cometadata/datacite-titles-descriptions-related-identifiers huggingface dataset:
DOI: 10.57982/qy0s-8t38
title: CombinADO, a Combination Intervention Strategy to Improve Health Outcomes for Adolescents Living with HIV, Protocol #2: Understanding the Characteristics and Experiences of Adolescents Living with HIV in Nampula, Mozambique, a Mixed-methods Study

description: The purpose of this study was to gather data to describe the demographic, biomedical, psychosocial, and behavioral characteristics of adolescents and young adults living with HIV (AYAHIV) in Nampula, Mozambique, to inform content of the multicomponent CombinADO intervention strategy, and to pilot measures for their social contextual relevance and comprehension by participants. A convenience sample of AYAHIV and a subset of their caregivers were recruited from three government health facilities in 2019 in Nampula, Mozambique. AYAHIV 15-19 years on antiretroviral therapy (ART), including females attending antenatal care, were eligible. A total of 212 AYAHIV (15-19 years) were enrolled. All participants completed a one-time quantitative survey that included questions related to sociodemographic characteristics, educational status, health history, sexual and reproductive health, and ART adherence. Routine HIV care data were extracted from medical charts.
DOI: 10.57982/b2h7-bz24
title: Parent Provider Alliance

description: Parents whose children die in pediatric intensive care units (PICUs) are at high risk for adverse health outcomes. The Collaborative Pediatric Critical Care Research Network (CPCCRN) previously demonstrated a high prevalence of complicated grief among parents whose children died in PICUs. Therapeutic alliance is the collaborative bond that develops between patients/families and their healthcare providers. The strength of therapeutic alliance has been shown to affect treatment outcomes for many conditions. What is not known is the extent to which therapeutic alliance can reduce complicated grief and other adverse health outcomes among parents after a child’s death in a PICU. During this multi-site longitudinal study, parents with a child that died in the PICU were surveyed at 6 and 13 months. The study found that among parents bereaved in the PICU, therapeutic alliance with physicians was moderately high. The study also found that mental health symptoms declined over time; however, symptoms persisted for many.
DOI: 10.57982/1wag-yb67
title: Hydrocortisone Treatment of Hypotension in Term and Late Preterm Infants: An Observational Study

description: This observational study collected information on the incidence and management of hypotension in babies born at term or late preterm that were admitted to Neonatal Intensive Care Units (NICUs) within the Neonatal Research Network (NRN). Participants included all newborn infants born at 34 0/7 weeks gestation or greater who were admitted to NICU Network centers and intubated and mechanically ventilated at less than 72 hours of age. The information gathered provided a framework for the design of a potential randomized controlled trial for the treatment of hypotension in neonates. This observational study was for a time-limited enrollment period; NRN centers enrolled until at least 50 patients were enrolled per center (for 800-1,000 subjects total).   More than half of the infants (N=419) met at least one definition of cardiovascular insufficiency (CVI). However, almost half of the treated infants met none of the definitions. Inotropic therapy was associated with increased mortality.
DOI: 10.57982/dtzx-jb64
title: Innovative Approaches for Minor Consent: Consent 2.0

description: ATN 150 examined how parental involvement in the consent process affects the acceptability of hypothetical participation in biomedical HIV prevention trials from the perspectives of minor adolescents and parents. The quasi-experimental design involved a simulated consent process for two HIV prevention trials to assess minors' willingness to participate (WTP) in such trials with varying degrees of parental involvement. The three consent conditions were minor self-consent, adult permission required, and parental permission required. Adolescents were randomized to one of these three consent conditions. Parents underwent a similar simulated consent process and rated the acceptability of all three consent conditions. No effect of consent condition on adolescent WTP in biomedical HIV prevention trials was found. There were significant differences in the acceptability of the consent conditions from the perspectives of parents with parental permission required most acceptable.
DOI: 10.57982/wz5a-c795
title: A Phase IV Randomized Trial to Evaluate the Virologic Response and Pharmacokinetics of Two Different Triple Antiretroviral Regimens in HIV Infected Women Initiated Between 28 and 36 Weeks of Pregnancy for the Prevention of Mother-to-Child Transmission

description: P1081 was a Phase IV multicenter, randomized, open-label trial comparing the virologic response, safety, and tolerability of raltegravir. The study population included Human Immunodeficiency Virus (HIV)-1 infected pregnant women with a gestational age between 28 and 36 weeks who are antiretroviral (ARV) na�ve or have received short-course zidovudine only for prevention of mother-to-child transmission in previous pregnancies, and their infants. The primary objectives were to compare the ability of two triple ARV regimens (one containing efavirenz and the other raltegravir) begun during the third trimester of pregnancy to achieve a viral load of < 200 copies/mL at the time of delivery and compare the safety and tolerability of two triple ARV regimens (one containing efavirenz and the other raltegravir) begun during the third trimester of pregnancy. All women received a randomized regimen from study entry through delivery. The study showed both regimens to be safe and well-tolerated. The rate of suppression at delivery was found to be higher with raltegravir, primarily with those enrolling in the third trimester. Pregnancy outcomes in this study were consistent with previous studies of initiation of other antiretroviral regimens in pregnancy. While the HIV perinatal transmission rate was not significantly different between treatment arms in our study, substantially fewer infants were infected in the raltegravir arm compared to the efavirenz arm. The results of this study support the use of raltegravir in pregnant women who present late for care.
DOI: 10.57982/ktrh-q152
title: Data Challenge - Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be

description: NuMoM2b studied underlying, interrelated, mechanisms of adverse pregnancy outcomes (e.g., preterm birth, preeclampsia, fetal growth restriction) in pregnant women with no previous pregnancy lasting 20 weeks-0 days or more estimated gestational age (nulliparas). The network included 8 clinical sites, subsites, NICHD, and a data center. Women enrolled early in pregnancy and were followed through delivery, with study visits at 6 weeks-0 days to 13 weeks-6 days, 16 weeks-0 days to 21 weeks-6 days, 22 weeks-0 days to 29 weeks-6 days gestation, and delivery. Data collected through interviews, self-administered questionnaires, clinical measurements, ultrasounds, and medical records review included demographic, psychosocial, dietary, physiologic, health, and pregnancy outcome information. Subsets of participants enrolled in sleep disordered breathing, sleep patterns and quality, and fetal adrenal gland substudies.
DOI: 10.57982/m3kt-4m26
title: Evaluation of HELPING BABIES BREATHE in Belgaum, Kenya and Nagpur: Does Implementation of HELPING BABIES BREATHE Save Lives?

description: Neonatal deaths now account for over 40% of the under 5 years old deaths. The primary objective of the HBB study was to evaluate the impact of implementing an integrated package of neonatal resuscitation training and equipment among health facility birth attendants in three Global Network sites: Belgaum (India), Eldoret (Kenya), and Nagpur (India). The primary hypothesis evaluated that HBB training materials resulted in a 20% reduction in the observed rate of overall perinatal mortality among births of ?1500g, pre- versus post-implementation in the participating clusters served by these facilities. The total cohort of 835 active Birth Attendees (BAs) trained and retrained in the HBB curriculum in 71 facilities in India and Kenya showed the lack of resuscitation training was evident by a large initial knowledge-skills gap among the BAs: at the initial HBB training, 74% of BAs passed the pre-training knowledge assessment but only 5% were able to demonstrate effective ventilation of the neonatal mannequin.
DOI: 10.57982/c325-q892
title: Young Adult Follow-Up Study (a component of the Oshikhandass Water and Sanitation, Health and Hygiene Interventions Study)

description: This study was a follow-up to a 1989-1996 study of diarrhea and pneumonia in children under age 5 years. The aim was to examine individual-level associations between childhood health and family socioeconomic indicators of early life adversity with adolescent health and development. The outcomes were: nonverbal reasoning scores using the Raven’s Progressive Matrices, self-reported health status, Body Mass Index, blood pressure, educational attainment and employment. It was hypothesized that early life experiences, within a context of poverty, manifested in reduced health and development in adolescence, which is the foundation of adult human capital. Adolescents/young adults were interviewed using a bespoke questionnaire; psychometric testing was conducted on the results of the Raven’s Matrices; a multivariable Bayesian network was constructed to explore structural relationships between variables.
DOI: 10.57982/395v-5996
title: Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location

description: This was a randomized controlled trial to compare three currently available management strategies for women with a persisting pregnancy of unknown location (PPUL), which made them at-risk for ectopic pregnancy. The study recruited hemodynamically stable women with a confirmed PPUL to be randomized to one of three strategies: 1) Uterine evacuation followed by methotrexate (MTX) for some (those that had evidence of a non-visualized ectopic pregnancy), 2) Empiric treatment with MTX for all, or 3) Expectant management. Randomization was 1:1:1 into these three arms. After randomization, they were followed and treated clinically, as was indicated by the progression of their condition. Primary outcome measures were the uneventful decline of hCG to 5 IU/mL.
DOI: 10.57982/z8hs-xm81
title: Improving Reproductive Fitness Through Pretreatment With Lifestyle Modification in Obese Women With Unexplained Infertility

description: A two-arm, multicenter, prospective, randomized clinical trial of a lifestyle modification program that tracked increased physical activity and weight loss (intensive) compared with a recommendation to track of increased physical activity alone with weight maintenance (standard) in women with obesity and unexplained infertility. This 16-week period of lifestyle modification was followed by an open label empiric infertility treatment regimen consisting of three cycles of ovarian stimulation with oral medication (clomiphene citrate (CC)), triggering of ovulation with human chorionic gonadotropin (hCG), and intrauterine insemination (IUI). The goal for both treatment groups was to maintain levels of physical activity and weight achieved during the pretreatment phase during the empiric infertility treatment phase. The primary outcome of this study was a good birth outcome which was defined as singleton or twin infant(s) born at ? 37 weeks between 2500 and 4000g without a major congenital anomaly.
DOI: 10.57982/arn4-va15
title: Inhaled Nitric Oxide for Preterm Infants With Severe Respiratory Failure

description: This was a multicenter, randomized, blinded, controlled trial to determine whether inhaled nitric oxide (iNO) reduced the rate of death or bronchopulmonary dysplasia (BPD) in infants. The study included 420 neonates, born at less than 34 weeks of gestation, with a birth weight of 401-1500 grams, and with respiratory failure more than 4 hours after treatment with surfactant to receive placebo (simulated flow) or iNO (5 to 10 ppm). Infants with a response (an increase in the partial pressure of arterial oxygen of more than 10 mm Hg) were weaned. The rate of death or BPD was 80% in the iNO group, as compared with 82% in the placebo group, and the rate of BPD was 60% versus 68%. In conclusion, use of iNO in critically ill premature infants weighing less than 1500 grams does not decrease the rates of death or BPD. Outcomes of surviving infants were assessed at 18 to 22 months corrected age; iNO did not reduce death or neurodevelopmental impairment or improve neurodevelopmental outcomes.
DOI: 10.57982/t27x-9e36
title: A Randomized Trial of Vaginal Surgery for Uterovaginal Prolapse: Vaginal Hysterectomy with Native Tissue Vault Suspension vs. Mesh Hysteropexy Suspension

description: The primary purpose of this randomized clinical trial was to compare the effectiveness and safety of two transvaginal apical suspension strategies for uterovaginal prolapse: a mesh augmented hysteropexy versus vaginal hysterectomy and uterosacral ligament suspension (USLS). Postmenopausal women requesting surgery for symptomatic uterovaginal prolapse were randomized to receive one of the procedures and were then followed at 6-month intervals for 60 months. The primary treatment failure composite outcome (retreatment of prolapse, prolapse beyond the hymen, or prolapse symptoms) was evaluated with survival modeling. The study found that sacrospinous hysteropexy with graft resulted in a lower composite failure rate than vaginal hysterectomy after 5 years of follow-up.
DOI: 10.57982/000p-g430
title: Supplemental Data to Provide Additional Evidence of Safety and Efficacy for the Proposed Dosing Regimens of Fluconazole in Infants and Young Children

description: This was a multi-site retrospective data collection from the Pediatric Trials Network (PTN) Repository and Duke University Hospital electronic health records. The objective of this data collection was to provide supplemental data to support label change for fluconazole, and particularly evaluate adverse events associated with loading high-dose fluconazole compared to standard dose fluconazole in infants and children using real-world data.
DOI: 10.57982/xvkr-ca10
title: A Phase II Multicenter, Randomized, Double-Blind, Parallel Group, Dose-Ranging, Effect-Controlled Study to Determine the Pharmacokinetics and Pharmacodynamics of Sodium Nitroprusside (SNP) in Pediatric Subjects

description: This was a randomized, double-blind, parallel group, dose-ranging, effect-controlled, multicenter study examining the effects of sodium nitroprusside (SNP) in pediatric patients requiring relative induced hypotension during a surgical or medical procedure. The study goals were to define the onset and offset of blood pressure lowering effects of SNP, to construct a dose-response model that defines the relationship between SNP infusion rate and changes in blood pressure in pediatric patients, and to assess the safety of SNP in pediatric patients requiring controlled reduction of blood pressure. Additional goals were to establish the starting and maximum infusion rates for optimum blood pressure control and a safe dosing regimen. A total of 211 participants were enrolled, and 203 included in the intent-to-treat population. Results indicate that a reasonable starting dose for SNP in this group would be 0.3 �g/kg/min. The clinician can then increase infusion rate to achieve the desired reduction in blood pressure.
DOI: 10.57982/xzp0-tr80
title: Efficacy and Impact of Botulinum Toxin A versus Anticholinergic Therapy for the Treatment of Bothersome Urge Urinary Incontinence

description: Urinary incontinence is a condition that markedly impacts quality of life. Conservative first line treatments for urge incontinence combined with other overactive bladder (OAB) symptoms include behavioral therapy, pelvic floor training +/- biofeedback, or the use of anticholinergic medications. These treatment modalities may not result in total continence and are often not sustained for various reasons. Thus, the objective of the Anticholinergic versus Botox Comparison Study (ABC) was to determine whether a single intra-detrusor injection of botulinum toxin A (Botox A�) is more effective than a standardized regimen of oral anticholinergics in reducing urge urinary incontinence (UUI). Oral anticholinergic therapy and Botox A� by injection were associated with similar reductions in the frequency of daily episodes of UUI. The group receiving Botox A� was less likely to have dry mouth and more likely to have complete resolution of UUI but had higher rates of transient urinary retention and urinary tract infections.
DOI: 10.57982/6711-1r23
title: Tailored Motivational Interviewing Implementation Intervention (TMI) Effectiveness Trial in Multidisciplinary Adolescent HIV Care Settings

description: ATN 146 Tailored Motivational Interviewing Implementation Intervention (TMI) was tested in multidisciplinary adolescent HIV care settings. TMI is an evidence-based practice for patient-provider communication and behavior change. Aims were to determine its effect on provider fidelity, HIV cascade-related outcomes, sustainment fidelity, implementation barriers and facilitators, and cost effectiveness. A Dynamic Wait-list controlled design was used to deliver TMI in community-based settings (190 providers enrolled across 10 sites). The intervention included a group workshop, individual coaching, and quarterly competency assessments. It was hypothesized that MI competency would be higher during the intervention phase than baseline, and successful implementation would be associated with improved cascade-related outcomes. TMI demonstrated significantly higher competence during the intervention phase, maintained with only small reductions through the sustainment window. Analyses are underway for cascade-related outcomes.
DOI: 10.57982/g27w-aq15
title: A Randomized Controlled Trial of Benchmarking to Reduce Bronchopulmonary Dysplasia

description: This study tested whether Neonatal Intensive Care Unit (NICU) teams trained in benchmarking - comparing care practices between different NICUs to see which practices prevent bronchopulmonary dysplasia (BPD) - and quality improvement would change practices and improve rates of survival without BPD in inborn neonates with birth weights of <1250 grams. Benchmarking is a method involving detailed comparisons of processes between similar organizations. For this study, three NRN centers with the lowest rates of BPD were identified as Benchmark centers. During a 6-month pre-intervention period, details of care practices and management style at these centers were carefully assessed. Based on practices at these Benchmarking sites, a quality improvement program was developed. A total of 14 other NRN sites were randomized to either implement the benchmarking intervention (intervention sites) or continue with their usual care practices (control sites). After the 1-year intervention period, changes in the rate of survival without BPD at 36 weeks corrected age were compared between the intervention and control sites. Intervention centers implemented potentially better practices successfully; changes included reduced oxygen saturation targets and reduced exposure to mechanical ventilation. Lower oxygen saturation targets reduced oxygen levels in the first week of life. Despite these changes, rates of survival free of BPD were all similar between intervention and control groups and remained significantly less than the rate achieved in the best-performing centers (73.3%).
DOI: 10.57982/vt12-6h59
title: Pharmacokinetics of Anti-epileptic Drugs in Obese Children - Levetiracetam

description: This was a multi-center, prospective, open-label, pharmacokinetic (PK) and safety study of anti-epileptic drugs in obese children age 2 to less than 18 years of age who received drugs per standard of care, as prescribed by a treating clinician. Participants were enrolled under multiple drugs of interest, including levetiracetam. The PK of levetiracetam in children was well characterized with a 1-compartment  population PK model. After accounting for size-based differences using fat free mass, estimated glomerular filtration rate was associated with clearance of levetiracetam. A weight-based dosing regimen was recommended for levetiracetam oral solution dosing in 2 to <4 years. Weight-tiered dosing regimens were recommended for levetiracetam oral solution dosing and tablet dosing in obese participants 4 to <16 years. Levetiracetam was well tolerated in the study participants.
DOI: 10.57982/76e6-fj68
title: Clinical Trial of Low-Dose Aspirin to Prevent Preeclampsia in High Risk Women

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.
DOI: 10.57982/52w7-1t05
title: Clinical Trial of Low-Dose Aspirin (60 mg) as a Preventive of Preeclampsia 

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
DOI: 10.57982/t880-rf36
title: Global Network's Maternal Newborn Health Registry

description: The purpose of the Global Network for Women's and Children's Health Research is to develop and test feasible, sustainable interventions to improve the outcome of women and children and to develop research capacity in resource-poor settings. Because most of the sites have weak health care systems, unacceptably high rates of maternal and neonatal mortality and lack birth and death registries, they lack precise data on outcomes and measures of care. Information from a vital registry system will allow the Global Network to document maternal and neonatal mortality, design trials to address the major causes of poor outcome, assess the outcome of our interventions, and ultimately disseminate the results as the basis of public health policy
DOI: 10.5255/ukda-sn-856041
title: Towards a Relational Approach to Agency for Mapping Pathways Into and Out of Poverty: Life Histories, 2016-2020

description: Global poverty looks radically different in the 21st century as climate-related events, political-religious conflicts and economic growth-inequality nexuses add to persistent forms of social exclusion based on gender, race, and class. In this uncertain and unpredictable context, we require new approaches to understand complex pathways into and out of poverty, directing attention to poor people's collective capacity to bring about transformative change i.e., their agency, as constituted by social networks and relations with nature, and mediated by science and technology. The collection deposited includes the transcripts of life history interviews with anonymised participants in south India and in Kenya. Focus of the interviews was on understanding participants' relations with modern sciences and technologies as well as with social structures. The eventual aim was to understand how these socio-material relations constitute participants' agency. All names are pseudonyms.
DOI: 10.6084/m9.figshare.21565539
title: Sample N, V, T data for a 3D printer

description: this is sample data obtained from a 3D printer machine for its Noise, Vibration and Temprature of Nozzle
DOI: 10.25625/s8kvat/nb7eww
title: oil palm canopy cover with tree height and basal area_unpublished.tab

description: amount of canopy cover (column D) for all species with survival score in 2017 (1= survived) and tree height increment (F), basal area (G)