Browse Catalog of Studies
Showing 87 out of 87 studies
Study Description: A Phase II, randomized, double-blind, withdrawal to placebo study examining the efficacy, safety, and tolerability of sodium nitroprusside (SNP) in pediatric subjects. Objectives were to determine the persistence of the effect of SNP on blood pressure during stable infusion regimens lasting at least 12 hours and to assess the potential for rebound hypertension during a 30 minute blinded phase following administration of SNP for at least 12 hours when infusion is temporarily discontinued.
Study Description: The primary goal of ATN 084, a pilot study and sub-study of ATN 067, was to explore the feasibility and acceptability of index female recruiters identifying and recruiting their past and present male sexual partners to undergo HIV screening. In addition, the study included female friendship network members of the index recruiters who were enrolled in ATN 067 and were diagnosed with HIV. These young women were asked to recruit their past and present male sex partners to undergo HIV screening. Factors facilitating and hindering HIV screening of the male sexual partners were also examined.
Study Description: A cross-sectional pilot study that enrolled sexually experienced Hispanic/Latina and African American adolescent and young adult women to serve as index recruiters, who in turn recruited members of their female friendship network to undergo HIV screening. Participants were stratified into three groups based on self-reported HIV infection status. The feasibility and acceptability of identifying and recruiting young women who self-disclose their HIV status to serve as index recruiters were examined. Factors facilitating and hindering recruitment of friendship network members to undergo HIV screening, friendship network members undergoing HIV screening, and HIV negative and HIV status unknown index recruiters undergoing HIV screening were also examined.
Study Description: Describes the demographic, clinical, immunologic, and virologic characteristics of HIV-exposed uninfected infants and HIV-infected infants, children, and adolescents at clinical sites in Latin America. Biospecimens are available.
Study Description: Describes the characteristics of HIV-infected pregnant women and their HIV-exposed, uninfected children at clinical sites in Latin America, including the utilization of interventions related to decreasing the risk of mother-to-child transmission. Biospecimens are available.
Study Description: Describes the characteristics of HIV-infected pregnant women and their HIV-exposed infants at participating clinical sites in Latin America and the Caribbean, including the utilization of interventions related to decreasing the risk of mother-to-child transmission. Biospecimens are available.
Study Description: The second of two multiphase, multicenter trials that comprehensively examined lithium in the treatment of pediatric patients with bipolar I disorder. In the first phase, the Efficacy Phase, participants were randomized to either lithium or placebo for 8 weeks to determine efficacy. Eligible participants then continued in the Long-Term Effectiveness Phase for a maximum of 24 weeks of lithium treatment. Subsequently, participants meeting response criteria during the Long-Term Effectiveness Phase were eligible to continue in the Discontinuation Phase, when they were randomized to either placebo or lithium treatment for up to 28 weeks. Finally, those participants who experienced a mood relapse during the Discontinuation Phase were enrolled in an Open Label Restabilization Phase and treated with lithium for up to 8 weeks.
Study Description: This study developed a culturally appropriate secondary prevention intervention for young HIV+ women through focus groups. Focus groups were digitally recorded and transcribed. Focus groups informed the development of the intervention's framework and content areas. The intervention aimed to reduce the risk of young women infected with HIV transmitting the virus to their sexual partners, and to prevent young women infected with HIV from re-infection with a new viral strain or co-infection with another sexually transmitted disease.
Study Description: An exploratory mixed-methods study comparing a behavioral HIV-prevention intervention (Many Men, Many Voices or 3MV) alone to 3MV combined with a biomedical intervention (Pre-exposure Prophylaxis or PrEP). After completing the 3MV intervention, participants were randomly assigned to one of three study arms: 1) daily PrEP with emtricitabine and tenofovir (FTC/TDF); 2) placebo pill control; or 3) “no pill” control. Behavioral and biomedical data were collected at baseline and every 4 weeks for 24 weeks. Qualitative interviews with a subset of participants were completed at the end of the study to explore the feasibility and acceptability of the trial. Eligible youth who declined to participate were asked to complete a brief opinion survey about PrEP. In addition, a focus group was conducted with young men ages 16-17 years who have sex with men and who met all eligibility requirements except for age to discuss issues of feasibility and acceptability should they be eligible to enroll in a future similar trial.
Study Description: The PHACS AMP study is designed to define the impact of HIV infection and antiretroviral therapy on pre-adolescents and adolescents with perinatal HIV infection. Domains investigated include growth and sexual maturation; metabolic risk factors for cardiovascular disease; cardiac function; bone health; neurologic, neurodevelopment, language, hearing, and behavioral function; and adolescent gynecology and HPV infection. Biospecimens are available.
Study Description: An open label study to describe the safety and pharmacokinetics of intravenous acyclovir in premature infants with suspected systemic herpes simplex virus (HSV) infection. Dosing group assignments were based on gestational age (GA) and postnatal age (PNA). Protocol version 1.0 (n=13) included four groups, with GA 23-42 weeks and PNA up to 60 days; version 2.0 (n=19) included three groups, with GA 23-34 weeks and PNA <45 days. Acyclovir was administered every 8-12 hours for up to 3 days and was well tolerated. This study was conducted by the Pediatric Trials Network under the Best Pharmaceuticals for Children Act Program. Biospecimens were collected but are not currently available.
Study Description: ACT, funded by the NICHD, studied the feasibility, effectiveness and safety of a multifaceted intervention designed to increase the use of antenatal corticosteroids (ACS) at all levels of health care in low- and middle-income countries. Investigators conducted a two-arm parallel cluster randomized trial of women enrolled in the Global Network Maternal Newborn Health Registry. Intervention clusters received health-provider training, posters, pregnancy disc, and uterine height tape to facilitate identification of women at risk of preterm birth, and ACS kits. All health providers in intervention clusters were trained to identify women presenting before 36 weeks’ gestation with signs of labor, PPROM, pre-eclampsia/eclampsia, or obstetric hemorrhage as at high risk of preterm birth and potential candidates for ACS. The primary outcome was 28-day neonatal mortality among infants less than the 5th percentile for birth weight (a proxy for preterm birth).
Study Description: A mixed-methods study to characterize the HIV prevention and care continua among Transgender and Other Gender Minority Youth (TGMY) ages 16-24. Quantitative surveys and qualitative interviews were conducted with TGMY in care and TGMY not in care. In addition, qualitative interviews were conducted with health care and social service providers who work with TGMY. This study assessed transgender youth experiences with accessing services along the HIV prevention and care continua, including barriers and facilitators to service engagement.
Study Description: A sub-study of ATN 071 ("Neurocognitive Assessment in Youth Initiating HAART"), ATN 101 was an exploratory assessment comparing the results of a comprehensive neurocognitive evaluation carried out through ATN 071 to biomarkers within the plasma that correlate with immune activation, inflammation, and microbial translocation among study participants. Neurocognitive evaluations from ATN 071 were available for three years of follow-up; blood samples for ATN 101 were collected at the final ATN 071 study visit. In a subset of participants co-enrolled in ATN 061 ("Preservation and Expansion of T-cell Subsets Following HAART De-intensification to Atazanavir/ritonavir (ATV/r) in Adolescents and Young Adults with CD4 + T Cells > 350 cells/mm3 Initiating HAART), biomarkers were evaluated before and after the initiation of HAART.
Study Description: In this multicenter, randomized trial published in NEJM, 900 couples with unexplained infertility were enrolled to test the standard therapy of gonadotropin or clomiphene citrate for women with unexplained infertility against ovarian stimulation with letrozole to reduce multiple gestations while maintaining live birth rates. The primary outcome was the rate of multiple gestations among women with clinical pregnancies, and we found that in women with unexplained infertility, ovarian stimulation with letrozole resulted in a significantly lower frequency of multiple gestation but also a lower frequency of live birth, as compared with gonadotropin but not as compared with clomiphene.
Study Description: A cross-sectional sub-study of ATN 106 ("Network-Wide Assessment of Current Health Status and Behavioral Risk Factors: An Expanded Study for New Sites in ATN III"). In addition to sharing data collected in ATN 106, an oral rinse sample, the subject’s self reported history and medical chart abstraction of HPV vaccination status and history of oral condylomata, oral dysplasia and oral tumor viruses were collected. Oral rinse specimens were tested for HPV, EBV and KSHV viruses.
Study Description: A multi-center, six year longitudinal study examining bone accretion in a racially diverse cohort of 2014 healthy boys and girls ages 5-20 years at 5 clinical centers in the US. The BMDCS cohort included children with height, weight, and body mass index (BMI) between the 3rd and 97th percentile and with no previous or current conditions that might affect bone acquisition. Recruitment occurred in two phases: 1554 subjects ages 6 to 17 years were enrolled during 2002-2003; during 2006-2007 younger (5y) and older (19y) subjects were enrolled to extend the reference percentiles to ages 5-20 years. The second wave of participants were followed for 2 years. Annual assessments included linear growth, weight gain, pubertal maturation, nutritional status, exercise, bone mineral density (DXA by Hologic) and bone age comprised the main study measures. A subset of patients underwent pQCT and qCT. The reference curves generated by this carefully executed study are the gold standard for normal bone accrual.
Study Description: A multi-method, prospective study that assessed the transition process of behaviorally-infected HIV-positive youth, aged 18 to 24, as they transitioned from pediatric and adolescent-specific care to adult care. The transition process was characterized from the perspectives of HIV-positive youth, Adolescent Medicine Trials Unit (AMTU) clinic staff, and receiving adult clinic staff. Data on individual psychosocial, behavioral, and clinical factors affecting transition for adolescent and young adult participants were measured through ACASI surveys. Demographic, biomedical, antiretroviral therapy, and healthcare utilization visit information was collected through medical chart abstraction. Information on transition protocols was collected through semi-structured interviews with AMTU and adult clinic staff.
Study Description: Primary human trophoblasts release a repertoire of extracellular vesicles (EVs). Among them are nano-sized exosomes, which we found to suppress the replication of a wide range of DNA and RNA viruses. We report here our investigation of protein cargo of placental EVs including exosomes, microvesicles, and apoptotic blebs. We isolated EVs using ultracentrifugation and defined their purity using western analysis, electron microscopy, and nanoparticle tracking. We found that trophoblastic exosomes harbor a protein profile that is distinct from that of microvesicles or apoptotic blebs. Functionally, trophoblastic exosomes exhibit the highest anti-viral activity among the EVs. Our work suggests that human trophoblastic EVs may play a key role in maternal-placental-fetal communication.
Study Description: Two longitudinal studies were conducted for third generation subjects from pedigrees that were either at high risk for developing alcohol use disorders and related substance use disorders or were from control pedigrees. Approximately annual assessment in childhood and adolescence provided information on childhood problems. Interview in young adulthood provided information on substance use disorder outcome as well as other DSM-IV diagnoses.
Study Description: Initially designed as a randomized, double-blind, placebo-controlled clinical trial for children with autism spectrum disorder (ASD), enrollment ceased early due to lack of funding for extramural collaborators. One of the primary aims of the study was to establish the prevalence of hypocholesterolemia and hypercholesterolemia in idiopathic ASD. Available in DASH are laboratory results collected at multiple time points, including cholesterol levels, on 42 children enrolled during the first three years of the study
Study Description: A randomized, double-blind, placebo-controlled trial to evaluate the effectiveness of daily low-dose aspirin in preventing preeclampsia in nulliparous women who begin treatment at 13 to 25 weeks gestation
Study Description: A randomized, double-blind, placebo-controlled trial to examine whether daily administration of 60 mg of aspirin beginning at 13 to 26 weeks gestation will decrease the incidence of preeclampsia in pregnant women at high risk for developing the disease. High risk women enrolled were those with chronic hypertension, insulin-dependent diabetes, past history of preeclampsia, or multifetal pregnancy.
Study Description: A study in three phases that examined clinician behaviors with regard to recommending and prescribing pre-exposure prophylaxis (PrEP) as a primary HIV prevention strategy, and to identify knowledge-related and attitudinal factors associated with these behaviors. Through three phases, researchers used semi-structured interviews with ATN-affiliated clinicians to develop a new theory-based survey instrument, and administered the newly developed survey to clinicians. The primary objectives were to explore clinician attitudes and prescribing behaviors of PrEP for men who have sex with men (MSM) and heterosexually active adults and adolescents, and to identify factors associated with prescribing PrEP.
Study Description: Infants were enrolled into four groups: healthy term, preterm infants <1750g w/o significant morbidity, sibling of SIDS, and babies experiencing apparent life-threatening events. Objectives were to: determine monitor efficacy in identifying episodes endangering the infant's health; determine conditions optimizing use of apnea monitors in high risk infants; correlate physiological markers with the propensity for life-threatening events; and report on maturation of heart and respiratory function in sleeping infants. Data were collected from nightly home recordings (via CHIME Monitor device) and one sleep lab polysomnography (PSG) session (via CHIME Monitor and ALICE3 devices). CRF data include sociodemographic and medical information on mother and infant at entry and from scheduled medical follow-up visits through 1-year of age, weekly phone calls, monitor knowledge and satisfaction scales, periodic assessments with the Bayley II, NCAST, subscales of the Parenting Stress Index, and hospitalizations.
Study Description: A five-year, multi-site, prospective cohort study about stress and resilience and their influence on maternal allostatic load as a mediator of birth outcomes and child health and development. A limited number/types of biospecimens have been collected by the study investigators. For their availability to non-NIH scientists, please contact the following investigators: Chris Dunkel Schetter (firstname.lastname@example.org); Madeleine Shalowitz (Madeleine.Shalowitz@gmail.com); Calvin J. Hobel (Calvin.Hobel@cshs.org); Vernon M. Chinchilli (email@example.com).
Study Description: Connect to Protect (C2P): Partnerships for Youth Prevention Interventions was a multi-site, three-phase project with the overall goal of ultimately reducing HIV incidence and prevalence among youth through a community mobilization intervention. In Phase III of C2P (ATN 040) a community mobilization intervention that consisted of guiding C2P coalitions through a strategic planning process for the development and implementation of a local action plan was initiated and completed. As the evaluation sub-study of ATN 040, ATN 040b measured changes In HIV-related risk among high-risk youth at congregation venues, i.e., locations identified by youth, community partners, and C2P site staff as places where members of the population of focus "hang out." This study is a sub-study of another ATN study or studies. Please refer to the protocol for information regarding ATN study connections.
Study Description: Connect to Protect (C2P): Partnerships for Youth Prevention Interventions was a multi-site, three-phase project with the goal of reducing HIV incidence and prevalence among youth through a community mobilization intervention. The objective of ATN 040 (Part One of Phase III) was to initiate and complete an intervention that consisted of guiding C2P coalitions through a strategic planning process resulting in the development and implementation of a local action plan. The action plan focus was to change structural elements of affected communities believed to be associated with youth HIV acquisition and transmission. Each coalition's plan included: (1) identification of potential community structural changes and specific steps for how to effect such changes; and (2) selection of community-level Centers for Disease Control and Prevention (CDC)-endorsed HIV prevention program. This study is a component of other ATN phased studies. Please refer to the protocol for information regarding the other phases.
Study Description: Collected detailed information from electronic medical records for 228,438 deliveries in 19 U.S. hospitals. Primary objectives were to explore the underlying causes of the high cesarean rate in the U.S. population, describe contemporary labor progression at the national level, and determine when is the more appropriate time to perform a cesarean delivery in women with labor protraction and arrest. NOTE: Data requesters should refer to the "CSL Read Me" PDF describing data caveats.
Study Description: An exploratory laboratory-based evaluation of cellular immune response to immunization with hepatitis B surface antigen in HIV-infected and HIV-uninfected adolescents. This sub-study of ATN 024 and ATN 025 compared cellular immune response in responders and non-responders to immunization and evaluated the relationship of these factors to the persistence of known correlates of serologic protection for the hepatitis B virus.
Study Description: This study conducted formative research to develop a culturally appropriate secondary prevention intervention for HIV-positive black young men who have sex with men (B-YMSM). At two AMTU sites, a total of four focus groups guided the selection of the intervention content areas and the development of the intervention manual. The intervention aimed to address increasing engagement in HIV treatment, improving medication adherence, reducing sexual risk behaviors, reducing substance use behaviors, and increasing HIV status disclosure.
Study Description: This study determined program-level factors associated with the effectiveness of SMILE in CARING for YOUTH Linkage-to-Care (LTC) program networks at 15 Adolescent Medicine Trial Units (AMTUs). The various LTC programs at the AMTUs were evaluated and categorized. The study then examined associations between 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. This study focused on LTC programs at the AMTUs as the unit of analysis and not the youth themselves.
Study Description: The first national, randomized, single-blind study to systematically test a neurorehabilitation therapy - constraint induced movement therapy (CIMT) - among patients with the ability to initiate extension movements at the wrist and fingers and who had experienced a first stroke within 3 to 9 months prior to enrollment. Participants recruited from 247 clinics nationwide were randomized to receive CIMT to the more impaired upper extremity for two weeks upon enrollment or to receive the identical intervention 15-21 months post-stroke. Outcome measures were the Wolf Motor Function Test (WMFT) and Motor Activity Log (MAL) for functional improvements and the Stroke Impact Scale (SIS) for health-related quality of life.
Study Description: The study employed a randomized experimental design in which youth with type 1 diabetes and parents attending one of four clinical sites were stratified by degree of glycemic control and randomized to receive either standard care or a clinic-integrated behavioral intervention. The intervention provided experiential training for families in the use of a problem-solving approach for improving diabetes management. It was designed to be applicable to the broad population of youth with diabetes and their families, flexibly implemented and tailored to the varying needs of families, and delivered at a low intensity over time to meet the changing needs and roles of families during the period in which responsibility for diabetes management typically undergoes transition. A combination of in-person assessments, telephone assessments, and in-clinic data collection were utilized to assess glycemic control, adherence, quality of life, psychological status, and hypothesized mediators of these outcomes.
Study Description: An observational study of 60 women enrolled at the time of preterm or term cesarean delivery, when maternal and neonatal specimens were collected for DNA, RNA expression profiling, proteomic and metabolomic analyses, measurements of markers of pregnancy exposure, epigenetics, and histology. Participants were further grouped according to presence or absence of spontaneous onset of labor either in the presence or absence of premature rupture of membranes (preterm or term). Only data from participants who consented to secondary use of their data are included in this archive (49 women). Biospecimens are available.
Study Description: A multi-center observational genome-wide association study (GWAS) designed to determine if there is a genetic predisposition to idiopathic preterm birth. Maternal and neonatal DNA from 743 spontaneous preterm births (20 to less than 34 weeks gestation), and 752 controls (39 to less than 42 weeks gestation) were analyzed. GWAS, phenotype, and clinical data are available in dbGaP. Cases were 1:1 matched with controls according to race and ethnicity, maternal age, and parity. Biospecimens are available.
Study Description: A study to identify analytical biomarkers (proteins, DNA, etc.) that might help predict a pending preterm birth. Blood (whole blood & serum), urine, saliva and vaginal swab specimens were obtained from high risk women (with a history of previous spontaneous preterm birth) at different times during their current pregnancy to look for changes over time that would be predictive of a pending preterm delivery. Biospecimens are available.
Study Description: A multicenter study of hemophilia and its complications, HGDS was established in 1988. Data were prospectively collected in 14 U.S. hemophilia treatment centers through 1996/97. The HGDS investigated the effects of hemophilia and HIV on physical growth and maturation; immunological, neurological, and neuropsychological functioning; and the pathophysiology of HIV and hepatitis C. Research using the clinical data and stored samples continues and includes the genetic research that paved the way for development of the protease inhibitors currently used to treat HIV; studies that provided clues to viral characteristics of HIV and hepatitis B and C; research to identify genetic factors associated with the development of inhibitory antibodies to factor VIII; the relationship of inhibitors to cognitive development and academic achievement; studies of viral factors and how they relate to progression of HIV and hepatitis C; and research on the parenteral transmission of human viruses. Biospecimens are available.
Study Description: A multi-site study of 13-24 year-old Hispanic/Latino men who have sex with men, heterosexual men, and heterosexual women. Comparisons were made between alternative venue-based testing (AVT) and social and sexual network-based interviewing and HIV testing (SSNIT) strategies, assessing the most effective means for identifying undiagnosed HIV infection in young, at-risk Hispanics/Latinos. Study participants completed an audio computer-assisted self-interview (ACASI) and HIV screening. All participants with presumptive HIV+ screening results were referred for confirmatory testing and linkage to HIV medical care. In addition, a subset of SSNIT participants went on to recruit members of their social and sexual network who were eligible for study participation.
Study Description: A cross-sectional, three phase study which examined the relationship among ethnic, gay, masculine, and ego identities, and conflicts or difficulties faced by GBQ male youth working to integrate these identities. Phase I involved surveying GBQ male adolescents with quantitative measures and using this information to create a stratified purposive sample for Phase II. Phase II involved conducting in-depth individual qualitative interviews with a sub-sample of GBQ youth from Phase I, as well as individual and focus group validation check interviews with GBQ youth and adult experts. Phase III involved conducting focus groups with GBQ youth to develop the components of an HIV prevention intervention.
Study Description: A Phase II, open-label, multi-center study that evaluated the immunogenicity, safety, tolerability, and behavioral impact of an HPV-6, -11, -16, -18 vaccine in HIV-infected young women. The vaccine was administered at the recommended dose and schedule (Day 0, Week 8, and Week 24) with safety assessments after each vaccination and reactive antibody measurements pre- and post-vaccination. Attitudes and behaviors were measured using self-administered questionnaires.
Study Description: This study was 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 were conducted with health care providers working with adolescents living with HIV, and focus groups and individual interviews were conducted with adolescents living with HIV (ages 16-24). Findings from this study were 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.
Study Description: Pilot test of an HIV intervention to aid in the psychosocial adjustment of newly diagnosed youth (diagnosed for less than 15 months) to assess its acceptability and feasibility preliminary to and leading up to a full-scale, randomized trial. Individual sessions and focus groups were conducted across three ATN sites in order to identify the challenges, strengths, and needed areas of support/assistance associated with receiving an HIV diagnosis. These data were used to guide the development of an intervention manual.
Study Description: Examined whether endovaginal sonography can identify a group of high risk women whose mid-trimester cervical characteristics define them as candidates for a future clinical trial of cerclage or other intervention strategies. Cervical length was the primary variable of interest.
Study Description: An open-label, multiple-dose study to determine the safety, tolerability, and pharmacokinetics of meropenem in preterm and term infants less than 91 days of age with suspected or confirmed intra-abdominal infections. Biospecimens are available.
Study Description: National observational study to examine infant sleep practices and factors associated with adherence to the American Academy of Pediatrics back-to-sleep recommendations and related infant care practices. Nighttime caregivers of infants less than eight months of age were surveyed during 1992 to 2010 about their infant's sleep position, reasons for their choice of sleep position, specific sources of sleep position recommendations, and other practices, such as bed sharing, bedding used, and use of pacifiers.
Study Description: A cross sectional study that enrolled youth, ages 12 through 24, who received care for HIV infection at sites participating in the ATN during the study period. The study was conducted in one visit and examined a broad spectrum of youth engaged in care at ATN sites including those newly enrolled in care. Information was collected on rates of adherence to medical regimens, sexual risk behaviors, substance use and mental health concerns, and basic demographic and biomedical data to understand risk behaviors, risk and protective factors, and relationships between factors in adolescents and young adults with HIV infection.
Study Description: A cross sectional study that enrolled youth ages 12-24 years who received care during the study period for HIV infection at five newly participating ATN Adolescent Medicine Trials Units (AMTUs). The study was conducted in one visit and examined a broad spectrum of youth engaged in care at the AMTUs, including those newly enrolled in care. Information was collected on rates of adherence to medical regimens, sexual risk behaviors, substance use and mental health concerns, and basic demographic and biomedical data to understand risk behaviors, risk and protective factors, and relationships between factors in adolescents and young adults with HIV infection.
Study Description: A prospective cohort study comparing neurocognitive functioning in four groups of youth, ages 18-24 years, with behaviorally acquired HIV infection: two groups with CD4+ T-cells greater than 350 cells/mm3 and HIV RNA equal to or greater than 1,000 copies/ml - one initiating early highly active antiretroviral therapy (HAART) (Group 1), the other not initiating treatment (Group 2); and two groups with CD4+ T-cells less than 350 cells/mm3 - one initiating HAART according to then current DHHS guidelines (Group 3), the other not initiating treatment (Group 4). Groups 2 and 3 represented standard of care. The study provided preliminary data to test the hypothesis that initiating HAART earlier than DHHS guidelines suggested at that time resulted in better neurocognitive function in comparison with no treatment or treatment initiated according to DHHS recommendations.
Study Description: The goal of the NEXT Generation Health Study was to examine trajectories of adolescent health and health behaviors through the transition from high school to emerging adulthood. Data was collected annually for seven years (2010 – 2017) from a national probability sample of adolescents. The cohort was tracked from 10th grade through four years post-high-school, permitting a unique opportunity to examine predictors of changes in health behaviors and mental health during significant family, education, and/or career transitions. Self-report of health status, health behaviors, and health attitudes were collected via annual in-school (Wave 1) and online surveys (Wave 2 through Wave 7). Anthropometric measurements (height, weight, waist circumference) were gathered on all participants during the first three assessments. Additional biomarker and anthropometric data (Waves 1-4) were obtained on a small subsample of participants. Data from waves 1-6 are being released for public access now.
Study Description: Describes the demographic, clinical, immunologic, and virologic characteristics of children who acquired HIV infection through mother-to-child transmission. Subjects were evaluated every six months for up to five years for complications of both the disease and its treatments. Biospecimens are available.
Study Description: A pilot observational study to examine the effectiveness of using selected obstetrical factors to predict the survival of extremely low birth weight infants. Attitudes of physicians, estimated gestational age, estimated fetal weight, and ultrasound data were among the factors examined.
Study Description: The objectives of the Optimal Trial are to compare sacrospinous ligament fixation (SSLF) to uterosacral vaginal vault ligament suspension (ULS); and to assess the role of perioperative behavioral therapy/pelvic muscle training (PMT) in women undergoing vaginal surgery for apical or uterine prolapse and stress urinary incontinence.
Study Description: No proven therapy to restore ovarian function and fertility is available to patients with karyotypically normal spontaneous premature ovarian failure. We know that one-half of these patients have primordial follicles remaining in the ovary, and these follicles can function intermittently. This is a diagnostic omnibus protocol that permits baseline clinical evaluation of patients with premature ovarian failure. The findings will determine patients' suitability for specifically focused therapeutic research protocols. Whole exome sequences (WXS), phenotype, and clinical data for a subset of patients are available in dbGaP repository.
Study Description: ATN 137 examined the primacy of decisional autonomy and associations of autonomous research consent and subsequent participation-associated outcomes among younger and older young men who have sex with men (YMSM) and transgender women who have sex with men and were enrolled in ATN 110 or ATN 113. The study also explored participants’ experiences with other unique study-related procedures, such as self-testing for HIV and use of Wisepill devices.
Study Description: A multi-phase, multi-center trial that examined lithium in the treatment of pediatric patients (ages 7-17 years) with bipolar I disorder. There were four phases: 1) the Pharmacokinetic Phase included 8 weeks of open label treatment to determine empirically based dosing strategies for children and adolescents with bipolar disorder; 2) after completing the Pharmacokinetic Phase, eligible participants continued in the Long-Term Effectiveness Phase for a maximum of 16 weeks of lithium treatment; 3) participants meeting response criteria during the Long-Term Effectiveness Phase were eligible to continue in the Discontinuation Phase, when they were randomized to either placebo or lithium treatment for up to 28 weeks; and 4) participants who experienced a mood relapse during the Discontinuation Phase were enrolled in an open label Restabilization Phase and treated with lithium for up to 8 weeks.
Study Description: Compared the efficacy and safety of three antiretroviral regimens [standard zidovudine (ZDV) regimen vs. ZDV and nevirapine (NVP) vs. ZDV, lamivudine (3TC) and nelfinavir (NFV)] administered for the prevention of vertical HIV-1 transmission to infants born to HIV-1-infected women who did not receive antiretroviral therapy during the current pregnancy. Primary outcome measure was HIV-1 infection at 3 months in infants uninfected at birth. This study was conducted by the National Institute of Allergy and Infectious Diseases (NIAID) HIV Prevention Trials Network (HPTN). Biospecimens are available.
Study Description: An observational study examining the proportion of youth at Adolescent Medicine Trials Units (AMTUs) engaged in care, prescribed antiretroviral therapy (ART), and attained viral suppression per subject year. Psychosocial and risk-taking behavioral data of study subjects were collected using an Audio Computer-Assisted Self-Interview (ACASI) at study entry. Biomedical, antiretroviral therapy, and healthcare utilization information of study subjects was abstracted through retrospective and prospective medical record reviews covering a total maximum of 24 months per subject. Data on missed visits and other healthcare services utilization were abstracted from electronic appointment systems or other electronic systems at clinical sites. Data were also collected from each AMTU to assess clinic level variables at baseline (within 30 days of protocol registration) and 48 and 96 weeks after baseline.
Study Description: A qualitative study that explored the interrelationships between 1) abuse and sexual risk behavior, and 2) abuse, sexual risk behavior, and substance use in 18 to 24 year-old females with behaviorally-acquired HIV infection. An open-ended in-depth interview, occurring over one to two sessions, was conducted with each participant.
Study Description: In this study published in NEJM, 750 infertile women diagnosed with PCOS were enrolled, and we found that letrozole is better than the current standard therapy in increasing live births for women with polycystic ovary syndrome, which is a leading cause of female infertility.
Study Description: A randomized, proof-of-concept study of adolescents and young adults aged 18-24 years with confirmed HIV acquired after age 9 with CD4+ T cells above 350 cells/mm3 who were randomized 3:1 to begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r, or other recommended NRTI backbone with ATV/r upon entry. Subjects in the experimental group who achieved virologic control by week 24 and maintained good control through 48 weeks would de-intensify to ATV/r alone and be followed for an additional two years. Subjects randomized to the standard care arm began HAART with TDF/FTC/ATV/r, AZT/3TC/ATV/r, or other recommended ATV/r based HAART regimen and followed for a total of three years. Subjects on the standard care arm would begin therapy when the CD4+ T cell count dropped below 350 cells/mm3 or other clinical criteria necessitating treatment as determined by the site clinician. Some biospecimens are available; for inquiries, please contact Dr. John Sleasman (firstname.lastname@example.org).
Study Description: A multi-center, cross-sectional study of HIV infected and uninfected males, ages 12 to 24, that evaluated the prevalence and severity of morphologic and metabolic abnormalities in HIV-infected young men and assessed the drug and non-drug factors related to these abnormalities. Differences in glucose metabolism, lipids, lactate, body composition, and bone density between HIV infected and uninfected young men were assessed to understand the pathophysiological effects of protease inhibitor (PI)-based and non-nucleoside reverse transcriptase inhibitor (NNRTI)-based therapies in young men. One study visit conducted over 1 or more days included survey questionnaires, DEXA scanning, collection of blood and urine specimens, anthropometric measurements, and blood tests examining glucose and lipid metabolism and levels of C-Reactive protein and lactate. Biospecimens are available.
Study Description: A cross-sectional study that enrolled adolescent and young women, ages 12 through 24, to evaluate the prevalence and severity of morphologic and metabolic abnormalities and to assess the drug and non-drug factors related to these abnormalities. The study assessed differences in glucose metabolism, lipids, lactate, body composition, and bone density between HIV infected and uninfected young women to understand the pathophysiological effects of protease inhibitor (PI)- and non-nucleoside analogue reverse transcriptase inhibitor (NNRTI)-based therapies in young females. One study visit conducted over 1 or more days included survey questionnaires, DEXA scanning, anthropometric measurements, and blood tests examining lactate, glucose, and lipid metabolism. Biospecimens are available.
Study Description: A two-group randomized repeated measures design that examined the efficacy of Project ACCEPT (Adolescents Coping, Connecting, Empowering and Protecting Together) compared with an attention-controlled health education comparison intervention (HEALTH). Goals of the intervention were to improve engagement in care, decrease psychosocial barriers to care, and decrease sexual risk for youth newly diagnosed with HIV. Data were primarily collected through Audio Computer-Assisted Self-Interview (ACASI) questionnaires and medical record abstraction.
Study Description: A group-randomized controlled design to test the efficacy of the Project ÒRÉ intervention, a community-based adolescent social network HIV/STI intervention tailored to African American culture. Four community based organization sites (CBOs) were randomly assigned to an experimental or attention control condition. In both conditions, sexually experienced African American adolescent females recruited members of their friendship group for the five-hour program. In the experimental condition, the intervention group received the half-day Project ÒRÉ intervention. The attention control group received a standard health promotion control program which had been used previously with similar populations. All participants completed pre-, post-, and 3-month follow-up self-administered questionnaires. In the experimental condition, a subset of groups participated in a process evaluation focus group immediately following the program.
Study Description: A pre-exposure prophylaxis (PrEP) demonstration project and Phase II safety study to obtain additional data on the safety of emtricitabine/tenofovir (FTC/TDF (Truvada®)) and evaluate patterns of use, rates of adherence, and patterns of sexual risk behavior among YMSM (inclusive of transgender women) who were provided with open label FTC/TDF and information on the safety and efficacy of PrEP from prior studies. This project also explored the feasibility and acceptability of implementing two different efficacious risk reduction interventions prior to provision of PrEP - Many Men, Many Voices (3MV) and Personalized Cognitive Counseling (PCC).
Study Description: A prospective cohort study that enrolled both HIV+ and HIV- pregnant women (n=450) at 5 obstetric clinics in New York City between 1986-1991. Of those that were HIV+, few had been exposed to antiretroviral therapy. Objectives were to: 1) ascertain the probability of perinatal transmission of retroviruses (RVs) to offspring of HIV+ pregnant women; 2) determine if RV infection in the mother increases the likelihood of adverse pregnancy outcomes; 3) quantitate the spectrum of immunologic and clinical disorders up to age four for children at risk for RV infection; 4) determine the effect of HIV status on pregnancy; 5) develop a serum bank as a resource for new serologic markers of RV infectivity and exposure; 6) obtain prolonged follow-up of RV-infected women and children; 7) have a population available for possible studies of heterosexual or household transmission of RVs; and 8) assist in planning the allocation of healthcare resources for HIV-infected children. Biospecimens are available.
Study Description: A mix-method study that investigated associations among HIV-positive YMSM's racial identities, sexual orientation identities, and identities as HIV-positive young men with their stressors, coping mechanisms, and health behaviors. Phase 1 of the study involved an in-depth qualitative interview with 54 participants. Phase 2 of the study involved completion of one assessment battery administered on a laptop computer via Audio Computer Assisted Self Interview (ACASI) with 200 participants
Study Description: This large multicenter trial tested whether cerebral cooling initiated within 6 hours of birth and continued for 72 hours would reduce the risk of death and moderate to severe neurodevelopmental injury at 18-22 months corrected age. Infants at least 36 weeks gestation with an abnormal blood gas within 1 hour of birth, or a history of an acute perinatal event and a 10-min Apgar score <5, or continued need for ventilation were screened. Following a neurological exam, those with moderate to severe encephalopathy were randomized to a 72-hour period of total body cooling (cooling blanket, followed by slow re-warming).
Study Description: A randomized, double-blind, placebo-controlled trial of directly observed vitamin D versus placebo every 4 weeks for 48 weeks. Participants included HIV-infected youth ages 16-24 with viral load <200 copies/mL, and taking TDF-containing combination antiretroviral therapy for >180 days. Whole-body, spine, and hip BMD and BMC were assessed using DXA at baseline and at study weeks 24 and 48.
Study Description: This study was a randomized, double-blind, placebo-controlled prospective study. The study tested the hypothesis that in a population of adolescents and young adults with HIV infection who are being treated with tenofovir as part of an antiretroviral (ARV) combination regimen, vitamin D supplementation will decrease renal phosphate loss, increase plasma phosphate, decrease plasma PTH, and improve markers of bone turnover, including a decrease in plasma N-telopeptide and BAP. A randomized, placebo-controlled trial was conducted over 12 weeks, with four arms: those who received tenofovir and vitamin D, those who received tenofovir and no vitamin D, those who received vitamin D and no tenofovir, and those who received neither tenofovir nor vitamin D.
Study Description: An observational cohort sub-study of subjects enrolled in ATN 110 or ATN 113, and prescribed daily coformulated emtricitabine/tenofovir (FTC/TDF (Truvada®)) as part of ATN 110 or ATN 113, with the primary objective of measuring the magnitude of change in parathyroid hormone (PTH) from baseline to week 48. Renal, endocrine, and bone biochemistry changes and pathophysiology were explored as secondary objectives. Subjects were HIV uninfected YMSM, inclusive of transgender women, and were to be followed for at least 48 weeks; seronegative subjects in the Extension Phase of ATN 110 or ATN 113 were followed for an additional 48 weeks in the Extension Phase of ATN 117.
Study Description: An observational, retrospective study that included analysis of safety data on infants who had been admitted to intensive care nurseries who received acyclovir as standard of care for confirmed herpes simplex virus (HSV) infection. Sources of data were the Pediatrix Medical Group database and medical charts from four clinical sites (n=49). Publications from two major clinical trials of acyclovir in neonatal HSV infection were also reviewed for safety data. This study was conducted by the Pediatric Trials Network under the Best Pharmaceuticals for Children Act Program.
Study Description: A prospective, observational study of women with singleton pregnancies to identify and evaluate tests which could define a group of patients with at least a twofold increase in risk of spontaneous preterm delivery. Primary outcome was delivery from 23 to 34 weeks gestation following spontaneous preterm labor or premature rupture of membranes.
Study Description: A prospective proof of concept study of subjects who had successfully suppressed their HIV-1 RNA levels for a minimum of 6 months prior to study entry on highly active antiretroviral therapy (HAART) including a protease inhibitor (PI). The study assessed the impact of switching from continuous HAART with a PI to short-cycle therapy (SCT). The primary objective was to show that the rate of viral load rebound on SCT does not exceed that which would be expected in subjects on continuous therapy. While maintenance of viral load suppression can be viewed as either a safety or efficacy endpoint, the trial was construed as an assessment of safety. The study was co-endorsed by the Pediatric AIDS Clinical Trials Group (PACTG).
Study Description: Population-based case–control study of the causes and extent of stillbirth (SB) in the United States. Participants were recruited at delivery between March 2006 and September 2008 from 59 urban and rural hospitals in 5 geographic areas. All women with SB and a representative sample of women with live births, oversampled for those delivering at <32 weeks gestation and those of African descent delivering at =32 weeks gestation, were approached for enrollment. Pregnancy terminations were excluded. The study included maternal interview, chart abstraction, placental exam, and postmortem (SB only). Data collection focused on surveillance and epidemiology, maternal disease, immunology and infections, placental pathology, and genetics. A subset of SCRN participants consented to re-contact which examined subsequent pregnancies and pregnancy complications, grief resolution, and whether life-course stresses and environmental factors were associated with an increased risk of SB. Biospecimens are available.
Study Description: A longitudinal pilot sub-study of ATN 110 and ATN 113 assessing how structural (physical settings) and partnership factors affect adherence of young men who have sex with men to Pre-Exposure Prophylaxis (PrEP). The study compared levels of adherence reported in the Interactive Questionnaire System (iQS) to those collected in ATN 110 or ATN 113 by ACASI, Wisepill, and drug concentration levels in blood and hair. The iQS was administered at study entry (ATN 110 or ATN 113 week 24) and week 24 (ATN 110 or ATN 113 week 48) visits.
Study Description: This study sought to construct and modify a culturally-based secondary prevention intervention targeted toward HIV-positive black young men who have sex with men. The feasibility and acceptability of the intervention were explored in Trial 1 and Trial 2; the potential efficacy of the intervention was assessed in Trial 2. Primary outcomes examined were health promotion behaviors (i.e., treatment adherence, sexual risk reduction, reduction in substance use behaviors, and HIV status disclosure). Psychosocial factors (i.e., self-esteem, critical consciousness, and socio-political awareness) were examined as secondary outcomes.
Study Description: The BioCycle Study is a prospective cohort study completed at the University at Buffalo and offers a unique and comprehensive assessment of menstrual cycle function. The primary goal of the BioCycle Study was to better understand the intricate relationship between reproductive hormone levels and oxidative stress during the menstrual cycle. Multiple markers of oxidative stress, reproductive hormones, inflammation, and metabolic biomarkers were measured in a cohort of 259 women of reproductive age over the course of two menstrual cycles. Fertility monitors were utilized to time the subjects' visits to ensure appropriate timing of biospecimen collection. Additional information regarding diet, lifestyle, and physical measurements was obtained throughout the study via standardized questionnaires, anthropometric assessments, and daily diaries. Participants were highly adherent to the study protocol, with 94% of all women completing seven or eight visits per cycle.
Study Description: A prospective, longitudinal study of women, their pregnancies and deliveries, and the health and development of the children born from these pregnancies. Families who were members of the Kaiser Foundation Health Plan in Oakland, California were enrolled between 1959 and 1966. Children born to the enrolled women were followed through 1972. Mothers provided information about fathers. Biospecimens are available, including father specimens. Please contact Dr. Barbara Cohn (email@example.com) to obtain biospecimens. Additional data files from follow-up studies in the CHDS are available to researchers who would like to set up collaborations to access them. Please send an email to firstname.lastname@example.org for more information.
Study Description: 784 ethnically diverse students, first grade students were recruited and followed with annual assessments of academic, behavioral, and social functioning for 14 years. Aim 1 was to use a bilingual, prospective longitudinal methodology to test the effects of grade retention on students’ subsequent academic, social, emotional, and behavioral outcomes and to examine the social processes that mediate retention’s effects at different ages and grades. Aim 2 was to test theoretical models of child and environmental factors that influence academic trajectories of academically at-risk children, with a specific focus on social-relational processes. Aim 3 was to investigate the role of ethnicity, language, and culture as they relate to the first two specific aims. Over 50 journal articles reports results. Grade retention does not impair academic achievement but negatively impacts high school graduation. Peer and teacher relationships are key to students’ school engagement and achievement.
Study Description: An exploratory, cross-sectional research study to examine HIV risk behaviors of male-to-female transgender youth 15 to 24 years of age in two large U.S. cities. Surveys were conducted at club/bar venues and on the street. Semi-structured in-depth qualitative interviews were conducted with a subset of participants; data from those interviews are not available.
Study Description: A laboratory-based sub-study of ATN 061 and ATN 071 that examined the effect of early treatment (HAART at CD4+ T cells > 350 cells/mm3) followed by treatment de-intensification to atazanavir/ritonavir (ATV/r) monotherapy on steady-state frequencies of replication-competent CD4+ T cell Human Immunodeficiency Virus (HIV)-1 reservoirs or cell-associated infectivity (CAI) and persistent low-level viremia (LLV), and their contribution to successful long-term control of HIV-1 replication among HIV-1 infected adolescents and young adults, ages 18 to 24 years. Biospecimens are available.
Study Description: A two-phase study that tested a behavioral intervention to treat depression in HIV-positive adolescents and young adults. Sites were assigned to either the Combination Cognitive Behavioral Therapy (CBT) and Medication Management (MM) (COMB) group or the Treatment as Usual (TAU) group. Phase I was a 24-week pilot test of CBT and MM manuals at sites assigned to the COMB group. Phase II was a feasibility study of the revised CBT and MM manuals. The intervention targeted symptoms of depression, motivation for medical and depression treatment, adherence to medical care, and wellness behaviors.
Study Description: An open-label, multi-center study to evaluate the single dose pharmacokinetics of intravenous lorazepam in pediatric patients aged 3 months to less than 18 years treated for status epilepticus (SE) or with a history of SE. Cohort assignment was based on medical history: Cohort 1 included Emergency Department or hospital patients in SE receiving lorazepam; Cohort 2 included patients with epilepsy admitted for an elective dose of lorazepam. Subjects were stratified by age in each cohort. Participants in Cohort 1 received lorazepam 0.1 mg/kg up to a maximum dose of 4 mg/kg. Participants in Cohort 2 received lorazepam 0.05 mg/kg up to a maximum dose of 2 mg/kg. This study was conducted under the Best Pharmaceuticals for Children Act Program.
Study Description: A randomized, double-blinded trial comparing the efficacy and safety of intravenous lorazepam to diazepam in pediatric patients aged 3 months to less than 18 years treated for status epilepticus (SE) or with a history of SE. For patients in whom SE was not terminated by benzodiazepines, data were collected prospectively regarding subsequent medications, dosing, and effectiveness. Cohort assignment was based on medical history: Cohort 1 included patients presenting to the Emergency Department (ED) in SE with prior informed consent; Cohort 2 included patients presenting to the ED in SE without prior informed consent and enrolled under Exemption from Informed Consent (EFIC). Subjects were stratified by age in each cohort and randomized to receive lorazepam 0.1 mg/kg up to maximum dose 4 mg or diazepam 0.2 mg/kg up to maximum dose 8 mg. A second dose, if required for ongoing convulsions, was half of the first dose. This study was conducted under the Best Pharmaceuticals for Children Act Program.
Study Description: A multi-site study that assessed the reliability of the HIV Treatment Readiness Measure (HTRM). The psychometric properties of the HTRM and test-retest reliability were assessed with a sample of HIV positive youth between 13 and 24 years of age that were highly active antiretroviral therapy (HAART) naive (never having taken HAART) or HAART experienced (at least one experience taking HAART and not taken HAART 30 days prior to study entry). The HTRM is a tool to assist clinicians in determining whether youth living with HIV are ready to initiate HAART, and to identify youth in need of additional support services to facilitate their adherence to HAART.