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NCT ID: NCT01319487 Completed - Clinical trials for Diabetic Macular Edema

Safety and Efficacy Study of Topical Administration of FOV2304 (High Dose or Low Dose) for the Treatment of Center-involving Clinically Significant Macular Edema Associated With Diabetic Retinopathy

Start date: May 2011
Phase: Phase 2
Study type: Interventional

The purpose of the study is to determine whether concentrations of FOV2304 (high dose or low dose) administered in the eye are more effective than placebo in treating patients with diabetic macular edema, following 12 weeks of treatment.

NCT ID: NCT01318941 Completed - Clinical trials for Diabetic Macular Edema

Observe the Effectiveness and Safety of Ranibizumab in Real Life Setting

LUMINOUS
Start date: March 2011
Phase: N/A
Study type: Observational

This study will describe the long-term safety and effectiveness, treatment patterns,and patient reported quality of life associated with ranibizumab treatment in routine clinical practice for all approved indication included in the local product label.

NCT ID: NCT01318850 Completed - Schizophrenia Clinical Trials

Effects of Cognitive Remediation Therapy on Schizophrenia Patients Through Functional Magnetic Resonance Imaging

Start date: January 2008
Phase: N/A
Study type: Interventional

Cognitive Remediation Therapy (CRT) can enhance cognitive performance in patients with schizophrenia improving clinical outcome. However, the neurobiological mechanism underlying cognitive improvement is not well understood. The aim of this study is to investigate functional connectivity patterns before and after the neurocognitive rehabilitation therapy, especially in fronto-temporal circuitry.

NCT ID: NCT01318694 Completed - Clinical trials for Hepatitis C, Chronic

Efficacy and Safety Study of DEB025/Alisporivir Combined to Peg-IFN and Ribavirin in Chronic Hepatitis C Genotype 1 Treatment-naïve Patients

Start date: March 2011
Phase: Phase 3
Study type: Interventional

This study will assess the safety and efficacy of Alisporivir when added to pegIFN and Ribavirin to optimize treatment in patient infected with the Hepatitis C virus who have not been previously treated for this condition

NCT ID: NCT01318486 Completed - Clinical trials for Chronic Kidney Disease

HepZero:Heparin Free Dialysis With Evodial

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

The study hypothesis is that with Evodial in patients requiring heparin free dialysis, the heparin free treatment can be performed easily (without saline flushes or blood predilution) and is at least not inferior and maybe superior to the standard care heparin free treatment in terms of clotting.

NCT ID: NCT01316406 Completed - Clinical trials for Palmar-Plantar Erythrodysesthesia Syndrome

Safety and Efficacy Placebo Controlled Study of ATH008 Cream in PPES Patients Secondary to Capecitabine

Start date: February 2011
Phase: Phase 2
Study type: Interventional

The aim of this study is to evaluate the safety and efficacy of ATH008 cream in patients with Palmar-Plantar Erythrodysesthesia Syndrome (PPES) secondary to capecitabine therapy. In part I, the safety and plasmatic levels of the active ingredient and its metabolite will allow to determine the most appropriate and beneficial dose for the second part of the study. In Part II, the efficacy of ATH008 cream in reducing the number of patients presenting PPES grade 2/3 secondary to capecitabine therapy following a four times daily application will be tested.

NCT ID: NCT01316367 Completed - Clinical trials for Type 2 Diabetes Mellitus

Effectiveness of PRECEDE Model for Health Education on Changes and Level of Control in Patients With Type 2 Diabetes Mellitus

Start date: February 2003
Phase: Phase 4
Study type: Interventional

BACKGROUND: Individual health education is considered to be essential in the overall care of patients with type 2 diabetes (DM2), although there is some uncertainty regarding its metabolic control benefits. There have been very few randomized studies on the effects of individual education on normal care in DM2 patients with a control group, and none of these have assessed the long-term results. Therefore, this study aims to use this design to assess the effectiveness of the PRECEDE (Predisposing, Reinforcing, Enabling, Causes in Educational Diagnosis, and Evaluation) education model in the metabolic control and the reduction of cardiovascular risk factors, in patients with type 2 diabetes. METHODS: An open community randomized clinical trial will be carried out in 8 urban community health centers in the Northeastern Madrid (Spain). Six hundred patients with DM2 will be randomized in two groups: PRECEDE or conventional model for health promotion education. The main outcome measures is glycated hemoglobin A1C, body mass index (BMI), blood pressure, lipids and control criteria during the 2-year follow-up period.

NCT ID: NCT01316276 Completed - Cystic Fibrosis Clinical Trials

Extension Study of Liposomal Amikacin for Inhalation in Cystic Fibrosis (CF) Patients With Chronic Pseudomonas Aeruginosa (Pa) Infection

Start date: October 5, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long term safety and tolerability of Liposomal Amikacin for Inhalation (LAI) 590 mg once daily (QD) in Cystic Fibrosis patients with chronic infection due to pseudomonas aeruginosa. This long-term, open-label, multi-cycle extension study enrolled subjects who had successfully completed study TR02-108, were compliant with the study protocol, and did not meet any of the listed study discontinuation criteria. The safety and tolerability of LAI were evaluated for up to approximately 2 years.

NCT ID: NCT01316263 Completed - Clinical trials for Gastrointestinal Stromal Tumor (GIST)

A Study of IMC-3G3 in Previously Treated Patients With Unresectable and/or Metastatic Gastrointestinal Stromal Tumors

Start date: August 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the tumor response of stable disease (SD) partial response, or complete response (according to RECIST 1.1 criteria) at 12 weeks in patients with Gastrointestinal Stromal Tumors (GIST) harboring PDGFRα mutations and patients with GIST not harboring PDGFRα mutations.

NCT ID: NCT01315678 Completed - Clinical trials for Pseudomonas Aeruginosa Infection

Study to Evaluate Arikayce™ in CF Patients With Chronic Pseudomonas Aeruginosa Infections

Start date: February 29, 2012
Phase: Phase 3
Study type: Interventional

A major factor in the respiratory health of Cystic Fibrosis (CF) participants is the prevalence of chronic Pseudomonas aeruginosa (Pa) infections. The Pa infection rate in CF patients increases with age and by age 18 years approximately 85% of CF patients in the US are infected. Liposomal amikacin for inhalation (Arikayce™) was developed as a possible treatment for chronic infection due to Pa in CF patients. The purpose of this study is to determine whether Arikayce™ is effective in treating chronic lung infections caused by Pa in CF participants. The effectiveness, safety, and tolerability of Arikayce™ will be compared to Tobramycin TOBI®, an inhalation antibiotic already available for use.