About 575,464 results

Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) in Acute Manic Episodes Associated With Bipolar I Disorder

Mar 26th, 2014 - This was a phase II, double-blind, fixed multiple dose, randomised, placebo-controlled, multicentre clinical trial in patients with a diagnosis of bipolar I disorder who experienced an acute manic (including mixed) episode. Patients who met the selection criteria at randomisation visit (V) (V2, Day 1) were randomised to 1 of 4 treatment groups: 600, 1200, or 1800 mg eslicarbazepine acetate, or ...

Study of Epratuzumab in Systemic Lupus Erythematosus

May 20th, 2014 - Epratuzumab is an investigational antibody designed to help treat SLE. The purpose is to evaluate safety and long term efficacy in concert with standard SLE treatments

Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma

May 21st, 2014 - OBJECTIVES: I. Determine the maximum tolerated dose of filgrastim (G-CSF)-fetal liver tyrosine kinase-3 (Flt3K) fusion protein when combined with melanoma peptide vaccine comprising tyrosinase:368-376 peptide, gp100:209-217 antigen, and MART-1:26-35 antigen emulsified in Montanide ISA-51 in patients with completely resected stage III or IV melanoma. II. Determine the toxicity and safety of this...

Monoclonal Antibody Therapy in Treating Patients With Advanced Kidney Cancer

Jun 19th, 2013 - OBJECTIVES: I. Determine the effect of monoclonal antibody VEGF on time to progression, angiogenesis, and overall survival in patients with unresectable advanced renal cell cancer. II. Evaluate serum antibody levels and biologically active vascular endothelial growth factor levels in the plasma of patients treated with this regimen. III. Evaluate the toxicity of this regimen in these patients. ...

Contingency Management for Smoking in Substance Abusers

Nov 20th, 2011 - Patients (N=102) who meet diagnostic criteria for alcohol, cocaine, marijuana, or opiate abuse or dependence will meet with research staff on two days for quit preparation sessions (2 per day). These sessions include testing a breath sample for evidence of smoking twice each day (separated by at least 5 hours), counseling based on Public Health Service (PHS) guidelines for quitting smoking duri...

Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress

Oct 1st, 2017 - In comparison to the general population, military personnel and veterans are at increased risk of developing both substance use disorders (SUDs) and post-traumatic stress disorder (PTSD). Despite promising developments in the past decade, the treatment of patients with SUDs and comorbid PTSD is woefully inadequate (Back, 2010; Back et al., 2014; Brady et al., 2007; McCauley et al., 2012). One o...

Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients

Jan 5th, 2015 - Recurrent digital ulcers (DU) are a manifestation of vascular disease in patients with systemic sclerosis (SSc), are an important source of morbidity and lead to impaired function in these patients. In this study, we are investigating whether treatment with the endothelin receptor antagonist, macitentan, decreases the development of new digital ulcers in patients with SSc. Macitentan is a highl...

Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects

Jan 15th, 2015 - Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387) were 2 identically designed, Phase 3, 12-week, randomized, double-blind, double-dummy, parallel-group, multicenter studies recruiting subjects from distinct sites. These studies evaluated the efficacy, safety, and tolerability of levodopa-carbidopa intestinal gel (LCIG) in the treatment of levodopa-responsive subjects with advanc...

Eculizumab to Treat Paroxysmal Nocturnal Hemoglobinuria

Mar 3rd, 2008 - Paroxysmal nocturnal hemoglobinuria (PNH) is an acquired clonal disorder of the hematopoietic stem cell characterized by intravascular hemolysis, hemoglobinuria, anemia, and thrombosis. The clinical features of PNH result from the lack of one or more of the GPI-linked proteins that serve to protect cells from autologous complement mediated attack. Two such proteins, CD55 (decay accelerating fac...

Effect of a Component of Fish Oil on Exercise-Induced Bronchoconstriction and Airway Inflammation in Asthma

May 25th, 2011 - To date, fish oil supplementation studies in patients with asthma have used a combination of omega-3 polyunsaturated fatty acids. A study on the specific formula that is most effective in preventing exercise-induced bronchoconstriction (EIB) has yet to be conducted in humans. Nevertheless, it has been shown that a docosahexaenoic acid (DHA) metabolite, protectin D1, is involved in the active re...

Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus

Dec 27th, 2010 - Study 0018 (NCT00107978) compares the safety and effectiveness of an investigational drug, telavancin, and an approved drug, vancomycin, for the treatment of complicated skin and skin structure infections.

Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)

Sep 5th, 2017 - A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam (CAZ-AVI, formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Therapy in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis, With a Gram Negative Pathogen in Hospitalized Adults

Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis

Apr 15th, 2014 - The AIR-BX2 study enrolled people with non-cystic fibrosis (non-CF) bronchiectasis and gram-negative airway infection. Participants received two 28-day courses of either Aztreonam for Inhalation Solution (AZLI) or placebo taken 3 times a day. Each course was followed by a 28-day off-drug period. Following the two blinded courses, all participants received a 28-day course of open-label AZLI then...

Sodium Butyrate For Improving Cognitive Function In Schizophrenia

May 1st, 2017 - The persistent cognitive deficits which can be appreciated across the course of SZ, from prodromal to chronic SZ, may be the most important underlying dysfunction in preventing functional, occupational, and social recovery in SZ compared to other symptom domains. Sodium butyrate is a short chain fatty acid and binds to the zinc site of histone deacetylases (HDAC). The inhibition of HDAC results...

Photodynamic Therapy in Treating Patients With Skin Cancer

Jan 30th, 2013 - OBJECTIVES: Characterize the penetration of topically applied aminolevulinic acid (ALA) into the lesions of patients with primary basal cell and squamous cell carcinomas. Quantitate the depth of fluorescence achievable with varying application periods of ALA in these patients. Compare the results of tissue fluorescence with surface fluorescence measurements in these patients. OUTLINE: This is a...

Chemotherapy in Treating Patients With Solid Tumors

Jul 2nd, 2013 - OBJECTIVES: I. Evaluate the safety and plasma concentration profiles of oblimersen (G3139) administered alone or in combination with docetaxel in patients with advanced solid tumors expressing the bcl-2 oncogene. II. Determine the plasma concentration profiles, maximum tolerated dose (MTD), and/or optimal biologic dose (OBD) of this treatment regimen in these patients. III. Determine the antitu...

[Trial of device that is not approved or cleared by the U.S. FDA]

Jul 15th, 2015

Safety and Efficacy of IDP-122 in the Treatment of Plaque Psoriasis

Feb 14th, 2018 - A multicenter, double-blind, randomized, parallel-group study designed to assess the safety and efficacy of IDP-122 Lotion in comparison with its vehicle. To be eligible for the study, subjects must be at least 18 years of age and have a clinical diagnosis of moderate to severe psoriasis (defined as an IGA score of 3 or 4).

A Study in Healthy Volunteers and Patients With Chronic Hepatitis B

Jul 5th, 2018 - This two-part, Phase 1 protocol will be the first clinical study of ABI-H0731. Part I will be a Phase 1a dose-ranging assessment of ABI-H0731 in healthy adult volunteers. If the dose-related safety, tolerability and pharmacokinetics (PK) of ABI-H0731 in human volunteers are deemed satisfactory, then the study will advance to Part II, a Phase 1b dose-ranging assessment of ABI-H0731 in non-cirrho...

Percentage of Secondary Prevention Patients Treated to Their LDL-C Targets

Oct 29th, 2014 - A cholesterol/lipid profile screening project of high risk patients with hyperlipidaemia (secondary prevention) who already receive cholesterol-lowering therapy. Lipid profile and rate of patients who are treated to target (which is <100mg/dl for patients with high risk and <70mg/dl for patients at very high risk) are screened (hospital-based specialists). The doctors therapy decisions after th...