bluuebunny/crossref_metadata_2025_split huggingface dataset:
Budget impact analysis of robotic exoskeleton use for locomotor training following spinal cord injury in four SCI Model Systems
Authors: Pinto Daniel , Garnier Mauricio , Barbas Jason , Chang Shuo-Hsiu , Charlifue Susan , Field-Fote Edelle , Furbish Catherine , Tefertiller Candy , Mummidisetty Chaithanya K. , Taylor Heather , Jayaraman Arun , Heinemann Allen W. 
Published: January 2020

AbstractBackgroundWe know little about the budget impact of integrating robotic exoskeleton over-ground training into therapy services for locomotor training. The purpose of this study was to estimate the budget impact of adding robotic exoskeleton over-ground training to existing locomotor training strategies in the rehabilitation of people with spinal cord injury.MethodsA Budget Impact Analysis (BIA) was conducted using data provided by four Spinal Cord Injury (SCI) Model Systems rehabilitation hospitals. Hospitals provided estimates of therapy utilization and costs about people with spinal cord injury who participated in locomotor training in the calendar year 2017. Interventions were standard of care walking training including body-weight supported treadmill training, overground training, stationary robotic systems (i.e., treadmill-based robotic gait orthoses), and overground robotic exoskeleton training. The main outcome measures included device costs, training costs for personnel to use the device, human capital costs of locomotor training, device demand, and the number of training sessions per person with SCI.ResultsRobotic exoskeletons for over-ground training decreased hospital costs associated with delivering locomotor training in the base case analysis. This analysis assumed no difference in intervention effectiveness across locomotor training strategies. Providing robotic exoskeleton overground training for 10% of locomotor training sessions over the course of the year (range 226–397 sessions) results in decreased annual locomotor training costs (i.e., net savings) between $1114 to $4784 per annum. The base case shows small savings that are sensitive to parameters of the BIA model which were tested in one-way sensitivity analyses, scenarios analyses, and probability sensitivity analyses. The base case scenario was more sensitive to clinical utilization parameters (e.g., how often devices sit idle and the substitution of high cost training) than device-specific parameters (e.g., robotic exoskeleton device cost or device life). Probabilistic sensitivity analysis simultaneously considered human capital cost, device cost, and locomotor device substitution. With probabilistic sensitivity analysis, the introduction of a robotic exoskeleton only remained cost saving for one facility.ConclusionsProviding robotic exoskeleton for over-ground training was associated with lower costs for the locomotor training of people with SCI in the base case analyses. The analysis was sensitive to parameter assumptions.
Early fulminant BK polyomavirus-associated nephropathy in two kidney transplant patients with low neutralizing antibody titers receiving allografts from the same donor
Authors: Lorentzen Elias Myrvoll , Henriksen Stian , Kaur Amandeep , Kro Grete Birkeland , Hammarström Clara , Hirsch Hans H. , Midtvedt Karsten , Rinaldo Christine Hanssen 
Published: January 2020

AbstractBackgroundBK Polyomavirus (BKPyV) causes premature graft failure in 1 to 15% of kidney transplant (KT) recipients. High-level BKPyV-viruria and BKPyV-DNAemia precede polyomavirus-associated nephropathy (PyVAN), and guide clinical management decisions. In most cases, BKPyV appears to come from the donor kidney, but data from biopsy-proven PyVAN cases are lacking. Here, we report the early fulminant course of biopsy-proven PyVAN in two male KT recipients in their sixties, receiving kidneys from the same deceased male donor.Case presentationsBoth recipients received intravenous basiliximab induction, and maintenance therapy consisting of tacrolimus (trough levels 3–7 ng/mL from time of engraftment), mycophenolate mofetil 750 mg bid, and prednisolone. At 4 weeks post-transplant, renal function was satisfactory with serum creatinine concentrations of 106 and 72 μmol/L in recipient #1 and recipient #2, respectively. Plasma BKPyV-DNAemia was first investigated at 5 and 8 weeks post-transplant being 8.58 × 104and 1.12 × 106copies/mL in recipient #1 and recipient #2, respectively. Renal function declined and biopsy-proven PyVAN was diagnosed in both recipients at 12 weeks post-transplant. Mycophenolate mofetil levels were reduced from 750 mg to 250 mg bid while tacrolimus levels were kept below 5 ng/mL. Recipient #2 cleared BKPyV-DNAemia at 5.5 months post-transplant, while recipient #1 had persistent BKPyV-DNAemia of 1.07 × 105copies/mL at the last follow-up 52 weeks post-transplant. DNA sequencing of viral DNA from early plasma samples revealed apparently identical viruses in both recipients, belonging to genotype Ib-2 with archetype non-coding control region. Retrospective serological work-up, demonstrated that the donor had high BKPyV-IgG-virus-like particle ELISA activity and a high BKPyV-genotype I neutralizing antibody titer, whereas both KT recipients only had low neutralizing antibody titers pre-transplantation. By 20 weeks post-transplant, the neutralizing antibody titer had increased by > 1000-fold in both recipients, but only recipient #2 cleared BKPyV-DNAemia.ConclusionsLow titers of genotype-specific neutralizing antibodies in recipients pre-transplant, may identify patients at high risk for early fulminant donor-derived BKPyV-DNAemia and PyVAN, but development of high neutralizing antibody titers may not be sufficient for clearance.
Inhalation of welding fumes reduced sperm counts and high fat diet reduced testosterone levels; differential effects in Sprague Dawley and Brown Norway rats
Authors: Skovmand Astrid , Erdely Aaron , Antonini James M. , Nurkiewicz Timothy R. , Shoeb Mohammad , Eye Tracy , Kodali Vamsi , Loeschner Katrin , Vidmar Janja , Agerholm Jørgen S. , Goericke-Pesch Sandra , Vogel Ulla , Hougaard Karin S. 
Published: January 2020

AbstractBackgroundPrevious studies have shown that inhalation of welding fumes may induce pulmonary and systemic inflammation and organ accumulation of metal, to which spermatogenesis and endocrine function may be sensitive. Also obesity may induce low-grade systemic inflammation. This study aimed to investigate the effects on sperm production of inhaled metal nanoparticles from stainless steel welding, and the potential exacerbation by intake of a high fat diet. Both the inbred Brown Norway and the outbred Sprague Dawley rat strains were included to study the influence of strain on the detection of toxicity. Rats were fed regular or high fat (HF) diet for 24 weeks and were exposed to 20 mg/m3of gas metal arc-stainless steel (GMA-SS) welding fumes or filtered air for 3 h/day, 4 days/week for 5 weeks, during weeks 7–12. Outcomes were assessed upon termination of exposure (week 12) and after recovery (week 24).ResultsAt week 12, the GMA-SS exposure induced pulmonary inflammation in both strains, without consistent changes in markers of systemic inflammation (CRP, MCP-1, IL-6 and TNFα). GMA-SS exposure lowered daily sperm production compared to air controls in Sprague Dawley rats, but only in GMA-SS Brown Norway rats also fed the HF diet. Overall, HF diet rats had lower serum testosterone levels compared to rats on regular diet. Metal content in the testes was assessed in a limited number of samples in Brown Norway rats, but no increase was obsedrved. At week 24, bronchoalveolar lavage cell counts had returned to background levels for GMA-SS exposed Sprague Dawley rats but remained elevated in Brown Norway rats. GMA-SS did not affect daily sperm production statistically significantly at this time point, but testicular weights were lowered in GMA-SS Sprague Dawley rats. Serum testosterone remained lowered in Sprague Dawley rats fed the HF diet.ConclusionExposure to GMA-SS welding fumes lowered sperm production in two strains of rats, whereas high fat diet lowered serum testosterone. The effect on sperm counts was likely not mediated by inflammation or lowered testosterone levels. The studied reproductive outcomes seemed more prone to disruption in the Sprague Dawley compared to the Brown Norway strain.
Debranching thoracic endovascular aortic repair for distal aortic arch aneurysm in elderly patients aged over 75 years old
Authors: Shiraya Suguru , Nakamura Yoshinobu , Harada Shingo , Kishimoto Yuichiro , Onohara Takeshi , Otsuki Yuki , Kurashiki Tomohiro , Horie Hiromu , Nishimura Motonobu 
Published: January 2020

Abstract
Background
We examined the outcome of debranching thoracic endovascular aortic repair (d-TEVAR) without sternotomy for distal aortic arch aneurysm in patients aged ≥75 years.

Methods
Patients who underwent d-TEVAR or TAR for aortic arch aneurysm between 2008 and 2015 at our hospital and aged ≥75 years were included. Age, sex, left ventricular ejection fraction, preoperative creatinine level, diabetes, cerebrovascular disease, and chronic obstructive pulmonary disease were matched using PS.

Results
Among 74 patients (d-TEVAR: 51, TAR: 23), 17 patients in each group were matched. No difference in surgical outcome was detected between the d-TEVAR and TAR groups, including 30-day death (0% vs. 0%), hospital death (5.8% vs. 0%: p = 0.31) and incidence of cerebral infarction (5.8% vs. 7.6%: p = 0.27) as well as the long-term outcomes of 5-year survival (92.8% vs. 74.8%: p = 0.30) and 5-year aorta-related event-free rate (88.2% vs. 100%: p = 0.15). Average duration of ICU stay (1.3 ± 1.1 days vs. 5.6 ± 1.3 days: p = 0.025) and hospital stay (16.5 ± 5.2 days vs. 37.7 ± 19.6 days: p = 0.017) were significantly shorter in the d-TEVAR group.

Conclusion
Our results indicated that d-TEVAR is less invasive without affecting long-term outcome up to 5 years. Although the number of the patients included in the study was small, debranching TEVAR could be one of the treatments of the choice in the elderly, especially with comorbidities.
A surgical case of mediastinal hematoma caused by a minor traffic injury
Authors: Suzuki Katsuyuki , Shiono Satoshi , Hayasaka Kazuki , Endoh Makoto 
Published: January 2020

Abstract
Background
Mediastinal hematoma rarely occurs after a minor traffic injury.

Case presentation
A woman in her forties was transferred to the emergency room by ambulance due to a traffic accident. Computed tomography (CT) revealed no abnormal findings, and she went home. Two days after the accident, the contrast-enhanced CT was repeated, which revealed cervical and mediastinal hematomas. Because it was possible that there was active bleeding from the right inferior thyroid artery, embolization of the right inferior thyroid artery was performed; however, her condition further deteriorated, so we performed emergency surgery to achieve hemostasis and remove the hematoma. Because of oozing from the right thyroid lobe, we performed right hemithyroidectomy and drainage of mediastinal space and right thoracic cavity. Since there was no bleeding site in the mediastinum, we thought that the mediastinal hematoma was due to bleeding from the thyroid gland. Her postoperative course was uneventful, and she is doing well at 9 months of follow-up after surgery.

Conclusions
It is possible that mediastinal hematoma might be caused by a minor traffic injury.
Protective effects of essential oil from Fructus Alpiniae zerumbet on retinal Müller gliosis via the PPAR-γ-p-CREB signaling pathway
Authors: Yang Hong , Gan Shiquan , Jiang Zhaohui , Song Xiaomei , Chen Tingting , Xu Yini , Fu Lingyun , Zhang Yanyan , Tao Ling , Shen Xiangchun 
Published: January 2020

AbstractBackgroundDiabetic retinopathy (DR) involves extensive retinal damage and is one of the most common and serious complications of diabetes mellitus. Hyperglycemia is the major pathological trigger for diabetic complications. Müller cell gliosis, a key pathophysiological process in DR, could finally lead to vision loss. Our previous finding revealed that the essential oil of FructusAlpiniae zerumbet(EOFAZ) protects human umbilical vein endothelial cells (HUVECs) against high glucose (HG)-induced injury via the PPAR-γ signal. However, Whether EOFAZ could prevent HG-induced Müller cell gliosis through the PPAR signaling remains unclear.MethodsThe neuroprotective effects of EOFAZ were evaluated in HG-treated rat retinal Müller cells (RMCs) and DR rat model.ResultGFAP and VEGF upregulation is the biomarker of Müller glial reactivity gliosis. Results suggested that EOFAZ could remarkably ameliorate retinal reactive gliosis by suppressing p-CREB and GFAP and VEGF downstream effectors. Its effects on PPAR-γ, a major target for currently available anti-diabetes drugs, were also investigated. EOFAZ treatment remarkably attenuated the reduction of PPAR-γ and high level of p-CaMK II and p-CREB in HG-treated RMCs and diabetic rats. Furthermore, the activation and ectopic expression of PPAR-γ downregulated p-CREB and p-CaMK II in HG-treated RMCs. By contrast, CaMK II inhibitor KN93 and CREB gene silencing did not significantly affect the PPAR-γ expression.ConclusionsA novel PPAR-γ-p-CREB signaling pathway accounts for the inhibitory effect of EOFAZ on RMCs gliosis. These findings provide scientific evidence for the potential use of EOFAZ as a complementary and alternative medicine for DR prevention and treatment in the future.
Current shreds of evidence on the anticancer role of EGCG in triple negative breast cancer: an update of the current state of knowledge
Authors: Bimonte Sabrina , Cascella Marco , Barbieri Antonio , Arra Claudio , Cuomo Arturo 
Published: January 2020

AbstractTriple-Negative Breast Cancer (TNBC), represents a subtype of breast cancer in which the estrogens receptor (ER) negative, the progesterone receptor (PR) negative and the human epidermal growth factor receptor 2 (HER2) negative, are not expressed. Thusly, TNBC does not respond to hormonal therapies or to those targeting the HER2 protein receptors. To overcome this flawed issue, new alternative therapies based on the use of natural substances, as the (−) - epigallocatechin 3-gallate (EGCG), has been proposed. It is largely documented that EGCG, the principal constituent of green tea, has suppressive effects on different types of cancer, including breast cancer, through the regulation of different signaling pathways. Thus, is reasonable to assume that EGCG could be viewed as a therapeutic option for the prevention and the treatment of TNBC. Here, we summarizing these promising results with the scope of turn a light on the potential roles of EGCG in the treatment of TNBC patients.
Cross-sectional and prospective study on anti-Müllerian hormone changes in a cohort of pre-menopausal women with a history of differentiated thyroid cancer
Authors: Mittica Miranda , Dotto Andrea , Comina Martina , Teliti Marsida , Monti Eleonora , Giusti Massimo 
Published: January 2020

Abstract
Background
Anti-Müllerian hormone (AMH) decreases acutely after post-surgical radioactive iodine (RAI) ablation in females with differentiated thyroid cancer (DTC).

Aim
We performed a cross-sectional and prospective study on AMH levels in pre-menopausal females with a history of DTC.

Methods
Fifty-nine females after surgery and RAI (group 1) and 30 females after surgery alone (group 2) were studied. The control group consisted of 141 healthy women (group 3). The prospective study was performed in 43 and 14 females from groups 1 and 2, respectively.

Results
On first evaluation, AMH levels were similar in groups 1 and 2, but lower than in group 3. In all groups, AMH was negatively related with chronological age and FSH levels. When subjects were stratified according to age, AMH levels were not different between groups. When AMH was evaluated up to 2 years after the baseline evaluation, no changes emerged in either group of women with DTC. In the prospective study, the incidence of abnormal menstrual cycles and the onset of menopause were observed in similar percentages of women with a history of RAI-treated DTC and of those treated with surgery alone.

Conclusions
AMH can be considered a reliable index of ovarian reserve in women with DTC. Chronological age is the main factor influencing AMH levels in both DTC patients and controls. After age-related stratification, AMH levels are similar in women with DTC treated with RAI and those treated with surgery alone.
A prospective, randomized, single-blind, multicentre, phase III study on organ preservation with Custodiol-N solution compared with Custodiol® solution in organ transplantation (kidney, liver and pancreas)
Authors: Kniepeiss Daniela , Houben Philipp , Stiegler Philipp , Berghold Andrea , Riedl Regina , Kahn Judith , Schemmer Peter 
Published: January 2020

Abstract
Background
Organ preservation before transplantation is still a challenge. Both the University of Wisconsin and Bretschneider’s histidine-tryptophan-ketoglutarate (HTK; Custodiol®) solution are standard for liver, kidney and pancreas preservation. Organ preservation with both solutions is comparable; recently, however, Custodiol® solution has been modified to Custodiol-N according to the needs of today. Thus, our study was defined to study its effect in clinical transplantation.

Methods
Patients undergoing kidney transplantation (n = 412) (including approximately 30 combined kidney–pancreas) or liver transplantation (n = 202) receive grafts that have been cold stored in either Custodiol® or Custodiol-N to demonstrate noninferiority of Custodiol-N regarding both graft function and graft injury after transplantation.

Discussion
Preclinical data have clearly shown that Custodiol-N is superior to Custodiol® in cold static organ preservation via mechanisms including inhibition of hypoxic cell injury, cold-induced cell injury and avoidance of adverse effects during warm exposure to the solution. Further clinical safety data on Custodiol-N for cardioplegia are available. Thus, this study was designed to compare Custodiol® with Custodiol-N for the first time in a prospective, randomized, single-blinded, multicentre, phase III clinical transplantation trial.

Trial registration
Eudra-CT, 2017–002198-20. Registered on 28 November 2018.
Implementing complaint-directed mini-interventions for depressive complaints in primary care to increase participation among patients with a lower socioeconomic status: design of a cluster randomised controlled trial
Authors: Leone Stephanie S. , Lokman Suzanne , Boon Brigitte , van der Poel Agnes , Smit Filip , Zijlstra-Vlasveld Moniek , Smeets Odile 
Published: January 2020

Abstract
Background
Depression is a major public health concern. E-health interventions for preventing and reducing depressive complaints have proven to be effective, and have the potential to make (mental) health care more accessible and efficient. However, the reach of these interventions needs to be improved, especially among people with a lower socioeconomic status (SES). Stimulating and supporting implementation of e-health in primary care, and offering guidance from general practice nurses (GP nurses) may be important strategies to achieve this.

Methods/design
The online ‘Complaint Directed Mini-Interventions’ (CDMIs) for stress, sleep and worry complaints, which were found to be (cost-)effective in a self-guided format, will be implemented in the primary care setting using a blended care format (i.e. combining e-health with face-to-face sessions) with minimal guidance provided by the GP nurse. The main aim is to evaluate whether a SES-sensitive implementation strategy improves the participation rate (i.e. reach) of lower-SES patients in the blended online CDMIs as compared to a regular implementation strategy in a cluster randomised controlled trial. Randomisation will occur at the level of the GP nurse, and 228 patients will be included in the study. The primary outcome is the participation rate (completing at least one face-to-face session and two online exercises) of the lower-SES target group. It is hypothesised that this percentage will be higher in the SES-sensitive group as compared to the regular group. Secondary objectives are to evaluate the implementation process, to monitor and evaluate psychological complaints (depression, sleep, stress, worry and anxiety) and well-being over time. Patient assessments will take place at baseline, 3 and 12 months post baseline.

Discussion
This study should contribute to our knowledge of reaching the lower-SES groups with a brief and complaint-specific blended approach for depressive complaints in primary care. It should also further our knowledge on successful strategies to implement depression prevention in primary care.

Trial registration
Netherlands Trial Register, ID: NL6595. Registered on 12 November 2017.
A systematic review of the efficiency of recruitment to stroke rehabilitation randomised controlled trials
Authors: McGill Kris , Sackley Catherine M. , Godwin Jon , McGarry Jodie , Brady Marian C. 
Published: January 2020

Abstract
Introduction
Randomised controlled trials (RCTs) that fail to meet their recruitment target risk increasing research waste. Acute stroke RCTs experience notable recruitment issues. The efficiency of recruitment to stroke rehabilitation RCTs has not been explored.

Aims and objectives
To explore recruitment efficiency and the trial features associated with efficient recruitment to stroke rehabilitation RCTs.

Methods
A systematic review of stroke rehabilitation RCTs published between 2005 and 2015 identified in a search of the Cochrane Stroke Group (CSG) Trials Register from 35 electronic databases (e.g. Medline, CINAHL; EMBASE), clinical trial registers, and hand-searching. Inclusion criteria are stroke rehabilitation intervention, delivered by a member of the rehabilitation team, and clinically relevant environment. We extracted data on recruitment efficiency and trial features.

Results
We screened 12,939 titles, 1270 abstracts and 788 full texts, before extracting data from 512 included RCTs (n = 28,804 stroke survivor participants). This is the largest systematic review of recruitment to date. A third of stroke survivors screened consented to participate (median 34% (IQR 14–61), on average sites recruited 1.5 participants per site per month (IQR 0.71–3.22), and one in twenty (6% (IQR 0–13) dropped out during the RCT. Almost half (48%) of those screened in the community were recruited compared to hospital settings (27%). Similarly, almost half (47%) those screened at least 6 months after stroke participated, compared to 23% of stroke survivors screened within a month of stroke. When one recruiter screened multiple sites, a median of one stroke survivor was recruited every 2 months compared to more than two per month when there was a dedicated recruiter per site. RCT recruitment was significantly faster per site, with fewer dropouts, for trials conducted in Asia (almost three stroke survivors monthly; 2% dropout) compared to European trials (approximately one stroke survivor monthly; 7% dropout).

Conclusions
One third of stroke survivors screened were randomised to rehabilitation RCTs at a rate of between one and two per month, per site. One in twenty did not complete the trial. Our findings will inform recruitment plans of future stroke rehabilitation RCTs. Limited reporting of recruitment details restricted the subgroup analysis performed.

Trial registration
Prospective Register of Systematic Reviews, registration number CRD42016033067.