bluuebunny/crossref_metadata_2025_split huggingface dataset:
Large-scale (Phase III) evaluation of broflanilide 50WP (VECTRON™ T500) for indoor residual spraying for malaria vector control in Northeast Tanzania: study protocol for a two-arm, non-inferiority, cluster-randomised community trial
Authors: Tungu Patrick K. , Rowland Mark W. , Messenger Louisa A. , Small Graham J. , Bradley John , Snetselaar Janneke , Kirby Matthew J. , Mbewe Njelembo J. 
Published: February 2022

Abstract
Background
Indoor residual spraying (IRS) is a major method of malaria vector control across sub-Saharan Africa. Effective control is being undermined by the rapid spread of insecticide resistance. There is major investment in development of new insecticides for IRS that possess novel modes of action, long residual activity, low mammalian toxicity and minimal cross-resistance. VECTRON™ T500, a new IRS product containing the active ingredient broflanilide as a 50% wettable powder (WP), has been shown to be efficacious against pyrethroid susceptible and resistant vector species on mud and concrete substrates in experimental hut (Phase II) trials.

Methods
A two-arm non-inferiority cluster randomized controlled trial (Phase III) will be undertaken in Muheza District, Tanga Region, Tanzania. VECTRON™ T500 will be compared to the IRS product Fludora® Fusion (clothianidin 50% WP + deltamethrin 6.25% WP). The predominant malaria vectors in the study area are pyrethroid-resistant Anopheles gambiae s.s., An. arabiensis and An. funestus s.s. Sixteen village clusters will be pair-matched on baseline vector densities and allocated to reference and intervention arms. Consenting households in the intervention arm will be sprayed with VECTRON™ T500 and those in the reference arm will be sprayed with Fludora® Fusion. Each month, CDC light traps will collect mosquitoes to estimate changes in vector density, indoor biting, sporozoite and entomological inoculation rates (EIR). Susceptibility to IRS active ingredients will be assessed using World Health Organisation (WHO) bottle bioassays. Target site and metabolic resistance mechanisms will be characterised among Anopheles field populations from both trial arms. Residual efficacy of both IRS products will be monitored for 12 months post intervention. Questionnaire and focus group discussions will explore factors that influence adherence, adverse effects and benefits of IRS.

Discussion
This protocol describes a large-scale non-inferiority evaluation of a novel IRS product to reduce the density and EIR of pyrethroid-resistant Anopheles vectors. If VECTRON™ T500 proves non-inferior to Fludora® Fusion, it will be considered as an additional vector control product for malaria prevention and insecticide resistance management.
Trial registration: ClinicalTrials.gov, NCT05150808, registered on 26 November 2021. Retrospectively registered.
High procalcitonin levels associated with increased intensive care unit admission and mortality in patients with a COVID-19 infection in the emergency department
Authors: Tong-Minh Kirby , van der Does Yuri , Engelen Susanna , de Jong Evelien , Ramakers Christian , Gommers Diederik , van Gorp Eric , Endeman Henrik 
Published: February 2022

Abstract
Background
Patients with a severe COVID-19 infection often require admission at an intensive care unit (ICU) when they develop acute respiratory distress syndrome (ARDS). Hyperinflammation plays an important role in the development of ARDS in COVID-19. Procalcitonin (PCT) is a biomarker which may be a predictor of hyperinflammation. When patients with COVID-19 are in the emergency department (ED), elevated PCT levels could be associated with severe COVID-19 infections. The goal of this study is to investigate the association between PCT levels and severe COVID-19 infections in the ED.

Methods
This was a retrospective cohort study including patients with a confirmed COVID-19 infection who visited the ED of Erasmus Medical Center in Rotterdam, the Netherlands, between March and December 2020. The primary outcome was a severe COVID-19 infection, which was defined as patients who required ICU admission, all cause in-hospital mortality and mortality within 30 days after hospital discharge. PCT levels were measured during the ED visit. We used logistic regression to calculate the odds ratio (OR) with 95% confidence interval (95% CI) and corresponding area under the curve (AUC) of PCT on a severe COVID-19 infection, adjusting for bacterial coinfections, age, sex, comorbidities, C-reactive protein (CRP) and D-dimer.

Results
A total of 332 patients were included in the final analysis of this study, of which 105 patients reached the composite outcome of a severe COVID-19 infection. PCT showed an unadjusted OR of 4.19 (95%CI: 2.52–7.69) on a severe COVID-19 infection with an AUC of 0.82 (95% CI: 0.76–0.87). Corrected for bacterial coinfection, the OR of PCT was 4.05 (95% CI: 2.45–7.41). Adjusted for sex, bacterial coinfection, age any comorbidity, CRP and D-dimer, elevated PCT levels were still significantly associated with a severe COVID-19 infection with an adjusted OR of 2.11 (95% CI: 1.36–3.61). The AUC of this multivariable model was 0.85 (95%CI: 0.81–0.90).

Conclusion
High PCT levels are associated with high rates of severe COVID-19 infections in patients with a COVID-19 infection in the ED. The routine measurement of PCT in patients with a COVID-19 infection in the ED may assist physicians in the clinical decision making process regarding ICU disposition.
Prevalence of reflux nephropathy in Iranian children with solitary kidney: results of a multi-center study
Authors: Esteghamati Maryam , Sorkhi Hadi , Mohammadjafari Hamid , Derakhshan Ali , Sadeghi-Bojd Simin , Momtaz Hossein Emad , Mohkam Masoumeh , Safaeian Baranak , Hooman Nakysa , Safaeiasl Afshin , Sepahi Mohsen Akhavan , Ghasemi Khadijeh , Bazargani Zahra , Emami Elham 
Published: February 2022

Abstract
Background
Given the importance of the function of the remnant kidney in children with unilateral renal agenesis and the significance of timely diagnosis and treatment of reflux nephropathy to prevent further damage to the remaining kidney, we aimed to determine the prevalence of reflux nephropathy in this subgroup of pediatric patients.

Methods
In general, 274 children referred to pediatric nephrologists in different parts of Iran were evaluated, of whom 199 had solitary kidney and were included in this cross-sectional study. The reasons for referral included urinary tract infection (UTI), abnormal renal ultrasonography, being symptomatic, and incidental screening. Demographic characteristics, including age and gender were recorded. History of UTI and presence of vesicoureteral reflux (VUR) were evaluated.

Results
Of the 274 children evaluated in this study with the mean age (SD) of 4.71 (4.24) years, 199 (72.6%) had solitary kidney. Among these, 118 (59.3%) were male and 81 (60.7%) were female, 21.1% had a history of UTI, and VUR was present in 23.1%. The most common cause of referral was abnormal renal ultrasonography (40.2%), followed by incidental screening (21.1%), being symptomatic (14.1%), and UTI (5.5%). In 116 children (58.3%), the right kidneys and in 83 (41.7%) the left kidneys were absent. Besides, 14.6% of the participants had consanguineous parents and 3% had a family history of solitary kidney. Upon DMSA scan, the single kidney was scarred in 13.1%, of which only 7.5% were associated with VUR. In addition, proteinuria and hematuria were observed in 6.5% and 1.5% of children, respectively.

Conclusions
The prevalence of reflux nephropathy was 7.5% in children with solitary kidney with a male predominance. Given the relatively high prevalence of reflux nephropathy in these children, screening for VUR in the remnant kidney appears to be essential in this population.
Choice in episiotomy – fact or fantasy: a qualitative study of women’s experiences of the consent process
Authors: Djanogly Tanya , Nicholls Jacqueline , Whitten Melissa , Lanceley Anne 
Published: February 2022

Abstract
Background
Consent to episiotomy is subject to the same legal and professional requirements as consent to other interventions, yet is often neglected. This study explores how women experience and perceive the consent process.

Methods
Qualitative research in a large urban teaching hospital in London. Fifteen women who had recently undergone episiotomy were interviewed using a semi-structured interview guide and data was analysed using thematic analysis.

Results
Three themes captured women’s experiences of the episiotomy consent process: 1) Missing information – “We knew what it was, so they didn’t give us details,” 2) Lived experience of contemporaneous, competing events – “There’s no time to think about it,” and 3) Compromised volitional consent – “You have no other option.” Minimal information on episiotomy was shared with participants, particularly concerning risks and alternatives. Practical realities such as time pressure, women’s physical exhaustion and their focus on the baby’s safe delivery, constrained consent discussions. Participants consequently inferred that there was no choice but episiotomy; whilst some women were still happy to agree, others perceived the choice to be illusory and disempowering, and subsequently experienced episiotomy as a distressing event.

Conclusions
Consent to episiotomy is not consistently informed and voluntary and more often takes the form of compliance. Information must be provided to women in a more timely fashion in order to fulfil legal requirements, and to facilitate a sense of genuine choice.
A Comprehensive Prognostic Analysis of POLD1 in Hepatocellular Carcinoma
Authors: Tang Hui , You Tingting , Sun Zhao , Bai Chunmei 
Published: February 2022

Abstract
Background
DNA polymerase delta 1 catalytic subunit (POLD1) plays a key role in DNA replication and damage repair. A defective DNA proofreading function caused by POLD1 mutation contributes to carcinogenesis, while POLD1 overexpression predicts poor prognosis in cancers. However, the effect of POLD1 in hepatocellular carcinoma (HCC) is not well-understood.

Methods
Expression patterns of POLD1 were evaluated in TCGA and the HPA databases. Kaplan-Meier curves and Cox regression were used to examine the prognostic value of POLD1. The prognostic and predictive value of POLD1 was further validated by another independent cohort from ICGC database. The influences of DNA copy number variation, methylation and miRNA on POLD1 mRNA expression were examined. The correlation between infiltrating immune cells and POLD1 expression was analyzed. GO and KEGG enrichment analyses were performed to detect biological pathways associated with POLD1 expression in HCC.

Results
POLD1 was overexpressed in HCC (n = 369) compared with adjacent normal liver (n = 50). POLD1 upregulation was significantly correlated with positive serum AFP and advanced TNM stage. Kaplan–Meier and multivariate analyses suggested that POLD1 overexpression predicts poor prognosis in HCC. DNA copy gain, low POLD1 methylation, and miR‑139-3p downregulation were associated with POLD1 overexpression. Besides, POLD1 expression was associated with the infiltration levels of dendritic cell, macrophage, B cell, and CD4 + T cell in HCC. Functional enrichment analysis suggested “DNA replication”, “mismatch repair” and “cell cycle” pathways might be involved in the effect of POLD1 on HCC pathogenesis. Additionally, POLD1 mRNA expression was significantly associated with tumor mutation burden, microsatellite instability, and prognosis in various tumors.

Conclusions
POLD1 may be a potential prognostic marker and promising therapeutic target in HCC.
Holmium laser-assisted laparoscopic partial cystectomy for bladder cancer: a single-institutional pilot study with technical feasibility and short-term oncological outcome
Authors: Kim Kang Sup , Kim Sang Hoon , Cho Hyuk Jin , Sur Hong Jin , Choi Yong Sun 
Published: February 2022

Abstract
Background
In selected patients with bladder cancer, partial cystectomy is an alternative treatment for bladder preservation with fair oncologic result. During partial cystectomy, tumor margin demarcation is difficult. Various methods were adopted, however, there is no standard for tumor margin demarcation. We aimed to introduce and provide our experience with holmium laser-assisted method with ten patients.

Methods
From March 2016 and February 2019, patients who want partial cystectomy for bladder cancer were enrolled in this study. Inclusion criteria were stage T2 or T3 disease and tumor location restricted within the dome, and lateral, posterior side of the bladder were included. Transurethral holmium laser-assisted mucosal incision was made and deepened until perivesical fat. Minimal Safety margin for 5-10 mm were spared, and tumor removal was done laparoscopically.

Results
Ten patients underwent holmium laser-assisted laparoscopic partial cystectomy. All procedures were done without complication. The tumor locations were laterally in seven patients, dome in two patients, and posterior wall in one patient. Pathologic examination of surgical margin showed no cancer cell involvement in all cases. There were no recurrences or metastases for 12 months follow up.

Conclusions
Holmium laser-assisted laparoscopic partial cystectomy is effective and safe technique in carefully selected patients. To achieve precise and appropriate surgical margin during the laparoscopic partial cystectomy, holmium laser resection provides feasible and safe method that assists in bladder incision with minimal ureteral orifice involvement.

Trial registration
Retrospectively registered.
A new association of Oculoauriculovertebral spectrum and persistent fifth aortic arch -double lumen aorta: a case report
Authors: Balaban İsmail , Bilgici Meltem Ceyhan , Baysal Kemal 
Published: February 2022

AbstractBackgroundOculo-auriculo-vertebral spectrum is a heterogeneous group of genetic disorder, also known as Goldenhar Syndrome, which has several phenotypic features including craniofacial anomalies, cardiac, vertebral and central nervous system defects. Cardiovascular anomalies include ventricular septal defects, atrial septal defects, patent ductus arteriosus, Tetralogy of Fallot, double outlet right ventricle, aberrant right subclavian artery, coarctation of aorta, transposition of the great arteries, double inlet left ventricle, cor triatriatum, pulmonary artery stenosis, aortic stenosis, persistent left superior vena cava, partially or totally abnormal pulmonary venous return and bicuspid aortic valve. Persistent fifth aortic arch, also named as double lumen aortic arch, is a very rare cardivascular anomaly and usually associate other cardiac defects.Case presentationWe present a 7 month old patient with oculo-auriculo-vertebral spectrum signs as facial asymmetry, short neck, choanal atresia, cleft palate, bilateral preauricular skin tags, bilateral hypoplastic ear lobes, epibulbar dermoid cyst, rib, vertebrae and cardiovascular anomalies. Cardiovascular anomalies detected with echocardiography and computed tomography were malalignment ventricular septal defect and double lumen aorta, known as persistent fifth aortic arch.ConclusionVarious cardiovascular anomalies may accompany Goldenhar Syndrome. We present a case with persistent fifth aortic arch and Oculo-auriculo-vertebral spectrum and this is a new association that was not reported before in the literature.
Drivers of purchase decisions for cannabis products among consumers in a legalized market: a qualitative study
Authors: Donnan Jennifer , Shogan Omar , Bishop Lisa , Najafizada Maisam 
Published: February 2022

Abstract
Background
Cannabis was legalized in Canada for non-medical use in 2018. The goal of legalization was to improve health and safety by creating access to regulated products, with accurate product labels and warnings and no risk of contamination. However, more than 2 years post-legalization, a large proportion of purchases are still suspected to be through unlicensed retailers. This study sought to identify the factors that influenced the purchase decisions of cannabis consumers in Newfoundland and Labrador (NL).

Methods
Semi-structured focus groups and interviews were conducted in NL with individuals who were > 19 and had purchased cannabis within the last 12 months. All sessions were conducted virtually, audio-recorded, and transcribed. A thematic analysis was conducted, and two members of the research team coded the data using NVivo. A combination of deductive and inductive coding was carried out, themes from the literature were identified, and new themes from the transcripts were discovered. A final coding template of the data was agreed upon by the team through discussion and consensus.

Results
A total of 23 individuals (30% women) participated, with 83% coming from urban areas. While all cannabis product types were discussed, the conversation naturally focused on dried flower products. Participants discussed a variety of considerations when making purchase decisions categorized around five broad themes: 1) price, 2) quality, 3) packaging and warnings, 4) the source of the cannabis, and 5) social influences. The price difference between licensed and un-licensed sources was commonly discussed as a factor that influenced purchase decisions. Product quality characteristics (e.g. size, color, moisture content) and social influences were also considered in purchase decisions. Participants were generally indifferent to packaging and warning labels but expressed concern about the excessive packaging required for regulated products.

Conclusion
This study explores the many attributes that influence purchase decisions for dried leaf cannabis. Understanding the drivers of purchase decisions can help inform policy reforms to make regulated cannabis products more appealing to consumers. Further research is needed to measure the effect of each attribute on cannabis purchase decisions.
A trend analysis of the prevalence of opioid misuse, social support, and suicide attempt among American Indian/Alaska native high school students in New Mexico: 2009–2019 Youth Risk Resiliency Survey (YRRS)
Authors: Agyemang Daniel Opoku , Madden Erin Fanning , English Kevin , Venner Kamilla L. , Rod Handy , Singh Tejinder Pal , Qeadan Fares 
Published: February 2022

Abstract
Background
American Indian and Alaska Native (AI/AN) youth face stark inequities in opioid misuse, social support, and suicide attempt. This study examined trends in these behavioral measures among AI/AN students in New Mexico (NM).

Methods
Using the NM oversampled Youth Resiliency and Risk Survey (NM-YRRS, 2009 – 2019: odd years), prevalence estimates of opioid misuse, social support (SS), and suicide attempt for AI/AN high school students were generated. Trends over time were assessed via linear regression of weighted proportions according to Peter Armitage. Stratified trends by demographics were also employed.

Results
While the prevalence of suicide attempt did not change significantly over time, it was consistently higher among females (2011–2019), those who misused opioids, received low social support, had a mother with less than high school education, had a C, D, or F for academic performance, and non-straight students relative to their counterparts. In particular, the prevalence of suicide attempt among AI/AN students who reported opioid misuse in 2009 was significantly higher by 25.4% than their counterparts who did not report opioid misuse (35.8% vs. 10.4%.) A significant decreasing trend over time (2009–2017) was observed for opioid misuse (16.1%↓8.8%, p-value = 0.0033), including when stratifying by sex (males: 15.9%↓9%, p-value = 0.002; females: 16.2%↓8.6%, p-value = 0.012). Youth with high maternal education exhibited significant decline in opioid misuse (13.5%↓6.7%, p-value = 0.019; 2011–2017.) Opioid misuse increased significantly from 2017 to 2019 (8.8%↑12.9%, p-value < 0.0001.) For instance, in 2019 among AI/AN students who reported low social support, opioid misuse was roughly doubled (18.9% vs. 8.5%, p < 0.0001), and suicide attempt was tripled (21.3% vs. 7.0%, p < 0.0001) compared to students with high social support.

Conclusion
No significant trend was observed for suicide attempt. We observed a significant decreasing trend in opioid misuse between 2009 through 2017 but a significant increase from 2017 to 2019. A higher level of maternal education (college or above), and an A or B school grade performance were protective against both opioid misuse and suicide attempt.
The effects of a real-life lifestyle program on physical activity and objective and subjective sleep in adults aged 55+ years
Authors: Vanderlinden J. , Boen F. , Puyenbroeck S. Van , van Uffelen J. G. Z. 
Published: February 2022

Abstract
Study objectives
Age related changes in sleep result in an increasing prevalence of poor sleep in mid-aged and older adults. Although physical activity has shown to benefit sleep in studies in controlled settings, this has not yet been examined in a real-life lifestyle program. The aims of this study were to: 1) examine the effects of a lifestyle program on moderate-to-vigorous physical activity and objective and subjective sleep in adults aged 55+ years; and 2) examine if the effects differed between good and poor sleepers.

Methods
This controlled pretest-posttest trial examined the effects of the 12-week group-based real-life lifestyle program ‘Lekker Actief’ on moderate-to-vigorous physical activity (measured using accelerometers) and sleep (measured using accelerometers and the Pittsburgh Sleep quality Index, PSQI). The main component of the program was a 12-week progressive walking program, complemented by an optional muscle strengthening program and one educational session on healthy nutrition. Of the 451 participants who were tested pre-intervention, 357 participants completed the posttest assessment (200 in the intervention group and 157 in the control group). Effects on moderate-to-vigorous physical activity and on objective sleep (sleep efficiency, total sleep time, wake time after sleep onset (WASO) and number of awakenings) as well as subjective sleep (sleep quality) were examined in crude and in adjusted multiple regression models. An interaction term between program (control versus intervention) and sleep category (good and poor) was included in all models.

Results
Moderate-to-vigorous physical activity levels significantly increased in the intervention group compared with the control group (43,02 min per day; 95%CI: 12.83–73.22; fully adjusted model). The interaction terms revealed no differences between good and poor sleepers regarding the effect of the intervention on moderate-to-vigorous physical activity. There were no significant effects on sleep, except for good sleepers who showed an increase in number of awakenings/night by 1.44 (CI 95% 0.49; 2.24).

Conclusions
Although this program was effective in increasing physical activity, it did not improve sleep. Lifestyle programs should be promoted to increase physical activity, but more is needed to improve sleep as well.
This trial was registered at ClinicalTrials.gov (Trial registration NCT03576209).