bluuebunny/crossref_metadata_2025_split huggingface dataset:
First-in-Human Study in Healthy Subjects with the Noncytotoxic Monoclonal Antibody OSE-127, a Strict Antagonist of IL-7Rα
Authors: Poirier Nicolas , Baccelli Irène , Belarif Lyssia , Abès Riad , Teppaz Géraldine , Mary Caroline , Poli Sonia , Fromond Claudia , Girault Isabelle , Pengam Sabrina , Soma Emilienne , De Sa Fanny , Conduzorgues Jean-Pascal , Braudeau Cécile , Josien Regis , Volckaert Bram , Costantini Dominique , Corallo Frédérique 
Published: February 2023

Abstract
OSE-127 is a humanized mAb targeting the IL-7Rα-chain (CD127), under development for inflammatory and autoimmune disease treatment. It is a strict antagonist of the IL-7R pathway, is not internalized by target cells, and is noncytotoxic. In this work, a first-in-human, phase I, randomized, double-blind, placebo-controlled, single-center study was carried out to determine the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of OSE-127 administration. Sixty-three healthy subjects were randomly assigned to nine groups: six single ascending dose groups with i.v. administration (0.002–10 mg/kg), a single s.c. treatment group (1 mg/kg), and two double i.v. injection groups (6 or 10 mg/kg). Subjects were followed during &lt;146 d. OSE-127’s pharmacokinetic half-life after a single dose increased from 4.6 (1 mg/kg) to 11.7 d (10 mg/kg) and, after a second dose, from 12.5 (6 mg/kg) to 16.25 d (10 mg/kg). Receptor occupancy was ≥95% at doses ≥0.02 mg/kg, and this saturation level was maintained &gt;100 d after two i.v. infusions at 10 mg/kg. IL-7 consumption was inhibited by OSE-127 administration, as demonstrated by a decreased IL-7 pathway gene signature in peripheral blood cells and by ex vivo T lymphocyte restimulation experiments. OSE-127 was well tolerated, with no evidence of cytokine-release syndrome and no significant alteration of blood lymphocyte counts or subset populations. Altogether, the observed lack of significant lymphopenia or serious adverse events, concomitant with the dose-dependent inhibition of IL-7 consumption by target cells, highlights that OSE-127 may show clinical activity in IL-7R pathway–involved diseases.
Relationship of vitamin D level with insulin dosage required based on insulin therapy protocol
Authors: Niakan Lahiji Mohammad , Moghaddam Omid Moradi , Ameri Forough , Pournajafian Alireza , Mirhosseini Farnaz 
Published: February 2023

An Expression of Concern has been published | View
Update to April 27th, 2023: The Publisher is glad to inform the readers that the issue discussed in the Expression of Concern has been favorably resolved and we have no longer cause of concern regarding this paper.

The deficiency of vitamin D (VD) amongst Iranian people is high and also is related on hyperglycemia. This study aims to evaluate the association of VD levels with the required dose of insulin prescribed based on an insulin therapy protocol in critical condition patients admitted to intensive care unit (ICU), in an investigation based in Iran. This cross-sectional study was performed on patients who required insulin due to hyperglycemia. The relationship between serum VD level and the required dose of insulin prescribed based on insulin therapy protocol in this group of patients was investigated. A total of 172 patients with a mean age of 46.93 ± 31.9 years were included in this study. Across the included participants, 78.8% of patients had VD deficiency, 11.9% had insufficient VD and 9.3% had normal VD levels. There was a significant difference in mean blood sugar between the VD deficiency group and the normal group. VD levels were also significantly higher in men than women. Furthermore, the HbA1C hemoglobin level in patients with VD deficiency was significantly higher compared to the group with normal levels of VD. Our findings suggest that decreased VD is associated with increased blood sugar and insulin requirements in patients admitted to ICU. Women are at a higher risk for VD deficiency. We hope that these findings may help inform relevant treatment strategies.
A Rasch analysis of the High Potential Trait Indicator: A South African sample
Authors: Semmelink David S. , Maree David J.F. 
Published: February 2023

The reliability and validity of the six traits comprising the High Potential Trait Indicator (HPTi) were evaluated using Rasch analysis. Focus was designated to the unidimensionality and local independence of each subscale; fit to the Rasch model; person reliability and separation; and differential item functioning (DIF). Secondary data, obtained from intellectual property rights holder Thomas International, were used for analysis with a sample of 1257 South African respondents. One of the six traits, Curiosity (0.73), was found to be reliable. Traits Adjustment (0.69) and Competitiveness (0.69) border on the accepted cut-off of 0.70. Risk Approach (0.64) obtained the lowest reliability, closely followed by Conscientiousness (0.65) and Ambiguity Acceptance (0.65). Six of the 78 HPTi items did not fit the Rasch model, all of which underfit the model. Trait Curiosity was found not to be unidimensional, while the Ambiguity Acceptance scale approached the value at which a scale is considered multidimensional. One item was identified to be threatening the unidimensionality of the Curiosity scale based on both the factor loadings of the principal components analysis of the residuals and underfitting the Rasch model. The differential item functioning (DIF) analysis found no item bias between genders, female and male. Eleven items displayed DIF across ethnicities and home language groups. The most severe instance of DIF occurred in trait Competitiveness, yet it had only one item experiencing DIF. Trait Conscientiousness, however, contained four items experiencing various severities of DIF.Contribution: This study highlighted the shortcomings of the current HPTi in the South African context through Rasch analysis. The findings illustrate the difficult nature of creating ideal personality instruments in the South African context, thus contributing to the body of knowledge of personality assessments in South Africa.
Martin Luther and Aesop: Fables as tales of morality for today?
Authors: Potgieter Raymond 
Published: February 2023

Ancient Aesopian fables continued to capture the imagination, reaching even into Lutheran Wittenberg. Luther, concerned to address morality within the church and community, sanctioned the use of fables with some caution. Ever cautious not to obscure the gospel, he referred to fables as a tool in his preaching and his table-talks. This is a neglected tool, the rediscovery of which may prove useful to pastoral ministry for its ability to stimulate visualising and excite verbal communication in illustrating something of the complexity of Christian and daily living. While fables never gained much popularity in Reformed circles, it is worth revisiting for insights in how Martin Luther put it to use.Contribution: As in Reformation Wittenberg, a fable today has the latent promise to be a useful instrument in promoting gospel morality not only among children, but also among adults. To successfully reach that end, the church needs to be creative, even to the extent of fashioning contemporary fables to address daily tensions within its community and beyond.
Prevalence of peste des petits ruminants virus antibodies in sheep and goats sera from Central-Western Sudan
Authors: Ali Safa E.M. , Ahmed Yassin A.M. , Osman Alwia A. , Gamal Eldin Omiema A. , Osman Nussieba A. 
Published: February 2023

Clinical signs suggestive of peste des petits ruminants (PPR) involved herds of small ruminants, which were described elsewhere in Sudan. Peste des petits ruminants was confirmed using an Immunocapture ELISA (IC-ELISA) assay in samples of infected and dead animals in areas of outbreaks. Therefore, to update information regarding the current situation and for assessment of the serological prevalence of PPR in small ruminants mingled at Central and Western Sudan during 2018–2019, 368 sera were collected from sheep (325 sera) and goats (43 sera) with different ages and breeds. These sera included 186 sera (173 sheep and 13 goats) from White Nile State and 182 sera (152 sheep and 30 goats) from Kordofan States. Competitive ELISA demonstrated higher prevalence of PPRV antibodies of 88.9%, 90.7% and 88.6% in both sheep and goats, goats, and sheep sera, respectively. Moreover, 100%, 94.7% and 78.5% seroprevalence values were demonstrated in South Kordofan, North Kordofan and White Nile States. The higher seroprevalence values detected in sera of unvaccinated sheep and goats indicated the wide exposure of these animals to PPRV and presence of protection following PPR viral infection. The findings of the study indicated that PPR is endemic in the surveyed areas of Sudan.Contribution: The study will contribute effectively to the global eradication programme of PPR organised by the World Organization for Animal Health (WOAH, formerly OIE) and Food and Agriculture Organization (FAO). To completely eliminate PPR from Sudan by 2030, local efforts should be directed towards effectively and wholly vaccinating small ruminants using PPRV vaccine especially in routes of seasonal animal’s movement and shared grazing areas.
Evaluation of the Effect of Carvedilol in Preventing Right Ventricular Dysfunction in Breast Cancer Patients Receiving Anthracycline
Authors: Karvandi Mersede , Ghadyani Mojtaba , Mohebbi Nahid , Tabarraee Mehdi , Salari Sina 
Published: February 2023

Background:
Today, it has been shown that it is possible for right ventricular (RV) wall motion abnormalities or RV functional disorders to occur during cancer treatment. Now, considering the effect of carvedilol on beta 1, 2, and alpha receptors and its antioxidant properties, it seems that it can prevent RV abnormalities. Therefore, the aim of this study was to investigate the possible protective effects of carvedilol in preventing RV dysfunction in patients with breast cancer treated with anthracyclines.

Materials and Methods:
The present single-blind clinical trial study was performed on 23 patients with breast cancer that 12 of them received only the anthracycline antineoplastic doxorubicin (Adriamycin®) chemotherapy (control group) and 11 patients received carvedilol in addition to anthracycline. To evaluate the effect of carvedilol, patients underwent transthoracic echocardiography before intervention and 2 weeks after the end of treatment with anthracyclines.

Results:
The two parameters of RV ejection fraction and RV fractional area change in the carvedilol group with a mean of 66.41% ± 8.10% and 51.85% ± 6.89% were slightly higher than the control group with a mean of 64.58% ± 6.83% and 50.48 ± 5.79%, respectively, which was not statistically significant (P > 0.05). In contrast, RV S wave tissue Doppler imaging (S-TDI) in the control group with a mean of 0.13 ± 0.02 m/s was significantly lower than the carvedilol group with a mean of 0.14 ± 0.02 m/s (P = 0.022).

Conclusion:
According to the results of the present study, the effect of using carvedilol as a preservative on improving RV function was seen compared to the control group, although this difference was not statistically significant.
A Process Evaluation of the Isfahan Antibiotic Awareness Campaign: Developing Engagement on Antimicrobial Resistance
Authors: Rostami Soodabeh , Kassaian Nazila , Nokhodian Zary , Ataei Behrooz , Zamanimoghadam Ali , Nasri Parto , Ahangarzadeh Shahrzad , Tahvilian Zohreh , Shoaei Parisa , Shahzamani Kiana , Hashemi Fatemeh Khoshdel 
Published: February 2023

Background:
One of the most prominent global health threats is antibiotic resistance, leading to infection treatment failure. The first Iranian antibiotic awareness week campaign was initiated to improve the prudent use and wise prescription of antibiotics.

Materials and Methods:
The Isfahan antibiotic awareness campaign was held from November 30 to December 6, 2019, among two targeted populations; the general population and health-care workers by Isfahan University of Medical Sciences. In this campaign held in the main squares, streets, and a city's referral hospital, various educational methods were used to aware and sensitize the general population and medical staff about antibiotics and microbial resistance. These methods include face-to-face training, brochures, advertisement posters and billboards around the city, educational videos, social media messages, retraining for medical doctors and medical specialists, and interviewing in the Islamic Republic of Iran Broadcast.

Results:
Two hundred and twenty general practitioners, medical specialists, and residents participated in two retraining educational conferences in Al-Zahra Hospital, Isfahan, Iran. The mean score satisfaction of the two conferences was three from four. Nearly 2000 of the general population were under face-to-face educational programs whom after that, 83.6% had the correct answer to the questions around antimicrobial awareness.

Conclusions:
This campaign was an excellent experience as a pilot study with appealing issues. Further, activities are required to improve engagement with the target population and determine the impact of this campaign on antibiotic consumption and prescription behavior among the public and health-care professionals.
Thalidomide for the Treatment of COVID-19 Pneumonia: A Randomized Controlled Clinical Trial
Authors: Amra Babak , Ashrafi Farzaneh , Torki Mehdi , Hashemi Marzieh , Shirzadi Mohamad , Soltaninejad Forogh , Sadeghi Somayeh , Salmasi Mehrzad , Sami Ramin , Darakhshandeh Ali , Nasirian Maryam , Pourajam Samaneh 
Published: February 2023

Background:
Coronavirus disease 2019 has become a public health concern with a high number of fatalities. Thalidomide can target inflammatory mediators and decrease inflammation in SARS-CoV-2.

Materials and Methods:
An open-label, randomized controlled trial was conducted on patients with compatible lung high-resolution computed tomography scan for COVID-19 pneumonia and moderate involvement. Childbearing-age women were excluded. A total of 20 patients in the control group receiving usual treatment were compared with 26 patients in the case group who in addition to the same regimen also received thalidomide. The primary outcome was time for clinical recovery (TTCR) and intensive-care unit (ICU) admission.

Results:
From April 25 to August 8, 2020, based on the inclusion criteria, 47 patients were assigned to the study. Patients receiving thalidomide had a mean TTCR of days 5.5 (95% confidence interval [CI], 0.7–10.3), as compared with days 5.3 (95% CI, 1.7–8.9) with control (odds ratio 0.01; 95% CI, −1.58–1.59, P = 0.807). The incidence of ICU admission was 27% in the thalidomide group compared with 20% in the control group (odds ratio 3.89; 95% CI, 0.55–27.4, P = 0.425). The mean length of stay in hospital in both groups was 10 days. Progressive improvement in respiratory rate, fever, and O2 saturation during the study was seen in both groups without a significant difference between the thalidomide and control group (P > 0.05).

Conclusion:
This study investigated the effects of thalidomide to treat moderate COVID-19 clinical outcomes. The results established that this drug regimen did not add more effect to usual treatment for moderate COVID-19 pneumonia.
Antidepressants and the Risk of Psoriasis Induction: A Case–Control Study
Authors: Sadatmadani Seyedeh-Fatemeh , Siadat Amir Hossein , Iraji Fariba , Alsahebfosoul Fereshteh 
Published: February 2023

Background:
Psoriasis (PSO) is a common chronic autoimmune skin disease with a significant psycho-socio-economic burden. Some antidepressants (ADs) such as fluoxetine and bupropion can induce or exacerbate PSO. This study aimed to investigate the correlation between ADs history before PSO onset, and the risk of PSO induction, in Isfahan province, Iran.

Materials and Methods:
In this case–control study, 80 patients with PSO were selected by non-probability sampling method, and 80 healthy individuals were selected using simple random sampling. They were interviewed and medical information was recorded. Chi-square, Mann–Whitney, and Kruskal–Wallis tests for dichotomous or categorical data, and independent-sample t test for continuous data were used. Statistical significance was taken as P ≤ 0.05.

Results:
In this case–control study, a total of 160 individuals, 80 participants in each group, were included. The mean age of the total samples was 44.8 ± 16 years. Forty-three percent of the individuals were women. PSO familial history in the cases was significantly higher than the control group (OR = 11.94, P = 0.001). It was revealed that use of ADs by patients before PSO induction, was greater than the controls (OR = 2.78, P = 0.058).

Conclusions:
Past history of ADs in the cases before PSO onset, was higher than the controls, indicating a possible association between ADs and the risk of PSO induction. This study can be effective to pay more attention to the possible complications of ADs and PSO risk factors. Accurate knowledge of PSO risk factors will be useful for better management and morbidity reduction.
A Study of the Profile and the Impact of Diabetes, Steroid and Stress Hyperglycaemia on COVID-19 Outcomes
Authors: Kulkarni Shruthi , Fernandes Jonita , Selvam Sumithra , Idiculla Jyothi 
Published: February 2023

Background:
Diabetes Mellitus (DM) and hyperglycaemia (HG) have been identified as risk factors for morbidity and mortality in coronavirus disease 19 (COVID-19) infection. However, a detailed study of various categories of HG and the impacts and characteristics of each of these on COVID-19 was considered important to address this metabolic disorder in COVID-19.

Aims:
This study aimed to describe the patterns of HG and its impact on the clinical outcomes in hospitalised patients with COVID-19 infection.

Methodology:
Data on 1000 consecutive patients with COVID-19 were analysed using Statistical Package for Social Sciences (SPSS) version 20.0 software (SPSS Inc., Chicago, IL, USA).

Results:
A total of 1000 patients were included for analysis The overall mean age of the study group was 52.77 + 19.71 with 636 (63.6%) male patients; 261 had mild, 317 moderate, and 422 severe infections; and 601 had HG (New-onset DM 66, known DM 386, steroid-induced HG 133 and stress HG 16). The HG group has significantly higher levels of inflammatory markers and worse outcomes. Blood glucose levels were higher in patients with known DM. The ROC cut-off of total steroids to predict mortality in the HG group was 84 mg versus 60 mg in the normoglycaemia group. The ROC cut-off of FBS to predict mortality in the overall HG group was 165, with AUC 0.58 (95% CI 0.52, 0.63, P = 0.005), whereas that for pre-existing DM and steroid HG were 232 and 166, which were also significant. There was a wide variation in mean glucose levels against time.

Conclusion:
HG is an independent predictor of mortality, with the highest significance in the steroid-induced category. COVID-19 morbidity and mortality can be minimised by identifying the blood glucose range for best results and instituting appropriate treatment guidelines.
Effect of Hydroxychloroquine on Glycemic Variability in Type 2 Diabetes Patients Uncontrolled on Glimepiride and Metformin Therapy
Authors: Rajput Rajesh , Saini Suyasha , Rajput Siddhant , Upadhyay Parankush 
Published: February 2023

Background and Aims:
No study to date has assessed the effect of hydroxychloroquine on various parameters of glycaemic variability. To assess the effect of hydroxychloroquine on glycaemic variability in type 2 diabetes patients uncontrolled on glimepiride and metformin.

Methods:
A total of 30 T2DM patients aged 18–65 years uncontrolled on glimepiride and metformin therapy with HbA1c 7.5–10% (58–86 mmol/mol) were given adjunctive hydroxychloroquine 400 mg during the 12-week study period. The glycaemic variability parameters such as standard deviation of 24 hours of blood glucose, mean of daily differences (MODD) and mean amplitude of glycaemic excursion (MAGE) were assessed by continuous glucose monitoring system (CGMS) data at baseline and at 12 weeks after the addition of hydroxychloroquine 400 mg. Efficacy was assessed by change in fasting, postprandial plasma glucose and HbA1c from baseline to 12 weeks of addition of 400 mg hydroxychloroquine.

Results:
There was a significant reduction in all parameters of glycaemic variability including MAGE, MODD, standard deviation of 24-hour blood glucose and average blood glucose as well as a significant reduction in fasting, postprandial blood glucose and glycated haemoglobin post 12 weeks of adjunctive treatment with hydroxychloroquine. At the end of 12 weeks of adjunctive treatment with hydroxychloroquine, there was a significant improvement in the percentage of time spent in the target glucose range of 3.9–8.3 mmol/L (70–150 mg/dL).

Conclusion:
The addition of hydroxychloroquine in uncontrolled diabetes significantly reduces all glycaemic parameters including all parameters of glycaemic variability and hence can be an effective add-on to patients uncontrolled on glimepiride and metformin therapy.
Changes in visual acuity using low vision devices in patients with Leber hereditary optic neuropathy: A retrospective study
Authors: Gopalakrishnan Sarika , Bhaskaran Gnanapoonkodi , Jayasankar Ompriya , Selvakumar Ambika , Raman Rajiv 
Published: February 2023

Purpose:
This study was conducted to estimate the visual acuity improvement in patients with Leber hereditary optic neuropathy (LHON) with the help of low vision devices (LVDs) and to analyze the types of distant and near LVDs prescribed to the patients with LHON.

Methods:
A retrospective case review of 74 subjects with LHON who were referred to a low vision care clinic at a tertiary eye center from 2016 to 2019 were recruited. The reason for referral was assessed from the patients’ electronic medical records (EMR). Demographic data of the patients, visual acuity status, type of LVD prescribed, and visual acuity improvement with LVD were documented.

Results:
Out of 74 patients, 91.9% (n = 68) were male, and the median age of patients was 21 (16) years. A 4× monocular telescope was prescribed for 2.7% of patients (n = 2) and SEETV binocular telescope for 1.4% (n = 1) was advised for distance. The most commonly prescribed near LVD was the 6× cutaway stand magnifier for 22 patients (29.7%). Four patients (5.4%) were prescribed with Notex, the most commonly prescribed non-optical LVD. Niki CCTV (12.2%, n=9) was the most commonly prescribed assistive device. The subjects were divided into three groups based on age: group I consisted of those <18 years of age, group II 18–40 years, and group III >40 years for the interpretation of visual improvement. There was a statistically significant improvement (group I: P < 0.001, group II: P < 0.0001, group III: P < 0.003) in near vision with help of LVDs in all three groups.

Conclusion:
The use of LVDs and rehabilitation can help patients with LHON to lead a better life and will be more beneficial.