bluuebunny/crossref_metadata_2025_split huggingface dataset:
Pharmacokinetics of tenofovir alafenamide with and without cobicistat in pregnant and postpartum women living with HIV
Authors: Brooks Kristina M. , Momper Jeremiah D. , Pinilla Mauricio , Stek Alice M. , Barr Emily , Weinberg Adriana , Deville Jaime G. , Febo Irma L. , Cielo Mikhaela , George Kathleen , Denson Kayla , Rungruengthanakit Kittipong , Shapiro David E. , Smith Elizabeth , Chakhtoura Nahida , Rooney James F. , Haubrich Richard , Espina Rowena , Capparelli Edmund V. , Mirochnick Mark , Best Brookie M. 
Published: November 2020

Objective:
To evaluate the pharmacokinetics of tenofovir alafenamide (TAF) 10 mg with cobicistat and 25 mg without boosting in pregnant and postpartum women with HIV and to characterize TAF placental transfer and infant washout pharmacokinetics.

Design:
Open-label, multicenter phase IV prospective study of TAF pharmacokinetics during pregnancy, postpartum, delivery, and infant washout.

Methods:
Pregnant women receiving TAF 10 mg with cobicistat or TAF 25 mg without boosting as part of clinical care had intensive pharmacokinetic assessments performed during the second and third trimesters, and 6–12 weeks postpartum. Maternal and cord blood samples were collected at delivery, and washout pharmacokinetic samples were collected in infants. TAF concentrations were quantified using liquid chromatography/mass spectrometry. Comparisons between pregnancy and postpartum were made using geometric mean ratios (90% confidence intervals) and Wilcoxon signed-rank tests.

Results:
Thirty-one pregnant women receiving TAF 10 mg with cobicistat-boosting and 27 women receiving TAF 25 mg without boosting were enrolled. TAF exposures did not significantly differ between pregnancy and postpartum when administered as 10 mg with cobicistat. Antepartum TAF exposures with the 25 mg dose were 33–43% lower in comparison with postpartum, but comparable with those measured in nonpregnant adults. TAF was below the lower limit of quantitation in 43 of 44 cord blood, 41 of 45 maternal blood at delivery, and all infant washout samples.

Conclusion:
TAF exposures were comparable or higher than those measured in nonpregnant adults during pregnancy and postpartum. These findings provide reassurance on adequate TAF exposures during pregnancy, and support efforts to expand the use of TAF in pregnant women with HIV.
Mitochondrial DNA haplogroups and weight gain following switch to integrase strand transfer inhibitor-based antiretroviral therapy
Authors: Erlandson Kristine M. , Wu Kunling , Lake Jordan E. , Samuels David C. , Bares Sara H. , Tassiopoulos Katherine , Koethe John R. , Brown Todd T. , Leonard Michael , Benson Constance A. , Haas David W. , Hulgan Todd 
Published: November 2020

Background:
Integrase strand transfer inhibitor (INSTI)-based antiretroviral therapy (ART) has been associated with excess weight gain in some adults, which may be influenced by genetic factors. We assessed mitochondrial DNA (mtDNA) haplogroups and weight gain following switch to INSTI-based ART.

Methods:
All AIDS Clinical Trials Group A5001 and A5322 participants with mtDNA genotyping who switched to INSTI were included. mtDNA haplogroups were derived from prior genotyping algorithms. Race/ethnicity-stratified piecewise linear mixed effects models assessed the relationship between mtDNA haplogroup and weight change slope differences before and after switch to INSTI.

Results:
A total of 291 adults switched to INSTI: 78% male, 50% non-Hispanic White, 28% non-Hispanic Black, and 22% Hispanic. The most common European haplogroups were H [n = 66 (45%)] and UK [32 (22%)]. Non-H European haplogroups had a significant increase in weight slope after the switch. This difference was greatest among non-H clade UK on INSTI-based regimens that included tenofovir alafenamide (TAF) [3.67 (95% confidence interval 1.12, 6.21) kg/year; P = 0.005]. Although small sample size limited analyses among non-Hispanic Black and Hispanic persons, similarly significant weight gain was seen among the most common African haplogroup, L3 [n = 29 (39%); slope difference 4.93 (1.54, 8.32) kg/year, P = 0.005], after switching to TAF-containing INSTI-based ART.

Conclusion:
Those in European mtDNA haplogroup clade UK and African haplogroup L3 had significantly greater weight gain after switching to INSTI-based ART, especially those receiving TAF. Additional studies in large and diverse populations are needed to clarify the mechanisms and host risk factors for weight gain after switching to INSTI-based ART, with and without TAF.
Losartan to reduce inflammation and fibrosis endpoints in HIV disease
Authors: Baker Jason V. , Wolfson Julian , Collins Gary , Morse Caryn , Rhame Frank , Liappis Angelike P. , Rizza Stacey , Temesgen Zelalem , Mystakelis Harry , Deeks Steven , Neaton James , Schacker Timothy , Sereti Irini , Tracy Russell P. 
Published: November 2020

Background:
Persistent inflammation and incomplete immune recovery among persons with HIV (PHIV) are associated with increased disease risk. We hypothesized that the angiotensin receptor blocker (ARB) losartan would reduce inflammation by mitigating nuclear factor (NF)κB responses and promote T-cell recovery via inhibition of transforming growth factor-beta (TGFβ)-mediated fibrosis.

Methods:
Losartan (100 mg) versus placebo over 12 months was investigated in a randomized (1 : 1) placebo-controlled trial, among PHIV age at least 50 years, receiving antiretroviral therapy (ART), with HIV RNA less than 200 copies/ml and CD4+ cell count 600 cells/μl or less. Inflammation, fibrosis and myocardial biomarkers were measured in blood using ELISA, electrochemiluminescence and immunoturbidimetric methods, and T-cell and monocyte phenotypes were assessed with flow cytometry among a subset of participants. Changes over follow-up in (log-2 transformed) biomarkers and cell phenotypes (untransformed) were compared between losartan and placebo arms using linear mixed models.

Results:
Among 108 PHIV (n = 52 to losartan; n = 56 to placebo), 97% had a month 12 visit. Median age was 57 years and baseline CD4+ cell count was 408 cells/μl. Losartan treatment was not associated with an improvement in interleukin-6 levels, or other blood measures of inflammation, immune activation, fibrosis activity or myocardial function. CD4+ and CD8+ T cells also did not differ by treatment group. Losartan reduced SBP and DBP by 6 and 5 mmHg, respectively.

Conclusion:
Among older PHIV with viral suppression, losartan did not improve blood measures of inflammation nor T-cell immune recovery. Losartan treatment is unlikely to reduce inflammation associated comorbidities to a clinically meaningful degree, beyond the benefits from lowering blood pressure.

ClinicalTrials.gov:
NCT02049307.
Interventions to improve daily medication use among adolescents and young adults: what can we learn for youth pre-exposure prophylaxis services?
Authors: Velloza Jennifer , Kapogiannis Bill , Bekker Linda-Gail , Celum Connie , Hosek Sybil , Delany-Moretlwe Sinead , Baggaley Rachel , Dalal Shona 
Published: November 2020

Objective:
Oral pre-exposure prophylaxis (PrEP) is an important HIV prevention method and studies have shown that young people ages 15–24 have difficulty adhering to daily PrEP. The field of PrEP delivery for young people is relatively nascent and lessons about potential PrEP adherence interventions could be learned from the larger evidence base of adherence interventions for other daily medications among youth.

Design:
Systematic review of adherence support interventions for adolescents.

Methods:
We searched PubMed, CINAHL, EMBASE, and PsycINFO through January 2020 for oral contraceptive pill (OCP), antiretroviral therapy (ART), asthma, and diabetes medication adherence interventions. We reviewed primary articles about OCP adherence interventions and reviewed systematic reviews for ART, asthma, and diabetes medication adherence interventions. Studies were retained if they included participants’ ages 10–24 years; measured OCP, ART, asthma, or diabetes medication adherence; and were systematic reviews, randomized trials, or quasi-experimental studies.

Results:
Fifteen OCP articles and 26 ART, diabetes, and asthma systematic reviews were included. Interventions that improved medication adherence for OCPs, ART, asthma, and diabetes treatment included reminder text messages, computer-based and phone-based support, and enhanced counseling. Multi-month prescriptions and same-day pill starts also were found to improve OCP adherence and continuation. Adolescent-friendly clinics and peer-based counseling significantly improved ART adherence, and telemedicine interventions improved diabetes medication adherence.

Conclusion:
Interventions that improve medication adherence among youth include enhanced counseling, extended pill supply, adolescent-friendly services, and text message reminders. PrEP programs could incorporate and evaluate such interventions for their impact on PrEP adherence and continuation among at-risk adolescents.
Craniomaxillofacial Surgery Techniques of 15th Century Turkish Surgeon Serefeddin Sabuncuoglu
Authors: Doğan Fatih , Tutak Fatma Nilay 
Published: November 2020

Introduction:
Şerefeddin Sabuncuoğlu, in his surgical medicine book entitled “Imperial Surgery” (Cerrâhiyetü’l-Hâniyye) that was published in the 15th century, described many diseases using colored miniatures, and explained the repair of these conditions using surgical methods and the required patient care after surgery. In his handwritten treatise, Sabuncuoğlu raised the curtain on his surgical methods with his illustrations. As a first in medical history, Sabuncuoğlu's book should be considered one of the most important original works from that era.

Materials and Method:
The handwritten “Imperial Surgery” is presented in three chapters divided into 194 sections, and describing 147 surgical procedures with miniature drawings, 160 surgical instruments and 10 types of incision.

Results:
A separate chapter is allocated to craniomaxillofacial surgery in Imperial Surgery, containing 53 of the total 194 sections. The first chapter describes the use of branding (cauterization) for the treatment of headache and facial diseases. The second chapter describes the treatment of hydrocephalus, headache, vascular surgery, and the surgical treatment of tumors in the head and face. The third chapter describes in detail the treatment of cranial fractures, nasal fractures, mandibular fractures and mandibular dislocations.

Conclusion:
The basic craniomaxillofacial surgery concepts, the descriptions of craniomaxillofacial diseases, the scales indicating the general patient conditions, and the surgical therapies, incisions, surgical instruments, postoperative care and complications put forward in the book are discussed in the present study. In the light of this seminal study, the authors of the present study suggest that Sabuncuoğlu should be considered and dignified as one of the leading pioneers of craniomaxillofacial surgery.
A Simple Method of Transoperative Maxillomandibular Fixation in Pediatric Facial Fractures
Authors: Rodrigues Moacyr Tadeu Vicente , Schueng Filipe E. A. , Mendes Bruno Coelho , Vale Daniel Santiago , Souza Fabrício Guimarães de , Nóia Cláudio Ferreira 
Published: November 2020

Abstract
Maxillomandibular fixation in pediatric facial fractures is quite challenging to be achieved, especially in mid-mixed dentition. Traditional well established intermaxillary devices have a lot of limitations in these patients. This article presents a case of a 9-year-old female patient with a displaced mandibular fracture in which orthodontic buttons were used for transoperative maxillomandibular fixation followed by internal fixation after adequate occlusion reestablishment and fracture reduction. The method showed high efficacy and celerity, allowing the success of treatment, with satisfactory evolution of the patient.
The Orthognathic Quality of Life Questionnaire: Translation and Validation into Dutch
Authors: Ploumen Roan L.M. , Duininck Jorrit M. , Jonkman Ronald E.G. , Nolte Jitske W. , Becking Alfred G. 
Published: November 2020

Objective:
The aim of this study is to translate and validate the Orthognathic Quality of Life Questionnaire (OQLQ) in the Dutch language (OQLQ-NL).

Methods:
The translation of the OQLQ into the Dutch language was performed following the guidelines for the Process of Cross-Cultural Adaption of Self-Report Measures. Sixty-two patients who received orthognathic surgery in the past 10 years were included for participation. Internal reliabilities of the OQLQ-NL were evaluated for multiple item scales with the use of the Cronbach alpha coefficient. For the establishment of the test–retest reliability, the OQLQ-NL was repeated with a 2-week interval and the intraclass correlation coefficient was calculated. Spearman correlation was used to test the correlation with the OHIP-49NL and the FACE-Q, to be able to evaluate the construct validity of the OQLQ-NL.

Results:
Thirty-five patients filled in the OQLQ-NL, OHIP49NL, and FACE-Q upon arrival and 22 patients returned the OQLQ-NL after 2 weeks (response rate of 56.6% and 62.9%, respectively). The OQLQ-NL showed excellent results in internal reliability and test–retest reliability. The vast majority of the correlations between the domains of the questionnaires were as expected. Data from this study and previous studies confirm the construct validity of the OQLQ-NL

Conclusion:
The OQLQ-NL appears to be a valid and reliable instrument to measure quality of life for patients receiving orthognathic surgery in the Netherlands.
Endoscopic Endonasal Management of Pterygopalatine Fossa Tumors
Authors: Ozawa Hiroyuki , Sekimizu Mariko , Saito Shin , Nakamura Shintaro , Mikoshiba Takuya , Toda Masahiro , Ogawa Kaoru 
Published: November 2020

Abstract
Surgical removal of pterygopalatine fossa (PPF) tumors with endoscopic endonasal approach is still challenging. The present study aimed to evaluate our endoscopic endonasal management of PPF tumors based on the tumor pathology and purpose of the surgery. This comprised both a single nostril approach for biopsy and a binostril approach for complete resection of benign and noninfiltrating tumors. Based on this strategy, 12 patients underwent endoscopic endonasal surgery for PPF tumors between 2013 and 2018. The patients’ data were analyzed retrospectively to demonstrate the significance of our treatment scheme. The surgery was terminated only after taking a biopsy specimen in 6 patients. Other 6 patients underwent gross total resection or bulk tumor reduction. Final pathological diagnosis was malignant in 6 cases and benign in the remaining 6. Post-operative treatment was needed in 7 patients. Four operations for the 6 patients who underwent either debulking or radical surgery were performed by the binostril approach; while 5 surgeries for the 6 biopsy patients were performed by the single nostril approach. Postoperative complications were tolerable. Endoscopic resection should be adopted preferentially for benign tumors that can be removed in a piecemeal fashion. However, as most malignant tumors were impossible to resect with a negative margin, priority should be given to tumor biopsy using an endoscopic approach, which is less invasive than an open approach, and an appropriate treatment customized to the pathological diagnosis should be administered.
Disparity of Racial/Ethnic Representation in Publications Contributing to Overactive Bladder Diagnosis and Treatment Guidelines
Authors: Brown Oluwateniola , Siddique Moiuri , Mou Tsung , Boniface Emily R. , Volpe Katherine A. , Cichowski Sara ,   AUGS Disparities Special Interest Group
Published: November 2020

Objective
The aim of the study was to compare the racial/ethnic representation in studies supporting the 2019 American Urological Association/Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction overactive bladder diagnosis and treatment guideline to the racial/ethnic distribution of the U.S. population.

Methods
We analyzed the race and ethnicity of participants in the articles cited in the 2019 American Urological Association/Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction nonneurogenic overactive bladder guidelines. The primary outcome was the representation quotient, the ratio of the proportion of a racial/ethnic group in the guideline studies relative to the estimated proportion of that group in the U.S. population. Data were analyzed using descriptive statistics and Pearson χ2 test.

Results
There were 387 studies included, 35% of which reported participants’ race. Of the studies that included U.S. participants, 111 (61%) reported race and 44 (24%) reported Hispanic ethnicity. The representation quotient for White and Asian participants was 1.06 and 1.62, indicating overrepresentation relative to the U.S. population, respectively. The representation quotient for Black, Hispanic, and American Indian/Alaska Native participants was 0.85, 0.56, and 0.02, respectively, indicating underrepresentation for these groups. Evaluation of the representation quotients over time revealed no meaningful change in representation from 1990 to 2019 for any racial/ethnic group.

Conclusions
The evidence based on the overactive bladder guidelines is derived from studies that frequently failed to report race/ethnicity and is not reflective of the U.S. population. Black, Hispanic, and American Indian/Alaska Native participants that are underrepresented in U.S.-based studies, highlighting the need for more inclusive recruitment strategies in overactive bladder research.
COVID-19-related mortality by age groups in Europe: A meta-analysis
Authors: Cohen Jérémie F. , Korevaar Daniël A. , Matczak Soraya , Brice Joséphine , Chalumeau Martin , Toubiana Julie 
Published: November 2020

AbstractBackground and ObjectivesTo date, more than 1,000,000 confirmed cases and 65,000 deaths due to coronavirus disease 2019 (COVID-19) have been reported globally. Early data have indicated that older patients are at higher risk of dying from COVID-19 than younger ones, but precise international estimates of the age-breakdown of COVID-19-related deaths are lacking.Materials and MethodsWe evaluated the distribution of COVID-19-related fatalities by age groups in Europe. On April 6, 2020, we systematically reviewed COVID-19-related mortality data from 32 European countries (European Union/European Economic Area and the United Kingdom). We collated official reports provided by local Public Health or Ministry of Health websites. We included countries if they provided data regarding more than 10 COVID-19-related deaths stratified by age according to pre-specified groups (i.e., < 40, 40-69, ≥ 70 years). We used random-effects meta-analysis to estimate the proportion of age groups among all COVID-19-related fatalities.ResultsThirteen European countries were included in the review, for a total of 31,864 COVID-19-related deaths (range: 27-14,381 per country). In the main meta-analysis (including data from Germany, Hungary, Italy, Netherlands, Portugal, Spain, Switzerland; 21,522 COVID-19-related fatalities), the summary proportions of persons < 40, 40-69, and ≥ 70 years of age among all COVID-19-related deaths were 0.1% (0.0-0.2%; I2 24%), 12.8% (10.3-15.6%; I2 94%), and 84.8% (81.3-88.1%; I2 96%), respectively.ConclusionsPeople under 40 years of age represent a small fraction of the total number of COVID-19-related deaths in Europe. These results may help health authorities respond to public concerns and guide future physical distancing and mitigation strategies.
Preterm birth rates in a large tertiary Australian maternity centre during COVID-19 mitigation measures
Authors: Gallo Linda A. , Gallo Tania F. , Borg Danielle J. , Moritz Karen M. , Clifton Vicki L. , Kumar Sailesh 
Published: November 2020

AbstractObjectivesTo compare the prevalence of live preterm birth rates during COVID-19 restriction measures with infants born during the same weeks in 2013-2019 in Queensland, Australia.Design, setting, participantsDeidentified obstetric and neonatal data were extracted from the Mater Mothers’ electronic healthcare records database. This is a supra-regional tertiary perinatal centre.Main outcome measuresLogistic regressions were used to examine preterm birth rates during the beginning of COVID-19 restrictions (16 March-17 April; “early”; 6,955 births) and during the strictest part of COVID-19 restrictions (30 March-1 May; “late”; 6,953 births), according to gestational age subgroups and birth onset (planned or spontaneous). We adjusted for multiple covariates, including maternal age, body mass index, ethnicity, parity, socioeconomic status, maternal asthma, diabetes mellitus and/or hypertensive disorder. Stillbirth rates were also examined (16 March-1 May).ResultsA reduction in planned moderate/late preterm births was observed primarily during the early restriction period compared with the same calendar weeks in the previous seven years (29 versus an average of 64 per 1,000 births; adjusted odds ratio [aOR] 0.39, 95% CI 0.22-0.71). There was no effect on extremely or very preterm infants, spontaneous preterm births, or stillbirth rates. Rolling averages from January to June revealed a two-week non-significant spike in spontaneous preterm births from late-April to early-May, 2020.ConclusionsPlanned births for moderate/late preterm infants more than halved during early COVID-19 mitigation measures. Together with evidence from other nations, the COVID-19 pandemic provides a unique opportunity to identify causal and preventative factors for preterm birth.