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Showing 14401-14420 of 17,868 trials
NCT00280137
To examine the psychometric properties of a brief quality of life (QOL) instrument for use in pediatric systemic lupus erythematosus (SLE). The purpose of this prospective study is primarily to determine the validity and reliability of a new health-related quality of life (HRQOL) measure in children with systemic lupus erythematous (SLE). We wish to secondarily examine concordance between child- and parent-reports of the HRQOL measure and identify factors associated with poorer HRQOL in them. Earlier studies have shown that SLE significantly impacts QOL in adults. At present, there is no disease-specific instrument for measuring HRQOL in children with SLE. In response to these concerns, we developed the "Simple Measure of Impact of Lupus Erythematosus in Youngsters© (SMILEY©). Establishing the validity and reliability of SMILEY©, examining child-parent agreement and identifying factors associated with poorer HRQOL will enable us to measure the impact of SLE in children, and formulate appropriate interventions for this sensitive population. We plan the following specific aims: 1. to determine construct validity and reliability of SMILEY© child and parent versions in children with SLE using gold standards (Pediatric Quality of Life inventory - PedsQL generic and rheumatology modules, Childhood Health Assessment Questionnaire -CHAQ) 2. to determine responsiveness of SMILEY© 3. to examine level of agreement between child- and parent-reports of SMILEY© in children with SLE 4. to identify medical (steroid use, use of disease modifying agents such as cytoxan, cellcept, thalidomide, or cyclosporine, disease duration, disease activity and disease damage etc.) and psychosocial (self-concept, socioeconomic status) factors that affect HRQOL (as measured by child- and parent-reports of SMILEY© and PedsQL generic and rheumatology modules) and physical function 5) to translate, adapt and validate SMILEY in different languages
NCT01423253
Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with mixed features.This clinical study is designed to test how well Lurasidone works to treat major depressive disorder with mixed features over time.
NCT00396097
To demonstrate that an individualized, formula-based Genotropin regimen for children with Idiopathic Short Stature will lead to a targeted height gain (to reach the target of 10th percentile (%), or -1.3 SDS) during 24 months of treatment. The endpoint at 4 years is to explore treatment efficiency over four years of two formula-based dose regimens (sub-arms) compared to standard treatment
NCT01705145
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD), of ivacaftor in children with cystic fibrosis (CF) who are 2 through 5 years of age and have a CF Transmembrane Conductance Regulator (CFTR) gating mutation in at least 1 allele. Part A is designed to evaluate the safety and PK of multiple-dose administration of ivacaftor in participants 2 through 5 years of age and to confirm the doses for Part B. Part B is designed to evaluate the safety, PK, PD, and efficacy of ivacaftor in participants 2 through 5 years of age.
NCT02366169
This registry is intended as an observational, post-marketing surveillance tool. The registry allows collection of baseline demographics and user experience of the commercially available MUSE system. Data collection aims to aggregate a minimum of 3 years follow-up on a large number of subjects during use outside the constraints of a prescribed clinical study.
NCT01230827
The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in patients who have active juvenile idiopathic arthritis (JIA) and at least 5 joints with active arthritis that have poor response to methotrexate.
NCT01172704
This is a two-arm randomized controlled trial (RCT) for 308 seriously mentally ill adults (SMI) engaging in risky sexual and/or drug use behavior, comparing a brief HIV primary and secondary prevention intervention \[Skills building and Motivational Interviewing (SB-MI) to Care as Usual (CAU)\]. The study setting is a large urban safety net Medical Center and outcomes will be measured at 3, 6, and 12 months. The SB-MI intervention (3 sessions + booster) was initially developed as the experimental condition in an R34 pilot project which demonstrated its feasibility and promise. For the proposed project, the investigators will recruit a larger sample which includes men and women with and without HIV, from various ethnic and racial groups, sexual orientations and housing arrangements, as well as a range of psychiatric disorders and functional capacities. In this way the investigators can more rigorously demonstrate the promise of SB-MI with SMI. The investigators will also conduct a sub-study after the 6 month follow-up to examine the impact at 12 months of an additional booster session for SB-MI participants. The investigators specific aims are: 1. To examine the effectiveness of a brief, tailored primary and secondary risk reduction strategy to CAU for people with serious mental illness. The desired outcomes include: * Decreased frequency of risk behaviors (number of partners, number of encounters) * Increased use of barrier precautions and IV needle cleaning * Positive changes in information and motivation, as well as risk behaviors * Increased HIV Counseling and Testing for those who do not know their HIV status 2. To examine the effectiveness of a 2nd booster session after the 6 month follow-up for ½ of participants randomized to SB-MI. The primary outcome will be: * Decreased frequency of risk behaviors and increased use of barrier precautions at the 12 month follow-up
NCT00543725
The purpose of this trial is to compare the effectiveness, safety and tolerability of TMC278 given at a dose of 25 mg once daily versus efavirenz (EFV) at a dose of 600 mg once daily, when combined with a background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors ( investigator choice of ABC/3TC, TDF/FTC or AZT/3TC) in HIV-1 infected patients who have not yet taken any anti-HIV drugs. The following evaluations will be done: antiviral activity, immunologic changes, and viral geno-/phenotype evolution, relationship of Pharmacokinetics (PK) and PK/Pharmacodynamics and Medical resource utilization and treatment adherence.
NCT00960531
The purpose of this study is to assess the long term safety, tolerability, and immunogenicity of ACC-001, an investigational vaccine, plus QS-21 in subjects with mild to moderate Alzheimer's disease.
NCT01825330
The study tests the effect of the NeuroAD on Alzheimer patients' cognitive function. The NeuroAD uses non-invasive stimulation of both magnetic and cognitive training.
NCT00608881
The goals of this trial are to determine if coenzyme Q10 is effective in slowing the worsening symptoms of Huntington's disease and to learn about the safety and acceptability of long-term coenzyme Q10 use by determining its effects on people with Huntington's disease.
NCT00120289
The purpose of this study is to determine whether raising "good cholesterol" with a drug based on the vitamin niacin, while lowering "bad cholesterol" with a statin drug, can prevent more heart disease than the statin alone.
NCT02114151
The purpose of the study is to investigate the efficacy and safety of 12 weeks of simeprevir (150 mg qd) in combination with sofosbuvir (400 mg qd) in chronic hepatitis C virus (HCV) genotype 1 infected men and women with cirrhosis who are HCV treatment-naïve or treatment-experienced.
NCT01628913
This was a multicenter, open label, randomized phase II study to evaluate the efficacy and safety of BEZ235 as compared to everolimus in patients with advanced, low to intermediate grade pancreatic neuroendocrine tumor (pNET).
NCT01456195
The purpose of this study is to determine the efficacy and safety of TAK-875 (fasiglifam), once daily (QD), in participants with type 2 diabetes mellitus (T2DM).
NCT01778049
The objective of the study is to investigate the efficacy, safety and tolerability of linagliptin 5 mg qd compared to placebo given for 24 weeks in inadequately controlled T2DM patients on empagliflozin 10 mg or 25 mg and maximum tolerated dose of metformin. The primary objective of efficacy evaluation is planned after 24 weeks of treatment. The study is designed to show superiority of the combination of empagliflozin and linagliptin over empagliflozin alone.
NCT02293265
This will be a non-drug interventional cross-sectional study, where the screening visit and study visit can occur on the same day. Investigational product will not be administered. Approximately 790 subjects with severe asthma will be screened to achieve a total of at least 750 evaluable study subjects. The study will not include a run-in or follow-up period. This study will provide a more reliable description of the severe asthma patient landscape with respect to the potential eligibility for treatment with mepolizumab, omalizumab, and reslizumab. This study aims to estimate the potential overlap of patients eligible for treatment with mepolizumab and those eligible for treatment with omalizumab and/or reslizumab. Additionally, the current study will also ascertain and describe reslizumab eligibility with respect to both mepolizumab and omalizumab, in the severe asthma patient population.
NCT01827228
Half or more of HIV transmission events may occur within the period of high infectivity (and often high risk behavior) that can last 11 months or more after a person is initially infected. Unfortunately, neither test-and-treat intervention methods nor Acute HIV Infection projects have found effective ways to intervene against transmission during this risky "recent infection" period. The investigators seek to develop effective intervention techniques against HIV transmission during the recent infection period using a combination of injection-, sexual- and social-network-based contact tracing methods; community alerts in the networks and venues of recent infectees; and the logic of going "up" and "down" infection chains. The investigators first Aim is to develop and evaluate ways to locate "seeds," defined as drug users and other people who have recently been infected. The investigators second Aim targets members of seeds' networks and people who attend their venues. The investigators will test them for acute and for recent infection, and alert them to the probability that their networks contain highly-infectious members so they should reduce their risk and transmission behaviors for the next several months to minimize their chances of getting infected. This may also reduce transmission by untested people with recent infection. Community, network and venue education about the need and value of supporting those with recent infection should reduce stigma. The investigators third Aim is to reduce HIV transmission and to develop new ways to evaluate "prevention for positives" generally as well as The investigators own success in reducing transmission. The investigators will do this using a combination of follow-up interviews and testing, including of viral loads; phylogenetic techniques; and discrete event simulation modeling to assess The investigators effectiveness.
NCT00354341
This study will assess the effect of anemia correction with NeoRecormon on cardiac structure and function in patients with early diabetic nephropathy. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.
NCT02353663
Rheumatic heart disease remains a major challenge in low and middle income countries. Early detection of clinically silent valvular lesions by screening echocardiography allows timely implementation of secondary antibiotic prevention, and may prevent progression of disease to severe valvular damage and heart failure. The objective of the study is to assess the prevalence of rheumatic heart disease among schoolchildren in Arequipa, Peru. Subsequently, the investigators will evaluate progression of disease in children with early stages of subclinical rheumatic heart disease. The investigators will perform a population-based observational survey for rheumatic heart disease using portable echocardiography among schoolchildren aged 5 to 16 years from randomly selected public and private schools. Rheumatic heart disease will be documented both according to the modified World Health Organization definition and the echocardiographic criteria suggested by the World Heart Federation.
