bluuebunny/crossref_metadata_2025_split huggingface dataset:
Comparative evaluation of efficacy, pharmacodynamics, and safety of Hetero’s adalimumab (Mabura®, Hetero Biopharma Ltd.) and reference adalimumab (Humira®, Abbvie Inc.) in patients with active rheumatoid arthritis on concomitant methotrexate therapy
Authors: Sinha Shubhadeep , Ghosh Biswadip , Bandyopadhyay Syamasis , Fatima Firdaus , Bandi Vamsi Krishna , Thakur Pankaj , Reddy Bala , Chary Sreenivasa , Talluri Leela , Gupta Ajay , Kale Amit Ramchandra , Gupta Anil Kumar , P Ashok Kumar , Reddy Diwakar , Mohammed Younus , Shekar Soma , T Sudheer , Goni Vijay G. , Sharma Vishnu , Yeligod Vishwanath 
Published: June 2020

Abstract
Background
Our study aimed to compare efficacy and safety of Hetero’s adalimumab (Mabura®, Hetero Biopharma Limited) versus reference adalimumab (Humira®, Abbvie Inc.) in Indian patients with active rheumatoid arthritis (RA) concomitant on methotrexate (MTX) therapy.

Methods
Patients (n = 168) were randomized (2:1) to receive either test or reference product for 24 weeks with concomitant MTX. Proportion of patients achieving American College of Rheumatology 20 (ACR20) criteria at week 12 was the primary endpoint. Changes in Disease Activity Score of 28 joints–C-reactive protein (DAS28-CRP), Health Assessment Questionnaire–Disability Index (HAQ-DI), and patients achieving ACR20 at week 24, ACR50/70 at weeks 12 and 24 were secondary endpoints.

Results
Patients achieving ACR20 responses with test (96.43%) were similar to reference (96.43%) in intention-to-treat (ITT) analysis at week 12. Proportional difference (PD) between groups (PD [95% CI] 0.0 [− 6.0, 6.0], p = 1.000) for ACR20 at week 12 for ITT analysis showed lower limit of the two-sided 95% CI was above the pre-specified noninferiority margin of − 15%. Similar trend in PP analysis (PD [95% CI] 0.0 [− 0.03, 0.07], p = 1.000), confirmed therapeutic equivalence. No significant difference was noted between arms for patients attaining ACR20 at week 24 and ACR50/70 at weeks 12 and 24 (all p > 0.05). DAS28-CRP and HAQ-DI were similar between groups. Total of 54 patients reported 88 AEs during the study. Out of these, 60 AEs were reported in 34 patients with Hetero-Adalimumab and 28 AEs were reported in 20 patients with Reference-Adalimumab. Total two patients, one in each group reported two serious adverse events (Sinusitis and Viral infection) during the study and resolved completely. No deaths and no life threatening AEs were reported.

Conclusion
Results demonstrated Hetero’s adalimumab is as effective and well tolerated as reference adalimumab in patients with active RA concomitantly on MTX therapy.

Trial registration
CTRI/2016/04/006884, Registered on 28/04/2016.
Endovascular stenting of medically refractory intracranial arterial stenotic (ICAS) disease (clinical and sonographic study)
Authors: Nassef Ayman Mohamed , Awad Eman Mahmoud , El-bassiouny Ahmed Ali , Afify Hossam Eldin Mahmoud , Yousef Romany Adly , Shafik Mohamed Ahmed 
Published: June 2020

Abstract
Background
Atherosclerotic intracranial arterial stenosis (ICAS) is one of the most common causes of stroke worldwide and is associated with a high risk of recurrent stroke. Patients with a recent transient ischemic attack (TIA) or stroke and severe stenosis (70 to 99% of the diameter of a major intracranial artery) are at particularly high risk for recurrent stroke in the territory of the stenotic artery (approximately 23% at 1 year) despite medical treatment. Therefore, alternative therapies are urgently needed for these patients.

Objective
To determine the efficacy and safety of angioplasty with stenting in medically refractory ICAS and to compare its effectiveness with optimal medical treatment.

Subjects and methods
Fifty patients with symptomatic ICAS despite medical treatment (i.e, recurrent stroke or TIA) were enrolled and equally randomized in a prospective study where twenty-five patients underwent angioplasty with stenting and twenty-five patients received optimal medical treatment. Clinical assessment with NIHSS and mRS were done at 0, 3, and 6 months, and transracial Doppler (TCD) assessment of ICAS was done at 0 and 3 months after treatment.

Results
The interventional group had a better clinical outcome with mean NIHSS scores (5.2 ± 4.2, 4.43 ± 4.28 and 3.9 ± 4.7) at baseline, 3 and 6 months, respectively, in comparison to the medical group with mean NIHSS (4.5 ± 4.2, 11.42 ± 6.3, and 8.5 ± 5.1) and better functional outcome with mean mRS scores (1.3 ± 0.96, 1.2 ± 1.13, and 1.0 ± 1.13) at baseline, 3 and 6 months, respectively, in comparison to the medical group (0.84 ± 0.75, 2.28 ± 1.2, and 2 ± 1.24). TCD assessment of ICAS showed a marked reduction of the percentage of stenosis on 3 months of follow-up among the interventional groups (only 5.6% had > 70% stenosis) in comparison to the medical group (85.7% had > 70% stenosis). Recurrent ischemic events on 6 months of follow-up were 16% among interventional groups in comparison to 84% among medical groups. The mortality rate was 8% among interventional groups due to subarachnoid hemorrhages (SAH) related to procedure in comparison to 28% among medical groups secondary to ischemic events. The intraoperative success rate was 96% with the failure of stent deployment in 1 patient due to the tortuous anatomy of vessels. Early post interventional complication rate, i.e, SAH was 8%. Late post interventional restenosis and occlusion rates were 8% on 3 months of follow-up.

Conclusion
Endovascular stenting of medically refractory ICAS is more efficacious and effective with better clinical and functional outcomes than optimal medical treatment; however, its safety is still debatable.

Trial registration
Done at ClinicalTrials.gov. Trial ID (NCT Number) NCT04393025.
Comparison of bupivacaine versus bupivacaine-dexamethasone infiltration for postoperative analgesia in skin graft donor sites: a randomized trial
Authors: Mahrose Ramy , Elsayed Ahmed Mohammed , Sabry Asmaa Adel 
Published: June 2020

AbstractBackgroundSkin grafting, both partial and complete thickness, is frequently used in reconstruction of traumatic soft tissue defects. It is of great value not only for functional and anesthetic purposes in the field of plastic surgery, but also for other surgical specialties.Of all the problems in the early postoperative period, pain is considered the most important, ameliorating it can lead to significant reduction in postoperative morbidity and faster recovery of the skin donor site.ObjectiveTo evaluate use of dexamethasone as adjuvant for bupivacaine in subcutaneous local anesthesia infiltration for skin graft donor sites, on quality of pain relief and total dose of analgesic requirements in the early hours postoperatively.MethodsNinety-five patients were randomly allocated to receive local bupivacaine infiltration (group LB) (48 patients), or dexamethasone plus bupivacaine (group LB + D) (47 patients) in skin donor site after skin harvesting. In addition to basic demographic data, patients were compared for numerical rating scale (NRS), total dose of morphine including morphine equivalents, time to 1st breakthrough pain (over an observational period during the first 12 h postoperatively) and duration of surgery.ResultsNumerical rating scale figures were significantly better (P< 0.05) in group (LB + D) than group (LB) in the first 7 h postoperatively. Likewise, consumption of morphine or its equivalents was considerably less, as well as time to first breakthrough pain. Duration of surgery was not significantly different between both groups.ConclusionAddition of dexamethasone to bupivacaine provided effective analgesia for patients undergoing skin grafting surgery, with less need for rescue analgesia in the early postoperative period to bupivacaine alone.
Diagnostic accuracy of serum endothelin-1 in patients with HCC on top of liver cirrhosis
Authors: Elbadry Mohammad M. , Tharwat Mina , Mohammad Emad F. , Abdo Ehab F. 
Published: June 2020

Abstract
Background
Hepatocellular carcinoma (HCC) is one of the most common cancers and one of the main causes of cancer-related deaths. As the overall survival of patients with cirrhosis has improved and the global incidence of HCC has continued to increase, strategies for the early detection of HCC are urgently needed for better prognosis. In this study, we aimed to assess the accuracy of endothelin-1 in the diagnosis of HCC in cirrhotic patients in comparison with alpha-fetoprotein (AFP) and whether it could predict its vascular spread. This is a case–control study that included 70 cirrhotic patients with or without hepatocellular carcinoma. Patients were subjected to complete medical history taking, clinical examination and laboratory investigations including serum endothelin-1, alpha-fetoprotein, abdominal ultrasound and Triphasic multi-slice computed tomography (CT; abdomen and pelvis). The outcome results obtained for endothelin-1 were used to assess its diagnostic accuracy in HCC diagnosis and the prediction of presence of vascular spread.

Results
There was a statistically significant increase in serum endothelin-1 in HCC in comparison to cirrhotic patients and normal persons (P value < 0.001). Sensitivity, specificity, and positive and negative predictive values at cut-off point of 5.2 pg/ml for HCC were 90%, 100%, 100%, and 90.9% respectively. There was no statistically significant association between serum endothelin-1 level and portal vein thrombosis in HCC (P value = 0.547).

Conclusion
Endothelin-1 has high sensitivity and specificity for diagnosis of hepatocellular carcinoma. However, it has little value for prediction of its vascular spread.
Robust control of a multi-bus DC microgrid based on adaptive Lyapunov function method
Authors: Rezaei Mohammad Mahdi , Shojaeian Shahrokh , Rouhollahi Rasoul 
Published: June 2020

AbstractDue to the development of power electronic devices, the DC microgrids are competing AC microgrids, and even in some areas, such as efficiency, reliability, stability, DC microgrids are superior. In spite of mentioned advantages, the main technical challenge related to operation of the DC microgrids is to provide a fast and stable voltage regulation. In this paper, a robust control structure is proposed for multi-bus DC microgrids. Adopting master–slave control strategy, an adaptive voltage control scheme is proposed to robustly maintain the master unit voltage at the nominal value. In addition, an adaptive current controller is designed to robustly regulate the current of all the DG units in the grid-connected mode, as well as the slave units in the islanded mode of operation. All of the controllers are designed based on local measurements and are independent with respect to parameters, dynamic, and topology of the DCMG loads. The control scheme is shown to be stable and robust subject to parametric uncertainties and various types of disturbances. The consistent and effectiveness of the proposed control scheme is demonstrated through simulation studies in MATLAB®software environment.
Experience of transfer from child to adult mental health services of young people with autism spectrum disorder
Authors: Merrick Hannah , King Chris , McConachie Helen , Parr Jeremy R. , Le Couteur Ann 
Published: June 2020

Background
Transition from child-centred to adult mental health services has been reported as challenging for young people. It can be especially difficult for young people with autism spectrum disorder (ASD) as they manage the challenges of adolescence and navigate leaving child and adolescent mental health services (CAMHS).

Aims
This study examines the predictors of transfer to adult mental health services, and using a qualitative analysis, explores the young people’s experiences of transition.

Method
A UK sample of 118 young people aged 14–21 years, with ASD and additional mental health problems, recruited from four National Health Service trusts were followed up every 12 months over 3 years, as they were discharged from CAMHS. Measures of mental health and rich additional contextual information (clinical, family, social, educational) were used to capture their experiences. Regression and framework analyses were used.

Results
Regression analysis showed having an attention-deficit hyperactivity disorder diagnosis and taking medication were predictors of transfer from child to adult mental health services. Several features of young people's transition experience were found to be associated with positive outcomes and ongoing problems, including family factors, education transitions and levels of engagement with services.

Conclusions
The findings show the importance of monitoring and identifying those young people that might be particularly at risk of negative outcomes and crisis presentations. Although some young people were able to successfully manage their mental health following discharge from CAMHS, others reported levels of unmet need and negative experiences of transition.
Effect of Vitamin D Supplementation on the Incidence of Diabetes Mellitus
Authors: Barbarawi Mahmoud , Zayed Yazan , Barbarawi Owais , Bala Areeg , Alabdouh Ahmad , Gakhal Inderdeep , Rizk Fatima , Alkasasbeh Mariam , Bachuwa Ghassan , Manson JoAnn E 
Published: June 2020

Abstract

Context
The effect of vitamin D supplementation on the risk of type 2 diabetes mellitus (T2DM) remains controversial because most randomized controlled trials (RCTs) have been small or have reported low doses of vitamin D.

Objective
To conduct a meta-analysis of RCTs testing vitamin D supplementation in the prevention of T2DM.

Data Sources
Database search of PubMed/MEDLINE, EMBASE, and the Cochrane Library was performed by 2 reviewers from inception through September 15, 2019.

Study Selection
We included RCTs that reported the effect of vitamin D supplementation for at least 1 year on T2DM prevention.

Data Extraction
Two independent reviewers extracted the data. The risk ratios (RRs) and 95% confidence intervals (CIs) were reported. Primary outcome of the meta-analysis was the incidence of T2DM.

Data Synthesis
Nine RCTs were included (43 559 participants). The mean age (standard deviation) was 63.5 (6.7) years. The RR for vitamin D compared with placebo was 0.96 (95% CI, 0.90-1.03); P = 0.30. In trials testing moderate to high doses of supplementation (≥1000 IU/day), all conducted among participants with prediabetes, the RR for vitamin D compared with placebo was 0.88 (95% CI, 0.79-0.99). In contrast, the trials testing lower doses, which were conducted in general population samples, showed no risk reduction (RR, 1.02; 95% CI, 0.94-1.10; P, interaction by dose = 0.04).

Conclusion
In patients with prediabetes, vitamin D supplementation at moderate to high doses (≥1000 IU/day), significantly reduced the incidence risk of T2DM, compared with placebo.
Insulin Sensitizers for Improving the Endocrine and Metabolic Profile in Overweight Women With PCOS
Authors: Xing Chuan , Li Chunzhu , He Bing 
Published: June 2020

Abstract

Objective
To evaluate the efficacy of insulin sensitizers on menstrual frequency, sex hormone, and metabolic parameters in overweight women with polycystic ovary syndrome (PCOS).

Methods
We searched multiple databases from inception to September 2019 for randomized controlled trials. Network meta-analysis was conducted using multivariate random effects method.

Results
Fourteen trials reporting on 619 women were included. Compared with metformin, metformin + thiazolidinediones (TZDs) was more superior in menstrual recovery (weighted mean difference [WMD] 3.68; 95% credibility interval [CrI], 1.65 to 8.20), metformin +  glucagon-like peptide-1 (GLP-1) receptor agonists was more effective in decreasing androstenedione (WMD −2.53; 95% CrI, −3.96 to −1.09), both metformin + GLP-1 receptor agonists (WMD 9.22; 95% CrI, 5.46 to 12.98) and metformin + TZDs (WMD 4.30; 95% CrI, 0.78 to 7.82) were more effective in increasing sex hormone–binding globulin (SHBG), while TZDs were less effective in decreasing body mass index (BMI) (WMD 1.69; 95% CrI, 0.72 to 2.66). Compared with GLP-1 receptor agonists, metformin + GLP-1 receptor agonists was associated with higher SHBG (WMD 7.80; 95% CrI, 4.75 to 10.85), lower free testosterone (WMD −1.77; 95% CrI, −3.25 to −0.29), lower androstenedione (WMD −2.70; 95% CrI, −3.91 to −1.50) and lower fasting blood glucose (WMD −0.41; 95% CrI, −0.73 to −0.08).

Conclusion
For overweight women with PCOS, both metformin combined with GLP-1 receptor agonists and metformin combined with TZDs appear superior to monotherapy in improving hyperandrogenemia. Metformin combined with TZDs could be particularly effective in promoting the recovery of menstruation. Metformin combined with GLP-1 receptor agonists has the additional advantage of improving fasting glucose when compared with GLP-1 receptor agonists alone. TZDs are inferior to metformin in decreasing BMI.
Association Between Exposure to Ambient Air Pollution and Thyroid Function in Korean Adults
Authors: Kim Hyun-Jin , Kwon Hyuktae , Yun Jae Moon , Cho Belong , Park Jin-Ho 
Published: June 2020

Abstract

Context
Although a significant relationship has been reported between air pollution and thyroid function in limited samples or regions, few studies have addressed this association in the general population.

Objective
Using a nationwide sample of Korean adults, we investigated the association between exposure to air pollution and thyroid function, and whether this association differed between subgroups stratified according to age or body mass index (BMI).

Methods
We included 4704 adults in the final analysis and used each person’s annual average exposure to 4 air pollutants, namely, particulate matter with an aerodynamic diameter less than or equal to 10 μm (PM10), nitrogen dioxide (NO2), sulfur dioxide, and carbon monoxide (CO). We measured serum thyrotropin (TSH) and free thyroxine (FT4) concentrations as indicators of thyroid function according to age and BMI.

Results
The annual average exposure to NO2 and CO was significantly associated with an elevated TSH and reduced FT4 concentration after adjusting for possible confounding factors (all P &lt; .05). In men, in addition to these 2 pollutants, PM10 exposure was positively associated with TSH level (P = .03). Age-stratified analysis showed stronger effects of NO2 and CO exposure in older than in younger adults. Exposure to these air pollutants was related to serum TSH and FT4 concentrations in people with overweight or obesity but not in those of normal weight.

Conclusions
This study provides the first evidence that air pollution exposure is linked to thyroid function in the general population and that this association may be stronger in older or overweight or obese adults.
Circulating Myeloid-derived Suppressor Cells Facilitate Invasion of Thyroid Cancer Cells by Repressing miR-486-3p
Authors: Chen Li , Xiong Li , Hong Shubing , Li Jin , Huo Zijun , Li Yudong , Chen Shuwei , Zhang Quan , Zhao Ruiying , Gingold Julian A , Zhu Xiaonan , Lv Weiming , Li Yanbing , Yu Shuang , Xiao Haipeng 
Published: June 2020

Abstract

Background
Myeloid-derived suppressor cells (MDSCs) have become increasingly recognized as facilitators of tumor development. However, the role of MDSCs in papillary thyroid carcinoma (PTC) progression has not been clearly explored.

Objective
We aimed to evaluate the levels and function of circulating MDSCs in PTC.

Methods
The proportion of circulating polymorphonuclear (PMN)-MDSCs and mononuclear-MDSCs from patients with PTC or benign thyroid nodules and healthy controls was measured using flow cytometry. For immunosuppressive activity analysis, sorted circulating MDSCs were cocultured with CD3/CD28-costimulated T lymphocytes and the proliferation of T cells was determined. PTC cell lines (TPC-1 and BC-PAP) were cocultured with PMN-MDSCs, and the effects on cell migration, invasion, proliferation, and apoptosis were evaluated. The differential expressed microribonucleic acids (RNAs) and messenger RNAs and their function were also explored in TPC-1 cells cocultured with or without PMN-MDSCs.

Results
PMN-MDSCs were increased in peripheral blood mononuclear cells of patients with PTC. Circulating PMN-MDSCs displayed strong T cell suppressive activity. PTC cells demonstrated enhanced invasive capabilities in vitro and in vivo when cocultured with sorted PMN-MDSCs. PMN-MDSCs decreased expression of miR-486-3p and activated nuclear factor kappa B2 (NF-κB2), a direct target of miR-486-3p. Rescue of miR-486-3p diminished the cell migration and invasion induced by PMN-MDSCs.

Conclusion
Collectively, our work indicates that circulating PMN-MDSCs promote PTC progression. By suppressing miR-486-3p, PMN-MDSCs promote the activity of the NF-κB2 signaling pathway, resulting in accelerated invasion of PTC cells, which may provide new therapeutic strategies for treatment of thyroid cancer.
Estimating the Prevalence of Pseudomyxoma Peritonei in Europe Using a Novel Statistical Method
Authors: Patrick-Brown Thale Dawn J. H. , Carr Norman John , Swanson David M. , Larsen Stein , Mohamed Faheez , Flatmark Kjersti 
Published: June 2020

Abstract
Background
The determination of the incidence and prevalence of rare diseases is important for economists and health-care providers. Pseudomyxoma peritonei (PMP) is a rare, slow-growing abdominal cancer that represents a substantial burden on both patients and health-care systems. The incidence rate was previously approximated at 1–2 people per million per year; this incidence has never been challenged, and the prevalence has not been estimated.

Methods
Epidemiological data from Norway and England were obtained and analysed to calculate a minimum incidence rate based on the number of patients having a first surgical intervention for PMP. A novel method was then used to determine a prevalence rate for PMP, incorporating incidence, death, and cure rates in a multi-year analysis that accounted for the increasing population of Europe over a 10-year period.

Results
An incidence rate of 3.2 people per million per year was calculated, with a corresponding estimated prevalence rate of 22 people per million per year. By this calculation, 11,736 people in Europe were estimated to be living with PMP in 2018.

Conclusion
Incidence and prevalence are essential tools for assessment of the financial and human cost of a disease. For rare diseases, such as PMP, the lack of accurate registries presents a particular challenge in determining such health-related statistical parameters. Based on our calculations, a significant number of people are living with PMP in Europe, underlining the need for appropriate resource allocation to ensure that adequate health-care measures are provided.