Feb 4th, 2010 - The study is designed to investigate the pharmacokinetic behaviour of the free base formulation of AZD9668. The study will compared the relative bioavailability of the free base formulation at two different dose levels compared to the tosylate salt formulation.

Sep 14th, 2017 - The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.

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...

Dec 11th, 2012 - This is a Multicenter, Open-Label, Phase II Study of lapatinib in Combination with Vinorelbine in women with documented evidence of HER2/neu positive breast cancer which is metastatic or recurrent and with or without prior chemotherapy or anti-HER2/neu targeted therapy in the metastatic and relaps setting. Patients will receive 1250mg lapatinib once a day and vinorelbine 25mg/sqm IV Day 1and Da...

Feb 10th, 2011 - One form of male sexual dysfunction is premature ejaculation (PE), which is also referred to as rapid ejaculation (RE). The study consists of 2 phases: pre-randomization phase (a screening visit and a 2-week baseline period); 12-week double-blind treatment phase during which patients will receive one of 2 doses of dapoxetine or placebo for use on an "as-needed" basis. The total duration of the ...

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...

Oct 10th, 2012 - The purpose of this study is to evaluate the efficacy and safety of ONO-1101 in postoperative supraventricular tachyarrhythmias.

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...

Jan 22nd, 2017 - This is a placebo controlled study evaluating the effectiveness of medication in preventing depressive episodes in subjects with a history of Seasonal Affective Disorder (SAD).

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

May 5th, 2008 - We will perform a randomized clinical trial following a modification of a previously published protocol (Merten et al.JAMA 2004;291(19):2328-34). Patients will be randomly assigned to one of two groups of treatment. Group A will receive 1 cc/kg/hour of 0.9% saline infusion starting 12 hours before and continuing 12 hours after the procedure. Group B will receive 3 cc/kg of sodium bicarbonate so...

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.

May 9th, 2010 - OBJECTIVES: Assess the safety and toxicity of cellular adoptive immunotherapy using autologous CD8+ antigen-specific T-cell clones in patients with metastatic melanoma. Estimate the duration of in vivo persistence of adoptively transferred CD8+ antigen-specific cytotoxic T-cell clones in these patients. Evaluate the antitumor effects of CD8+ antigen-specific T-cell clones in these patients. OUT...

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...

Jun 10th, 2010 - OBJECTIVES: Determine the maximum tolerated dose and dose-limiting toxicity of irinotecan and capecitabine when given in combination with a fixed dose of oxaliplatin in patients with advanced solid tumors. Determine the pharmacokinetic parameters of this regimen in these patients. Determine the antitumor response of these patients treated with this regimen. OUTLINE: This is a dose-escalation st...

Aug 28th, 2014 - OBJECTIVES: I. Determine the antitumor effects of SU5416 in patients with chemotherapy refractory cutaneous AIDS-related Kaposi's sarcoma. II. Determine the safety and tolerability of this regimen in these patients. III. Determine the pharmacokinetics of this regimen in these patients. IV. Determine the safety of this regimen on HIV replication and immune parameters in these patients. V. Determ...

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...

Feb 10th, 2013 - OBJECTIVES: I. Assess the toxicity associated with repeated vaccination with recombinant vaccinia virus expressing prostate-specific antigen (rV-PSA) in patients with metastatic adenocarcinoma of the prostate. II. Determine the optimal dose of rV-PSA given at monthly intervals based on cellular and hormonal immunity. III. Determine whether vaccination with rV-PSA is associated with anti-tumor a...