bluuebunny/crossref_metadata_2025_split huggingface dataset:
Surgical treatment strategies for extra-pelvic intravenous leiomyomatosis
Authors: Li Hua , Xu Jing , Lin Qiaowei , Zhang Yong , Zhao Yun , Tong Hanxing , Tu Ruiqin , Xu Demin , Wang Chunsheng , Lu Weiqi 
Published: June 2020

Abstract
Background
Extra-pelvic intravenous leiomyomatosis (IVL) extending into inferior vena cava (IVC) or heart (i.e. intracardiac leiomyomatosis, ICL) is an extremely rare benign disease. No consensus has been reached on the optimal surgical strategy. The aim of this study is to introduce four types of one-stage surgical strategies including less invasive options and a guideline to select patient-specific strategy for this disease.

Methods
Twenty-four patients of extra-pelvic IVLs receiving one-stage resections at the Zhongshan Hospital from July 2011 to November 2019 were reviewed retrospectively. Base on the initial experiences of the indiscriminate choices of tumor thrombectomies through sterno-laparotomy under cardiopulmonary bypass (CPB) in 6 ICLs, an anatomy-based guideline for four types of surgical strategies was developed and applied for the next 18 patients.

Results
Under the direction of guideline, tumor thrombectomies through single laparotomy were applied without CPB in 2 ICLs and 4 IVLs confined in IVC, or with CPB in 7 ICLs. Guideline-directed double-incisions with CPB were applied in only 5 ICLs, including 1 receiving mini-thoracotomy and 4 receiving sternotomy because of tumor adherences with right atriums in 2 and with pulmonary arteries in 2. All 24 patients accomplished one-stage panhysterectomy, bilateral adnexectomy and complete resections of intracaval and intracardiac tumors. For residual pelvic intravenous tumors in 19 patients, 17 received macroscopically complete resections while the other 2 failed because of high risk of hemorrhage. Intraoperative blood losses, operation time and hospitalization expense in the single-laparotomy non-CPB group were significantly lesser than the other groups. In CPB groups, inpatient stay and hospitalization expense in the single-incision group were significantly lesser than the double-incisions group. All patients were alive and free of recurrences during a mean follow-up of 35.4 ± 27.2 months (range, 1–100 months). The pelvic tumor residues in 2 patients remained unchanged for 51 and 52 months since operation, respectively.

Conclusions
For various extra-pelvic IVLs, the 4 types of surgical strategies including less invasive options are feasible, providing these are selected by a guideline base on the tumor extension and morphology. The proposed guideline is believed to accommodate more patients receiving less invasive surgery without compromising the curative effect.
The vascular endothelium: the cornerstone of organ dysfunction in severe SARS-CoV-2 infection
Authors: Pons Stéphanie , Fodil Sofiane , Azoulay Elie , Zafrani Lara 
Published: June 2020

AbstractIn severe SARS-CoV-2 infections, emerging data including recent histopathological studies have emphasized the crucial role of endothelial cells (ECs) in vascular dysfunction, immunothrombosis, and inflammation.Histopathological studies have evidenced direct viral infection of ECs, endotheliitis with diffuse endothelial inflammation, and micro- and macrovascular thrombosis both in the venous and arterial circulations. Venous thrombotic events, particularly pulmonary embolism, with elevated D-dimer and coagulation activation are highly prevalent in COVID-19 patients. The pro-inflammatory cytokine storm, with elevated levels of interleukin-6 (IL-6), IL-2 receptor, and tumor necrosis factor-α, could also participate in endothelial dysfunction and leukocyte recruitment in the microvasculature. COVID-19-induced endotheliitis may explain the systemic impaired microcirculatory function in different organs in COVID-19 patients. Ongoing trials directly and indirectly target COVID-19-related endothelial dysfunctions: i.e., a virus-cell entry using recombinant angiotensin-converting enzyme 2 (ACE2) and transmembrane protease serine 2 (TMPRSS-2) blockade, coagulation activation, and immunomodulatory therapies, such as anti-IL-6 strategies. Studies focusing on endothelial dysfunction in COVID-19 patients are warranted as to decipher their precise role in severe SARS-CoV-2 infection and organ dysfunction and to identify targets for further interventions.
Hypertonic sodium lactate improves microcirculation, cardiac function, and inflammation in a rat model of sepsis
Authors: Besnier Emmanuel , Coquerel David , Kouadri Geoffrey , Clavier Thomas , Favory Raphael , Duburcq Thibault , Lesur Olivier , Bekri Soumeya , Richard Vincent , Mulder Paul , Tamion Fabienne 
Published: June 2020

Abstract
Background
Hypertonic sodium lactate (HSL) may be of interest during inflammation. We aimed to evaluate its effects during experimental sepsis in rats (cecal ligation and puncture (CLP)).

Methods
Three groups were analyzed (n = 10/group): sham, CLP-NaCl 0.9%, and CLP-HSL (2.5 mL/kg/h of fluids for 18 h after CLP). Mesenteric microcirculation, echocardiography, cytokines, and biochemical parameters were evaluated. Two additional experiments were performed for capillary leakage (Evans blue, n = 5/group) and cardiac hemodynamics (n = 7/group).

Results
HSL improved mesenteric microcirculation (CLP-HSL 736 [407–879] vs. CLP-NaCl 241 [209–391] UI/pixel, p = 0.0006), cardiac output (0.34 [0.28–0.43] vs. 0.14 [0.10–0.18] mL/min/g, p < 0.0001), and left ventricular fractional shortening (55 [46–73] vs. 39 [33–52] %, p = 0.009). HSL also raised dP/dtmax slope (6.3 [3.3–12.1] vs. 2.7 [2.0–3.9] 103 mmHg/s, p = 0.04), lowered left ventricular end-diastolic pressure-volume relation (1.9 [1.1–2.3] vs. 3.0 [2.2–3.7] RVU/mmHg, p = 0.005), and reduced Evans blue diffusion in the gut (37 [31–43] vs. 113 [63–142], p = 0.03), the lung (108 [82–174] vs. 273 [222–445], p = 0.006), and the liver (24 [14–37] vs. 70 [50–89] ng EB/mg, p = 0.04). Lactate and 3-hydroxybutyrate were higher in CLP-HSL (6.03 [3.08–10.30] vs. 3.19 [2.42–5.11] mmol/L, p = 0.04; 400 [174–626] vs. 189 [130–301] μmol/L, p = 0.03). Plasma cytokines were reduced in HSL (IL-1β, 172 [119–446] vs. 928 [245–1470] pg/mL, p = 0.004; TNFα, 17.9 [12.5–50.3] vs. 53.9 [30.8–85.6] pg/mL, p = 0.005; IL-10, 352 [267–912] vs. 905 [723–1243] pg/mL) as well as plasma VEGF-A (198 [185–250] vs. 261 [250–269] pg/mL, p = 0.009).

Conclusions
Hypertonic sodium lactate fluid protects against cardiac dysfunction, mesenteric microcirculation alteration, and capillary leakage during sepsis and simultaneously reduces inflammation and enhances ketone bodies.
Intra-cluster correlation coefficients in primary care patients with type 2 diabetes and hypertension
Authors: Lee Yi Lin , Lim Yvonne Mei Fong , Law Kian Boon , Sivasampu Sheamini 
Published: June 2020

Abstract
Introduction
There are few sources of published data on intra-cluster correlation coefficients (ICCs) amongst patients with type 2 diabetes (T2D) and/or hypertension in primary care, particularly in low- and middle-income countries. ICC values are necessary for determining the sample sizes of cluster randomized trials. Hence, we aim to report the ICC values for a range of measures from a cluster-based interventional study conducted in Malaysia.

Method
Baseline data from a large study entitled Evaluation of Enhanced Primary Health Care interventions in public health clinics (EnPHC-EVA: Facility) were used in this analysis. Data from 40 public primary care clinics were collected through retrospective chart reviews and a patient exit survey. We calculated the ICCs for processes of care, clinical outcomes and patient experiences in patients with T2D and/or hypertension using the analysis of variance approach.

Results
Patient experience had the highest ICC values compared to processes of care and clinical outcomes. The ICC values ranged from 0.01 to 0.48 for processes of care. Generally, the ICC values for processes of care for patients with hypertension only are higher than those for T2D patients, with or without hypertension. However, both groups of patients have similar ICCs for antihypertensive medications use. In addition, similar ICC values were observed for clinical outcomes, ranging from 0.01 to 0.09. For patient experience, the ICCs were between 0.03 (proportion of patients who are willing to recommend the clinic to their friends and family) and 0.25 (for Patient Assessment of Chronic Illness Care item 9, Given a copy of my treatment plan).

Conclusion
The reported ICCs and their respective 95% confidence intervals for T2D and hypertension will be useful for estimating sample sizes and improving efficiency of cluster trials conducted in the primary care setting, particularly for low- and middle-income countries.
Two-by-two factorial randomised study within a trial (SWAT) to evaluate strategies for follow-up in a randomised prevention trial
Authors: Bradshaw Lucy E. , Montgomery Alan A. , Williams Hywel C. , Chalmers Joanne R. , Haines Rachel H. 
Published: June 2020

Abstract
Background
Failure to collect outcome data in randomised trials can result in bias and loss of statistical power. Further evaluations of strategies to increase retention are required. We assessed the effectiveness of two strategies for retention in a randomised prevention trial using a two-by-two factorial randomised study within a trial (SWAT).

Methods
Parents of babies included in the host trial were randomised to (1) short message service (SMS) notification prior to sending questionnaires at 3, 6, 12 and 18 months versus no SMS notification and (2) a £10 voucher sent with the invitation letter for the primary follow-up visit at 24 months or given at the visit. The two co-primary outcomes were collection of host trial (1) questionnaire data at interim follow-up times and (2) primary outcome at 24 months during a home/clinic visit with a research nurse.

Results
Between November 2014 and November 2016, 1394 participants were randomised: 350 to no SMS + voucher at visit, 345 to SMS + voucher at visit, 352 to no SMS + voucher before visit and 347 to SMS + voucher before visit. Overall questionnaire data was collected at interim follow-up times for 75% in both the group allocated to the prior SMS notification and the group allocated to no SMS notification (odds ratio (OR) SMS versus none 1.02, 95% CI 0.83 to 1.25). Host trial primary outcome data was collected at a visit for 557 (80%) allocated to the voucher before the visit in the invitation letter and for 566 (81%) whose parents were allocated to receive the voucher at the visit (OR before versus at visit 0.89, 95% CI 0.69 to 1.17).

Conclusion
There was no evidence of a difference in retention according to SMS notification or voucher timing. Future synthesis of SWAT results is required to be able to detect small but important incremental effects of retention strategies.

Trial registration
ISRCTN registry, ID: ISRCTN21528841. Registered on 25 July 2014. SWAT Repository Store ID 25.
Using systematic data categorisation to quantify the types of data collected in clinical trials: the DataCat project
Authors: Crowley Evelyn , Treweek Shaun , Banister Katie , Breeman Suzanne , Constable Lynda , Cotton Seonaidh , Duncan Anne , El Feky Adel , Gardner Heidi , Goodman Kirsteen , Lanz Doris , McDonald Alison , Ogburn Emma , Starr Kath , Stevens Natasha , Valente Marie , Fernie Gordon 
Published: June 2020

Abstract
Background
Data collection consumes a large proportion of clinical trial resources. Each data item requires time and effort for collection, processing and quality control procedures. In general, more data equals a heavier burden for trial staff and participants. It is also likely to increase costs. Knowing the types of data being collected, and in what proportion, will be helpful to ensure that limited trial resources and participant goodwill are used wisely.

Aim
The aim of this study is to categorise the types of data collected across a broad range of trials and assess what proportion of collected data each category represents.

Methods
We developed a standard operating procedure to categorise data into primary outcome, secondary outcome and 15 other categories. We categorised all variables collected on trial data collection forms from 18, mainly publicly funded, randomised superiority trials, including trials of an investigational medicinal product and complex interventions. Categorisation was done independently in pairs: one person having in-depth knowledge of the trial, the other independent of the trial. Disagreement was resolved through reference to the trial protocol and discussion, with the project team being consulted if necessary.

Key results
Primary outcome data accounted for 5.0% (median)/11.2% (mean) of all data items collected. Secondary outcomes accounted for 39.9% (median)/42.5% (mean) of all data items. Non-outcome data such as participant identifiers and demographic data represented 32.4% (median)/36.5% (mean) of all data items collected.

Conclusion
A small proportion of the data collected in our sample of 18 trials was related to the primary outcome. Secondary outcomes accounted for eight times the volume of data as the primary outcome. A substantial amount of data collection is not related to trial outcomes. Trialists should work to make sure that the data they collect are only those essential to support the health and treatment decisions of those whom the trial is designed to inform.
Impact of routine assessment of health-related quality of life coupled with therapeutic information on compliance with endocrine therapy in patients with non-metastatic breast cancer: protocol for a randomized controlled trial
Authors: Mamguem Kamga Ariane , Di Martino Cyril , Anota Amelie , Paget-Bailly Sophie , Coutant Charles , Arveux Patrick , Desmoulins Isabelle , Dabakuyo-Yonli Tienhan Sandrine 
Published: June 2020

Abstract
Background
Despite its proven efficacy in reducing recurrence and improving survival, adherence to endocrine therapy (ET) is suboptimal in women with breast cancer (BC). Health-related quality of life (HRQoL) in BC has been widely studied and many positive effects have been highlighted. Recently, a link between HRQoL and compliance with ET has been suggested, which would suggest a potential role for HRQoL assessment in improving compliance with ET. With the advent of digital technologies, electronic collection of HRQoL on a tablet is now possible. Thus, we hypothesize that systematic HRQoL assessment (using a tablet, prior to each consultation, with presentation of scores to clinicians) coupled with therapeutic information could have an impact on 12-month compliance with ET in patients with non-metastatic BC.

Methods
In this study, we will include 342 women with non-metastatic hormone receptor–positive BC with an indication for treatment with ET. Patients will be randomly assigned 1:1 by minimization and stratified by age, stage, type of ET prescribed, and presence of comorbidities (or not) in two arms. The intervention will consist of numerical HRQoL assessment using the CHES (Computer-based Health Evaluation System) software before each consultation (with delivery of scores to clinicians) coupled with therapeutic information. Therapeutic information will consist of three workshops related to understanding the prescription, nutrition, and fatigue. A reminder letter will be sent to patients every month. Patients in the control group will follow standard care. HRQoL will be assessed using a classic “paper-pencil” collection at baseline in both arms to ensure comparability between arms and at 12 months. The primary endpoint is 12-month compliance with ET. Patient satisfaction with care and the clinicians’ perception of the usefulness of routine HRQoL assessment will also be assessed.

Discussion
This study will allow clinicians to identify and better understand the areas in which patients who receive ET have difficulties and thus it will assist clinicians with patient management. Systematic evaluation of HRQoL could provide an additional endpoint for measuring patients’ health status and treatment-related symptoms, including ET. If the results of this study are positive, this intervention could be proposed as an integral part of daily clinical practice in patients who receive ET.

Trial registration
ClinicalTrials.govNCT04176809. Registered Nov. 25, 2019.
Using targeting to recruit men and women of color into a behavioral weight loss trial
Authors: Crane Melissa M. , Seburg Elisabeth M. , Levy Rona L. , Jeffery Robert W. , Sherwood Nancy E. 
Published: June 2020

Abstract
Background
The majority of participants in weight loss trials are non-Hispanic White women, while men and women of color are underrepresented. This study presents data obtained from non-targeted and targeted recruitment approaches in a trial of behavioral weight loss programs to (1) describe the yields from each approach and (2) compare the demographics, weight control histories, and study involvement of samples recruited by each approach.

Methods
Data for this observational study include source of recruitment, demographic information, weight loss experiences (e.g., lifetime weight loss, current weight loss behaviors), and completion of the 6-month assessment visit.

Results
Men comprised 14.2% of participants who responded to non-targeted recruitment efforts, while targeted efforts yielded 50.4% men. Similarly, people of color comprised 12.8% of those who responded to non-targeted approaches, whereas targeted recruitment methods yielded 47.2% people of color. Men recruited through targeted methods were younger (p = 0.01) than men recruited through non-targeted means but were otherwise similar. Women of color recruited through targeted methods reported use of fewer weight loss strategies relative to women of color recruited through non-targeted means (p = 0.006) but were otherwise similar. There were no differences by recruitment method on retention to the study.

Conclusions
Using targeted recruitment methods increased the ethnic and gender diversity of the recruited sample without reducing study retention. This targeting also increased the enrollment of women with less weight loss experience who may not have otherwise sought out a weight loss program. Developing and implementing a targeted recruitment plan should be considered early in the clinical trial development process.

Trial registration
Clinicaltrials.gov, NCT02368002. Registered on 20 February 2015.
The sociability spectrum: evidence from reciprocal genetic copy number variations
Authors: López-Tobón Alejandro , Trattaro Sebastiano , Testa Giuseppe 
Published: June 2020

AbstractSociability entails some of the most complex behaviors processed by the central nervous system. It includes the detection, integration, and interpretation of social cues and elaboration of context-specific responses that are quintessentially species-specific. There is an ever-growing accumulation of molecular associations to autism spectrum disorders (ASD), from causative genes to endophenotypes across multiple functional layers; these however, have rarely been put in context with the opposite manifestation featured in hypersociability syndromes. Genetic copy number variations (CNVs) allow to investigate the relationships between gene dosage and its corresponding phenotypes. In particular, CNVs of the 7q11.23 locus, which manifest diametrically opposite social behaviors, offer a privileged window to look into the molecular substrates underlying the developmental trajectories of the social brain. As by definition sociability is studied in humans postnatally, the developmental fluctuations causing social impairments have thus far remained a black box. Here, we review key evidence of molecular players involved at both ends of the sociability spectrum, focusing on genetic and functional associations of neuroendocrine regulators and synaptic transmission pathways. We then proceed to propose the existence of a molecular axis centered around the paradigmatic dosage imbalances at the 7q11.23 locus, regulating networks responsible for the development of social behavior in humans and highlight the key role that neurodevelopmental models from reprogrammed pluripotent cells will play for its understanding.
Surgical debridement of corneal shield ulcers in pediatric patients: two case reports and a review of the literature
Authors: Stock Ricardo Alexandre , Lazzari Silvia Letícia Teixeira , Martins Isadora Proner , Bonamigo Elcio Luiz 
Published: June 2020

Abstract
Background
Ocular allergy is a common disease, especially in the pediatric population, with unpleasant and long-term consequences, including corneal complications and decreased visual acuity. This study reports two cases of corneal shield ulcer due to vernal keratoconjunctivitis, with good results of surgical debridement performed after failure of long-term clinical treatment. Furthermore, this study highlights that this therapeutic approach, although less common, is efficient in treating refractory cases that cause suffering in pediatric patients.

Case presentation
The first patient was a 7-year-old Caucasian boy with chronic ocular allergy, especially photophobia, who had been treated with eye drops, antihistamine, and corticosteroids for 60 days without success. Biomicroscopy of the right eye showed the presence of gelatinous limbus, giant papillae in the tarsal conjunctiva, and a shield ulcer measuring 6.0 mm vertically and 2.7 mm horizontally. Surgical debridement was performed, and the ulcer did not recur. The second patient was a 4-year-old Caucasian boy with chronic ocular allergy, especially itching and photophobia, who had been treated with eye drops for 1 year without success. Biomicroscopy of the left eye showed a shield ulcer, with a dense central corneal plaque, measuring 8 mm vertically and 3.5 mm horizontally. Surgical debridement of the ulcer was performed immediately because of the chronicity of the case and severity of the lesion, and the treatment was effective.

Conclusions
The treatment of shield ulcers caused by vernal keratoconjunctivitis in the two reported cases was curative and definitive by surgical debridement in the 7-month follow-up period. Therefore, the early debridement of shield ulcers refractory to drug treatment can considerably reduce the time of disease evolution and the probability of ocular complications caused by clinical treatment or disease chronicity. However, this approach is rarely described in the literature and needs to be included in the ophthalmologist’s therapeutic arsenal.