Jan 9th, 2018 - The beneficial effects of glycemic control on both survival and function of transplanted kidneys in patients with type 1 diabetes mellitus have been recognized. The purpose of this study is to reverse hyperglycemia and insulin dependency, by islet cell transplantation, in patients with type 1 diabetes mellitus who have a stable kidney allograft. The study primary efficacy endpoint is graft surv...
Mar 6th, 2012 - Selenium is an essential nutrient. Selenium carries out its biological functions through selenoproteins. The most abundant selenoprotein in the plasma is selenoprotein P, which is largely synthesized in the liver. Patients with liver disease often have less than half the selenoprotein P levels of normal individuals. This suggests that people with liver disease are not meeting their selenium req...
Apr 22nd, 2013 - Evidence have shown benefits of gut flora modulation in treatment of irritable bowel syndrome (IBS), but few reports are available on the effects of multistrain probiotics and there are few reports available in this regard from our society. Thus, we investigated if probiotics are effective in our patients as well. We hypothesize that the multistrain probiotic Balance containing seven bacteria s...
Feb 21st, 2012 - This was a Phase III, multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group study of up to 9 weeks in duration. Seven days of QID single-blind placebo administration (via MDI) was followed by 56 days of QID double-blind active treatment. Following the run-in period, each subject was randomized to one of the following three treatments: levalbuterol HFA MDI 90 mcg ...
Nov 22nd, 2011 - This study will evaluate the safety and effectiveness of oxcarbazepine (Trileptal) as add-on therapy in the treatment of partial seizures in pediatric patients 1 month to 3 years of age.
Mar 14th, 2013 - The purpose of this study is to determine if intravitreal injection of Vitrase (ovine hyaluronidase) clears vitreous hemorrhage
Jun 23rd, 2005 - Examine the ability of thymopentin (Timunox) to: Reduce the amount and/or frequency of virus isolation. Stimulate the immune system and alter the clinical findings in patients infected with HIV who do not yet have AIDS.
Jun 20th, 2013 - OBJECTIVES: I. Determine the maximum tolerated dose of gemcitabine in combination with radiation therapy to patients with locally advanced and/or unresectable adenocarcinoma of the pancreas. II. Determine the dose limiting toxic effects of this combination therapy in these patients. III. Evaluate the ability of these patients to tolerate induction and then maintenance therapy with gemcitabine p...
May 24th, 2012 - Evaluation of previous patients who received doses of 40 or 80 mcg gp160 vaccine indicates that, although serum anti-gp160 antibody responses were detected, the level and duration of those responses were limited. A preliminary observation suggests that weak functional antibody responses may develop following the 18 month booster of 40 or 80 mcg; therefore, a dose of gp160 vaccine having potenti...
May 3rd, 2012 - This study will assess efficacy, safety and tolerability of agomelatine (AGO178) 25 mg and 50 mg in patients with Major Depressive Disorder (MDD). This study includes an 8-week double-blind phase and a 52-week open-label phase.
Feb 7th, 2013 - This is a multicenter, randomized, double-blind, parallel-group, dose-ranging, comparator-controlled study of the effect of pantoprazole on intragastric pH after successful endoscopic hemostasis in hospitalized patients. Patients will receive either intravenous pantoprazole (one of two regimens) or ranitidine (the comparator) within 2 hours of successful hemostasis and administration will conti...
Jun 24th, 2013 - Although patient reminder/recall systems have been shown to be effective at improving vaccination coverage levels for infants and younger children, little is known about the effectiveness of such systems for increasing immunization rates in adolescent populations. The process of reminder/recall in adolescents, and vaccination of adolescents overall, presents particular challenges. Adolescents a...
Oct 28th, 2015 - The purpose of this project is to compare the performance of the Pediatric Vision Scanner (PVS) with the Gold Standard Examination to determine the effectiveness of the PVS at detecting amblyopia and strabismus.
Mar 10th, 2011 - The purpose of this research study is to observe body contour changes following treatment using the MC1 device. The MC1 System is FDA cleared for relief of minor muscle aches, pain and muscle spasm, temporary improvement in local blood circulation, and temporary reduction in the appearance of cellulite.
Jul 12th, 2012 - OBJECTIVES: Determine the role of peak delivery time on the tolerability of irinotecan when administered with chronomodulated fluorouracil, leucovorin calcium, and oxaliplatin as first- or second-line therapy in patients with locoregional or metastatic colorectal cancer. Determine the antitumor activity of this regimen. OUTLINE: This is a randomized, multicenter study. Patients are stratified a...
Jun 4th, 2013 - OBJECTIVES: Determine the recommended phase II dose of monoclonal antibody anti-anb3 integrin in patients with irinotecan-refractory advanced colorectal cancer. Determine the safety and tolerance of this drug in these patients. Determine any antitumor activity of this drug in these patients. Determine the objective response rate, response duration, and time to progression in patients treated wi...
Nov 24th, 2013 - This study is being conducted to evaluate a novel method of augmenting a weak Lower Esophageal Sphincter (LES) with a magnetic esophageal sphincter device.
Oct 1st, 2012 - A prospectively planned interim analysis will be performed on the double-blind data.
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
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...