering IOP in Glaucoma Patients Undergoing Cataract Surgery (HORIZON)

Start date: January 2012
Phase: N/A
Study type: Interventional

This clinical trial is a prospective, randomized, controlled, multicenter, study. After informed consent is obtained, patients will be evaluated for eligibility based on glaucoma severity, eye health, and visual acuity. Following successful screening, use of all topical glaucoma medications will be stopped for a period of "washout" to establish a qualifying medication-free intraocular pressure (IOP) value. Clinical follow up will be scheduled over the course of the 24 month study, and examinations will be repeated to monitor eye health. At the 1 and 2 year follow up, those patients on ocular hypotensive medications will be instructed to washout, and then have the diurnal (IOP taken in the morning, mid-day, and afternoon in the same day) IOP evaluation. Annual follow up will occur up to 5 years. The primary effectiveness endpoint is a decrease in diurnal IOP from baseline compared to the 24 months diurnal IOP following medication washout.

NCT ID: NCT01538654 Completed - Obesity Clinical Trials

Enteroprotein Modified Fast ( EMF )

EMF
Start date: March 10, 2011
Phase: N/A
Study type: Observational

The purposes of the esperience is: 1. to verify the safety of protein sparing modified fast(PSMF) by enteral route ( EMF )performed in cycles of ten days/months for six months 2. to compare EMF with oral PSMF clinically ( appetite control, fat freemass mantainance, polmonary function tests and metabolic pattern) 3. to verify the weight mantainance after 6 months from the treatment suspension

NCT ID: NCT01538602 Completed - Clinical trials for Polycystic Ovary Syndrome

Mean Platelet Volume and TXA2 Levels in Patients With Polycystic Ovary Syndrome (PCOS)

Start date: n/a
Phase: N/A
Study type: Observational

Polycystic ovary syndrome (PCOS)is closely associated with insulin resistance and hyperinsulinemia as well as with increased incidence in diabetes, hypertension, dyslipidemia and atherosclerosis. Indeed, subjects with PCOS were reported to carry an increased long-term cardiovascular risk, among others. Aiming to correlate the mean platelet volume, the thromboxane A2 level and the PCOS, an observational study was planned. Clinical evaluation of metabolic outcomes in PCOS patients is compared to a placebo group.

NCT ID: NCT01538381 Completed - Clinical trials for Carcinoma, Squamous Cell of Head and Neck

Neoadjuvant Afatinib Window Study in Squamous Cell Carcinoma of the Head and Neck

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

The general objectives are to evaluate the pre-operative activity and the safety of afatinib in head and neck cancer and to explore the different downstream molecular pathways to identify tumor response and resistance mechanisms. The results from this study can be used to conduct a larger trial that would allow us to confirm or validate the hypotheses generated.

NCT ID: NCT01538225 Completed - Multiple Sclerosis Clinical Trials

Neurophysiological Study of Sativex in Multiple Sclerosis (MS) Spasticity

NS-MSS
Start date: April 2012
Phase: Phase 3
Study type: Interventional

Aim of this randomized, double-blind, placebo-controlled, cross-over study is to investigate cannabinoid-induced changes in neurophysiological parameters in a group of 40 patients with secondary or primary progressive Multiple Sclerosis (MS).

NCT ID: NCT01538043 Completed - Clinical trials for Osteoarthritis, Knee

Spa Therapy in Knee Osteoarthritis: Study on Cost/Effectiveness - Cost/Utility and Possible Mechanisms of Action

Start date: December 2010
Phase: Phase 4
Study type: Interventional

The aim of this study is to evaluate both cost/effectiveness- cost/utility and the possible mechanisms of action of spa therapy in patients with primary knee osteoarthritis (OA).

NCT ID: NCT01537302 Completed - Clinical trials for Total Atherosclerotic Occlusion of Femoral Artery

Chronic Total Occlusion Crossing With the Ocelot System - CONNECT II

CONNECTII
Start date: February 2012
Phase: N/A
Study type: Interventional

Evaluation of the safety and effectiveness of the Ocelot System to provide OCT-assisted orientation while simultaneously crossing totally occluded femoropopliteal arteries.

NCT ID: NCT01537042 Completed - Clinical trials for End-Stage Renal Disease

A Sleep Laboratory Study to Investigate the Safety and Efficacy of the Rotigotine Skin Patch in Subjects With Restless Legs Syndrome and End-Stage Renal Disease Requiring Hemodialysis

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

This is a sleep laboratory study to evaluate the efficacy and safety of Rotigotine in subjects with Restless Legs Syndrome and End-Stage Renal Disease requiring hemodialysis. The objectives are to demonstrate superiority of Rotigotine against Placebo as well as to investigate the effect of Rotigotine on quality of life and sleep.