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NCT01976299
The Osprey Medical AVERT System is indicated to reduce contrast media (CM) exposure to the kidneys during percutaneous coronary procedures thereby reducing the risk of contrast induced nephropathy (CIN).
NCT02638129
The purpose of this study is to evaluate cardiovascular (CV) safety of naltrexone hydrochloride (HCl) and bupropion HCl extended release combination (NB) compared with placebo and rule out excess risk of major adverse cardiovascular events (MACE) when given in combination with standard of care in overweight and obese participants with documented history of CV disease.
NCT02080689
The influence of Decipher test on urologist and patient treatment plan choices immediately post RP and at the time of PSA rise or BCR
NCT01049789
This is a two-phase study that is designed to test a novel behavioral intervention to treat depression in Human Immunodeficiency Virus (HIV) adolescents and young adults. Four Adolescent Trials Network (ATN) sites will be assigned to either the Combination Cognitive Behavioral Therapy and Medication Management (COMB) treatment group or the Treatment as Usual (TAU) group. Phase I involves pilot testing of a 24-week intervention consisting of Cognitive Behavioral Therapy (CBT) and Medication Management (MM) manuals at sites assigned to the COMB treatment group. Participants enrolled at TAU sites will receive treatment for depression that is typical at that site, which may include medication management, psychosocial therapy, or a combination of the two. Psychopharmacological and psychosocial interventions will not be standardized and participants may receive any depression treatment recommended by the site clinicians while on study. Study coordinators and site clinicians, regardless of group assignment, will document depression symptoms and treatment regimens for all participants for 24 weeks. In addition, site staff and participants at COMB sites will participate in an exit interview. The findings from these interviews will be used to revise both CBT and MM intervention manuals at the end of Phase I. Phase II is a feasibility study of the revised CBT and MM manuals. Phase II involves similar procedures as Phase I; sites assigned to COMB will implement the revised CBT and MM manuals. Participants at TAU sites will receive treatment for depression that is typical at that site. As in Phase I, psychopharmacological and psychosocial interventions will not be standardized and participants may receive any depression treatment recommended by the site clinicians while on study. Depression symptoms and treatment regimens for all participants will be documented for 24 weeks. Additionally, all Phase II participants will have 2 follow-up visits at weeks 36 and 48. Again, site staff and participants at COMB sites will participate in an exit interview. The findings from these interviews will be used to revise both CBT and MM manuals at the end of Phase II.
NCT02449629
This study uses a transformative multiphasic mixed-methods research design that incorporates elements of the following designs: * Sequential: a secondary data analysis was conducted, using data from ATN 039, ATN 086, and ATN 106, to influence the development of the qualitative interview and quantitative survey instruments for primary data collection. * Convergent parallel: concurrent collection and analysis of both qualitative and quantitative primary data that will be combined to address the study objectives.
NCT00686049
The goal of this study is to assess the reliability of the HIV Treatment Readiness Measure (HTRM) to assist clinicians in: (1) determining whether or not youth living with HIV are ready to initiate HAART and (2) identifying youth who may be in need of additional support services to facilitate their adherence to HAART. The current study will examine the psychometric properties of the HTRM and establish its test-retest reliability over a two week period. If the HTRM is found to be reliable, a subsequent study will examine its predictive validity.
NCT02438592
This is an observational study involving retrospective and prospective medical record review covering a total maximum of 104 weeks (24 months) per subject. An Audio Computer- Assisted Self-Interview (ACASI) at study entry will assess demographic and psychosocial variables of study subjects. Data will also be collected to assess clinic level variables. Definitions of engagement, prescription of antiretroviral therapy (ART), and viral suppression in the Continuum of Care (CoC) will utilize common definitions including those by U.S. Department of Health and Human Services (DHHS) and Health Resources and Services Administration (HRSA) HIV/AIDS Bureau (HAB). Data will be collected in a large, simple trial design manner to provide all elements for both the primary and secondary outcomes.
NCT00703040
This first phase of a two-phase study involves three components: 1. Review of existing linkage-to-care protocols and sources of referrals for care; 2. Semi-structured telephone or face-to-face interviews with a minimum of two personnel per site who are associated with linkage to medical care. (Preference will be given to personnel with direct experience in linkage to care); and 3. Structured observations of referral sessions.
NCT01203332
The proposed research will include adolescent and young adult Hispanic/Latino men who have sex with men (MSM) and heterosexual men and women, aged 13-24 years, and will be based at 13 ATN Adolescent Medicine Trial Units (AMTUs) that provide clinical care and psychosocial services to the target group. In 10 of the 13 sites, comparisons will be made between alternative venue-based testing (AVT) and social and sexual network-based interviewing and HIV testing (SSNIT) strategies to assess which, among these approaches, is the most effective means for identifying undiagnosed human immunodeficiency virus (HIV) in young, at-risk Hispanics/Latinos. Three of the sites will focus solely on use of SSNIT for identifying undiagnosed HIV in our target group of adolescents and young adults. All study participants will complete an audio computer-assisted self-interview (ACASI) and undergo HIV screening. Participants with presumptive HIV positive screening results will be referred to the local AMTU for confirmatory testing, post-test counseling and referrals for linkage to HIV medical care. Linkage to care for ATN 096 study participants will be conducted in accordance with the Strategic Multisite Initiative for the Identification, Linkage, and Engagement in Care of Youth with Undiagnosed HIV Infection (SMILE in CARING for YOUTH) Program (ATN 093), a collaboration of the CDC and NICHD/ATN, to ensure that youth who test positive for HIV as part of this protocol are linked with treatment and care.
NCT01751620
The proposed study is a two-group randomized repeated measures design that will examine the efficacy of Project ACCEPT (Adolescents Coping, Connecting, Empowering and Protecting Together) to improve engagement in care among youth newly diagnosed with HIV at five AMTU sites across the United States. Youth will be randomized into one of two study arms; Project ACCEPT, the intervention, or HEALTH, the health education attention-controlled comparison condition. Both arms consist of two individual sessions followed by six group sessions and a final individual session which is expected to take approximately nine weeks after which youth will have four follow-up visits at the following time points: * post intervention (immediately after the last session); * 3 months post the last session; * 6 months post the last session; and * 12 months post the last session. The trial will be repeated in up to three waves.
NCT02366533
The goal of ATN 093 is to determine program-level factors associated with the effectiveness of SMILE in Caring for Youth Linkage-to-Care (LTC) program network at the 15 Adolescent Medicine Trial Units (AMTU). This will be accomplished by evaluating and categorizing the various LTC programs at the AMTUs and then examining the association between the LTC program characteristics (providers, practices, and systems) and the proportion of Human Immunodeficiency Virus (HIV)-infected youth, ages 12-24 years old, inclusive, linked to care and maintained in care. As such, this study focuses on LTC programs at the AMTUs as the unit of analysis and not the youth themselves.
NCT00142753
This is an exploratory, laboratory-based evaluation of cellular immune response to immunization with hepatitis B surface antigen in HIV-infected and HIV-uninfected adolescents. This is a substudy of ATN 024 and ATN 025. This substudy will compare cellular immune response in responders and nonresponders to immunization and also evaluate the relationship of these factors to the persistence of known correlates of serologic protection for the hepatitis B virus.
NCT01230021
This trial is conducted in Europe and United States of America (USA). The aim of this clinical trial is to investigate the pharmacokinetics (at which rate the substance is distributed and eliminated from the body) and the safety profile of catridecacog (recombinant factor XIII (rFXIII)) in children with congenital FXIII A-subunit deficiency. Young children (1 to less than 6 years old) with congenital FXIII deficiency are evaluated.
NCT03063489
Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Instillations of Loteprednol Etabonate Ophthalmic Gel, in Normal Healthy Volunteers
NCT00273273
The purpose of this project is to study the pharmacokinetics of a once-daily antiretroviral medication used to treat adolescents and young adults with HIV infection.
NCT01322217
This study will collect information on health status and risk behaviors, as well as basic demographic and biomedical information for a group of HIV positive adolescents receiving care at sites newly participating in ATN III.
NCT00891644
This is the second phase of a two-phase, cross-sectional study of linkage to medical care of HIV positive youth. Social, psychological and behavioral factors associated with receipt of care will be evaluated. This study will also compare three methods for recruitment of out-of-care youth using a randomized permuted block list of possible sequences.
NCT00255892
This study is an exploratory qualitative investigation of the challenges, strengths, and needed areas of support associated with receiving an HIV diagnosis among youth living with HIV. Qualitative interviews will be conducted with health care providers who work with adolescents living with HIV and focus groups will be conducted with adolescents who are living with HIV (ages 16-24). One third of the focus groups will be conducted in Spanish. Findings from this study will be used to create an outline and development plan for a culturally-sensitive and developmentally appropriate intervention (or set of interventions) for youth recently diagnosed with HIV.
NCT00841360
This is a pilot study with a cross-sectional research design to recruit Hispanic/Latina and African American adolescent and young adult women, aged 13-24 years to serve as index recruiters, who will in turn recruit members of her female friendship network, aged 13 years and older to undergo HIV screening. This approach seeks to identify new HIV infections in the target population.
NCT01467375
This trial is conducted in Oceania and North America. The aim of this trial is to assess the long term safety and efficacy of biphasic insulin aspart 30 in subjects with type 2 diabetes who have completed the BIAsp-1234 trial.