bluuebunny/crossref_metadata_2025_split huggingface dataset:
Early high-dose vitamin C in post-cardiac arrest syndrome (VITaCCA): study protocol for a randomized, double-blind, multi-center, placebo-controlled trial
Authors: Rozemeijer Sander , de Grooth Harm-Jan , Elbers Paul W. G. , Girbes Armand R. J. , den Uil Corstiaan A. , Dubois Eric A. , Wils Evert-Jan , Rettig Thijs C. D. , van Zanten Arthur R. H. , Vink Roel , van den Bogaard Bas , Bosman Rob J. , Oudemans-van Straaten Heleen M. , de Man Angélique M. E. 
Published: August 2021

Abstract
Background
High-dose intravenous vitamin C directly scavenges and decreases the production of harmful reactive oxygen species (ROS) generated during ischemia/reperfusion after a cardiac arrest. The aim of this study is to investigate whether short-term treatment with a supplementary or very high-dose intravenous vitamin C reduces organ failure in post-cardiac arrest patients.

Methods
This is a double-blind, multi-center, randomized placebo-controlled trial conducted in 7 intensive care units (ICUs) in The Netherlands. A total of 270 patients with cardiac arrest and return of spontaneous circulation will be randomly assigned to three groups of 90 patients (1:1:1 ratio, stratified by site and age). Patients will intravenously receive a placebo, a supplementation dose of 3 g of vitamin C or a pharmacological dose of 10 g of vitamin C per day for 96 h. The primary endpoint is organ failure at 96 h as measured by the Resuscitation-Sequential Organ Failure Assessment (R-SOFA) score at 96 h minus the baseline score (delta R-SOFA). Secondary endpoints are a neurological outcome, mortality, length of ICU and hospital stay, myocardial injury, vasopressor support, lung injury score, ventilator-free days, renal function, ICU-acquired weakness, delirium, oxidative stress parameters, and plasma vitamin C concentrations.

Discussion
Vitamin C supplementation is safe and preclinical studies have shown beneficial effects of high-dose IV vitamin C in cardiac arrest models. This is the first RCT to assess the clinical effect of intravenous vitamin C on organ dysfunction in critically ill patients after cardiac arrest.

Trial registration
ClinicalTrials.gov NCT03509662. Registered on April 26, 2018. https://clinicaltrials.gov/ct2/show/NCT03509662European Clinical Trials Database (EudraCT): 2017-004318-25. Registered on June 8, 2018. https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-004318-25/NL
Feasibility of Comparative Health Research Outcome of Novel Surgery in prostate cancer (IP4-CHRONOS): statistical analysis plan for the randomised feasibility phase of the CHRONOS study
Authors: Day Emily , Prevost A. Toby , Sydes Matthew R. , Reddy Deepika , Shah Taimur T. , Winkler Mathias , Dudderidge Tim , Staffurth John , McCracken Stuart , Khoo Vincent , Jadav Puja , Klimowska-Nassar Natalia , Sasikaran Thiagarajah , Ahmed Hashim U. , Fiorentino Francesca 
Published: August 2021

Abstract
Background
Randomised controlled trials (RCTs) for surgical interventions have often proven difficult with calls for innovative approaches. The Imperial Prostate (IP4) Comparative Health Research Outcomes of Novel Surgery in prostate cancer (IP4-CHRONOS) study aims to deliver level 1 evidence on outcomes following focal therapy which involves treating just the tumour rather than whole-gland surgery or radiotherapy. Our aim is to test the feasibility of two parallel RCTs within an overarching strategy that fits with existing patient and physician equipoise and maximises the chances of success and potential benefit to patients and healthcare services.

Methods and design
IP4-CHRONOS is a randomised, unblinded multi-centre study, including two parallel randomised controlled trials targeting the same patient population: IP4-CHRONOS-A and IP4-CHRONOS-B.
IP4-CHRONOS-A is a 1:1 RCT and the other is a multi-arm, multi-stage (MAMS) RCT starting with three arms and a 1:1:1 randomisation. The two linked RCTs are discussed with patients at the time of consent and the choice of A or B is dependent on physician and patient equipoise. The primary outcome is the feasibility of recruitment, acceptance of randomisation and compliance to allocated arm.

Results
This paper describes the statistical analysis plan (SAP) for the feasibility study within IP4-CHRONOS given its innovative approach. Version 1.0 of the SAP has been reviewed by the Trial Steering Committee (TSC), Chief Investigator (CI), Senior Statistician and Trial Statistician and signed off. The study is ongoing and recruiting. Recruitment is scheduled to finish later in 2021. The SAP documents approved methods and analyses that will be conducted. Since this is written in advance of the analysis, we avoid bias arising from prior knowledge of the study data and findings.

Discussion
Our feasibility analysis will demonstrate if IP4-CHRONOS is feasible in terms of recruitment, randomisation and compliance, and whether to continue both A and B or just one to the main stage.

Trial registration
ISRCTN ISRCTN17796995. Registered on 08 October 2019
Gastric glomus tumor: a case report and review of the literature
Authors: Tsagkataki Eleni S. , Flamourakis Mathaios E. , Gkionis Ioannis G. , Giakoumakis Michail I. , Delimpaltadakis Georgios N. , Kazamias Georgios M. , Giannikaki Elpida S. , Christodoulakis Manousos S. 
Published: August 2021

AbstractIntroductionGastric glomus tumor is a rare mesenchymal neoplasm. There are only a few cases of the tumor showing malignancy, and there are no specific guidelines for the management of this entity.Case presentationWe present the case of a 53-year-old Caucasian male who was hospitalized for anemia. Computerized tomography of the abdomen depicted a mass between the pylorus of the stomach and the first part of the duodenum. Preoperative diagnosis was achieved with pathology examination of the biopsies taken via endoscopic ultrasound and upper gastrointestinal endoscopy. An antrectomy with Roux-en-Y anastomosis and appendicectomy, due to suspicion of appendiceal mucocele, were performed. The patient had an uneventful postoperative recovery and was discharged 5 days later.DiscussionPreoperative diagnosis of a gastric glomus tumor is difficult owing to the location of the tumor and the lack of specific clinical and endoscopic characteristics. Furthermore, it is exceptional to establish diagnosis with biopsies taken through endoscopic ultrasound or upper gastrointestinal endoscopy, prior to surgical resection. Although most glomus tumors are benign and are not known to metastasize, there are rare examples of glomus tumors exhibiting malignancy. Treatment of choice is considered wide local excision with negative margins. However, long-term follow-up is required as there is the possibility of malignancy.ConclusionThe aim of this report is to enlighten doctors about this uncommon pathologic entity. Surgical resection is considered the golden standard therapy to establish a diagnosis and evaluate the malignant potential.
Existence and uniqueness of a finite energy solution for the mixed value problem of porous thermoelastic bodies
Authors: Marin M. , Vlase S. , Carstea C. 
Published: August 2021

AbstractWe consider the mixed problem with boundary and initial data in thermoelasticity of porous bodies with dipolar structure. By generalizing some known results developed by Dafermos in a more simple case of the classical theory of elasticity, we prove new theorems in which we address the issues regarding the uniqueness and existence of a solution with finite energy of the respective problem after we define this type of solution.
Enhancing learning potential score in EFL listening comprehension and self-regulation through self-regulated dynamic assessment procedures
Authors: Abdolrezapour Parisa , Ghanbari Nasim 
Published: August 2021

AbstractThis study aimed to integrate self-regulation strategies into dynamic assessment procedures of listening comprehension in an EFL setting and examine the possibility of raising EFL students’ listening comprehension and self-regulation skills. In addition, it explored the possibility of enhancing EFL learners’ potential scores in listening comprehension and self-regulation through applying self-regulation activities as a tool for motivating learners while being assessed. The assessment procedure was based on Vygotsky’s notion of the zone of proximal development and self-regulated intervention. The participants were 49 Iranian EFL learners in three groups: a control group, which received the institute’s regular instructional activities; a comparison group, which received dynamic assessment (DA); and an experimental group which received self-regulated dynamic assessment (SR-DA) procedures, in the form of an intervention focusing on cognitive, emotional, and behavioral self-regulation states of learners. Results of the study pointed to the potential of SR-DA for enhancing the students’ learning potential over and beyond that which is available from the DA (as offered to the comparison group) and the static testing (as offered to the control group). The results have important implications for a theoretical understanding of the mechanisms through which EFL learners develop necessary self-regulation skills in the EFL context.
The efficiency of mandibular mini-implants in reducing adverse effects of class II elastics in adolescent female patients: a single blinded, randomized controlled trial
Authors: El-Dawlatly Mostafa M. , Mabrouk Mohamed A. , ElDakroury Amr , Mostafa Yehya A. 
Published: August 2021

Abstract
Background
Excessive proclination of lower incisors and other undesirable consequences usually result from the use of class II elastics during orthodontic treatment. The purpose of this study was to attempt to limit the adverse effects of class II elastics by the use of mini implants placed in the mandibular arch in adolescent class II female patients.

Methods
The sample comprised 28 patients, (a mean age of 15.66 ± 2 years for intervention group and 15.1 ± 2.2 years for conventional group) with one-fourth or one-half unit class II canine relationship. The sample was divided into two equal groups. Randomization was carried out by a computer sequence generator with a 1:1 allocation ratio. In the intervention group, the mini implants were inserted between the lower second premolar and first molar, while the conventional group underwent regular class II elastics therapy. The active elastics treatment time was 8 months for both groups. Results were assessed by measurements from pre- and post-elastics lateral cephalometric radiographs.

Results
The change in L1 inclination (0.97 ± 0.92°) and L1 AP position (0.31 ± 0.63 mm) did not show a statistically significant difference between the two groups, but a statistically significant difference was found in the U1 retroclination (5.23 ± 1.92°) and U1 distal movement (4.05 ± 1.4 mm) [P ˂ 0.001] and [P ˂ 0.05] respectively in favor of the intervention group.

Conclusion
Mini-implants in conjunction with class II elastics had no skeletal effect, mainly dentoalveolar and it did not prevent the proclination of lower incisors. There was more distal movement in the upper incisors in the skeletal anchorage group which helped in enhancing the camouflaging of class II malocclusion.

Trial registration
Trial registered “FUE.REC (10)/10-2018” at the FUE registration council for clinical trials/IOP Orthodontic Program October 2018.
Complement factor D is linked to platelet activation in human and rodent sepsis
Authors: Sommerfeld O. , Dahlke K. , Sossdorf M. , Claus R. A. , Scherag A. , Bauer M. , Bloos F. 
Published: August 2021

Abstract
Background
The complement factor D (CFD) exerts a regulatory role during infection. However, its physiological function in coagulopathy and its impact on the course of an infection remains unclear.

Materials
Wild-type and CFD-deficient mice (n = 91) were subjected to cecal ligation and puncture to induce sepsis. At several time points, markers of coagulation and the host-immune response were determined. Furthermore, in patients (n = 79) with sepsis or SIRS, CFD levels were related to clinical characteristics, use of antiplatelet drugs and outcome.

Results
Septic CFD-deficient mice displayed higher TAT complexes (p = 0.02), impaired maximal clot firmness, but no relevant platelet drop and reduced GPIIb/IIIa surface expression on platelets (p = 0.03) compared to septic wild-type mice. In humans, higher CFD levels (non-survivors, 5.0 µg/ml to survivors, 3.6 µg/ml; p = 0.015) were associated with organ failure (SOFA score: r = 0.33; p = 0.003) and mortality (75% percentile, 61.1% to 25% percentile, 26.3%). CFD level was lower in patients with antiplatelet drugs (4.5–5.3 µg/ml) than in patients without.

Conclusion
In mice, CFD is linked to pronounced platelet activation, depicted by higher GPIIb/IIIa surface expression in wild-type mice. This might be of clinical importance since high CFD plasma concentrations were also associated with increased mortality in sepsis patients.
Pharmacokinetics and biodistribution of a novel anticancer thyrointegrin αvβ3 antagonist: triazole modified tetraiodothyroacetic acid conjugated to polyethylene glycol (P-bi-TAT)
Authors: Fujioka Kazutoshi , Godugu Kavitha , Mousa Shaker A. 
Published: August 2021

Abstract
We previously developed a triazole modified tetraiodothyroacetic acid (TAT) conjugated to a polyethylene glycol (PEG)-based thyrointegrin αvβ3 antagonist targeted compound, called P-bi-TAT. It exhibited potent anti-angiogenic and anticancer activities in vivo. The objective of the current study is to develop a quantitative bioanalytical method for P-bi-TAT using liquid chromatography-tandem mass spectrometry (LC-MS/MS) and to elucidate pharmacokinetics (PK) and biodistribution of P-bi-TAT in animals. We used in-source collision-induced dissociation (CID) for ionization of P-bi-TAT in the positive mode, followed by multiple reaction monitoring (MRM) for quantification. P-bi-TAT was quantified using P-mono-TAT as an internal standard because of its similarity in structure and physicochemical properties to P-bi-TAT. The LOQ for P-bi-TAT was 30 ng/μL and the recovery efficiency was 76% with the developed method. Cmax and AUC results at different doses (1, 3, 10 mg/kg) in rats suggest that P-bi-TAT is dose-dependent within the range administered. Results for Cmax and AUC in monkeys at a low dose (25 mg/kg) were comparable to those in rats. Biodistribution of subcutaneously administered P-bi-TAT in the brain of rats ranged from 7.90 to 88.7 ng/g brain weight, and levels of P-bi-TAT in the brain were dose-dependent. The results suggest that P-bi-TAT is a potential candidate as a molecular-targeted anticancer therapeutic with blood-brain barrier permeability and acceptable PK parameters. Its accumulation in organs, toxicokinetic, and pharmacodynamics needs to be further investigated.

Graphical Abstract
Transcortical approaches to large intraventricular tumors: a prospective case series of 20 patients
Authors: Elkallaf Mohamed AbdAllah , Elsaadany Waleed , Moussa Wael Mohamed Mohamed , Fayed Ahmed Abdel Aziz 
Published: August 2021

Abstract
Background
Large intraventricular tumors (IVTs) impose technical and surgical challenges, due to their enormous sizes, mass effect, vast extensions, and vascularity.

Objective
The authors aim at presenting their results, clinical outcomes, and the surgical strategies in the management of large IVTs through transcortical approaches.

Methods
A prospective trial was conducted at the Main Hospital of Alexandria University, Egypt, between August 2018 and October 2020 on 20 patients harboring IVTs larger than 5 cm or bilaterally represented. The variables evaluated included the extent of resection, postoperative neurological deficits, blood loss, surgical approaches, intraoperative challenges, complications, adjuvant therapies, Glasgow Outcome Scale, hydrocephalus, and cerebrospinal fluid (CSF) diversion.

Results
The study included 20 cases (9 males and 11 females). Mean age at diagnosis was 16.1 years (range 1–45). Mean follow-up was 12 months (range 9–26). Primary tumor locations were ventricular body, atrium, temporal horn, and frontal horn in 11, 5, 3, and 1 cases, respectively. Main pathologies were central neurocytomas (7 patients/35%), ependymomas (3 patients/15%), and subependymal giant cell astrocytoma (SEGA) (3 patients/15%). Excision was gross total (n = 19) and near-total (n = 1). Significant intraoperative bleeding (n = 6). Postoperative minor intraventricular hemorrhage (n = 6), subdural collections (n = 8), hydrocephalus (n = 9), memory affection (n = 4), and motor deficits (n = 4). Postoperative Glasgow Outcome Scale of 5/5 (n = 20), no mortalities were recorded. preoperative seizures (n = 7), new onset postoperative seizures (n = 2).

Conclusion
Surgical approaches to large tumors of the lateral ventricles should be tailored to the variability of tumor locations, dimensions, extensions, and the individual morbid anatomy, in addition to the surgeon’s experience and preferences. Trans-cortical approaches can provide safe surgical corridors to tackle these challenging subtypes of IVTs with good clinical outcomes, tumor resectability rates, and seizure control.
Anionic surfactant sulfate dodecyl sodium (SDS)-induced thermodynamics and conformational changes of collagen by ultrasensitive microcalorimetry
Authors: Zhang Jie , Wang Chunhua , Zhang Fengteng , Lin Wei 
Published: August 2021

Abstract
In this communication, sulfate dodecyl sodium (SDS)-induced thermodynamics and conformational changes of collagen were studied. We used ultrasensitive differential scanning calorimetry (US-DSC) to directly monitor the thermal transition of collagen in the presence of SDS. The results show that SDS affects the conformation and thermal stability of collagen very differently depending on its concentrations. At CSDS ≤ 0.05 mM, the enhanced thermal stability of collagen indicates the stabilizing effect by SDS. However, a further increase of SDS leads to the denaturation of collagen, verifying the well-known ability of SDS to unfold proteins. This striking difference in thermodynamics and conformational changes of collagen caused by SDS concentrations can be explained in terms of their interactions. With increasing SDS, the binding of SDS to collagen can be dominated by electrostatic interaction shifting to hydrophobic interaction, and the latter plays a key role in loosening and unfolding the triple-helix structure of collagen. The important finding in the present study is the stabilizing effect of SDS on collagen molecules at extreme low concentration.

Graphical abstract
Clinicopathologic features and therapy outcome in childhood Hodgkin’s lymphoma: a report from tertiary care center in Saudi Arabia
Authors: Alkhayat Nawaf , Alshahrani Mohammad , Elyamany Ghaleb , Sedick Qanita , Ibrahim Walid , Hamzi Hasna , Binhassan Amal , Othman Mohamed , Alshieban Saeed , Aljabry Mansour S. , Asiri Shuaa , Alzouman Muneerah , Alsuhaibani Omar , Alabbas Fahad , Alsharif Omar , Elborai Yasser 
Published: August 2021

AbstractBackgroundHodgkin lymphoma (HL) is lymphoid neoplasm usually affecting lymphatic system; it accounts 3.6% of cancers in Saudi Arabia. Modern treatment protocols had shown particular success rates in overall-survival (OS) and event-free-survival (EFS). In our study, we reviewed the medical records of 80 pediatric and young adolescent patients diagnosed HL from January 2006 to July 2020, treated at tertiary care hospital in Riyadh, Saudi Arabia. Demographic, clinical, and pathological data were explored. First line therapy was ABVD, COG, COPP, R-CHOP, or radiotherapy alone in 53/80 (66.4%), 24/80 (30%), 1/80 (1.2%), 1/80 (1.2%), or 1/80 (1.2%) patients; respectively. Response assessment was done by CT + / − PET scan after first 2 cycles then every 2 cycle and end of therapy. Another assessment was done if any clinical suspicion of recurrence.ResultsMedian age 11 (range 3–16) years. Males to females 1.3:1. Seventy-two out of eighty (90%) patients showed first complete remission (CR1) and maintained remission for median 40 (range 7–136) months. Eight out of eighty (10%) patients showed refractory disease. Nineteen patients received salvage therapy (ICE or ESHAP/brentuximab vedotin or gemcitabine/brentuximab vedotin), 14/19 (73.7%) had 2nd complete remission (CR2) for median time 24 (ranged 9–78) months, while 5/19 (26.3%) did not show any response. Five-year OS and EFS were 95% and 75%. Two patients had 2ry malignant neoplasms, one had AML and died, the other had malignant fibrous histocytoma and still alive. None of our patients had fertility problem. Also, they did not experience chronic pulmonary or cardiotoxicity. Classic Hodgkin’s lymphoma: nodular sclerosis subtype was more prominent (55%) than mixed cellularity subtype (22.5%), which is similar to several European and US studies, lymphocyte rich (11.25%) and lymphocyte depleted (0%), while nodular lymphocyte predominant Hodgkin’s lymphoma (11.25%).ConclusionsOur study provided unique descriptive study of childhood HL, in Saudi Arabia, with valuable insight into the long-term outcome and late toxicity. Our results are comparable to other studies in the Middle East and European countries.
Association of microalbuminuria with left ventricular dysfunction in type 2 diabetes mellitus
Authors: Mehta Jiteshri , Godbole Varsha Y. , Mehta Kedar G. , Lalithambigai A. 
Published: August 2021

Abstract
Background
The prevalence of diabetes mellitus is on rising trend in developing countries like India. In type 2 diabetes patients, albuminuria has been shown to predict development of dysfunction in other organ systems such as kidneys, nervous system, and retina and increase risk of cardiovascular (CV) morbidity and mortality. In this study, we plan to assess association of microalbuminuria with left ventricular dysfunction in type 2 diabetes mellitus.

Results
This cross-sectional study was conducted among 100 type 2 diabetes mellitus patients attending a tertiary care hospital in Gujarat, Western India. Based on urine albumin excretion status, they were divided in two groups of 50 each—normoalbuminuric and microalbuminuric patients. The mean FBS, PPBS, and HbA1c level was significantly lower in normoalbuminuric group compared to microalbuminuric group. There was an increase in cholesterol, triglyceride, VLDL, and LDL levels and decrease in HDL levels in microalbuminuric group as compared to normoalbuminuric group. Multivariate logistic regression analysis revealed that increase in age and a decrease in E/A ratio in patients with microalbuminuria was significantly associated with left ventricular diastolic dysfunction (LVDD).

Conclusion
The presence of microalbuminuria is associated with increased likelihood of LVDD in type 2 diabetes patients. Increase in age and decrease in E/A ratio show direct and independent association with LVDD in normotensive diabetic patients with microalbuminuria. Therefore, diabetes patients who have microalbuminuria should be regularly (or more frequently) evaluated for development of LVDD using Echocardiography. This can allow early identification of myocardial diastolic dysfunction.