bluuebunny/crossref_metadata_2025_split huggingface dataset:
Safety and immunogenicity after a 30-month boost of a subtype C ALVAC-HIV (vCP2438) vaccine prime plus bivalent subtype C gp120/MF59 vaccine boost (HVTN 100): A phase 1–2 randomized double-blind placebo-controlled trial
Authors: Naicker Vimla , Laher Fatima , Bekker Linda-Gail , Seaton Kelly E. , Allen Mary , De Rosa Stephen , Yates Nicole L. , Mkhize Nonhlanhla N. , Saunders Kevin , Heptinstall Jack , Malahleha Mookho , Mngadi Kathryn , Daniels Brodie , Innes Craig , Yu Chenchen , Modise Tandile , Bekker Valerie , Grunenberg Nicole , Furch Briana , Miner Maurine D. , Phogat Sanjay , Diazgranados Carlos A. , Gurunathan Sanjay , Koutsoukos Marguerite , Van Der Meeren Olivier , Roxby Alison C. , Ferrari Guido , Morris Lynn , Montefiori David , McElrath M. Juliana , Tomaras Georgia D. , Moodie Zoe 
Published: September 2024

Induction of broad, durable immune responses is a challenge in HIV vaccine development. HVTN 100 Part A administered subtype C-containing ALVAC-HIV at months 0 and 1, and ALVAC-HIV with bivalent subtype C gp120/MF59 at months 3, 6 and 12. As IgG binding antibody and T-cell responses were similar or greater at month 12.5 vs. month 6.5, but waned by month 18, we investigated vaccine-elicited immune responses after a month 30 boost in this study, HVTN 100 Part B. From 13 September 2017 to 7 August 2018, a subgroup of vaccinees was randomized to receive intramuscular injections of ALVAC+gp120/MF59 (n = 32) or gp120/MF59 alone (n = 31) and a subgroup of placebo recipients was administered placebo (n = 7) at month 30. Primary outcomes were safety, IgG binding antibodies (bAbs) to vaccine-specific and V1V2 Env proteins and vaccine-specific CD4+ T cells at month 30.5. Secondary outcomes included neutralizing and antibody dependent cellular cytotoxicity functions and durability at months 30 and 36. Both vaccine groups had an acceptable safety profile. There were no statistically significant differences in the occurrence or level of IgG bAbs between the vaccine boost groups for any vaccine-specific or V1V2 antigens. IgG responses were higher to vaccine-matched gp120 than to V1V2. The booster vaccination restored the magnitude-breadth IgG bAb response to V1V2 antigens at month 30.5. However, it rapidly waned by month 36. CD4+ T-cell response rates to the 3 vaccine-matched Env antigens for the combined vaccine groups ranged from 37% at month 30, boosted to as high as 91% at month 30.5, and waned by month 36 to as low as 44%, with no significant differences between the vaccine boost groups. Because these responses waned after 6 months, additional strategies may be needed to maintain the durability of prime-boost vaccine regimens and to generate these or other immune responses that confer protection.
Trial registration: South African National Clinical Trials Register (SANCTR number: DOH—27-0215-4796) and ClinicalTrials.gov (NCT02404311).
A multi-centre, tolerability study of a cannabidiol-enriched Cannabis Herbal Extract for chronic headaches in adolescents: The CAN-CHA protocol
Authors: Chhabra Manik , Lewis Evan C. , Balshaw Robert , Stewart Breanne , Zaslawski Zina , Lowthian Trinity , Alidina Zahra , Chesick-Gordis Melila , Xie Wenli , Drögemöller Britt I. , Wright Galen E. B. , Birnie Kathryn A. , Boerner Katelynn E. , Tsang Vivian W. L. , Irwin Samantha Lee , Pohl Daniela , Weil Alexander G. , Sell Erick , Penz Erika , Robson-MacKay Amy , Mbabaali Sophia , Blackman Stephanie , Gordon Shanlea , Alcorn Jane , Huntsman Richard J. , Oberlander Tim F. , Finley G. Allen , Kelly Lauren E. 
Published: September 2024

Introduction
Cannabis products have been used in the management of headaches in adults and may play a role in pediatric chronic pain. Canadian pediatricians report increasing use of cannabis for the management of chronic headaches, despite no well-controlled studies to inform its dosing, safety, and effectiveness. The aim of our clinical trial is to determine the dosing and safety of a Cannabidiol (CBD)-enriched Cannabis Herbal Extract (CHE) for the treatment of chronic headaches in adolescents.

Methods and analysis
Youth, parents, and an expert steering committee co-designed this tolerability study. Twenty adolescents (aged 14 to 17 years), with a chronic migraine diagnosis for more than 6 months that has not responded to other therapies will be enrolled into an open label, dose escalation study across three Canadian sites. Study participants will receive escalating doses of a CBD-enriched CHE (MPL-001 with a THC:CBD of 1:25), starting at 0.2–0.4 mg/kg of CBD per day and escalating monthly up to 0.8–1.0 mg/kg of CBD per day. The primary objective of this study is to determine the safety and tolerability of CBD-enriched CHE in adolescents with chronic migraine. Secondary objectives of this study will inform the development of subsequent randomized controlled trials and include investigating the relationship between the dose escalation and change in the frequency of headache, impact and intensity of pain, changes in sleep, mood, function, and quality of life. Exploratory outcomes include investigating steady-state trough plasma levels of bioactive cannabinoids and investigating how pharmacogenetic profiles affect cannabinoid metabolism among adolescents receiving CBD-enriched CHE.

Discussion
This protocol was co-designed with youth and describes a tolerability clinical trial of CBD-enriched CHE in adolescents with chronic headaches that have not responded to conventional therapies. This study is the first clinical trial on cannabis products in adolescents with chronic headaches and will inform the development of future comparative effectiveness clinical trials.

Trial registration
CAN-CHA trial is registered with ClinicalTrials.gov with a number of register NCT05337033.
Mainly heterosexual, bisexual, or other?: The measurement of sexual minority status and its impact on analytic sample, demographic distribution and health outcomes
Authors: Tabor Evangeline , Kneale Dylan , Patalay Praveetha 
Published: September 2024

Background
Sexual orientation has been measured in a wide variety of ways which reflect both theoretical and practical considerations. However, choice of sexual orientation measure and recoding strategy can impact analytic sample, as well as demographic and health profiles, in analyses of sexual minority populations. We aimed to examine how choice of sexual orientation dimension and recoding decisions impact estimates in the sexual minority population in two population-based studies in the UK.

Methods
We used data collected at age 17 (2018) in the UK Millennium Cohort Study and at sweep six (2012–13) and eight (2017–18) of the English Longitudinal Study of Ageing. Descriptive statistics were used to examine the impact of choice of sexual orientation dimension (i.e. identity, attraction and experience) and recoding decisions on achieved analytic sample and composition by selected demographic and health measures within and between datasets.

Results
Dimension choice and recoding decisions resulted in variation in analytic sample. For example, more respondents reported some same-sex sexual attraction than reported a non-heterosexual identity (adolescents: 20.77% vs 8.97%, older adults: 4.77% vs 1.04%). Demographic distributions varied, but not substantially by dimension choice or recoding strategy. Overall, in both datasets sexual minority respondents were more likely to be White and in the highest quintiles for income and education than heterosexual respondents. Health status did not vary substantially by dimension choice or recoding strategy, however sexual minority respondents reported worse health than their heterosexual peers.

Conclusions
This study explores a range of practical and theoretical considerations when analysing sexual minority respondents using survey data. We highlight the impact recoding decisions may have on the numbers of sexual minority respondents identified within a dataset and demographic and health distributions in this understudied population. We also demonstrate the benefits of including multiple dimensions for capturing mechanisms of interest in elucidating ambiguous responses and exploring sexual diversity.
MicroRNA-199a-5p attenuates blood-brain barrier disruption following ischemic stroke by regulating PI3K/Akt signaling pathway
Authors: Ni Guangxiao , Kou Lulu , Duan Chunqiao , Meng Ran , Wang Pu 
Published: September 2024

Objective
To explore whether miR-199a-5p regulated BBB integrity through PI3K/Akt pathway after ischemia stroke.

Methods
Adult male Sprague-Dawley rats with permanent middle cerebral artery occlusion(MCAO) were used in experiment. The Ludmila Belayev 12-point scoring was used to measure the neurological function of MCAO rats. The Evans Blue Stain, immunofluorescence staining, western-blotting and RT-PCR were performed to evaluate the effects of miR-199a-5p mimic on BBB integrity in rats following MCAO.

Results
The result suggested that miR-199a-5p mimic treatment possessed the potential to boost proprioception and motor activity of MCAO rats. MiR-199a-5p decreased the expression of PIK3R2 after MCAO, activated Akt signaling pathway, and increased the expression of Claudin-5 and VEGF in the ischemic penumbra. Furthermore, miR-199a-5p alleviated inflammation after cerebral ischemia. BBB leakage and neurocyte apoptosis were cut down in MCAO rats treated with miR-199a-5p mimic.

Conclusions
MiR-199a-5p mimic decreased the expression of PIK3R2 and activated Akt signaling pathway after ischemia stroke, reduced the expression of inflammatory cytokines, and attenuated BBB disruption after ischemic stroke.
Identifying symptom cluster in cancer patients undergoing chemotherapy-in Vietnam: A cross-sectional study
Authors: Hoang Huong Thi Xuan , Le Quyen Thi Le , Do Vi Pham Nhat , Nguyen Anh Thi Hong , Bui Quang Vinh 
Published: September 2024

Background
Major cancer treatments can cause a wide range of unpleasant symptoms that burden oncology patients. Different symptom clusters (SC) among cancer patients have been reported in the literature. This study determined the prevalence of symptoms patients experience during chemotherapy treatment and identified symptom clusters among them.

Methods
A cross-sectional study was conducted among 213 cancer patients undergoing chemotherapy in three large hospitals in Vietnam. Symptoms were measured by the Memorial Symptom Assessment Scale.

Results
The most prevalent symptoms were lack of appetite (65.3%), difficulty sleeping (62.9%), dry mouth (57.7%), numbness (60.1%), hair loss (43.2%), change in the way food tastes (40.8%), and lack of energy (44.1%). Four symptom clusters were identified. Difficult concentration, pain, cough, and dizziness contributed to the first SC. The second one included lack of energy, numbness, change the food taste, and lack of appetite. Dry mouth, nausea, feeling bloated, problems with urination, hair loss, and constipation made up for the third SC. The final SC consisted of psychological symptoms, which were feeling nervous, feeling drowsy, feeling sad, worrying, problems with sexual interest or activity and difficulty sleeping.

Conclusion
The study demonstrated that respondents experienced various symptoms and symptom clusters during chemotherapy. These findings can be used to develop clinical guidelines for symptom assessment and management in oncology patients for healthcare professionals.
Modification of childcare’s outdoor setting for toddler physical activity and nature-based play: A mixed methods study
Authors: Kracht Chelsea L. , Staiano Amanda E. , Harris Melissa , Domangue Kristin , Grantham-Caston Michelle 
Published: September 2024

Background
Toddler physical activity is critical for child health, but little is known about its applications in early childhood education (ECE) centers. The aims of this study were 1) to determine if pragmatic and nature-based modifications to an ECE center’s outdoor setting were feasible and acceptable, and 2) to identify barriers and facilitators of toddler physical activity at ECE centers.

Methods
A multiphase mixed-methods study (QUANT+QUAL) was conducted. In the QUANT study, a stepped, sequential modification of the outdoor setting, using pragmatic and cost-effective nature-based elements, was conducted with a delayed control group over 10-weeks, with follow-up assessments 3-months later (week-20). Five elements (tree cookies, garden, teacher training, playground stencils, and nature table) were introduced individually. Feasibility was assessed using teacher surveys. Acceptability and engagement were assessed by direct observation of toddler use of outdoor elements. Accelerometers were used to assess toddlers’ physical activity during outdoor sessions. The QUAL study included semi-structured interviews from ECE center directors (n = 27, 55.6% African American, 92.5% female) that were analyzed using content analysis for themes related to 1) toddler physical activity, 2) barriers and facilitators to toddler outdoor environment changes, 3) perspectives on nature-based elements, and 4) provider training. Member check focus groups (n = 2, 7-10/group) were conducted for additional interpretation. All three sources were reviewed for integration.

Results
Toddlers engaged in physical activity for most of the outdoor sessions (>85%). This limited the effect of the intervention, but aligned with directors’ and members’ sentiments that toddlers were already quite active. Across directors, reported barriers to toddler outdoor environment changes were teacher turnover and finances. All nature-based elements, except the stencils, were feasible and acceptable, even at week-20. Directors and members identified additional age-appropriate elements, and desired pragmatic training with technical assistance and funding to implement these changes. Directors and members also desired a curriculum that could be used outdoors.

Conclusions
Nature-based elements were feasible and acceptable to toddlers. Directors were enthusiastic about nature-based elements, but barriers exist in linking directors with these elements. Opportunities to combine toddler-age curricula and pragmatic options for outdoor play may improve ECE centers’ outdoor settings and ultimately toddler health.
Anorectal Malformations (ARM) and associated maternal factors among children at Tikur Anbessa Specialized Hospital and St. Paul’s Hospital Millennium Medical College, Addis Ababa, Ethiopia: An unmatched case-control study
Authors: Solomon Samrawit , Temesgen Fisseha , Tibebu Solomon , Abebe Hana , Seyoum Girma 
Published: September 2024

Introduction
Anorectal malformations (ARMs) are birth defects that affect the rectum, anus, and surrounding structures. While genetic and environmental factors may contribute to the risk of developing ARMs, the exact causes are largely unknown. Notably, there is a lack of research investigating predisposing factors for ARMs within the Ethiopian population, despite the burden of this condition in the country.

Objective
The research study aimed at to examine the maternal risk factors linked to the occurrence of anorectal abnormalities in children receiving treatment at designated public hospitals located in Addis Ababa, Ethiopia.

Methods
An unmatched case-control study was conducted at selected hospitals on mothers and their children between August 2022 and January 2023. The sample consisted of pediatric patients admitted to pediatric surgical units. Cases were diagnosed with ARMs, while controls had no congenital anomalies. Data was collected from the mothers of both cases and controls. The data was validated and then exported to SPSS version 26 for analysis. The analysis employed descriptive statistics and binary logistic regression. In a multivariable model, an adjusted odds ratio (AOR) together with a 95% confidence interval and p-value < 0.05 was used to determine significance.

Result
This study included 68 ARM cases and 136 controls. Multivariable analysis found that a family history of birth defects (AOR = 6.15, 95% CI: 1.24–30.58), maternal alcohol use (AOR = 4.71, 95% CI: 1.71–12.00), first-trimester medication use (AOR = 4.86, 95% CI: 1.29–18.32), advanced maternal age (AOR = 4.22, 95% CI: 1.21–14.69), and unplanned pregnancy (AOR = 3.701, 95% CI: 1.551–8.828) were significant risk factors for ARM.

Conclusion
The study found that key risk factors for ARM include family history of birth defects, maternal alcohol use, first-trimester medication use, advanced maternal age, and unplanned pregnancy. These findings underscore the importance of tailored prevention strategies and screening programs to address the genetic, maternal lifestyle, and maternal health factors that contribute to this congenital disorder.
Preoperative dual-energy computed tomography and positron-emission tomography evaluation of lymph node metastasis in esophageal squamous cell carcinoma
Authors: Sun Xuyang , Niwa Tetsu , Kazama Toshiki , Okazaki Takashi , Koyanagi Kazuo , Kumaki Nobue , Hashimoto Jun , Ozawa Soji 
Published: September 2024

Purpose
To investigate the detectability of lymph node metastasis in patients with esophageal squamous cell carcinoma using a combination of dual-energy computed tomography (CT) and positron-emission tomography (PET) parameters.

Methods
We analyzed dual-energy CT and PET preoperative data in 27 consecutive patients with esophageal squamous cell carcinoma (23 men, 4 women; mean age, 73.7 years). We selected lymph nodes with a short-axis diameter of ≥5 mm and measured CT values, iodine concentrations, fat fractions, long- and short-axis diameters, and ratio of long- and short-axis diameters. We performed visual assessment of lymph node characteristics based on dual-energy CT and determined the maximum standardized uptake value via PET. The measured values were postoperatively compared between pathologically confirmed metastatic and nonmetastatic lymph nodes. Stepwise logistic regression analysis was performed to determine factors associated with lymph node metastasis. Diagnostic accuracy was assessed via receiver operating characteristic curve analysis.

Results
Overall, 18 metastatic and 37 nonmetastatic lymph nodes were detected. CT values, iodine concentrations, fat fractions, and the maximum standardized uptake values differed significantly between metastatic and nonmetastatic lymph nodes (p < 0.05). Stepwise logistic regression showed that iodine concentration and the maximum standardized uptake value were significant predictors of metastatic lymph nodes. The areas under the curve of iodine concentrations and maximum standardized uptake values were 0.809 and 0.833, respectively. The area under the curve of the combined parameters was 0.884, with 83.3% sensitivity and 86.5% specificity.

Conclusion
Combined dual-energy CT and PET parameters improved the diagnosis of lymph node metastasis in patients with esophageal cancer.
Mid-upper arm circumference as an indicator of nutritional status improvement in children aged 6-59 months with severe acute malnutrition
Authors: Putri Trivani , Prasetyadi Yosafat Lambang , Ibrahim Naufal Arkan Abiyyu , Hafifah Cut Nurul 
Published: September 2024

Background The prevalence of severe acute malnutrition (SAM) in Indonesia remains high, especially in children with pre-existing chronic disease. These children often present with conditions that could interfere with weight measurements, such as edema or organomegaly. Mid-upper arm circumference (MUAC) is a potential indicator of nutritional status improvement.
Objective To analyze the correlation between MUAC and body weight as parameters for nutritional improvement in children with SAM.
Methods We performed registry analysis of patients admitted to the Pediatric Ward, Cipto Mangunkusumo Hospital, Jakarta, Indonesia from November 2016 to December 2020. We included children aged 6-59 months who were severely wasted (z-score <-3 on the WHO weight-for-height growth chart), had no conditions that could alter weight measurement, and had a 7-day minimum hospital stay. Patients with missing body weight and/or MUAC data were excluded. MUAC and weight increment between admission and discharge were analyzed using bivariate correlation and linear regression analyses.
Results Out of 4,746 pediatric inpatients, 1,996 presented with SAM. Of these, 124 were eligible for analysis. Subjects’ median age was 18 (IQR 11-32) months and median length of stay was 16 days (IQR 9-29 days). Weight increment (g/kg/day) and MUAC increment (mm/day) were independently and significantly correlated (P<0.001; Spearman’s rho=0.414). An adequate weight increment of 5-10 g/kg/day was equivalent to a MUAC increment of 0.319-0.439 mm/day (P<0.001; R=0.374).
Conclusion MUAC increment has a moderate positive correlated with weight increment. MUAC is a useful parameter of nutritional status improvement in SAM patients, especially in patients with conditions that could interfere with weight measurement.
Die Rückkehr in die Zukunft
Authors: Lehmann Klaus-Dieter 
Published: September 2024

Zusammenfassung
Der Fall der Mauer und die daraus sich ergebenden zeitgeschichtlichen Veränderungen haben mein persönliches und berufliches Leben dramatisch verändert. Meine persönlichen Erinnerungen sollen davon einen Eindruck vermitteln. Verantwortlich für den Vereinigungsprozess von Deutscher Bücherei Leipzig und Deutscher Bibliothek Frankfurt zu sein, bedeutete nicht nur eine organisatorische, sondern auch eine zutiefst menschliche Erfahrung. Diese Art der Zusammenarbeit zeigte sich auch bei den möglich gewordenen Rückführungsverhandlungen zur „Beutekunst“, die aber erfolglos blieben.
Colorimetric correcting for sample concentration in stool samples
Authors: Delanghe Joris R. , Van Elslande Jan , Godefroid Maaike J. , Thieuw Barroso Alexandre M. , De Buyzere Marc L. , Maenhout Thomas M. 
Published: September 2024

Abstract

Objectives
Fecal immunochemical tests (FIT) for hemoglobin are currently considered the screening investigation of choice for colorectal cancer and are worldwide recommended. Similarly, fecal calprotectin is a widely used test for monitoring intestinal inflammation. The pre-analytical issues regarding stool samples have hardly been dealt with and are difficult to solve. Currently, there are no reference analytes available which allow to correct test results for the variable water content of the stool sample. Studies on preanalytics of stool samples have generally focused on sample preparation and sample storage, but generally have paid little attention to the variability in sample hydration and sample composition.

Methods
Stercobilin is a stable heme metabolite which is abundant in stool. Stercobilin concentration can be simply assayed in stool extracts using colorimetry (determination of the I index). Serum indices (H, I and L) and bilirubin concentration of fecal extracts were determined on a Atellica Platform (Siemens).

Results
The inter-individual variation of stercobilin was found to be high. Assaying stercobilin allows to correct for stool sample dilution. The median value of the I-index was used as a reference for correcting the data. Correcting fecal blood results for sample dilution resulted in a significant increase in positive tests (from 9.3 to 11.7 %). For calprotectin, correction resulted in 3.1 % extra positive results and 7.7 % negative results.

Conclusions
Except in the case of obstructive jaundice, this correction can be applied. Correcting test results of common fecal analytes like FIT and calprotectin may result in a better tailored test interpretation.