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Discover 17,526 clinical trials near North Carolina. Find research studies in your area.
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NCT00404768
Pre-Term Labor (prior to 37 weeks gestation) is the largest single cause of infant morbidity and mortality and is frequently associated with long-term disability. Oxytocin is a hormone produced by the body during labor. GSK221149A is an experimental drug that will be used to block the effects of oxytocin, and therefore pause or prevent contractions. In this study, patients with preterm labor will be given an intravenous infusion of GSK221149A over approximately 12 hours followed by an oral tablet in Parts A and B. In part C of this study, patients with preterm labor will be give an intravenous infusion of GSK221149A over approximately 48 hours. The use of a rescue tocolytic is allowed in the study.
NCT01449929
This study will be conducted in approximately 468 HIV-1 infected antiretroviral therapy (ART)-naïve subjects. Subjects will be randomized 1:1 to receive dolutegravir (DTG) 50 mg once daily (approximately 234 subjects) or darunavir/ritonavir (DRV/r) 800 mg/100 mg once daily (approximately 234 subjects), each in combination with fixed-dose dual nucleoside reverse transriptase inhibitor (NRTI) therapy (either abacavir/lamivudine (ABC/3TC) or tenofovir/emtricitabine (TDF/FTC). Subjects will be stratified by screening HIV-1 RNA and background NRTI selection. The primary analysis will take place after the last subject completes 48 weeks on therapy; an additional analysis will be conducted after the last subject completes Week 96 on study.
NCT01128959
The purpose of this study is to assess the safety and tolerability of intravenous (IV) carbamazepine (CBZ) administered as multiple 15 minute infusions and a single 5 minute infusion to adult patients with epilepsy on stable higher doses of oral CBZ.
NCT02230332
Beta-2-agonists are effective in reducing airway narrowing in asthma and protecting against stimuli that produce bronchoconstriction. The combination of long-acting beta agonists (LABA) and inhaled corticosteroids (ICS) has become the most commonly used asthma controller medication class in the United States, but unfortunately, even when LABAs are added to ICS and used regularly, 58-81% of patients with asthma fail to achieve total control. Regular use of beta-agonists, both short and long-acting, reduces the ability of these agents to protect against the airway narrowing that occurs in asthma in response to bronchoconstrictor stimuli. We refer to this reduced effect as loss of bronchoprotection. In this proof of concept trial we aim to determine if alendronate, which diminishes beta-2 adrenergic receptor internalization, can reduce the loss of bronchoprotection that occurs with regular use of LABAs, even when used in combination with ICS.
NCT02782130
This is a two-arm, randomized-controlled trial (RCT) that will test the acceptability, impact, and long-term sustainability of the Epic Allies intervention application (app), a theory-based mobile app that utilizes game mechanics and social networking features to improve engagement in care, antiretroviral therapy (ART) uptake, ART adherence, and viral suppression among HIV-positive young men who have sex with men (YMSM) and trans women who have sex with men. Subjects will be randomized to either the intervention branch of the Epic Allies app or the control branch of the app.
NCT02346214
The purpose of this study is to develop a novel, highly automated method of gestational age estimation at delivery combining anterior lens capsule vascularity (ALCV) and biophysical parameters appropriate for use in low income countries. The specific aims of the proposed study are: (1) To develop an algorithm to predict gestational age at delivery from 26 to 42 weeks' gestation with ALCV and key biophysical parameters (2)To evaluate the performance of ALCV and biophysical parameter-based gestational age estimates. Specifically, we hypothesize that the accuracy of the predictive algorithm will be comparable to commonly used measures of gestational age dating (±2 days) and have better precision (±14 days) than commonly used measures of gestational age dating.
NCT02641444
The purpose of this research study is to find out how the drugs Truvada® (tenofovir/emtricitabine), Isentress® (raltegravir), Reyataz® (atazanavir), Sustiva® (efavirenz), and Selzentry® (maraviroc) get into the intestines and the female genital tract. All of these drugs are very effective at reducing the number of HIV viruses in the blood, however it is unknown how the drugs move around inside tissues where HIV might be hiding. This study will determine specifically where in the tissue the drug and the HIV are located through the use of a new technology that takes creates a picture of the tissue. This information will help scientists determine the best way to make new drugs to target the hidden HIV in tissue.
NCT00435942
The purpose of this study is to evaluate the safety and efficacy of the Relay thoracic stent-graft system to treat thoracic aortic aneurysms. Efficacy will be evaluated by the device-related adverse event rate of endovascular repair (via Relay Thoracic Stent-Graft) through 1-year. Safety will be evaluated by comparing major adverse events through 1-year in subjects treated with the Relay Thoracic Stent-Graft to those who underwent surgical repair. Long term follow-up is conducted through 5 years.
NCT03233113
Exposure-based cognitive-behavioral therapy (i.e., "exposure therapy"), which entails repeated and prolonged confrontation with feared situations/stimuli, is the most effective treatment for anxiety disorders (e.g., arachnophobia). Safety behaviors are actions performed to prevent, minimize, or escape a feared catastrophe and/or associated distress (e.g., wearing thick shoes or gloves when around areas where there might be spiders). It is understood that safety behaviors contribute to the development and maintenance of anxiety disorders; accordingly, patients' safety behaviors are traditionally eliminated as soon as possible during exposure therapy (i.e., "response prevention"). Unfortunately, not everyone who receives exposure therapy benefits from this approach. To address the limitations of exposure's effectiveness, some experts have questioned the clinical convention of response prevention during exposure therapy. Specifically, they propose the "judicious use of safety behaviors": the careful and strategic incorporation of safety behaviors during exposure therapy. The controversial role of permitting safety behaviors during exposure has garnered substantial research attention, yet study findings are mixed. The current study, therefore, was designed to improve upon the methodological limitations of previous related research and examine the relative efficacy of traditional exposure with response prevention (E/RP) and the experimental exposure with the judicious use of safety behaviors (E/JU) in a sample of adults with arachnophobia. In light of previous related research, several hypotheses were made regarding the short- (posttreatment) and long-term (1-month follow-up) treatment effects: 1. Primary outcomes: E/RP participants will demonstrate greater improvement in spider phobia than the E/JU participants along behavioral and self-report symptom measures at follow-up. 2. Secondary outcomes: Treatment acceptability and tolerability will be higher for E/JU participants, relative to E/RP participants, before beginning exposures and at posttreatment, but not at follow-up. In addition, hypothesize that E/RP participants will report greater reductions in peak distress and greater improvements in distress tolerance relative to E/JU participants at follow-up. 3. Additional outcome: Exploratory analyses will be conducted to compare the relative rate of behavioral approach and exposure goal completion between treatment conditions.
NCT02427217
This is a multicenter, non interventional, retrospective cohort study with a prospective, observational follow-up component to investigate the safety and efficacy of FCH use in subjects with congenital fibrinogen deficiency. Data will be collected on the safety and efficacy of FCH as used for the treatment of acute bleeding episodes, routine prophylaxis and perioperative bleeding in these subjects. All subjects have received FCH and may continue to receive FCH at the discretion of the treating physician / Primary Investigator according to the standard of care at the participating study site.
NCT01119846
The purpose of this study is to see if GSK1292263 is safe and well-tolerated when administered to type 2 diabetics, and to get preliminary information about whether it may be effective in the treatment of type 2 diabetes.
NCT00683696
The EchoCRT trial evaluates the effects of Cardiac Resynchronization Therapy (CRT) on mortality and morbidity of subjects with heart failure due to left ventricular systolic dysfunction, already receiving optimized HF medication, with a narrow QRS width (\< 130 ms) and echocardiographic evidence of ventricular dyssynchrony.
NCT00951015
This Phase IIb study in HIV-infected antiretroviral naive subjects will select an optimal once daily dose of GSK1349572 from a range of doses for future evaluation.
NCT00673712
The main goals of the study are as follows: (1) to determine the correlation between pain management using continuous infusion of local anesthetics and the incidence of pneumonia and surgical infection in cardiac surgery patients; and (2) to evaluate the relationship between hospital-acquired pneumonia and surgical infection and patient outcomes, including length of hospital stay.
NCT02537470
This is a dose-ranging study to evaluate the efficacy, safety and tolerability of a range of doses of a biphasic formulation of remogliflozin etabonate compared to placebo, administered over 12 weeks in subjects with type 2 diabetes mellitus.
NCT02934360
The TR(ACE) Assay is a quantitative in vitro diagnostic test run on the TR(ACE) Instrument intended for the measurement of high molecular weight human DNA from plasma as an aid to monitoring disease progression or response to therapy or recurrent or residual disease.
NCT01772823
Approximately 200 HIV-uninfected young men who have sex with men (YMSM) at high risk of acquiring HIV infection, ages 18-22 years, inclusive, will be recruited across all participating Adolescent Medicine Trials Units (AMTU). The behavioral intervention will be assigned at the level of the site, which include Many Men, Many Voices (3MV) and Personalized Cognitive Counseling (PCC). Subjects will first complete the behavioral intervention offered at their respective site and then be provided with open label emtricitabine (FTC)/tenofovir (TDF) (Truvada®) as PrEP. Behavioral and biomedical data will be collected at baseline and 0, 4, 8, 12, 24, 36 and 48 weeks. Any subjects who become HIV infected during the course of the study will be discontinued from the study agent and followed for an additional 24 weeks after the study visit at which HIV infection is confirmed. Those subjects who meet specific bone or renal criteria at the Week 48 visit or the 24-Week HIV Seropositive visit will be followed for an additional 48 weeks in the Extension Phase to monitor longer-term outcomes of potential concerns.
NCT00820560
To establish the maximum tolerated dose (MTD) of INCB007839 given as multiple doses for 28 days and to determine if a higher MTD can be established when INCB007839 is administered in combination with prophylactic anticoagulation and with a 2 and a half day (5 doses) treatment interruption every two weeks.
NCT02465203
Follow-up for viral activity, changes in liver function and safety in patients with no SVR24 in feeder studies
NCT03401866
This clinical trial is to validate and demonstrate the clinical usefulness of a protocol for Magnetic Resonance Imaging (MRI) in people with high grade glioma brain tumors.
