bluuebunny/crossref_metadata_2025_split huggingface dataset:
A multicenter, prospective, inpatient feasibility study to evaluate the use of an intra-colonoscopy cleansing device to optimize colon preparation in hospitalized patients: the REDUCE study
Authors: Neumann Helmut , Latorre Melissa , Zimmerman Tim , Lang Gabriel , Samarasena Jason , Gross Seth , Brahmbhatt Bhaumik , Pazwash Haleh , Kushnir Vladimir 
Published: May 2021

AbstractBackgroundHigh quality bowel preparation prior to colonoscopy can be difficult to achieve in the inpatient setting. Hospitalized patients are at risk for extended hospital stays and low diagnostic yield due to inadequate bowel preparation. The Pure-Vu System is a novel device intended to fit over existing colonoscopes to improve intra-colonoscopy bowel preparation. The objective of the REDUCE study was to conduct the first inpatient study to evaluate optimization of bowel preparation quality following overnight preparation when using the Pure-Vu System during colonoscopy.MethodsThis multicenter, prospective feasibility study enrolled hospitalized subjects undergoing colonoscopy. Subjects recorded the clarity of their last bowel movement using a 5-point scale prior to colonoscopy. After one night of preparation, all enrolled subjects underwent colonoscopy utilizing the Pure-Vu System. The primary endpoint was improvement of colon cleanliness from baseline to post-cleansing with the Pure-Vu System as assessed by the improvement in Boston Bowel Preparation Scale (BBPS). An exploratory analysis was conducted to assess whether the clarity of the last bowel movement could predict inadequate bowel preparation.ResultsNinety-four subjects were included. BBPS analyses showed significant improvements in bowel preparation quality across all evaluable colon segments after cleansing with Pure-Vu, including left colon (1.74 vs 2.89; p < 0.0001), transverse colon (1.74 vs 2.91; p < 0.0001), and the right colon (1.41 vs 2.88; p < 0.0001). Prior to Pure-Vu, adequate cleansing (BBPS scores of ≥ 2) were reported in 60%, 62%, and 47% for the left colon, transverse colon, and right colon segments, respectively. After intra-colonoscopy cleansing with the Pure-Vu System, adequate colon preparation was reported in 100%, 99%, and 97% of the left colon, transverse colon, and right colon segments, respectively. Subjects with lower bowel movement clarity scores were more likely to have inadequate bowel preparation prior to cleansing with Pure-Vu.ConclusionsIn this feasibility study, the Pure-Vu System appears to be effective in significantly improving bowel preparation quality in hospitalized subjects undergoing colonoscopy. Clarity of last bowel movement may be useful indicator in predicting poor bowel preparation. Larger studies powered to evaluate clinical outcomes, hospital costs, and blinded BBPS assessments are required to evaluate the significance of these findings.Trial registrationEvaluation of the Bowel Cleansing in Hospitalized Patients Using Pure-Vu System (NCT03503162).
Low preoperative prealbumin predicts the prevalence of complications following liver transplantation
Authors: Li Yuancheng , Liu Xingchao , Jiang Yan , Wan Kun , Liu Wei , Ou Yanjiao , Bai Jie , You Yuemei , Hu Feng , Xu Zeliang , Bie Ping , Zhang Chengcheng , Zhang Leida 
Published: May 2021

Abstract
Background
As a nutritional index, preoperative serum prealbumin highly correlates with surgical complications. However, the correlation between preoperative prealbumin and postoperative complications remains unclear in liver transplantation (LT).

Methods
A total of 191 patients who underwent LT between 2015 and 2019 were included in the retrospective analysis. According to a cut-off value calculated from a receiver operating characteristic (ROC) curve, the patients were divided into normal and low preoperative prealbumin groups. Univariable and multivariable logistic regression analyses were used to identify independent risk factors for postoperative complications. In addition, patients were divided into subgroups by Model for End-stage Liver Disease (MELD) score, and the association between preoperative prealbumin and postoperative complications was also assessed in each group.

Results
A total of 111 (58.1%) patients were included in the low prealbumin group based on a cut-off value of 120 mg/L. The area under the ROC curve (AUC) was 0.754 (95% confidence interval [CI] 0.678–0.832). Low prealbumin (95% CI 1.51–12.8, P = 0.007) was identified as a predictor for postoperative complications based on multivariable regression. In the low and normal prealbumin groups, the prevalence rates of postoperative complications were 27.5% and 8.0% (P = 0.003) in the MELD score ≤ 15 subgroup and 53.3% and 20.0% (P = 0.197) in the MELD score > 15 subgroup, respectively.

Conclusions
Preoperative prealbumin was associated with postoperative complications in LT, and preoperative nutritional support benefitted postoperative recovery, especially for patients with low MELD scores.
Endoscopic resection combined with the Cryoballoon focal ablation system in the porcine normal esophagus: a preclinical study
Authors: Sunakawa Hironori , Yoda Yusuke , Takeshita Nobuyoshi , Hasegawa Hiro , Takashima Kenji , Kadota Tomohiro , Fujita Takeo , Akimoto Tetsuo , Fujii Satoshi , Yano Tomonori 
Published: May 2021

Abstract
Background
The Cryoballoon focal ablation system (CbFAS) for dysplastic Barrett’s esophagus is simple, time-saving and has high therapeutic efficacy. This study aimed to evaluate the technical feasibility and tissue damage with combination therapy of endoscopic resection (ER) and CbFAS in porcine models.

Methods
Three pigs (A, B, and C) were included, and all ER procedures were performed by endoscopic mucosal resection using the Cap method (EMR). Combination therapy for each pig was performed as follows: (a) CbFAS was performed for a post-EMR mucosal defect for Pig A; (b) CbFAS for post-EMR scar for Pig B, and (c) EMR for post-CbFAS scar for Pig C. All pigs were euthanized at 32 days after the initial procedure, and the tissue damage was evaluated.

Results
All endoscopic procedures were followed as scheduled. None of the subjects experienced anorexia, rapid weight loss, bleeding, and perforation during the observation period. They were euthanized at 32 days after the initial endoscopic procedure. On histological assessment, there was little difference between the tissue that was treated with CbFAS alone and that treated with CbFAS in combination with ER.

Conclusion
Combination therapy with ER and CbFAS can be technically feasible, and its outcome was not significantly different from CbFAS alone in terms of tissue damage.
Somatization in patients with predominant diarrhoea irritable bowel syndrome: the role of the intestinal barrier function and integrity
Authors: Prospero Laura , Riezzo Giuseppe , Linsalata Michele , Orlando Antonella , D’Attoma Benedetta , Di Masi Marta , Martulli Manuela , Russo Francesco 
Published: May 2021

Abstract
Background
Irritable bowel syndrome (IBS) is characterised by gastrointestinal (GI) and psychological symptoms (e.g., depression, anxiety, and somatization). Depression and anxiety, but not somatization, have already been associated with altered intestinal barrier function, increased LPS, and dysbiosis. The study aimed to investigate the possible link between somatization and intestinal barrier in IBS with diarrhoea (IBS-D) patients.

Methods
Forty-seven IBS-D patients were classified as having low somatization (LS = 19) or high somatization (HS = 28) according to the Symptom Checklist-90-Revised (SCL-90-R), (cut-off score = 63). The IBS Severity Scoring System (IBS-SSS) and the Gastrointestinal Symptom Rating Scale (GSRS) questionnaires were administered to evaluate GI symptoms. The intestinal barrier function was studied by the lactulose/mannitol absorption test, faecal and serum zonulin, serum intestinal fatty-acid binding protein, and diamine oxidase. Inflammation was assessed by assaying serum Interleukins (IL-6, IL-8, IL-10), and tumour necrosis factor-α. Dysbiosis was assessed by the urinary concentrations of indole and skatole and serum lipopolysaccharide (LPS). All data were analysed using a non-parametric test.

Results
The GI symptoms profiles were significantly more severe, both as a single symptom and as clusters of IBS-SSS and GSRS, in HS than LS patients. This finding was associated with impaired small intestinal permeability and increased faecal zonulin levels. Besides, HS patients showed significantly higher IL-8 and lowered IL-10 concentrations than LS patients. Lastly, circulating LPS levels and the urinary concentrations of indole were higher in HS than LS ones, suggesting a more pronounced imbalance of the small intestine in the former patients.

Conclusions
IBS is a multifactorial disorder needing complete clinical, psychological, and biochemical evaluations.
Trial registration: https://clinicaltrials.gov/ct2/show/NCT03423069.
Vonoprazan versus lansoprazole in the treatment of artificial gastric ulcers after endoscopic submucossal dissection: a randomized, open-label trial
Authors: Kawai Daisuke , Takenaka Ryuta , Ishiguro Mikako , Okanoue Shotaro , Gotoda Tatsuhiro , Kono Yoshiyasu , Takemoto Koji , Tsugeno Hirofumi , Fujiki Shigeatsu 
Published: May 2021

Abstract
Background
Vonoprazan is more potent and longer acting than traditional proton pump inhibitor. Although vonoprazan is expected to be superior to proton pump inhibitor, its efficacy in the treatment of gastric ulcers following endoscopic submucosal dissection (ESD) is not fully understood. The aim of this study was to evaluate the effectiveness of vonoprazan in artificial ulcer healing following ESD.

Methods
Patients with gastric tumors were randomly assigned to the vonoprazan group (group V) or lansoprazole group (group L) after ESD. Patients received intravenous lansoprazole (30 mg) twice on the day of ESD. Thereafter, patients were treated with vonoprazan (20 mg/day) in group V or lansoprazole (30 mg/day) in group L. Esophagogastroduodenoscopy was performed 4 and 8 weeks after the ESD.

Results
A total of 168 patients were analyzed. The 4-week healing rate for artificial ulcer was not significantly higher in group V versus group L (17/85, 20.0% vs. 14/83, 16.9%, respectively). In addition, there were no significant differences between the 4-week shrinkage rates between the two groups. Postoperative bleeding occurred in none of the patients in group V and three in group L. One patient in group V presented delayed perforation 2 days after ESD.

Conclusions
Vonoprazan might not be superior to lansoprazole in the healing of artificial gastric ulcer after ESD.
Trial registration: University hospital Medical Information Network (registration number: UMIN000016642), Registered 27 February 2015, https://www.umin.ac.jp/ctr/index-j.htm.
Multi-disciplinary supportive end of life care in long-term care: an integrative approach to improving end of life
Authors: Harasym Patricia M. , Afzaal Misha , Brisbin Sarah , Sinnarajah Aynharan , Venturato Lorraine , Quail Patrick , Kaasalainen Sharon , Straus Sharon , Sussman Tamara , Virk Navjot , Holroyd-Leduc Jayna M. 
Published: May 2021

Abstract
Background
Optimal supportive end of life care for frail, older adults in long term care (LTC) homes involves symptom management, family participation, advance care plans, and organizational support. This 2-phase study aimed to combine multi-disciplinary opinions, build group consensus, and identify the top interventions needed to develop a supportive end of life care strategy for LTC.

Methods
A consensus-building approach was undertaken in 2 Phases. The first phase deployed modified Delphi questionnaires to address and transform diverse opinions into group consensus. The second phase explored and prioritized the interventions needed to develop a supportive end of life care strategy for LTC. Development of the Delphi questionnaire was based on findings from published results of physician perspectives of barriers and facilitators to optimal supportive end of life care in LTC, a literature search of palliative care models in LTC, and published results of patient, family and nursing perspectives of supportive end of life care in long term care. The second phase involved World Café Style workshop discussions. A multi-disciplinary purposive sample of individuals inclusive of physicians; staff, administrators, residents, family members, and content experts in palliative care, and researchers in geriatrics and gerontology participated in round one of the modified Delphi questionnaire. A second purposive sample derived from round one participants completed the second round of the modified Delphi questionnaire. A third purposive sample (including participants from the Delphi panel) then convened to identify the top priorities needed to develop a supportive end-of-life care strategy for LTC.

Results
19 participants rated 75 statements on a 9-point Likert scale during the first round of the modified Delphi questionnaire. 11 participants (participation rate 58 %) completed the second round of the modified Delphi questionnaire and reached consensus on the inclusion of 71candidate statements. 35 multidisciplinary participants discussed the 71 statements remaining and prioritized the top clinical practice, communication, and policy interventions needed to develop a supportive end of life strategy for LTC.

Conclusions
Multi-disciplinary stakeholders identified and prioritized the top interventions needed to develop a 5-point supportive end of life care strategy for LTC.
Cost-utility analysis of a consensus and evidence-based medication review to optimize and potentially reduce psychotropic drug prescription in institutionalized dementia patients
Authors: Massot Mesquida Mireia , Folkvord Frans , Seda Gemma , Lupiáñez-Villanueva Francisco , Torán Monserrat Pere 
Published: May 2021

Abstract
Background
Growing evidence shows the effects of psychotropic drugs on the evolution of dementia. Until now, only a few studies have evaluated the cost-effectiveness of psychotropic drugs in institutionalized dementia patients. This study aims to assess the cost-utility of intervention performed in the metropolitan area of Barcelona (Spain) (MN) based on consensus between specialized caregivers involved in the management of dementia patients for optimizing and potentially reducing the prescription of inappropriate psychotropic drugs in this population. This analysis was conducted using the Monitoring and Assessment Framework for the European Innovation Partnership on Active and Healthy Ageing (MAFEIP) tool.

Methods
The MAFEIP tool builds up from a variety of surrogate endpoints commonly used across different studies in order to estimate health and economic outcomes in terms of incremental changes in quality adjusted life years (QALYs), as well as health and social care utilization. Cost estimates are based on scientific literature and expert opinion; they are direct costs and include medical visits, hospital care, medical tests and exams and drugs administered, among other concepts. The healthcare costs of patients using the intervention were calculated by means of a medication review that compared patients’ drug-related costs before, during and after the use of the intervention conducted in MN between 2012 and 2014. The cost-utility analysis was performed from the perspective of a health care system with a time horizon of 12 months.

Results
The tool calculated the incremental cost-effectiveness ratio (ICER) of the intervention, revealing it to be dominant, or rather, better (more effective) and cheaper than the current (standard) care. The ICER of the intervention was in the lower right quadrant, making it an intervention that is always accepted even with the lowest given Willingness to Pay (WTP) threshold value (€15,000).

Conclusions
The results of this study show that the intervention was dominant, or rather, better (more effective) and cheaper than the current (standard) care. This dominant intervention is therefore recommended to interested investors for systematic application.
Comparing rates of mycobacterial clearance in sputum smear-negative and smear-positive adults living with HIV
Authors: Machowski Edith E. , Letutu Matebogo , Lebina Limakatso , Waja Ziyaad , Msandiwa Reginah , Milovanovic Minja , Gordhan Bhavna G. , Otwombe Kennedy , Friedrich Sven O. , Chaisson Richard , Diacon Andreas H. , Kana Bavesh , Martinson Neil 
Published: May 2021

Abstract
Background
Pulmonary tuberculosis (TB) in people living with HIV (PLH) frequently presents as sputum smear-negative. However, clinical trials of TB in adults often use smear-positive individuals to ensure measurable bacterial responses following initiation of treatment, thereby excluding HIV-infected patients from trials.

Methods
In this prospective case cohort study, 118 HIV-seropositive TB patients were assessed prior to initiation of standard four-drug TB therapy and at several time points through 35 days. Sputum bacillary load, as a marker of treatment response, was determined serially by: smear microscopy, Xpert MTB/RIF, liquid culture, and colony counts on agar medium.

Results
By all four measures, patients who were baseline smear-positive had higher bacterial loads than those presenting as smear-negative, until day 35. However, most smear-negative PLH had significant bacillary load at enrolment and their mycobacteria were cleared more rapidly than smear-positive patients. Smear-negative patients’ decline in bacillary load, determined by colony counts, was linear to day 7 suggesting measurable bactericidal activity. Moreover, the decrease in bacterial counts was comparable to smear-positive individuals. Increasing cycle threshold values (Ct) on the Xpert assay in smear-positive patients to day 14 implied decreasing bacterial load.

Conclusion
Our data suggest that smear-negative PLH can be included in clinical trials of novel treatment regimens as they contain sufficient viable bacteria, but allowances for late exclusions would have to be made in sample size estimations. We also show that increases in Ct in smear-positive patients to day 14 reflect treatment responses and the Xpert MTB/RIF assay could be used as biomarker for early treatment response.
Management of prolonged first stage of labour in a low-resource setting: lessons learnt from rural Malawi
Authors: Bakker Wouter , van Dorp Elisabeth , Kazembe Misheck , Nkotola Alfred , van Roosmalen Jos , van den Akker Thomas 
Published: May 2021

Abstract
Background
Caesarean sections without medical indication cause substantial maternal and perinatal ill-health, particularly in low-income countries where surgery is often less safe. In presence of adequate labour monitoring and by appropriate use of evidence-based interventions for prolonged first stage of labour, unnecessary caesarean sections can be avoided. We aim to describe the incidence of prolonged first stage of labour and the use of amniotomy and augmentation with oxytocin in a low-resource setting in Malawi.

Methods
Retrospective analysis of medical records and partographs of all women who gave birth in 2015 and 2016 in a rural mission hospital in Malawi. Primary outcomes were incidence of prolonged first stage of labour based on partograph tracings, caesarean section indications and utilization of amniotomy and oxytocin augmentation.

Results
Out of 3246 women who gave birth in the study period, 178 (5.2%) crossed the action line in the first stage of labour, of whom 21 (11.8%) received oxytocin to augment labour. In total, 645 women gave birth by caesarean section, of whom 241 (37.4%) with an indication ‘prolonged first stage of labour’. Only 113 (46.9%) of them crossed the action line and in 71/241 (29.5%) membranes were still intact at the start of caesarean section. Excluding the 60 women with prior caesarean sections, 14/181 (7.7%) received oxytocin prior to caesarean section for augmentation of labour.

Conclusion
The diagnosis prolonged first stage of labour was often made without being evident from labour tracings and two basic obstetric interventions to prevent caesarean section, amniotomy and labour augmentation with oxytocin, were underused.
A novel nomogram containing acute radiation esophagitis predicting radiation pneumonitis in thoracic cancer receiving radiotherapy
Authors: Tang Wenjie , Li Xiaolin , Yu Haining , Yin Xiaoyang , Zou Bing , Zhang Tingting , Chen Jinlong , Sun Xindong , Liu Naifu , Yu Jinming , Xie Peng 
Published: May 2021

Abstract
Background
Radiation-induced pneumonitis (RP) is a non-negligible and sometimes life-threatening complication among patients with thoracic radiation. We initially aimed to ascertain the predictive value of acute radiation-induced esophagitis (SARE, grade ≥ 2) to symptomatic RP (SRP, grade ≥ 2) among thoracic cancer patients receiving radiotherapy. Based on that, we established a novel nomogram model to provide individualized risk assessment for SRP.

Methods
Thoracic cancer patients who were treated with thoracic radiation from Jan 2018 to Jan 2019 in Shandong Cancer Hospital and Institute were enrolled prospectively. All patients were followed up during and after radiotherapy (RT) to observe the development of esophagitis as well as pneumonitis. Variables were analyzed by univariate and multivariate analysis using the logistic regression model, and a nomogram model was established to predict SRP by “R” version 3.6.0.

Results
A total of 123 patients were enrolled (64 esophageal cancer, 57 lung cancer and 2 mediastinal cancer) in this study prospectively. RP grades of 0, 1, 2, 3, 4 and 5 occurred in 29, 57, 31, 0, 3 and 3 patients, respectively. SRP appeared in 37 patients (30.1%). In univariate analysis, SARE was shown to be a significant predictive factor for SRP (P < 0.001), with the sensitivity 91.9% and the negative predictive value 93.5%. The incidence of SRP in different grades of ARE were as follows: Grade 0–1: 6.5%; Grade 2: 36.9%; Grade 3: 80.0%; Grade 4: 100%. Besides that, the dosimetric factors considering total lung mean dose, total lung V5, V20, ipsilateral lung mean dose, ipsilateral lung V5, and mean esophagus dose were correlated with SRP (all P < 0.05) by univariate analysis. The incidence of SRP was significantly higher in patients whose symptoms of RP appeared early. SARE, mean esophagus dose and ipsilateral mean lung dose were still significant in multivariate analysis, and they were included to build a predictive nomogram model for SRP.

Conclusions
As an early index that can reflect the tissue’s radiosensitivity visually, SARE can be used as a predictor for SRP in patients receiving thoracic radiation. And the nomogram containing SARE may be fully applied in future’s clinical work.