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Discover 20,428 clinical trials near North Carolina. Find research studies in your area.
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NCT01699737
The purpose of this study is to evaluate the effect of JTT-851 on diabetes as well as to assess the safety, tolerability, and pharmacokinetics of JTT-851 in type 2 diabetic patients either treated with metformin or treatment-naïve.
NCT00411385
This is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of albumin interferon alfa-2b (alb-IFN)in combination with ribavirin compared with peginterferon alfa-2a (PEGASYS or PEG-IFNa2a) in combination with ribavirin in subjects with chronic hepatitis C, genotype 2/3 who are IFNa treatment naive.
NCT00924768
The purpose of this Phase 1 research study is to identify a dose of inhaled endotoxin that is safe (does not cause prolonged cough, shortness of breath or other problems), but causes changes in sputum cell samples that the scientists can measure. The investigators are also interested in seeing if the exposure to the endotoxin decreases the body's natural ability to clear mucus from the lungs.
NCT00310843
Attempt to identify genetic polymorphisms in interrogated pathways which may be associated with symptomatic hepatotoxicity or severe cutaneous toxicity observed in case patients within the first 8 weeks of nevirapine therapy.
NCT01706523
This is an open-label extension protocol that will provide necessary data on the safety, tolerability, pharmacokinetics and efficacy of STX209 among subjects with ASD.
NCT00823368
The subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22001 will be offered participation in 22001A which will evaluate secreted protein before and after treatment with STX209 and placebo to determine if they correlate with effectiveness of treatment or susceptibility to treatment with STX209. These same subjects will also be asked to contribute a blood sample for DNA (deoxyribonucleic acid) collection. The investigators will study the DNA to determine if STX209 works better in people with specific gene variations, or to find new gene variations that predict how well STX209 works.
NCT01555333
This study will enroll subjects who have completed Protocols 209FX301, 209FX302, or are currently participating in Protocol 2202 into a long-term study in which all subjects will receive active drug (arbaclofen).
NCT01911247
The overall goal of this proposal is to investigate the potential benefit of metformin as a novel therapy for the treatment of endometrial cancer. Investigators will evaluate the effect of short-term metformin treatment on the endometrium of obese women with endometrial cancer by comparing each patient's endometrial biopsy before treatment with metformin to their post-treatment hysterectomy specimen. Participants: Obese women who are to undergo surgical staging for endometrial cancer will also receive short-term treatment (1-4 weeks) with metformin that will continue until the day prior to surgical staging. The effect of metformin on proliferation, apoptosis and downstream signaling pathways will be compared between pre-treatment endometrial biopsies and post-treatment hysterectomy specimens. Tissue microarrays will be constructed and immunohistochemstry performed to evaluate proliferation, apoptosis and changes in critical signaling pathways mediated by metformin, and these findings will be correlated with our in vitro preclinical studies. Fresh tissue will also be obtained, and Western immunoblotting will be used to assess expression of the phosphorylated forms of the downstream targets of metformin. The hypothesis is that treatment with metformin will result in a decrease in proliferative markers and an increase in markers of apoptosis in the endometrial cancer tumors. AMPK phosphorylation and inhibition of critical downstream targets of the mTOR pathway will be seen in the post-treatment hysterectomy specimens. Metabolomic profiling will also be performed of tumors and associated biofluids (i.e. serum and urine) before and after treatment with metformin to identify potential biomarkers of response to this therapy.
NCT00992719
The purpose of this study is to evaluate the safety of a 2009 H1N1 influenza vaccine in pregnant women and to determine how their body reacts to different strengths of the vaccine. Two strengths of the H1N1 influenza vaccine will be tested. Since it is not known if the response to the vaccine in pregnant women is the same or different than in non-pregnant women, the study also includes a group of women who are not pregnant for comparison. Participants include 200 pregnant women and 100 non-pregnant women ages 18-39. Study procedures include physical exams, several blood samples and maintaining a memory aid to document daily temperature and side effects for 8 days following vaccination. Participants will be involved in study related procedures for about 6 months.
NCT00092924
The purpose of this study is to evaluate the efficacy and safety of TRM-1 in subjects with relapsed or refractory non-small cell lung cancer.
NCT00336492
The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade) in children with moderately to severely active ulcerative colitis.
NCT01199887
This is an open label, Phase One, multicenter study, designed to evaluate the safety, tolerability, to explore the biologic effects, and to explore the clinical effects of the following doses of IW001: 0.1mg/day, 0.5 mg/day, and 1.0 mg/day, when administered once a day orally for 24 weeks in patients with IPF.
NCT01077960
In Serono Study 24380, the antecedent protocol to Study 25373, patients were randomly assigned in a 3.0-to-1.0 ratio to Groups A and B. All patients in Group A received recombinant human growth hormone (Serostim®) 4 mg daily (the "induction" phase) for the first 12 weeks, and then were re-randomized to receive either placebo or Serostim 2 mg on alternate days (roughly equivalent to 1 mg daily) during Weeks 12-36 (the "maintenance" phase). All patients in Group B initially received placebo from baseline to Week 24, and then received Serostim® 4 mg daily from Weeks 24 to 36 (Grunfeld, 2007). In the follow-up Study 25373, any subject who was enrolled in Serono Study 24380 and was assigned to Group A, who fully completed all study visits without a major protocol violation, was eligible to enroll to receive re-treatment with Serostim at a dose of 4 mg daily for 12 weeks. During study 25373, safety was monitored by recording of adverse events and measurement of urinalysis and laboratory blood tests to assess fasting glucose, fasting insulin, and routine biochemistry and hematology parameters. At Week 12 or at the time of study termination, subjects underwent re-assessment of body composition via anthropometry measurements and dual photon absorptiometry (DXA) scanning. In addition, at study termination, measurements of insulin-like growth factor I (IGF-I), insulin-like growth binding protein 3 (IGFBP-3), fasting lipid profile, and oral glucose tolerance testing were obtained.
NCT01190111
This study was designed to evaluate the pharmacokinetics of 20µg/kg/week of Interleukin-7 (CYT107), the biological activity and safety of repeated cycles of CYT107, for a maximum of 4 cycles within 21 months and a maximum of 3 cycles within 12 months.
NCT00109733
The primary objective is to evaluate the efficacy and safety of two different dose regimens of r-hGH (Saizen®) in subjects with childhood-onset growth hormone deficiency (COGHD) during the transition phase from childhood to adulthood.
NCT00153985
The purpose of this study is to determine if treatment with reduced-dose busulfex, fludarabine and alemtuzumab (CAMPATH) followed by sten cell infusion will allow for donor stem cells to grow in patients with hemoglobinopathies bone marrow and restore circulating blood counts. In addition the incidence and severity of side effects and of graft vs. host disease (GVHD) will be monitored.
NCT00206076
The purpose of the study is to assess the safety and efficacy of mycophenolate mofetil alone, or with reduced dose cyclosporine (CsA) or tacrolimus, for immunosuppression long-term after liver transplantation, in an attempt to reduce the potential side effects from using cyclosporine or tacrolimus.
NCT00732940
The purpose of this study is to test the safety and tolerability of repeated subcutaneous (SC) doses of belimumab in subjects with SLE.
NCT00094848
The purpose of this study is to evaluate the safety, efficacy and exposure to TRM-1 in subjects with relapsed or refractory Non-Hodgkin's Lymphoma (NHL).
NCT00064051
RATIONALE: Drugs used in chemotherapy such as gemcitabine use different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth and may help gemcitabine kill more cancer cells by making them more sensitive to the drug. PURPOSE: This phase II trial is studying how well giving gemcitabine together with 3-AP works in treating patients with unresectable or metastatic pancreatic cancer.