cometadata/datacite-titles-descriptions-related-identifiers huggingface dataset:
DOI: 10.57982/b73w-0805
title: Novel Strategies to Prevent Malaria and Improve Maternal-Child Health in Africa (PROMOTE II) - Prevention of Malaria in HIV-uninfected Pregnant Women and Infants - Birth Cohort 3

description: In Africa, the only widely available tools for the prevention of malaria in pregnancy are insecticide treated bednets (ITNs) and intermittent preventive therapy (IPTp) with sulfadoxine-pyrimethamine (SP).We will test the hypothesis that IPTp with dihydroartemisinin-piperaquine (DP) -- which has been safely used for the treatment of uncomplicated malaria in pregnancy in studies from Asia -- will significantly reduce the risk of adverse birth outcomes from malaria in pregnancy and burden of malaria in infancy, compared to IPTp with SP (current Uganda Ministry of Health regimen). This will be a double-blinded randomized controlled phase III trial of 782 HIV-uninfected pregnant women in Busia district, Uganda, and the children born to them. HIV-uninfected women at 12-20 weeks gestation will be randomized in equal proportions to one of two IPTp treatment arms: 1) monthly SP, or 2) monthly DP. Both interventions arms will have either SP or DP placebo to ensure adequate blinding is achieved in the study.
DOI: 10.57982/w5f8-st25
title: Phase 2:  A Secondary Prevention Empowerment Intervention for Young Women Living with HIV

description: This study developed and adapted a culturally appropriate secondary prevention intervention for young, HIV-positive women through intervention groups, evaluated its acceptability and feasibility, made appropriate modifications, and manualized the intervention in preparation for a full-scale randomized trial. Once the intervention was developed and adapted, study sites piloted the intervention twice to enable modifications. The intervention aimed to reduce the risk of young women infected with HIV transmitting the virus to their sexual partners and prevent young women infected with HIV from re-infection with a new viral strain or co-infection with another sexually transmitted disease. A comparison group was conducted concurrently with the intervention group at each participating site in order to compare the outcomes of interest among the two different groups.
DOI: 10.57982/8fwg-qa50
title: Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care - Ampicillin

description: Aim: Characterize the pharmacokinetics (PK) of ampicillin administered to children per standard of care to address gap in pediatric labeling. Methods: The PK and safety analyses include ampicillin data from NICHD-2011-POP01 (“Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care”), a multicenter, prospective opportunistic PK study of understudied drugs in children less than 21 years of age who receive drugs per standard of care, as prescribed by a treating caregiver. The NICHD-2011-POP01 study enrolls participants under multiple drugs of interest (DOI) including ampicillin, and continues to enroll participants under other DOIs. Data from NICHD-2011-POP01 (Ampicillin) was analyzed as part of NICHD-2012-AMP01 study. Results: No AEs or SAEs related to study procedures were reported. No serious, unexpected, suspected, adverse reactions to Ampicillin were reported.
DOI: 10.57982/1mam-8q87
title: Project PrEPare – an Open Label Demonstration Project and Phase II Safety Study of Pre-exposure Prophylaxis Use Among 15 to 17 Year Old Young Men Who Have Sex With Men (YMSM) in the United States

description: This pre-exposure prophylaxis (PrEP) demonstration project and phase II safety study aimed to obtain additional data on the safety of emtricitabine/tenofovir (FTC/TDF (Truvada�)). 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 (Truvada�) and information on the safety and efficacy of PrEP from prior studies were evaluated. Furthermore, this project explored the feasibility and acceptability of implementing two different types of efficacious risk reduction interventions prior to the provision of PrEP – Many Men, Many Voices (3MV) and Personalized Cognitive Counseling (PCC).
DOI: 10.57982/84p7-c722
title: Ampicillin Pharmacokinetics and Safety in Infants

description: Aim: NICHD-2012-AMP01 study was designed to characterize the pharmacokinetics (PK) and safety of ampicillin administered to infants per standard of care to address gap in pediatric labeling. Methods: The PK analysis include ampicillin data from NICHD-2011-POP01 study. The safety analysis includes ampicillin data from 1) NICHD-2011-POP01 study 2) Pediatric Pharmacology Research Unit (PPRU) study and 3) Pediatrix Medical Group Database. Results: No AEs or SAEs related to study procedures were reported. No serious, unexpected, suspected, adverse reactions to Ampicillin were reported. From the Pediatrix database Adverse events during ampicillin exposure were uncommon. Shorter dosing intervals were associated with more frequent hematologic AEs for infants of all age groups.
DOI: 10.57982/bxmy-ca15
title: Turner Syndrome: Genotype and Phenotype

description: Turner syndrome (TS) is a sporadic disorder affecting ~ 1/2500 live female births, caused by the absence of all or significant parts of one sex-chromosome.  Developmental consequences include severe short stature, ovarian failure and distinctive cognitive and behavioral traits, sometimes with renal and cardiovascular defects. Adults with TS have excessive rates of osteoporosis, hypertension and diabetes mellitus, and high rates of morbidity and mortality.  This study aims to correlate TS phenotypes and genotypes, to identify X-chromosome genes and epigenetic mechanisms causing the different features of TS.  For TS subjects with a 45X genotype, the parental origin of the single normal X-chromosome will be traced. X chromosomal structural defects will be analyzed in relation to data from the Human Genome Project.  The elucidation of genetic mechanisms in TS will help improve the diagnosis and treatment of girls and women with this disorder and further our understanding of gene dosage effects in general.
DOI: 10.57982/c10w-nq30
title: Computer-Delivered Motivational Intervention to Prevent Adherence Problems Among Youth Newly Recommended for HIV Medications: Project MESA (Motivational Enhancement System for Adherence)

description: A two-phase study with the primary objective of adapting and piloting Motivational Enhancement System for Adherence (MESA), a brief, two-session, computer-based motivational intervention to prevent adherence difficulties among youth newly recommended to begin HAART. Phase I pre-tested the feasibility and acceptability of the beta version of MESA with Motivational Enhancement System for Health (MESH), a nutrition and exercise control intervention. Following analysis of Phase I responses and further modification of the intervention, Phase II (a pilot randomized controlled trial) was initiated. Phase II tested a two-session MESA intervention, as well as MESH (the attention control), matched for dose and delivery format.
DOI: 10.57982/d1se-rp71
title: Typology of Adherence in Adolescents: Phase II

description: A cross-sectional, observational study designed to assess the most prevalent combination of barriers to HIV medication adherence in adolescents, such as mental health disorders, substance abuse, and cognitive-behavioral and structural barriers. This was the second phase of a two-phase study. Findings from Phase I led to pilot testing and modification of two instruments: the Adherence Staging Algorithm and the Participant Assessment tool. In Phase II, these instruments were used to determine the prevalence of specific barriers to adherence among HIV infected youth requiring antiretroviral medication and the most common clusters of these barriers. Development of a validated cognitive-behavioral barriers schema for classifying HIV medication adherence in adolescents was also explored.
DOI: 10.57982/sjg5-ap19
title: Evaluation of HIV-Specific CD8+ T-Cell Responses and Escape Mutations as Explanations for the Observed Differences in Disease Progression Conferred by HLA Class I Alleles

description: ATN 026 investigated the association between HLA class I genotypes and differing HIV-1 disease progression. The study assessed HIV-1 specific CD8+ T-cell responses and the dominant HIV-1 genotype among individuals identified as HLA-B*27, B*35, B*53, and B*57 positive. Participants were followed for two years with medical history, physical exam, and blood sample collection performed every six months. All participants were previously enrolled in REACH, a 5-year longitudinal adolescent study. Some biospecimens are available; for inquiries, please contact Dr. Paul Goepfert (pgoepfert@uabmc.edu).
DOI: 10.57982/9c3x-yz90
title: Pharmacokinetics of Multiple Dose Methadone in Children

description: NICHD-2013-MTH01 was a multiple center, open label, prospective PK and safety profile study. The primary objective of this study was to describe the pharmacokinetics (PK) of enteral methadone in children to address gap in pediatric labeling. The PK and safety analyses also include methadone data from NICHD-2011-POP01 (Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care), a multiple center, prospective PK study of understudied drugs in children less than 21 years of age who receive drugs per standard of care, as prescribed by a treating caregiver. Safety, demographic, baseline, dosing, and PK variables were summarized separately. Methadone was well-tolerated at the doses studied in this population. There were no AEs related to study drug and all changes in laboratory values were clinically insignificant.
DOI: 10.57982/b7mw-dt09
title: Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care - Methadone

description: Aim: Characterize the pharmacokinetics (PK) of methadone administered to children per standard of care to address gap in pediatric labeling. Methods: The PK and safety analyses include methadone data from NICHD-2011-POP01 (“PK of Understudied Drugs Administered to Children per Standard of Care”), a multicenter, prospective opportunistic PK study of understudied drugs in children less than 21 years of age who receive drugs per standard of care, as prescribed by a treating caregiver. This study enrolls participants under multiple drugs of interest (DOI) including methadone, and continues to enroll participants under other DOIs. Data from this study was analyzed as part of NICHD-2013-MTH01 study. Results: There were no AEs related to study drug and all changes in laboratory values were clinically insignificant. Analyses of new diagnoses and clinical laboratory data from POP01 retrospective chart review suggest that methadone was well-tolerated in participants who received methadone indicated for pain.
DOI: 10.57982/m5bs-xz03
title: Adolescent Safer Sex Social Network Intervention

description: A Phase II, one-arm, pre-/post-test experimental design evaluating the feasibility, acceptability, and preliminary effectiveness of a small-group, peer-network behavioral intervention among adolescent males and females and their friendship networks. Index friends recruited members of their social network to comprise small cohorts of 8 to 16 adolescents who received the group intervention at the same time. The intervention was delivered in six small-group sessions conducted over a three week (two sessions per week) or six week (one session per week) period. The intervention focused on reducing risky sexual behavior, such as the concurrent use of alcohol and marijuana during sex, and increasing condom use.
DOI: 10.57982/6t6s-4212
title: Trichotomous Outcome Prediction in Critical Care

description: TOPICC was a prospective observational cohort study where a probability sample of all patients under 18 years of age, who were admitted to all non-neonatal Collaborative Pediatric Critical Care Network pediatric intensive care units (PICUs), were selected. During this time, the project looked to determine the optimal time window in which to collect data elements representing the initial medical and physiological condition of PICU patients. Also, investigators aimed to derive and validate a predictor of three or more outcome states following pediatric intensive care; death, survival with reduced functional status, and survival with normal or unchanged functional status. The ultimate goal of this study was to develop and validate a new predictive instrument to measure quality of care provided to children in PICUs across the country. This instrument will facilitate comparisons in quality of care and help inform the development of new interventions aimed at improving the quality of pediatric critical care.
DOI: 10.57982/2frt-6j77
title: INS-3: A Phase 3, Randomized, Double-Masked, Placebo-Controlled Study of the Efficacy and Safety of myo-Inositol 5% Injection to Increase Survival without Severe Retinopathy of Prematurity (Reduce-ROP) in Extremely Premature Infants

description: The objective of this study was to determine the efficacy and safety of myo-Inositol 5% Injection compared to placebo for increasing the probability of survival without severe Retinopathy of Prematurity in premature infants <28 weeks’ gestation followed through the determination of final/acute ROP
status or 55 weeks PMA.  The trial was stopped early based on a statistically significant increase in all-cause deaths through 55 weeks’ PMA in the myo-inositol group.
DOI: 10.57982/deap-2d64
title: Pharmacokinetics of Clindamycin and Trimethoprim-sulfamethoxazole in Infants and Children

description: Failure to account for childhood physiological changes can lead to improper dosing which is associated with decreased drug efficacy & safety. Population physiologically-based pharmacokinetic (PBPK) modeling helps predict optimal dosing based on physiologic parameters adjusted for developmental changes. PBPK models are mathematical constructs that use physiologic processes, drug characteristics & genetic variances to characterize dose-exposure relationships across the age continuum. Models integrate drug-specific & systems-specific info to predict effects of different factors (e.g., age, disease) on drug exposure. PBPK models can reduce the number of children needed for trials & maximize dose-based safety/efficacy. This trial evaluated a platform to validate PBPK models in children using Clindamycin & Bactrim, both among the most commonly used agents to treat gram-positive infections in children, and ideal candidates to evaluate PBPK models due to differing physico-chemical properties & elimination pathways.
DOI: 10.57982/g7qt-4q40
title: A Randomized Trial of Colpopexy and Urinary Reduction Efforts

description: This study will determine which, if any, clinical tests are useful for predicting post-operative urinary incontinence. The study will also determine if a Burch urethropexy should be performed routinely or selectively at the time of sacrocolpopexy in continent women.
DOI: 10.57982/d9de-2x12
title: Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling Trial

description: The overall objective of this study is to determine whether symptom-specific treatment of incontinence after prolapse surgery is equally effective to prophylactic treatment by adding TVT� at the time of the prolapse surgery among women with anterior vaginal prolapse but without pre-operative symptoms of stress urinary incontinence.
DOI: 10.57982/kg6t-av39
title: Pharmacokinetics of Antistaphylococcal Antibiotics in Infants - Rifampin

description: NICHD-2012-STA01 was a multiple center, open label, multiple-dose pharmacokinetic study. The primary objective of this study was to determine the pharmacokinetics (PK) of rifampin, ticarcillin-clavulanate, and clindamycin in infants to address gaps in pediatric labeling of these drugs. Only the data for rifampin is reported here. Twenty seven participants were enrolled. Overall, a total of 86 plasma concentrations from 22 participants were used to construct the population PK model. Rifampin PK was well characterized by a 1 compartment PK model, only postnatal age (PNA) was retained as significant for clearance. No adverse events were related to rifampin and there were no serious adverse events reported. Rifampin was well tolerated in the study population. In addition, body weight and PNA were significant covariates for clearance, indicating that rifampin in infants should be dosed using weight and PNA.
DOI: 10.57982/m8et-2z19
title: Surveillance Monitoring for ART Toxicities Study in HIV-uninfected Children Born to HIV-infected Women, PH100

description: The PHACS Surveillance Monitoring for ART Toxicities (SMARTT) Study was designed to identify potential adverse effects of ARV exposures in infants born to women with HIV infection, and to evaluate associations with ARV combinations and specific ARV drugs in order to help inform treatment guidelines for HIV-infected pregnant women. SMARTT follows two cohorts of HIV- and ART-exposed but uninfected children: the Static and Dynamic cohorts.  Domains of interest include birth outcomes, growth, metabolic, cardiac, neurological, neurodevelopmental, behavior, language, and hearing.  Biospecimens are available.
DOI: 10.57982/5mse-ms56
title: Connect to Protect (C2P): Building a Community-Based Infrastructure for HIV Prevention

description: This study sought to implement Connect to Protect (C2P), a community mobilization intervention intended to develop coalitions to plan for and bring about structural changes to reduce HIV incidence and prevalence among youth in targeted communities. A key aspect of the C2P approach was planning for sustainability beyond the ATN investment. The evaluation of C2P included both process evaluation of the mobilization efforts and outcome evaluation of the changes in individual risk factors associated with HIV transmission and acquisition. The study included extant data collection and mapping, collection of epidemiological HIV/STI data as well as HIV testing data, and key informant interviews.
DOI: 10.57982/ezb9-pc07
title: ATN 116 Structural Enhancements to the SMILE Program / ATN 128 PEACOC: A Multi-Agency (ATN-NIH-CDC-HRSA) Collaboration

description: ATN 116 utilized existing Connect to Protect (C2P) coalition infrastructure to address structural barriers hindering the ability of HIV-infected youth to link to care and remain engaged in care, continuing efforts outlined in ATN 095 and ATN 105. Enhanced strategic planning activities assisted coalitions in identifying structural changes to address Linkage-to-Care (LTC), Engagement-in-Care (EIC), and/or Retention-in-Care (RIC) outcomes for newly diagnosed HIV+ youth.

ATN 128 extended ATN 116, pairing four Ryan White Part D (RWD) sites with five Adolescent Medicine Trials Units. LTC Coordinators at the paired sites received intensive training in motivational interviewing focused on improving acceptance of LTC services and increasing adherence to HIV-related medical visits. RWD site personnel also joined C2P activities intended to address structural barriers to HIV care.
As ATN 128 is a continuation of ATN 116, the files should be analyzed together.
DOI: 10.57982/27g4-6e67
title: Connect to Protect (C2P) Partnerships for Youth Prevention Interventions: Phase II

description: Phase II of a three stage project to develop community-based HIV prevention interventions and form and maintain the necessary community collaborations to support ATN research activities. Phase II described specific locations or venues within high-risk areas where youth spent time. HIV risk behaviors, prevalence, and social networking patterns among youth at these venues were assessed. At a series of meetings, the researcher-community partners established in Phase I discussed Connect 2 Protect (C2P) findings and shared input on recruitment venues, strategies, and other relevant topics. Primary objectives of the study were to identify specific community venues where at-risk youth could be recruited for interventions within the high-risk areas identified in Phase I; describe HIV risk behaviors, social networks, and HIV seroprevalence of adolescents and young adults recruited from targeted venues; and assess the characteristics, quality, and outcomes of the community-researcher partnerships.
DOI: 10.57982/7ka4-x689
title: Enhancement of Connect to Protect (C2P) to Increase Structural Change and Reduce HIV Risk: Phase IV

description: This study sought to continue Connect to Protect (C2P) community mobilization efforts focused on developing coalitions to plan for and bring about structural changes aimed at reducing HIV incidence and prevalence among youth in targeted communities. The extent to which C2P activities influenced elements of the community affecting HIV-related risk prevention, testing, treatment, and linkage to healthcare among youth aged 12 to 24 was assessed. Enhanced strategic planning activities were designed to assist coalitions in identifying necessary and relevant structural changes, and investigators examined how attributes of the structural change objectives related to intermediate outcomes. Evaluation of C2P efforts included both process evaluation of the mobilization efforts and outcome evaluation of the changes in individual risk factors associated with HIV transmission and acquisition.
DOI: 10.57982/95ar-na03
title: Bleeding and Thrombosis During ECMO

description: Bleeding and thrombosis represent major adverse events during extracorporeal membrane oxygenation (ECMO). Complications resulting from these events can lead to death or need for long term rehabilitation support. Despite the increasing use of extracorporeal support and new technology which makes it simpler and potentially safer to apply, little scientific information regarding the predictors of bleeding or thrombosis exists.

This project sought to describe the incidence of bleeding and thrombosis in ECMO patients at Collaborative Pediatric Critical Care Research Network (CPCCRN) sites and to describe current anticoagulation monitoring practices. Additionally, it sought evidence of association between bleeding and thrombotic complications, laboratory coagulation measurements, patient characteristics, ECMO circuitry, and adherence to center-specific ECMO management protocols. Data was collected on 514 subjects receiving ECMO at CPCCRN sites over a 21-month period.
DOI: 10.57982/wvb3-1c47
title: Pharmacokinetics of Antistaphylococcal Antibiotics in Infants - Clindamycin

description: NICHD-2012-STA01 was a multiple center, open label, multiple-dose pharmacokinetic study. The primary objective of this study was to determine the pharmacokinetics (PK) of rifampin, ticarcillin-clavulanate, and clindamycin in infants to address gaps in pediatric labeling of these drugs. Only the data for clindamycin is reported here. Twenty one participants were enrolled under clindamycin, all of whom submitted at least one evaluable fresh plasma sample to be included with other protocol study data in various PK analyses. All participants were included in the safety population. No adverse events were related to clindamycin and there were five unrelated serious adverse events reported. Clindamycin was well tolerated in the study population.