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NCT00124449
The purpose of this study is to assess if Abatacept given for six months will prevent rheumatoid arthritis (RA) in patients who are at risk for the development of RA in comparison to placebo. High risk patients are defined as those having a positive laboratory test for anti-cyclic citrullinated peptide (anti-CCP2).
NCT00295633
The purpose of this clinical research study is to learn whether Saxagliptin added to thiazolidinedione (TZD) therapy is more effective than TZD alone as a treatment for Type 2 diabetic subjects who are not sufficiently controlled with TZD alone
NCT00803101
The purpose of this study is to evaluate efficacy, safety and tolerance of Beriplex® P/N (Kcentra) compared with plasma in regard to rapid reversal of coagulopathy induced by vitamin K antagonists in subjects who require immediate correction of international normalized ratio (INR) because of emergency surgery.
NCT01422876
This trial will evaluate use of BI 10773/linagliptin once daily (qd) fixed dose combination (FDC) in treatment naïve and metformin treated patients with type 2 diabetes mellitus to support approval by regulatory authorities.
NCT00521586
This study is to evaluate the safety, tolerability and immune response when 13-valent pneumococcal conjugate vaccine (13vPnC) and the trivalent inactivated flu vaccine (TIV) are given together to healthy adults aged 50-59 years who are naive to 23-valent pneumococcal polysaccharide vaccine (23vPS), or when the vaccines are given 1 month apart. It will also evaluate the immune response to 13vPnC once per year for 4 years and then to a second dose of 13vPnC given 5 years after the first dose.
NCT00375492
This trial is designed to compare the effects of twice-daily exenatide and twice-daily placebo on weight loss. This trial will evaluate overweight and obese subjects with type 2 diabetes who have inadequate glycemic control with metformin, sulfonylurea, or metformin plus a sulfonylurea. Subjects will be treated with exenatide or placebo in addition to their current oral antidiabetes agent regimen and participate in a lifestyle modification program.
NCT01727869
This is an open-label, multicenter, ascending multiple dose study of REGN1400 alone and in combination with erlotinib or cetuximab administered to patients with certain types of cancer.
NCT00117650
The purpose of this Phase 2 clinical research study is to examine the safety of an experimental gene transfer agent, Ad2/HIF-1α/VP16, and its ability to stimulate the growth of new blood vessels from existing blood vessels (a process called angiogenesis) in an attempt to improve the flow of blood in the legs of patients with peripheral arterial disease (PAD). Specifically, this study will enroll patients with severe intermittent claudication (IC) which is the stage of PAD in which a patient's walking ability is severely limited, causing pain in the legs upon exercise due to inadequate blood flow to the muscles of the lower limbs.
NCT00754039
The primary objective of this study is to compare the effect of Welchol in combination with TriCor compared to TriCor alone on low-density lipoprotein cholesterol (LDL-C) in patients with high cholesterol.
NCT00916006
This Phase III study is designed to assess the efficacy and safety of PEP005 Gel, 0.015% when applied to an area of skin containing 4-8 AK lesions on the face or scalp.
NCT00879944
The object of this research study is to examine these associations in children as very little is known about psoriasis and cardiovascular risk factors in the pediatric population.
NCT00081497
People with Fabry Disease have an alteration in their genetic material (DNA) which causes a deficiency of the alpha-galactosidase A enzyme. Fabrazyme (agalsidase beta) is a drug that helps to break down and removes certain types of fatty substances called "glycolipids". These glycolipids are normally present within the body in most cells. In Fabry disease, glycolipids build up in various tissues such as the liver, kidney, skin, and blood vessels because a-galactosidase A is not present, or is present in small quantities. The build up of glycolipid (globatriaosylceramide or GL-3) levels in these tissues in particular is thought to cause the clinical symptoms that are common to Fabry disease. This study analyzed the safety and efficacy of Fabrazyme in the treatment of patients with Fabry disease that previously participated in the AGAL-008-00 (NCT0074984) study.
NCT01226290
The primary objective of this study is to establish the effectiveness and confirm the safety of the VizAblate System in ablating symptomatic uterine fibroids.
NCT00137306
Comorbid depression has been consistently linked to worse outcomes for patients in substance abuse treatment programs. Practice guidelines recommend pharmacotherapy for comorbid depression if symptoms persist after a 4-week "wash-out" period for detoxification (e.g., Veterans Health Administration; American Psychiatric Association). Medications may be considered earlier if a patient has current symptoms and a history of major depressive disorder (MDD) during periods of sobriety. Current efficacy data suggest that antidepressant medication can improve both depression and substance use outcomes among comorbid patients Guideline-concordant use of antidepressant medication for persons with comorbid substance use and depressive disorders, however, is not routine in many VA substance abuse treatment settings.
NCT00754507
To determine the effects of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on atorvastatin therapy for at least 4 weeks.
NCT00755352
Determine the effect of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on pravastatin therapy for at least 4 weeks.
NCT00146770
This study is being conducted to collect additional long-term efficacy and safety data of Aldurazyme® (laronidase) patients with MPS I disease. Patients who were previously enrolled in the Phase 3 Double-Blind Study will be enrolled in this study.
NCT00701935
A multicenter, randomized, double-blind, placebo-controlled trial will assess the effects of twice-daily subcutaneous injection with exenatide versus treatment with matching placebo injection on abdominal visceral fat content.
NCT01149655
This will be a randomized, double-blind, placebo-controlled study consisting of a screening period, a conversion phase (Phase 1), a stabilization phase (Phase 2), and a double-blind maintenance treatment phase (Phase 3), and a follow up period. Subjects may be either outpatients or inpatients between screening and through the time they reach stabilization at the end of Phase 2; hospitalization is not a study requirement. However, eligible subjects must be outpatients at the beginning of Phase 3. Subjects will be assessed weekly during Phase 1, weekly for the first 4 weeks of Phase 2 and 3, and biweekly for the remaining weeks during each of Phases 2 and 3. Subjects will be encouraged to call the investigators with any exacerbation of psychotic symptoms and/or any tolerability issues. The investigator will also have the option to phone the subjects and their guardian(s) at any time to ensure clinical stability. A data monitoring committee (DMC) will provide oversight for safety monitoring and reviewing the interim analysis. One interim analysis is planned after 75% of the total expected number of impending relapse events (28 events) are achieved and will be conducted by an independent data analysis center. The DMC will make a recommendation about stopping or continuing the study based on safety and efficacy reviews. The results of the interim analysis and individual subject data will remain blinded to the sponsor during the course of the study until the DMC determines that the study will conclude based on the results of the interim analysis, or the study is completed after 37 endpoint events.
NCT00371436
The purpose of this multi-site randomized clinical study is to test a model treatment program in a VA Audiology clinic, to evaluate its efficacy, ease of implementation, and acceptability to audiologists.