bluuebunny/crossref_metadata_2025_split huggingface dataset:
Clinical characteristics, visceral involvement, and mortality in at-risk or early diffuse systemic sclerosis: a longitudinal analysis of an observational prospective multicenter US cohort
Authors: Jaafar Sara , Lescoat Alain , Huang Suiyuan , Gordon Jessica , Hinchcliff Monique , Shah Ami A. , Assassi Shervin , Domsic Robyn , Bernstein Elana J. , Steen Virginia , Elliott Sabrina , Hant Faye , Castelino Flavia V. , Shanmugam Victoria K. , Correia Chase , Varga John , Nagaraja Vivek , Roofeh David , Frech Tracy , Khanna Dinesh 
Published: June 2021

Abstract
Background
Early diffuse cutaneous systemic sclerosis (dcSSc) has the highest case fatality among rheumatic diseases. We report baseline characteristics, current immunosuppressive therapies, progression of skin and internal organ involvement, and mortality in a multicenter prospective cohort from the United States (US) of America.

Methods
We performed a longitudinal analysis of participants from 12 US centers, from April 2012 to July 2020. All participants had early dcSSc or were at-risk for dcSSc, with ≤2 years since the first non-Raynaud’s phenomenon (RP) symptom.

Results
Three hundred one patients were included with a baseline median disease duration of 1.2 years since RP and a mean modified skin score of 21.1 units. At baseline, 263 (87.3%) had definite dcSSc and 38 (12.7%) were classified as at-risk; 112 (49.6%) patients were positive for anti-RNA polymerase III antibodies. The median follow-up duration was 24.5 months (IQR = 10.3–40.7 months). One hundred ninety (63.1%) participants were treated with an immunosuppressive therapy, of which mycophenolate mofetil was most used at baseline and follow-up. Of 38 who were classified as at-risk at baseline, 27 (71%) went on to develop dcSSc; these patients were characterized by higher baseline mean HAQ-DI (0.8 versus 0.4, p = 0.05) and higher baseline mRSS (8.8 versus 4.4, p < 0.01) in comparison with those who remained as limited cutaneous SSc. In the overall cohort, 48 participants (21.1%) had clinically significant worsening of skin fibrosis, mainly occurring in the first year of follow-up; 41 (23.3%) had an absolute forced vital capacity decline of ≥10%. Twenty participants (6.6%) died, of which 18 died in the first 3 years of follow-up. Cardiac involvement (33.3%), gastrointestinal dysmotility (22.2%), and progressive interstitial lung disease (ILD) (16.7%) were the main causes of death.

Conclusion
This US cohort highlights the management of early SSc in the current era, demonstrating progression of skin and lung involvement despite immunosuppressive therapy and high mortality due to cardiac involvement.
GPS driving: a digital biomarker for preclinical Alzheimer disease
Authors: Bayat Sayeh , Babulal Ganesh M. , Schindler Suzanne E. , Fagan Anne M. , Morris John C. , Mihailidis Alex , Roe Catherine M. 
Published: June 2021

AbstractBackgroundAlzheimer disease (AD) is the most common cause of dementia. Preclinical AD is the period during which early AD brain changes are present but cognitive symptoms have not yet manifest. The presence of AD brain changes can be ascertained by molecular biomarkers obtained via imaging and lumbar puncture. However, the use of these methods is limited by cost, acceptability, and availability. The preclinical stage of AD may have a subtle functional signature, which can impact complex behaviours such as driving. The objective of the present study was to evaluate the ability of in-vehicle GPS data loggers to distinguish cognitively normal older drivers with preclinical AD from those without preclinical AD using machine learning methods.MethodsWe followed naturalistic driving in cognitively normal older drivers for 1 year with a commercial in-vehicle GPS data logger. The cohort included n = 64 individuals with and n = 75 without preclinical AD, as determined by cerebrospinal fluid biomarkers. Four Random Forest (RF) models were trained to detect preclinical AD. RF Gini index was used to identify the strongest predictors of preclinical AD.ResultsThe F1 score of the RF models for identifying preclinical AD was 0.85 usingAPOEε4 status and age only, 0.82 using GPS-based driving indicators only, 0.88 using age and driving indicators, and 0.91 using age,APOEε4 status, and driving. The area under the receiver operating curve for the final model was 0.96.ConclusionThe findings suggest that GPS driving may serve as an effective and accurate digital biomarker for identifying preclinical AD among older adults.
Review: microbial transformations of human bile acids
Authors: Guzior Douglas V. , Quinn Robert A. 
Published: June 2021

AbstractBile acids play key roles in gut metabolism, cell signaling, and microbiome composition. While the liver is responsible for the production of primary bile acids, microbes in the gut modify these compounds into myriad forms that greatly increase their diversity and biological function. Since the early 1960s, microbes have been known to transform human bile acids in four distinct ways: deconjugation of the amino acids glycine or taurine, and dehydroxylation, dehydrogenation, and epimerization of the cholesterol core. Alterations in the chemistry of these secondary bile acids have been linked to several diseases, such as cirrhosis, inflammatory bowel disease, and cancer. In addition to the previously known transformations, a recent study has shown that members of our gut microbiota are also able to conjugate amino acids to bile acids, representing a new set of “microbially conjugated bile acids.” This new finding greatly influences the diversity of bile acids in the mammalian gut, but the effects on host physiology and microbial dynamics are mostly unknown. This review focuses on recent discoveries investigating microbial mechanisms of human bile acids and explores the chemical diversity that may exist in bile acid structures in light of the new discovery of microbial conjugations.
Scaling standards-aligned instruction through teacher leadership: methods, supports, and challenges
Authors: Cassata Amy , Allensworth Elaine 
Published: June 2021

Abstract
Background
The Common Core Standards for Mathematics and Next Generation Science Standards were adopted by states with the goal of preparing students with knowledge and skills needed for college, careers, and citizenry. Adopting these standards necessitated considerable changes in instructional practice. While teacher leadership is known to be important for instructional change, there is little research that articulates the processes through which that influence occurs, and how contextual factors constrain or support those processes. This paper provides a case study of efforts in the Chicago Public Schools to promote widespread instructional change around standards reform through a teacher leader model using retrospective from 2013 to 2017 interviews with 16 math and science teacher leaders serving grades 6–12, along with quantitative analysis of district-wide data showing patterns of change and professional learning. It builds off prior research to articulate a framework of how teacher leaders promote instructional change.

Findings
There were five patterns of teacher leader action: inspiring others, sharing with colleagues, working in collaboration, advocating for change, and providing individual support, and an interplay between teacher actions and school-level contextual factors, with some contextual factors more important than others for different types of actions. In particular, sharing and collaborative work were facilitated in schools with designated collaboration time, trusting relationships, and colleagues who were also trained and knowledgeable about the new standards. The degree of collective efficacy the teacher leaders felt seemed to be driven mostly by the presence of other knowledgeable change agents in the school.

Conclusions and implications
The study adds to the existing literature on teacher leadership by articulating the mechanisms through which teachers exert influence around instructional improvement of their school peers and providing examples of each. Further, the study illustrates how these mechanisms are facilitated or constrained by the larger school context. Together, the articulation of mechanisms and contexts, along with illustrative examples, provides a guide for supporting instructional change through teacher leadership in schools and districts.
LISTEN UP (Locally Integrated Screening and Testing Ear aNd aUral Programme): a feasibility study protocol for a community pharmacy-based ear health intervention
Authors: Taylor Selina Maree , Cairns Alice , Mantzourani Efi , Glass Beverley D. 
Published: June 2021

AbstractBackgroundEar disease is a major cause of preventable hearing loss and is very common in rural communities, estimated to affect 1.3 million Australians. Rural community pharmacists are well placed to provide improved ear health care to people who are unable to easily access a general practitioner (GP). The purpose of this study is to apply an ear health intervention to the rural community-pharmacy setting in Queensland, Australia, to improve the management of ear disease. The aims are the following: (1) to evaluate the feasibility, potential effectiveness and acceptability of a community pharmacy-based intervention for ear health, (2) to evaluate the use of otoscopy and tympanometry by pharmacists in managing ear complaints in community pharmacy and (3) to evaluate the extended role of rural pharmacists in managing ear complaints, with the potential to expand nationally to improve minor ailment management in rural communities.Methods/designThis is a longitudinal pre- and post-test study of a community-pharmacy-based intervention with a single cohort of up to 200 patients from two rural community pharmacies. Usual care practices pertaining to the management of ear complaints will be recorded prior to the intervention for 8 weeks. The intervention will then be piloted for 6 weeks, followed by a 12 month impact study. Patients aged > 13 years presenting to the pharmacies with an ear complaint will be invited to participate. Trained pharmacists will conduct an examination including a brief history, hearing screening, otoscopy and tympanometry assessments. Patients will be referred to a general practitioner (GP) if required, according to the study protocol. Patients will complete a satisfaction survey and receive a follow-up phone call at 7 days to explore outcomes including prescribed medications and referrals. Pharmacists and GPs will complete pre- and post- intervention interviews. Patient, pharmacist and GP data will be analysed using descriptive statistics and thematic analysis for the qualitative data.DiscussionThis study will demonstrate the implementation of a screening and referring ear health intervention in rural community pharmacy. Feasibility, potential effectiveness and acceptability of the intervention will be assessed.Trial registrationAustralian and New Zealand Clinical Trial Registry Number:ACTRN12620001297910.
Use of Shockwave intravascular lithotripsy for the treatment of symptomatic and severely calcified superior mesenteric artery stenosis
Authors: Balboa Arregui Oscar , Seoane Pose Carmen , Balboa Alonso María , Bolaño Pampín Teresa 
Published: June 2021

Abstract
Background
We present the use of intravascular lithotripsy as a treatment for highly calcified superior mesenteric artery stenosis.

Case presentation
A 67-year-old diabetic man had chronic postprandial abdominal pain and weight loss. Computed tomography angiography revealed highly calcified stenosis of the superior mesenteric artery. Selective angiography confirmed severe stenosis. A Shockwave lithotripsy balloon catheter was successfully used via brachial access to modify calcified plaque and increase vascular lumen. After 12 months of follow-up the patient had gained weight and had no abdominal postprandial pain.

Conclusion
Intravascular lithotripsy could be considered a new treatment modality to modify calcified lesions in the visceral arteries. More controlled studies are needed to demonstrate the efficacy, safety and feasibility of this new technology.

Level of evidence
4, Case Report
Tetracarpidium conophorum seed extract reduces intestinal absorption, and increases cellular trapping of glucose
Authors: Ajilore Bamidele Stephen , Olorunnisola Olubukola Sinbad , Owoade Abiodun Olusoji 
Published: June 2021

Abstract
Background
Tetracarpidium conophorum is one of the numerous folklore medicinal plants for managing diabetes but the mode of action and bioactive compounds responsible for the antihyperglycemic property are missing in literatures. This study aimed at investigating the possible modes of its antihyperglycemic action using both in-vitro and ex-vivo methods. Powdered Tetracarpidium conophorum seed (TECOSE) was extracted with methanol using standard extraction procedure. Gas chromatography- Mass spectrometry (GCMS) analysis of the extract, and its effects on tissue glucose uptake, α-amylase, α-glucosidase and glucokinase enzymes were assessed using standard laboratory procedures.

Results
Seven heterocyclic compounds were identified by GCMS of which one is structurally related to sulphonylurea. TECOSE strongly inhibited α-glucosidase (IC50 = 1.90 mg/ml) but partially inhibited α-amylase (IC50 = 7.20 mg/ml) activities. Also, glucokinase activity and tissue glucose uptakes were significantly (p < 0.05) increased by TECOSE.

Conclusions
The results obtained deduced that antihyperglycemic action of TECOSE could be due to modulation of postprandial hyperglycaemia through inhibition of intestinal α-glucosidase, increasing glucokinase activity, improving peripheral glucose uptake by mimicking sulfonylurea action.
Psychological impact of an acute intervention on medical-psychological emergency unit professionals: the example of hurricane Irma
Authors: Razakarivony Oriane , Khanafer Nagham , Philippe Jean-Marc , Prieto Nathalie 
Published: June 2021

Background
Medical-psychological emergency units (Cellules d'Urgence Médico-Psychologiques, CUMP) are deployed following major events where there is a risk of psychological trauma, in order to provide acute and proper psychological care for the victims.

Aims
To describe and evaluate the risk of a psychological impact on CUMP professionals after their participation in the aftermath of the hurricane Irma natural disaster. CUMP teams consist of medical and paramedical staff, who can have permanent or volunteer status. We reasoned that there might be a psychological and emotional impact on CUMP professionals, despite their own expertise in the field, after their intervention following hurricane Irma.

Method
A cross-sectional survey was conducted during a feedback meeting. Participating professionals completed a sociodemographic questionnaire and the Professional Quality of Life (ProQOL) scale (5th French version), which is composed of three subscales: compassion satisfaction, burnout and secondary traumatic stress (STS).

Results
A total of 53 participants were included with 24 (45.3%) psychiatrists, 15 (28.3%) paramedical staff and 14 (26.4%) psychologists. The median age was 46 years (range 39–55.5) and 29 (54.7%) were women. We found that psychiatrists compared with other professions had higher secondary traumatic stress scores (P = 0.007) and that volunteer psychiatrists had higher burnout scores than permanent psychiatrists (P = 0.03).

Conclusions
These preliminary results suggest a psychological impact attributable to leadership status, which was reserved for psychiatrists. The results also underline the need for a supportive accompaniment for such teams by promoting formation improvement, psychological support and team cohesion.
Randomized, Double-Blind Trial on the Impact of Word Count in Cancer Clinical Trial Consent Forms
Authors: Almodallal Yahya , Duong Quyen , Satele Daniel , Novotny Paul , Cook Kathryn D. , Chauhan Cynthia , Daiss Michelle K. , Le-Rademacher Jennifer , Looker Sherry , Martin Nichole , Smestad Michanda F. , Winham Stacey J. , Mandrekar Sumithra J. , Jatoi Aminah 
Published: June 2021

PURPOSE:This randomized, double-blind study sought to understand whether cancer clinical trial consent form verbosity detracts from patients' decision making on trial enrollment.METHODS:This trial tested mock consent forms of 2,000, 4,000, and 6,000 words. The first two comprised the two experimental arms and the third the control arm. Phase II was conducted to identify the promising arm, which, in phase III, was compared with the control arm. Each consent form described the same trial. Eligible adult patients reported a cancer history and English literacy. The primary end point used a patient-reported Likert scale to assess the relationship between information in the consent form and trial decision making.RESULTS:In phase II, 93 patients were accrued and prompted the selection of the 2,000-word consent form for phase III. In phase III, 182 patients were recruited, resulting in 240 total evaluable patients to compare the 2,000-word versus the 6,000-word arm (control). For the primary end point, 103 (84%) and 107 (91%) patients in the 2,000- and 6,000-word arms, respectively, strongly agreed or agreed with the following: “The information in this consent form helped me make a decision about whether or not to enroll in the trial” (two-sided, P = .14). Median time to read each consent form was 8 and 12 minutes, respectively (two-sided, P < .0001). Among those assigned these consent forms, 84% and 73%, respectively (two-sided, P = .04) signed or expressed a willingness to sign.CONCLUSION:This study's primary end point was not met. However, secondary outcomes suggest a need to further study the efficiency and efficacy of shorter consent forms for cancer clinical trial enrollment.
Toward a Lowest Effective Dose of Cyproterone Acetate in Trans Women: Results From the ENIGI Study
Authors: Kuijpers Suzanne M E , Wiepjes Chantal M , Conemans Elfi B , Fisher Alessandra D , T’Sjoen Guy , den Heijer Martin 
Published: June 2021

Abstract

Context
Cyproterone acetate (CPA) is a competitive inhibitor of the androgen receptor and exerts negative hypothalamic feedback. It is often used in combination with estrogens in trans women to achieve feminization. However, CPA has been associated with side effects such as changes in liver enzyme concentrations and increases in prolactin concentrations. The question is whether the testosterone-lowering effect, as well as these side effects, are dose dependent.

Objective
To assess the lowest effective dose of CPA in trans women to prevent side effects.

Methods
This longitudinal study, conducted at gender identity centers in Amsterdam, Ghent, and Florence, is part of the European Network for the Investigation of Gender Incongruence (ENIGI), a multicenter prospective cohort study. Participants were trans women (n = 882) using estrogens only or in combination with 10, 25, 50, or 100 mg CPA daily. The primary outcome measure was the concentration of testosterone at 3 and/or 12 months of hormone therapy.

Results
Using estrogens only (without CPA) led to testosterone concentrations of 5.5 nmol/L (standard error of the mean [SEM] 0.3). All doses of CPA resulted in testosterone concentrations below the predefined threshold of suppression of 2 nmol/L (10 mg, 0.9 nmol/L, SEM 0.7; 25 mg, 0.9 nmol/L, SEM 0.1; 50mg, 1.1 nmol/L, SEM 0.1; 100 mg, 0.9 nmol/L, SEM 0.7). Higher prolactin and lower high-density lipoprotein concentrations were observed with increasing doses of CPA. No differences in liver enzyme concentrations were found between the doses.

Conclusion
Compared with higher doses of CPA, a daily dose of 10 mg is equally effective in lowering testosterone concentrations in trans women, while showing fewer side effects.
Circadian Rhythms Within the Female HPG Axis: From Physiology to Etiology
Authors: Shao Shuyi , Zhao Huanqiang , Lu Zhiying , Lei Xiaohong , Zhang Ying 
Published: June 2021

Abstract
Declining female fertility has become a global health concern. It results partially from an abnormal circadian clock caused by unhealthy diet and sleep habits in modern life. The circadian clock system is a hierarchical network consisting of central and peripheral clocks. It not only controls the sleep–wake and feeding–fasting cycles but also coordinates and maintains the required reproductive activities in the body. Physiologically, the reproductive processes are governed by the hypothalamic–pituitary–gonadal (HPG) axis in a time-dependent manner. The HPG axis releases hormones, generates female characteristics, and achieves fertility. Conversely, an abnormal daily rhythm caused by aberrant clock genes or abnormal environmental stimuli contributes to disorders of the female reproductive system, such as polycystic ovarian syndrome and premature ovarian insufficiency. Therefore, breaking the “time code” of the female reproductive system is crucial. In this paper, we review the interplay between circadian clocks and the female reproductive system and present its regulatory principles, moving from normal physiology regulation to disease etiology.
Global proteomic analyses of human cytotrophoblast differentiation/invasion
Authors: Chen Hao , Williams Katherine E. , Kwan Elaine Y. , Kapidzic Mirhan , Puckett Kenisha A. , Aburajab Rayyan K. , Robinson Joshua F. , Fisher Susan J. 
Published: June 2021

ABSTRACTDuring human pregnancy, cytotrophoblasts (CTBs) from the placenta differentiate into specialized subpopulations that play crucial roles in proper fetal growth and development. A subset of these CTBs differentiate along an invasive pathway, penetrating the decidua and anchoring the placenta to the uterus. A crucial hurdle in pregnancy is the ability of these cells to migrate, invade and remodel spiral arteries, ensuring adequate blood flow to nourish the developing fetus. Although advances continue in describing the molecular features regulating the differentiation of these cells, assessment of their global proteomic changes at mid-gestation remain undefined. Here, using sequential window acquisition of all theoretical fragment-ion spectra (SWATH), which is a data-independent acquisition strategy, we characterized the protein repertoire of second trimester human CTBs during their differentiation towards an invasive phenotype. This mass spectrometry-based approach allowed identification of 3026 proteins across four culture time points corresponding to sequential stages of differentiation, confirming the expression dynamics of established molecules and offering new information into other pathways involved. The availability of a SWATH CTB global spectral library serves as a beneficial resource for hypothesis generation and as a foundation for further understanding CTB differentiation dynamics.