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NCT00289783
This study evaluates the immunogenicity and consistency of 3 Hib-MenCY-TT vaccine lots and the safety and immunogenicity of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy infants at 2, 4, and 6 months of age. The study will also evaluate the safety and immunogenicity of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with M-M-R® II and Varivax® at 12 to 15 months of age.
NCT00282295
New immunization recommendations in the US include vaccination of adolescents against pertussis and meningococcal disease. The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention recommends that Tdap (Tetanus Toxoid, Reduced Diphtheria Toxoid And Acellular Pertussis Vaccine Adsorbed) and MCV4 (Meningococcal conjugate vaccine against serotypes A, C, Y and W-135) vaccines be administered to adolescents at the same office visit if vaccination with both vaccines is indicated. Therefore, this study is designed to evaluate the safety and immunogenicity of a booster vaccination with Boostrix co-administered with Menactra as compared to the administration of either vaccine alone in healthy adolescents 11 - 18 years of age.
NCT01123642
Functional recovery is of the utmost importance to evaluate in our returning Operation Enduring and Iraqi Freedom Veterans so that we can better understand their needs and experiences during the readjustment process from warzone to civilian life. Although most soldiers are resilient, concerning rates of PTSD (12-20%) and depression (14-15%) have been found, and as many as 24-35% report drinking more alcohol than they intended (Hoge et al., 2004). The current study proposes to follow returning Veterans for a one-year period to evaluate factors that influence the readjustment process and functional impairment. This information should guide the development of early intervention and treatment programs to help recovery.
NCT01597492
The purpose of this study is to assess the impact of belimumab on immune response to pneumococcal vaccine in subjects with Systemic Lupus Erythematosus (SLE).
NCT01561261
The long-term objective is to develop a tool to aid in making a timely and accurate diagnosis of acute compartment syndrome (ACS). The immediate objective is to develop a model to accurately predict the likelihood of ACS based on data available to the clinician within the first 48 hours of injury (specific clinical findings supplemented by muscle oxygenation measured by near-infrared spectroscopy (NIRS), and continuous intramuscular pressure (IMP) and perfusion pressure (PP) monitoring). Our primary outcome is the retrospective assessment of the likelihood of compartment syndrome made by a panel of clinicians using the following data: * A physiologic "fingerprint" composed of continuous pressure versus time curve, continuous oximetry values, response of muscle to fasciotomy when performed, and serum biomarkers of muscle injury (CPK levels). * Clinical and functional outcomes at 6 months post-injury including: sensory exam, muscle function, presence/absence of myoneural deficit, and patient reported function using the Short Musculoskeletal Function Assessment (SMFA).
NCT00058123
RATIONALE: Biological therapies such as poly-ICLC use different ways to stimulate the immune system and stop tumor cells from growing. PURPOSE: This phase II trial is studying how poly-ICLC works in treating patients with recurrent, progressive, or relapsed anaplastic glioma.
NCT02779192
SPI-1005 is a novel oral drug that contains a glutathione peroxidase mimetic (ebselen) that will be tested in subjects with a history of NIHL at risk for additional NIHL. The goal of this multi-center Phase 2b study is to determine whether SPI-1005 is effective in reducing an acute NIHL in this affected population. In this Phase 2b study subjects with prior NIHL will be enrolled and exposed to a calibrated sound challenge (CSC) that induces a slight acute NIHL.
NCT01871805
This non-randomized, open-label, multicenter study will evaluate the safety and efficacy of alectinib in participants with ALK-rearranged non-small cell lung cancer who failed crizotinib treatment. In Phase I, cohorts of participants will receive escalating doses of alectinib orally twice daily. In Phase II, patients who failed crizotinib treatment will receive the recommended phase II dose.
NCT02042898
TRICS-III is an international, multi-centre, open-label randomized controlled trial of two commonly used transfusion strategies in high risk patients having cardiac surgery using a non-inferiority trial design.
NCT01253447
This phase II trial is studying how well AKT inhibitor MK-2206 works in treating patients with relapsed or refractory acute myeloid leukemia (AML). AKT inhibitor MK-2206 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
NCT02239679
The purpose of this study is to determine if Levulan photodynamic therapy (PDT) is safe and effective in the treatment of actinic keratoses (AK) on the face, following treatment with liquid nitrogen cryotherapy.
NCT00699660
This project evaluated the impact of semi-structured, standardized interviews on the initial PTSD C\&P on the examination.
NCT01721109
The primary objectives of this study are to evaluate the steady-state pharmacokinetics (PK) and confirm the dose of the elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF) single-tablet regimen (STR) (Part A) and to evaluate the safety and tolerability of EVG/COBI/FTC/TDF STR through Week 48 (Part B) in HIV-1 infected, antiretroviral (ARV) treatment-naive adolescents. A total of 50 adolescent participants (12 to \< 18 years of age) will be enrolled to receive EVG/COBI/FTC/TDF as follows: * Part A: Twelve to 16 eligible participants will be enrolled to evaluate steady-state PK, and confirm the dose, with the intent to enroll at least 4 participants 12 to \< 15 and at least 4 participants 15 to \< 18 years of age. * Part B: Following confirmation of EVG exposure in at least 12 participants from Part A, 34 to 38 participants in addition to those enrolled in Part A will be enrolled to evaluate the safety, tolerability, and antiviral activity of EVG/COBI/FTC/TDF STR.
NCT00510874
The purpose of this study is to evaluate the safety and immune response of two-doses of GSK Biologicals' candidate influenza vaccine GSK 1557484A with or without adjuvant in adults. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
NCT03254199
The COMMIT Study will assess the safety and effectiveness of FLX-787 in men and women with Charcot-Marie-Tooth disease (CMT) experiencing muscle cramps. Participants will be asked to take two study products during the course of the study. One of these study products will be a placebo. Approximately 120 participants in 20 study centers across the United States are expected to take part. Participants will be in the study for approximately 3 months and visit the study clinic 3 times.
NCT03061071
This study is a prospective, multi-center, randomized crossover of the NightBalance SPT compared to APAP for the treatment of Positional Obstructive Sleep Apnea (POSA).
NCT03409965
This is a prospective, multi-site, non-randomized study evaluating the safety and effectiveness of the Infini and LaseMD Systems for combination treatment in wrinkles, texture, and pigmentation of the face and/or neck.
NCT00782626
The purpose of this research study is to learn if the study drug RAD001 can shrink or slow the growth of low-grade gliomas. Additionally, the safety of RAD001 will be studied. RAD001 is a drug that may act directly on tumor cells by inhibiting tumor cell growth and proliferation.
NCT01473771
The purpose of this multi-site randomized controlled trial is to determine if the Caring Letters intervention is effective in preventing suicide and suicidal behaviors among U.S. Service Members and Veterans. The primary aim of this project is determine whether caring communications following inpatient psychiatric treatment reduce suicide and self-inflicted injuries among U.S. military personnel and Veterans. The investigators will also explore treatment utilization by comparing the frequency of treatment visits after enrollment into the study. The following specific hypotheses will be tested: Hypothesis 1: During a two year follow-up after the index hospital discharge, the frequency of suicide will be lower among participants in the Caring Letters group compared to those in the Usual Care group. Hypothesis 2: The frequency of medically admitted self-inflicted injuries will also be lower in the Caring Letters group compared to the Usual Care group. Hypothesis 3: The time to suicidal act, among those who do subsequently exhibit one, will be longer among participants in the Caring Letters group compared to the Usual Care group.
NCT03635359
The purpose of this study is to develop and evaluate a blood test and automated microfluidic test platform for the prenatal screening of fetal aneuploidy.