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Discover 13,041 clinical trials near New York. Find research studies in your area.
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NCT02581410
The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' HZ/su vaccine in adults ≥ 65 years of age with and without Zostavax® vaccination at least 5 years earlier.
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.
NCT02186704
The primary aim of the "Sensing Atrial High Rate Episodes with DX System in Implantable Cardioverter Defibrillators Trial" (SENSE Trial) is to assess the efficacy of a implantable cardioverter-defibrillator (ICD) lead with dedicated atrial sensing dipoles in detecting atrial high rate episodes. The study hypothesis is that an ICD system with a lead with dedicated atrial sensing dipoles will have a diagnostic yield comparable to that of a standard dual chamber ICD system and superior to that of a standard single chamber ICD system.
NCT02398461
This is a Phase 1, multi-center, double-blind, randomized, placebo-controlled, dose-escalation study in subjects with relapsing Multiple Sclerosis (MS). The primary outcome will be the safety and tolerability of a single dose of rHIgM22 in relapsing MS subjects.
NCT02011503
The overall objective of this study is to evaluate the effectiveness of dehydrated human amnion/ chorion membrane (dHACM) in reducing time to complete wound closure in patients with venous leg ulcers (VLUs).
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.
NCT00129129
This study is evaluating the safety and immunogenicity of GSK Biologicals' Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, each administered at 2, 4, and 6 months of age, and compared to licensed meningococcal serogroups A, C, Y, and W-135 polysaccharide vaccine administered at 3 to 5 years of age. The safety and immunogenicity of a booster dose of Hib-MenCY-TT vaccine will be compared to a booster dose of licensed Hib conjugate vaccine, each administered at 12 to 15 months of age. The group primed with the Hib conjugate vaccine will re-randomized at 12-15 months of age to receive a booster dose of Hib-MenCY-TT or a booster dose of the Hib conjugate vaccine.
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.
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.
NCT01147328
The purpose of this study is to assess usage of the virtual health record (VHR), and determine the effects of this technology on healthcare utilization.
NCT01636453
To assess the safety and effectiveness of the Penumbra Liberty Stent System as adjunctive treatment to embolic coils for wide-neck, saccular, intracranial aneurysms in the internal carotid artery (ICA). The Liberty Stent System is an implantable device comprised of a stent and delivery system designed as an adjunct to embolic coils in the treatment of wide-neck, saccular, intracranial aneurysms. It has three components: an implant, an introducer sheath and a delivery wire assembly. The implant component is made of superelastic and biocompatible nitinol tubular material. Patients presenting with wide-neck, saccular, intracranial aneurysms in the internal carotid artery (ICA) from the cavernous segment to the carotid terminus (including the paraclinoid, ophthalmic, hypophyseal and posterior communicating segments) will receive stent assisted coiling by the Penumbra Liberty Stent with any approved embolic coils currently on the market. Wide-neck aneurysms are defined by a neck ≥4mm or a dome-to-neck ratio \<2. Each patient will be followed and assessed for 2, 6 and 12 months after enrollment.
NCT00278343
This phase II trial is studying how well cediranib maleate works in treating patients with persistent, recurrent, or refractory advanced ovarian epithelial, peritoneal cavity, or fallopian tube cancer. Cediranib maleate may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.
NCT00032344
Colorectal cancer is a leading cause of cancer death in the United States. Mortality remains high because most colorectal cancers are detected after there has been regional or distant spread, precluding curative surgical resection. With this in mind, screening strategies have been recommended for asymptomatic individuals which hope to reduce mortality from colon cancer by detecting and removing premalignant adenomatous polyps or early malignant lesions. Screening of asymptomatic individuals over age 50 with sigmoidoscopy and fecal occult blood tests has been advocated by the American Cancer Society. However, current screening will identify only 50% of patients who have adenomatous polyps. More sensitive tests for polyp detection, like colonoscopy, are costly, require extensive resources and are unlikely to be used for screening large populations. Ideal screening would identify patients with the highest risk of cancer and target more sensitive screening tests at this population. The identification of low cost, easily collectible risk factors which can be used to target patients for the more sensitive screening tests is the primary purpose of this study. Since a major segment of the veteran population is over the age of 50, there will be a substantial impact in reduction of both mortality and morbidity due to colon cancer and attendant cost savings to the VA for treatment if such risk factors can be identified. Phase I is a cross-sectional study designed to identify risk factors for large (\>1 cm) adenomatous polyps. Approximately 3200 asymptomatic subjects (age 50-75) have completed risk factor assessment, medical and dietary histories, and have undergone complete colonoscopy examination. This will identify for comparison purposes a polyp-free control group and is the first large prospective study to include such a group. Data at colonoscopy will characterize the prevalence, size and distribution of adenomatous polyps. This will permit an assessment of sensitivity of sigmoidoscopy in this population. In addition, tissue from normal rectal mucosa will be analyzed for evidence of cell proliferation activity. The primary focus of Phase I is a risk factor analysis. A multivariate analysis will be performed to determine the relationship of historical and environmental factors as well as cell proliferation activity with the presence of adenomatous polyps. A cohort consisting of a subgroup of polyp patients (large and small) and matched polyp-free controls will be tracked longitudinally to determine polyp occurrence/recurrence rates. Phase II of the study is a long-term follow-up study designed to evaluate the relative risk of two repeat colonoscopies. Phase III is an extension in follow-up of an additional five years, a total of ten years in all, to include all study patients. The primary focus will be on documenting long-term mortality and medical outcomes as well as occurrence/reoccurrence of neoplasia with special emphasis on ten-year cancer rates.
NCT01207687
People who have neurofibromatosis type 2 (NF2) can have tumors that grow on the auditory nerves and cause hearing loss. These tumors are called vestibular schwannomas (VSs), or acoustic neuromas. People with NF2 can also get schwannomas in other parts of their body, as well as tumors called meningiomas and ependymomas. Because VSs can cause hearing loss, many people with NF2 will have treatment to preserve their hearing. This treatment usually involves surgery. Because surgery has risks and is not able to help everyone with VSs, other methods of treatment are being explored. One area of exploration is looking to see if there is a drug that can be taken that might prevent the VSs from growing larger and causing hearing loss or brainstem compression. This study is exploring whether a drug that is approved by the FDA and is currently used to treat other tumors might also work to treat VSs. Based on people who have taken this drug to treat VSs already, there is some reason to think that it might be helpful to certain people with NF2. People enrolled in this study will receive the drug one time every three weeks for one year by infusion. This study will follow subjects over the course of the year that the person is taking the drug and for six months after the drug is stopped. This study is recruiting people who have NF2 and are currently having symptoms of tinnitus, dizziness, and/or hearing loss from their VSs. If you have NF2 and are currently having symptoms caused by your VSs, you may be eligible to participate.
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.
NCT02261974
Outside United States (OUS) Post-Market Parallel Group Exploratory Study Design The objective of this study is to determine the safety and effectiveness of the Viveve System to treat the vaginal introitus in women following vaginal birth(s) and in so doing improving vaginal laxity.
NCT01985243
Despite recent economic growth in Ghana, the prevalence of childhood malnutrition remains high. Wasting prevalence affected 29% among 6- to 8-months-old infants in 2008. Poor nutrition contributes to about one-third of child mortality, diminishes cognitive development, and is a major determinant of maternal mortality. The specific objectives of the 5-year project are to: (1) enhance human capacity of government, civil, and private institutions through improvement of knowledge and skills of personnel in agriculture, nutrition and health, entrepreneurship, and pedagogy; (2) identify information needs of local institutions that are not presently met and develop a representative and sustainable longitudinal data system to support evidence-based decision-making in programs; (3) increase vulnerable households' access to quality services in agriculture/fisheries, nutrition and health, and finance; (4) implement integrated intervention activities to improve infant and young child and adolescent nutrition outcomes; and (5) examine differential benefits of the interventions for diverse vulnerable populations. The project comprises two major activities: part I - the creation of a longitudinal data system to support evidence-based decision-making in programs, and part II - the implementation of intervention activities to improve nutrition outcomes. The survey will include demographic, socioeconomic, health, diet, and nutritional status information collected annually from a representative same of 1500 households with infants (0-12 mo) and 1500 households with adolescents (9-12 y). The data will be analyzed and presented rapidly each year to district program and policy leaders to assist them in developing their activity plans for the following year.
NCT02273037
A novel handheld Doppler has been developed which is rugged and is powered only by a hand crank. This study aims to test the use of this Doppler versus the Pinard horn to monitor the fetal heart rate in labour in a hospital setting in Uganda. The investigators propose that with its ease of use, both for the woman and midwife, midwives using the Doppler will identify more babies in need of prompt delivery and the risk of stillbirth and neonatal mortality will decline. In the research study, the investigators will compare the risk of stillbirths and neonatal mortality in two randomized groups of labouring women. The second part of the study consists of an audit of the documentation in labour by midwives. The partograph is an uncomplicated, low cost form on which observations during labour are documented. It includes three sections of information: fetal condition, maternal condition and labour progress. Although the use of a partograph during labour is strongly recommended by the WHO, there are limited published systematic evaluations of the correct use of the tool. The investigators aim to use this randomized trial design to assess rates of intrapartum stillbirth and neonatal mortality in the first 24 hours after delivery, and assess the quality of partographs comparing two groups. This trial will provide insights on the potential benefits of using handheld Doppler devices for intrapartum monitoring, and the audit of partograph quality will provide insights to improve care during labour. This study hypothesizes that the quality of partograph completion and of fetal heart rate monitoring may systematically differ between the Doppler and Pinard groups.
NCT02309411
The purpose of this study is to find out whether rivaroxaban is safe to use in children and how long it stays in the body. Safety will be assessed by looking at the incidence and types of bleeding events. There will also be a check for worsening of blood clots.
NCT02794519
Sirukumab is a fully human anti interleukin (IL)-6 immunoglobulin G1-kappa monoclonal antibody (MAb) which is in development for the treatment of rheumatoid arthritis (RA). The continuing unmet need in subjects with asthma refractory to corticosteroid therapy and increased understanding of asthma pathogenesis have stimulated the development of targeted biologics based on predictive biomarkers. The majority of approaches to date have targeted T Helper 2 (Th2) cytokines or their downstream effects. Targeting IL-6 in severe asthma represents an unprecedented approach that has potential to address non-Th2 drivers of severe asthma. This multicenter, randomized, double-blind (sponsor-unblind), placebo-controlled, parallel group study will investigate the efficacy of sirukumab compared to placebo in subjects having uncontrolled severe asthma despite use of high dose inhaled corticosteroid (ICS) in combination with long-acting Beta-agonist (LABA). The study will employ a variable treatment period for individual subjects. Dosing will continue every 4 weeks until week 44 (inclusive), or until 24 weeks after the final subject has been randomized, whichever the sooner. Upon receiving the final dose of study medicine or placebo, subjects will enter a 16 week Follow Up period. Overall, the duration of participation for subjects who complete the full 44-week treatment period and Follow Up period may be up to 64 weeks. Approximately 175 subjects will be randomized such that 140 evaluable subjects complete the study.
