bluuebunny/crossref_metadata_2025_split huggingface dataset:
Descriptive Analysis of Good Clinical Practice Inspection Findings from the Saudi Food and Drug Authority Running Title: SFDA GCP inspections
Authors: Arab Omaima O. , Aldayan Mohammed , Almowaizri Khalid , Alghamdi Ahmad , Alghamdi Jahad , Alharf Adel 
Published: August 2024

Abstract

Introduction
The Saudi Food and Drug Authority (SFDA) conducts inspections in accordance with Good clinical practice (GCP) to safeguard clinical trial integrity and protect the rights, safety, and welfare of study participants. These inspections ensure trials are conducted in compliance with GCP and applicable laws.
Objectives
The study aims to provide a description of GCP inspection findings and to analyze their impact on clinical trials ecosystems, and provide recommendations to improve clinical trial conduction in Saudi.
Methods
A review was conducted on inspection reports, with two senior independent inspectors examined, collected and categorized the data. Descriptive statistics were used to summarize the categorical variable by frequency distributions.
Results
A total of 131 GCP inspections were performed between 2017 and 2023. There was a total of 722 observations from 116 (88.5%) inspection visits, and the remaining 15 (11.5%) inspection visits had no observation. The highest number of visits were conducted in contract research organizations (CRO) (n=50; 38.2%) with 118 observations, followed by clinical investigator sites (n=46; 35.1%) with 313 observations, then bioequivalence centers (BE) (n=33; 25.2%) with 256 observations, and the last 2 (1.5%) visits were conducted in phase I clinical trials units with 35 observations.
Conclusion
This study assesses GCP inspection reports and examines the type of deficiencies and grades in each area. Observation findings category and grade vary by the type of organizations, which indicate the need for specific action plans addressing each organization type separately. This report provided recommendation based on the top most common findings to assist researchers and sponsors when conducting a clinical trial in Saudi Arabia.
Prediction model for spontaneous preterm birth less than 32 weeks of gestation in low-risk women with mid-trimester short cervical length
Authors: Huang Xiaoxiu , Zhou Yimin , Liu Bingqing , Huang Yuhui , Wang Mengni , Li Na , Li Baohua 
Published: August 2024

Abstract

Background
A short cervix in mid-trimester pregnancy is a risk factor for spontaneous preterm birth. However, there is currently a lack of predictive models and classification systems for predicting spontaneous preterm birth in these patients, especially those without additional risk factors for spontaneous preterm birth.
Methods
A retrospective observational cohort study of low-risk singleton pregnant women with a short cervix (≤ 25 mm) measured by mid-trimester fetal ultrasound scan between 22 and 24 weeks was conducted. A multivariate logistic regression model for spontaneous preterm birth < 32 weeks in low-risk pregnant women with a short cervix was constructed. Moreover, we developed a nomogram to visualize the prediction model and stratified patients into three low-, intermediate-, and high-risk groups based on the total score obtained from the nomogram model.
Results
Between 2020 and 2022, 213 low-risk women with a short cervix in mid-trimester pregnancy were enrolled in the study. Univariate logistic analysis revealed that a high body mass index, a history of three or more miscarriages, multiparity, a short cervical length, leukocytosis, and an elevated C-reactive protein level were associated with spontaneous preterm birth < 32 weeks, but multivariate analysis revealed that multiparity (OR, 3.31; 95% CI, 1.13–9.68), leukocytosis (OR, 3.96; 95% CI, 1.24–12.61) and a short cervical length (OR, 0.88; 95% CI, 0.82–0.94) were independent predictors of sPTB < 32 weeks. The model incorporating these three predictors displayed good discrimination and calibration, and the area under the ROC curve of this model was as high as 0.815 (95% CI, 0.700–0.931). Patients were stratified into low- (195 patients), intermediate- (14 patients) and high-risk (4 patients) groups according to the model, corresponding to patients with scores ≤ 120, 121–146, and > 146, respectively. The predicted probabilities of spontaneous preterm birth < 32 weeks for these groups were 6.38, 40.62, and 71.88%, respectively.
Conclusions
A noninvasive and efficient model to predict the occurrence of spontaneous preterm birth < 32 weeks in low-risk singleton pregnant women with a short cervix and a classification system were constructed in this study and can provide insight into the optimal management strategy for patients with different risk stratifications according to the score chart.
A pill for every ill. A mass rearing method to aliquot and hatch Aedes mosquito eggs using capsules
Authors: Balestrino F. , Puggioli A. , Mamai W. , Bellini R. , Bouyer J. 
Published: August 2024

Abstract

The sterile insect technique (SIT) is a sustainable genetic control method to suppress or even eradicate mosquito vector populations. The SIT requires a cost-effective production and release of radio sterilized insects of high and consistent quality and quantity. In this study, we report a new procedure to hatch, aliquot and introduce Aedes albopictus and Aedes aegypti larvae into larval mass rearing units using dissolvable vegetable capsules containing brushed eggs and larval diet. The results demonstrated that the egg brushing procedures, the opening of the hatching container and the presence of diet in the hatching solution increased Aedes eggs hatching success. The diet added during the hatching process decreased the dissolved oxygen (DO) concentration, which constituted the main stimulus for egg hatching success in both species. However, a DO reduction below 3 mg/l can effectively stimulate hatching in both species regardless of the deoxygenation method adopted. The capsule method produced similar hatching success without affecting larval survival and pupation rates in comparison with standard hatching procedures. The use of capsules eliminates intermediate laborious procedures for hatching, counting and transferring larvae into mass rearing trays with an expected improvement in production times and costs for Aedes SIT operational programs.
Cultural adaptation of an internet-based self-help app for grieving Syrian refugees in Switzerland
Authors: Aeschlimann Anaïs , Heim Eva , Hoxha Anna , Triantafyllidou Valentina , Killikelly Clare , Haji Farhad , Stöckli Rilana , Aebersold Monia , Maercker Andreas 
Published: August 2024

Abstract

Background: Loss and grief pose significant challenges for victims of armed conflicts, such as Syrian refugees. Internet-based interventions (IBIs) present a promising solution to address this treatment gap and provide adequate support. However, research on grief, grief support, and IBIs remain largely limited to Western cultural contexts and culturally adapted IBIs for grief are needed. Following the RECAPT framework, this study aimed to develop and further adapt a culturally sensitive IBI for bereaved Syrian refugees in Switzerland.
Methods: The study employed qualitative methods. Initially, formative research was conducted to create a first version of the intervention, including semi-structured interviews with 10 experts to identify necessary cultural adaptations. The preliminary version of the intervention was then presented to six potential users and three experts to gather feedback on additional cultural adaptations through two iterative feedback rounds. The first round involved semi-structured interviews using a "paper version" of the intervention, followed by a second round with a walk-through think-aloud protocol with a beta version. Data were analyzed using framework analysis.
Results: The input from various key informants at different stages of development provided valuable feedback on surface and deep structure adaptation, which may enhance treatment adherence, acceptance, and motivation.
Conclusions: These findings provide important insights and recommendations for the cultural adaptation of interventions and may help address the treatment gap for bereaved Syrian refugees.
Vertical stratification, climatic seasonality and human disturbances drive the diurnal butterflies (Lepidoptera: Papilionoidea) diversity in the Peruvian Amazon
Authors: Castelo Javier Amaru , Huayhua Carolina Milagros Herrera , Canales Andrea Valer 
Published: August 2024

Abstract

Different variables produce changes in the local diversity. They interact complexly to determine the community structure and have a variable effect. In diurnal butterflies, the effect of some variables is confusing due to the contrasting results found, appearing as if there are interactions between them. Most previous works studied, the effect of vertical stratification, climatic seasonality, and human disturbances separately without considering their interaction. In the present work, we evaluated the interaction of these variables using a Box-Cox transformation and Type III ANOVA, and their isolated effect using a Kruskal Wallis test with Dunn Post hoc test. We collected 7655 day-traps from 18 collection points at Manu Learning Centre Biological Station, a forest with a human disturbance gradient, from October 2011 to August 2023 in three different strata (high, medium, and low). We found 378 species from 159 genera. The Type III ANOVA revealed that vertical stratification interacts with the other two variables. In general, the effect of the stratification is negative, being lower in the high stratum. The impact of human disturbance was also negative, being higher in the most preserved forest. Finally, the intermediate climatic season had a greater diversity than the rainy and dry seasons. We concluded that the interaction of the vertical stratification with other variables explained the contrasted result found, the canopy is the last stratum to recover from a disturbance, the species of the high stratum can withstand seasonal variation, and the intermediate season exhibits higher diversity in non-seasonal Amazonian Forest.
The exploration of active components of 701 Dieda Zhentong patch and analgesic properties on chronic constriction injury rats
Authors: Meng Jun , Zhang Zhenglang , Wang Yujie , Long Lina , Luo Anqi , Luo Zhenhui , Cai Kexin , Chen Xi , Nie Hong 
Published: August 2024

Abstract

An increasing number of traditional Chinese medicine(TCM) have been confirmed to possess analgesic bioactivity. 701 Dieda Zhentong patch(701-DZP) which includes 14 kinds of TCMs exhibited excellent efficacy in alleviating back or leg pain after a soft-tissue injury. In this study, UPLC/MS was used to construct the fingerprint and potential bioactive ingredients of 701-DZP. 21 compounds were detected and identified in the fingerprint including 12 compounds that pass through the skin and 6 compounds observed in the plasma. Then, the role of 701-DZP in neuropathic pain(NPP) was assessed by network pharmacology and CCI rats. 701-DZP inhibited pain sensitization(MWT and TWL) and the release of inflammation mediators(IL-1β and IL-6) in CCI rats which were in keeping with the core targets of the PPI network. The results of IHC and Western blot showed that the expression of the P2X3 receptor in the DRG and SC of CCI rats was significantly reduced after the treatment with 701-DZP. Moreover, the 701-DZP down-regulated the level of phosphorylation of ERK1/2 MAPK instead of P38 MAPK in the DRG of CCI rats. In conclusion, this study has clarified 6 potential analgesic active compounds of 701-DZP and explored the analgesic properties, which may inhibit the expression of the P2X3 receptor to reduce the release of inflammatory mediators based on the ERK1/2 MAPK pathway to alleviate the NPP.
In vitro and in vivo anti-inflammatory properties of Annona muricata, Launaea taraxacifolia and Tridax procumbens leave extracts
Authors: KOUKOUI Omedine , BETIRA Mansouratou , AMAGBEGNON Jean-Baptiste , VIANOU Bertin , SETON Santorin , AUBOUY Agnès 
Published: August 2024

Abstract

Background
In recent years, the role of inflammation in the development of several non-communicable diseases such as diabetes, cardiovascular diseases and cancer has been increasingly highlighted. Many medicinal plants contain bioactive substances with anti-inflammatory activities. The objective of this work was to study cytotoxicity and anti-inflammatory activity of hydroethanolic extracts of the leaves of Annona muricata, Launaea taraxacifolia and Tridax procumbens, three plants used in traditional medicine in Benin.
Method
Cytotoxicity and anti-inflammatory activity of the extracts was first assessed in vitro on the human monocyte THP-1 cells. In vitro, cytotoxicity was measured using the lactate dehydrogenase (LDH) assay. LPS/IFNγ-activated THP-1 cells were used to evaluate the anti-inflammatory effect of the three extracts by measuring gene expression level of pro-inflammatory (COX2, TLR8) and anti-inflammatory (IL-10-Receptor 1) markers by RT-qPCR, and by measuring by ELISA the production of pro- and anti-inflammatory cytokines (TNF, IL1β, IL-10) by THP-1 cells. Second, the model of acute Wistar rat hind paw edema induced by 1% formalin was used for the in vivo anti-inflammatory test.
Results
In vitro, the three plant extracts were nontoxic to THP-1 cells until 250 µg/mL. Expression of the pro-inflammatory markers COX2 and TLR8 were significantly lower for LPS/IFNϒ activated-cells treated with plant extracts at 50 and 100 µg/mL compared to untreated activated cells (P ˂ 0.05). IL-10-R1 expression was similar in untreated and plant-treated LPS-IFNϒ activated-cells, except for treatment with 50 µg/mL L. taraxacifolia leaf extract which resulted in lower expression of IL-10-R1. The production of TNF was completely abolished following the three plant treatment at 100 µg/mL of LPS/IFNϒ activated-cells, while IL-1β production was reduced (P < 0.001). For the anti-inflammatory cytokine IL-10, the production was higher by activated cells after treatment with 100 µg/mL L. taraxacifolia extract compared to untreated activated cells (P < 0.05). In vivo, per os administration of the three extracts at 300 mg/kg significantly prevented paw edema in rats (P < 0.05), similarly to acetylsalycilic acid.
Conclusion
The results suggest that the hydro-ethanolic extracts of the three plants have significant anti-inflammatory properties and deserve further studies for their use in the treatment of inflammatory pathologies.
Tensions surrounding the use of inhaled asthma medication in The Gambia: a qualitative study of asthma patients and health care workers
Authors: Jayasooriya S , Inoue M , Allen H , Bojang M , Ceesay A , Touray S , Cooper R , Mortimer K , Balen J 
Published: August 2024

Abstract

Introduction:
Asthma-related mortality is high in low- and middle-income countries. Little is known about public perceptions of inhaled medicines.
Methods:
We conducted semi-structured interviews with asthma patients and health care workers at three public health facilities in The Gambia, between August and November 2022. Thematic analysis was used to interpret these data.
Results:
A total of 20 patients and 15 health care workers were interviewed. Both groups felt limited access to inhalers was a significant issue resulting in continued use of oral medications. While some patients recognised the benefits of inhaler use, beliefs that inhalers were dangerous were common. Reliance on oral short-acting beta agonists meant patients saw asthma as a recurrent acute condition resulting in an emphasis on hospital management with little awareness of inhaled preventative medicines.
Discussion:
Increasing access to inhaled medicines has the potential to save lives but socio-cultural factors in addition to medication supply need addressing.
Adsorption of Cationic Basic Fuchsin dye from aqueous solution on Green Synthesized Zinc oxide nanocomposite
Authors: Gbawoquiya Flomo L. , Rachna Km. , Singh Pramod K. , Noor I. M. , Yahya M Z A , Shankar Shiv 
Published: August 2024

Abstract

The cationic basic fuchsin (BF) dye was removed from wastewater using green synthesized Zinc oxide-reduced graphene oxide nanocomposite (ZnO-rGO NC) derived from Carica papaya leaf extract (CPLE). The nanocomposite was characterized using various techniques: XRD, FT-IR, TEM, EDX, and FE-SEM. Adsorption experiments were conducted to examine the effects of several experimental parameters, including contact time, solution pH, temperature, initial dye concentration, and adsorbent dose. The highest amount BF dye removal was attained at pH 7 at a temperature range of 35 to 50°C, and equilibrium time was reached in 60 minutes. The Langmuir isotherm model provided a good fit for adsorption isotherms. The determination of thermodynamic parameters, including ΔG°, ΔH°, and ΔS°, revealed that spontaneous adsorption took place as evidenced by the negative values of ΔG°. An exothermic reaction was indicated by the values of ΔH°. ZnO-rGO NC was used to remediate basic fuchsin dye (BF) dye-polluted wastewater at 50 mg/L− 1. The maximum amount of dye adsorbed was found to be approximately 84.08 mg/g, indicating that the predominant adsorption mechanism was cation exchange. Based on the results, ZnO-rGO NC was shown to be a good adsorbent.
Carbon Emission Pinch Analysis for Transformation of Polish Power Generation Sector
Authors: Poplewski Grzegorz , Ting Melvin , Foo Dominic C.Y. , Tan Raymond R. , Tan Yin Ling 
Published: August 2024

Abstract

Poland is taking serious measures to decarbonize its electricity generation sector by year 2050 in response to the global climate emergency. However, the pathway to reach this carbon neutrality target is still uncertain, given Poland’s current dependence on fossil fuels. Different decarbonization measures need to be examined and combined to achieve substantial reductions. In this work, carbon emission pinch analysis (CEPA) is used to plan and visualize deep emissions cuts for such a transition. Multiple scenarios were proposed in order for Polish energy generation sector to reach its CO2 emission targets in years 2030 and 2040. For instance, in Scenario 1, relative to 2022, coal was reduced by 36 times, and lignite was eliminated completely; while natural gas, onshore wind, agricultural biomass, photovoltaics have huge increase (238%, 154%, 235%, 301%, respectively), apart from having additional nuclear and offshore wind power (38 TWh and 61 TWh, respectively). Doing this achieves the 2040 emission target of 28.06 Mt CO2-eq/year. These results provide realistic benchmarks for the development and implementation of policies to realize Poland’s decarbonization ambitions.
Selection of Materials for Components of Brushed DC Machine Using VIKOR Method: A Thermal Consideration
Authors: Zulkafli M. N. A. , Rasid M. A. H. , Nafiz Daing M. 
Published: August 2024

Abstract

Excessive and unpredictable temperature rise in electrical machines can not only damage the motor over time but also induce errors in the control of the complex machinery and systems in which they are integrated. Traditionally, temperature reduction in electrical machines has been addressed through various optimization methods focusing on the geometric modification of different components independently. This study proposes and evaluates an alternative strategy by selecting material combinations using a multi-criteria decision-making (MCDM) tool known as the VIKOR method. The effectiveness of this method in proposing new materials to reduce temperature is verified using a validated LPTN thermal model developed for a small, brushed DC machine. In a copper losses test simulation with a 5A current injection, the winding temperature was reduced by 20°C by adopting the second material combination. This combination employs a ferrite magnet, Al 356-T6 for the casing, chrome steel for the bearing, metal graphite for the brush, and nylon for the slot winding paper insulation.
Elicitation of Glycyrrhiza glabra (L.) hairy roots by methyl jasmonate enhanced glycyrrhizin production
Authors: Abedi Zahra , Talebi Majid , Tabatabaei Badraldin Ebrahim Sayed 
Published: August 2024

Abstract

Glycyrrhizin is a valuable secondary metabolite with high medicinal properties, which is known as the most important compound in the licorice (Glycyrrhiza glabra L.). Considering the problems in growing plants in the field, the use of tissue culture techniques, especially hairy root culture, makes the production of glycyrrhizin simpler and more affordable. The influence of Agrobacterium rhizogenes strains on the efficiency of hairy root induction showed that the highest hairy roots were observed using MSU strain (80%). Also, the effect of explant type (leaf, stem and petiole) and age (two-week-old, three-week-old and four-week-old), light conditions (24 hours of darkness and 16 hours of light-8 hours of darkness) and carbohydrate source (3% glucose and 3% sucrose) showed that the production of hairy roots from this medicinal plant depends on the type and age of explant, light treatment and the composition of the culture medium and the highest hairy roots induction was observed in leaf explant (80%), three-week-old leaf (76.66%) and MS medium containing 3% sucrose (86.66%) and treatment of 24 hours of darkness (86.66%). The amount of glycyrrhizin in hairy root lines treated by 100 µM methyl jasmonate (MJA) after 24 hours increased in the no cutting treated line and decreased in the cutting treated lines compared to the control line. In conclusion, elicitation of G. glabra hairy root culture is a suitable platform for achieving high glycyrrhizin yields.
Temporal Dynamics of Malaria in Mizoram: A District wise Analysis
Authors: RANJAN MUKESH , Rafi Sana , Singh Mahendra , Singh Ashutosh , - Lalpawimawha , Zoramthanga R , - Vanlalhriatsaka 
Published: August 2024

Abstract

India is the largest contributor of incidence of malaria cases and related deaths in southeast Asian region. The state of Mizoram is one of the significant contributors of Malaria cases in India. The present study focuses on the transition of malaria cases in the districts of Mizoram from 2011 to 2020. Various indicators including total malaria cases (TMC), Percent of P. falciparum (% Pf), Annual Parasite Index (API), Total positivity Rate (TPR), Annual Blood Examination Rate (ABER), and malarial deaths are processed through descriptive statistics, correlation and ANOVA to understand the disease epidemiology for Mizoram. Results revealed that Lawngtlai, Lunglei and Mamit districts are the top three in average number of malaria cases while Champhai recorded the lowest cases of malaria. Mamit recorded the highest number of malaria related deaths. Age group wise analysis showed that Malaria prevalence is highest in 15 + years of age, and the lowest is in 0–4 years of age. The malarial incidences were highest in the year 2015 for different age groups and sex. Correlation analysis results in significant correlation between TMC vs API, TMC vs TPR, API vs TPR in district Lawngtlai. District wise analysis of Malaria cases showed statistically significant difference (p < 0.01) between Lawngtlai and Mamit, Lawngtlai and Saiha, Lawngtlai and Serchhip, Lawngtlai and Serchhip. Findings of this study help in policy interventions and framework. State Vector Borne Diseases Control Programme (Malaria) Mizoram should increase intensified surveillance and monitoring of malaria cases, targeted vector control interventions, improved access to malaria diagnosis and treatments, community-based education and awareness programs.