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Clinical application of a digital semi-rigid bridge space maintainer fabricated from polyetheretherketone for premature loss of primary molars

BMC Oral Health. 2023 Nov 29;23(1):944. doi: 10.1186/s12903-023-03570-2.

ABSTRACT

BACKGROUND: Premature loss of primary molars can be treated with a band loop space maintainer (SM). However, fabricating a conventional band loop SM requires multiple clinical and laboratory procedures, which can potentially affect the accuracy of the SM. Moreover, the conventional SM is unable to fully restore masticatory function and maintain the vertical dimension of the edentulous space. In this current study, a fully digital workflow to fabricate a semi-rigid bridge SM made from polyetheretherketone (PEEK) has been described and evaluated for its clinical effectiveness.

METHODS: A total of 15 children (eight males and seven females) between the ages of 4-8 years, who experienced the premature loss of a single primary molar, were included in this study. Digital impressions were taken using the CEREC CAD/CAM chair system and imported into CAD software to design the semi-rigid bridge SM, which was fabricated using PEEK block as the maintainer material. The digital SM was tried-in and bonded to the abutment with resin cement. The edentulous space was measured immediately after bonding (T0) and 1 month (T1), 3 months (T2), and 6 months (T3) after treatment. The periodontal condition and mobility of the SM and abutment were also examined.

RESULTS: The use of digital impressions resulted in a decreased occurrence of the pharyngeal reflex. The digital semi-rigid bridge SM, fabricated with PEEK, was both convenient and aesthetically pleasing, and successfully restored the anatomy and masticatory function of the missing primary molar. None of the 15 semi-rigid bridge SMs or abutments became loose or fell off during the study, and only one child presented with gingivitis. Furthermore, the difference in the edentulous space at T0, T1, T2, and T3 was not statistically significant (all P > 0.05).

CONCLUSIONS: The digital semi-rigid bridge SM fabricated with PEEK was clinically effective in maintaining the missing space and had advantages over the traditional band/crown loop SM.

PMID:38031148 | DOI:10.1186/s12903-023-03570-2

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HLA-B27 did not protect against COVID-19 in patients with axial spondyloarthritis – data from the ReumaCov-Brasil Registry

Adv Rheumatol. 2023 Nov 29;63(1):56. doi: 10.1186/s42358-023-00340-0.

ABSTRACT

BACKGROUND: Some studies have suggested the HLA-B27 gene may protect against some infections, as well as it could play a benefit role on the viral clearance, including hepatitis C and HIV. However, there is lack of SARS-CoV-2 pandemic data in spondyloarthritis (SpA) patients.

AIM: To evaluate the impact of HLA-B27 gene positivity on the susceptibility and severity of COVID-19 and disease activity in axial SpA patients.

METHODS: The ReumaCoV-Brasil is a multicenter, observational, prospective cohort designed to monitor immune-mediated rheumatic diseases patients during SARS-CoV-2 pandemic in Brazil. Axial SpA patients, according to the ASAS classification criteria (2009), and only those with known HLA-B27 status, were included in this ReumaCov-Brasil’s subanalysis. After pairing them to sex and age, they were divided in two groups: with (cases) and without (control group) COVID-19 diagnosis. Other immunodeficiency diseases, past organ or bone marrow transplantation, neoplasms and current chemotherapy were excluded. Demographic data, managing of COVID-19 (diagnosis, treatment, and outcomes, including hospitalization, mechanical ventilation, and death), comorbidities, clinical details (disease activity and concomitant medication) were collected using the Research Electronic Data Capture (REDCap) database. Data are presented as descriptive analysis and multiple regression models, using SPSS program, version 20. P level was set as 5%.

RESULTS: From May 24th, 2020 to Jan 24th, 2021, a total of 153 axial SpA patients were included, of whom 85 (55.5%) with COVID-19 and 68 (44.4%) without COVID-19. Most of them were men (N = 92; 60.1%) with mean age of 44.0 ± 11.1 years and long-term disease (11.7 ± 9.9 years). Regarding the HLA-B27 status, 112 (73.2%) patients tested positive. There were no significant statistical differences concerning social distancing, smoking, BMI (body mass index), waist circumference and comorbidities. Regarding biological DMARDs, 110 (71.8%) were on TNF inhibitors and 14 (9.15%) on IL-17 antagonists. Comparing those patients with and without COVID-19, the HLA-B27 positivity was not different between groups (n = 64, 75.3% vs. n = 48, 48%, respectively; p = 0.514). In addition, disease activity was similar before and after the infection. Interestingly, no new episodes of arthritis, enthesitis or extra-musculoskeletal manifestations were reported after the COVID-19. The mean time from the first symptoms to hospitalization was 7.1 ± 3.4 days, and although the number of hospitalization days was numerically higher in the B27 positive group, no statistically significant difference was observed (5.7 ± 4.11 for B27 negative patients and 13.5 ± 14.8 for B27 positive patients; p = 0.594). Only one HLA-B27 negative patient died. No significant difference was found regarding concomitant medications, including conventional or biologic DMARDs between the groups.

CONCLUSIONS: No significant difference of COVID-19 frequency rate was observed in patients with axial SpA regarding the HLA-B27 positivity, suggesting a lack of protective effect with SARS-CoV-2 infection. In addition, the disease activity was similar before and after the infection.

TRIAL REGISTRATION: This study was approved by the Brazilian Committee of Ethics in Human Research (CONEP), CAAE 30186820.2.1001.8807, and was registered at the Brazilian Registry of Clinical Trials – REBEC, RBR-33YTQC. All patients read and signed the informed consent form before inclusion.

PMID:38031143 | DOI:10.1186/s42358-023-00340-0

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Assessing consumers’ perception and demand on the community pharmacists’ dispensing

J Pharm Policy Pract. 2023 Nov 29;16(1):162. doi: 10.1186/s40545-023-00609-1.

ABSTRACT

BACKGROUND: This study aimed to assess the general public’s perception of services provided by community pharmacies, their willingness to utilize these services, their satisfaction with and understanding of community pharmacists, and their views on dispensing separation and pharmacy medicines (P medicines).

METHODS: An online cross-sectional study was conducted, in which questionnaires were distributed among the general public. A novel questionnaire was designed and validated specifically for this study. It was composed of six sections: demographics, pharmacy usage and service preferences, understanding and satisfaction with pharmacists, views on dispensing separation, private community pharmacies, and knowledge of P medicines. Statistical analyses such as one-way ANOVA, independent t test, and binary logistic regression were employed, with a p value of < 0.05 considered statistically significant.

RESULTS: The study received 222 responses. The majority of the respondents were females within the 20-29-year-old age group (62.2%). Most respondents preferred to consult doctors for medical treatment, with their primary reason for visiting community pharmacies being to collect prescribed medicines. About 52.7% of respondents expressed their willingness to avail of screening services and treatment for minor illnesses at community pharmacies. A statistically significant difference was found among different age groups regarding their views on the dispensing separation system, with those aged 41-50 years demonstrating higher scores. However, the binary logistic regression analysis did not reveal any statistical significance when comparing the understanding of P medicines among respondents.

CONCLUSIONS: In general, the public prefers to consult doctors for medical treatment and visit community pharmacies predominantly to collect prescriptions or purchase over-the-counter medications. Nonetheless, they are also open to utilizing services provided by community pharmacists, particularly screening services and treatment for minor illnesses.

PMID:38031133 | DOI:10.1186/s40545-023-00609-1

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Self-directed versus peer-supported digital self-management programmes for mental and sexual wellbeing after acquired brain injury (HOPE4ABI): protocol for a feasibility randomised controlled trial

Pilot Feasibility Stud. 2023 Nov 29;9(1):194. doi: 10.1186/s40814-023-01421-z.

ABSTRACT

BACKGROUND: Acquired brain injury (ABI) can lead to biopsychosocial changes such as depression, low self-esteem and fatigue. These changes can cause, and be caused by, sexual issues affecting relationships and wellbeing. Given the relationship between sexual wellbeing and mental health, it is feasible that supporting sexual wellbeing will benefit psychological wellbeing. However, neurorehabilitation is inconsistent and often fragmented across the UK, and psychological, sexual and social support are lacking. Research shows that self-management and peer-support programmes can improve quality of life, self-efficacy and psychological wellbeing after brain injury. This protocol describes a feasibility randomised controlled trial (RCT) of a digital self-management programme to support mental and sexual wellbeing (known as HOPE4ABI), co-designed with and for people with ABI.

METHODS: This mixed-methods feasibility RCT has two parallel trial arms of the 8-week digital HOPE4ABI self-management programme. Eligibility criteria include age > 18 years, diagnosed or suspected ABI > 3 months prior to trial entry, access to an Internet-enabled device and ability to engage with the intervention. Referrals to the study website will be made via the National Health Service (NHS), social media and partnering organisations. Sixty eligible participants will be randomised at a ratio of 1:1 to peer-supported (n = 30) or self-directed (n = 30) HOPE4ABI programmes. Primary feasibility outcomes include recruitment and retention rates, engagement, adherence and usage. Secondary outcomes related to standardised measures of quality of life, sexual wellbeing and mental wellbeing. Participants and peer facilitators will be interviewed after the course to assess acceptability across both trial arms.

DISCUSSION: This feasibility trial data is not sufficiently powered for inferential statistical analyses but will provide evidence of the feasibility of a full RCT. Quantitative trial data will be analysed descriptively, and participant screening data representing age, ethnicity and gender will be presented as proportions at the group level. These data may indicate trends in reach to particular demographic groups that can inform future recruitment strategies to widen participation. Progression to a definitive trial will be justified if predetermined criteria are met, relating to recruitment, retention, engagement and acceptability.

TRIAL REGISTRATION: ISRCTN46988394 registered on March 1, 2023.

PMID:38031132 | DOI:10.1186/s40814-023-01421-z

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Validation of a German-language modified Rankin Scale structured telephone interview at 3 months in a real-life stroke cohort

Neurol Res Pract. 2023 Nov 30;5(1):59. doi: 10.1186/s42466-023-00289-x.

ABSTRACT

BACKGROUND: The modified Rankin scale (mRS) at 3 months is established as the primary outcome measure in clinical stroke trials. Traditionally, the mRS is assessed through an unstructured face-to-face interview. This approach can be labor-intensive and lead to suboptimal inter-rater reliability. Recently, the Covid-19 pandemic made face-to-face contact even more challenging. To address these issues, we developed and validated a structured German-language questionnaire for mRS testing by telephone.

METHODS: In this prospective cohort study, we compared the mRS testing results of the standard face-to-face interview with those obtained in a structured interview by telephone using Cohen’s Kappa.

RESULTS: At our tertiary care stroke center, we included 108 patients who underwent both assessments. In 80.6% of cases (87/108) face-to-face and telephone interview reached identical scores. Linear weighted Kappa was 0.82 (p < 0.001). Unweighted Kappa for dichotomized mRS between fair (0-2) and poor (3-6) functional outcome was κ = 0.97 (p < 0.001).

CONCLUSIONS: Our study validates the use of the German-language structured telephone interview as a reliable instrument for the use in clinical trials. We encourage others to utilize the questionnaire. It is available as an Appendix (Additional file 1) to this publication.

PMID:38031129 | DOI:10.1186/s42466-023-00289-x

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Molecular characterization of Helicobacter pylori isolated from Nile Tilapia (Oreochromis niloticus) and fish handlers

BMC Vet Res. 2023 Nov 29;19(1):250. doi: 10.1186/s12917-023-03819-6.

ABSTRACT

BACKGROUND: Helicobacter pylori is a worldwide pathogen that affects both animals and humans with a wide environmental distribution, causing serious health problems in humans. This research has timely addressed the topic of new sources of H. pylori infection, which is currently a global issue, especially in developing countries. For this purpose, 115 Tilapia fish, 50 freshwater samples, and 88 fish-handlers’ stool samples were investigated for the presence of H. pylori in Qena Governorate, Egypt. The applied techniques were antigen screening tests, culturing, and molecular methods through ureC gene amplification, and 16 S rRNA characterization.

RESULTS: Helicobacter pylori was detected in 7.83%, 14%, 4.35%, and 12% of the investigated fish and water samples by culture and PCR methods, respectively. Out of the total studied participants, 40 tested positive for H. pylori when screened by stool antigen test, of which 35 (39.77%), and 31 (35.23%) were confirmed by conventional and molecular techniques, respectively. The Fisher’s exact test has shown a statistically significant correlation between H. pylori infection, sex, and age as risk factors, while the association was insignificant concerning the residence. Males contracted the infection at a higher rate than females (48.08% and 16.67%, respectively). Also, H. pylori infection rate was the highest among fish-handlers aged 36-45 years old (46.67%), followed by the 26-35 years old age group (39.53%). With regard to the residence, a higher occurrence rate was recorded in the rural (36.07%) than the urban population (33.33%). Helicobacter pylori isolates harbored the highest antimicrobial resistance against ampicillin (100%), metronidazole (95.24%), while the least antimicrobial resistance was recorded against levofloxacin (21.43%), and clarithromycin (26.20%). The phylogenetic analysis revealed a high degree of homology between the isolates selected from Tilapia fish, freshwater, and fish-handlers.

CONCLUSIONS: Our data emphasized the role that fish and freshwater play in disseminating H. pylori infection as one of the diseases that has a significant public health issue.

PMID:38031127 | DOI:10.1186/s12917-023-03819-6

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A bispecific Clec9A-PD-L1 targeted type I interferon profoundly reshapes the tumor microenvironment towards an antitumor state

Mol Cancer. 2023 Nov 29;22(1):191. doi: 10.1186/s12943-023-01908-6.

ABSTRACT

Despite major improvements in immunotherapeutic strategies, the immunosuppressive tumor microenvironment remains a major obstacle for the induction of efficient antitumor responses. In this study, we show that local delivery of a bispecific Clec9A-PD-L1 targeted type I interferon (AcTaferon, AFN) overcomes this hurdle by reshaping the tumor immune landscape.Treatment with the bispecific AFN resulted in the presence of pro-immunogenic tumor-associated macrophages and neutrophils, increased motility and maturation profile of cDC1 and presence of inflammatory cDC2. Moreover, we report empowered diversity in the CD8+ T cell repertoire and induction of a shift from naive, dysfunctional CD8+ T cells towards effector, plastic cytotoxic T lymphocytes together with increased presence of NK and NKT cells as well as decreased regulatory T cell levels. These dynamic changes were associated with potent antitumor activity. Tumor clearance and immunological memory, therapeutic immunity on large established tumors and blunted tumor growth at distant sites were obtained upon co-administration of a non-curative dose of chemotherapy.Overall, this study illuminates further application of type I interferon as a safe and efficient way to reshape the suppressive tumor microenvironment and induce potent antitumor immunity; features which are of major importance in overcoming the development of metastases and tumor cell resistance to immune attack. The strategy described here has potential for application across to a broad range of cancer types.

PMID:38031106 | DOI:10.1186/s12943-023-01908-6

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Presence of variable extrathoracic airflow limitation in patients with a negative methacholine challenge test

Allergy Asthma Clin Immunol. 2023 Nov 29;19(1):101. doi: 10.1186/s13223-023-00860-w.

ABSTRACT

PURPOSE: Determine whether variable extrathoracic airflow limitation (VEAL) is observed in patients with negative methacholine challenge tests (MCT).

METHODS: Electronic medical records of patients undergoing MCT at Jesse Brown VA Medical Center between January 2017 and December 2019 were reviewed. Only patients with negative MCT were selected. Pertinent demographic, clinical, and pulmonary function tests (PFT) and MCT data were abstracted from each record. Spirometric flow-volume loops recorded during each test were inspected by one co-author to determine the first inhaled methacholine concentration at which FEF50/FIF50 was either > 1 or further increased if baseline FEF50/FIF50 after nebulized saline (vehicle) already exceeded 1. Student’s t-test was used for statistical analysis. P < 0.05 was considered statistically significant.

RESULTS: One hundred and twenty-seven consecutive patients with normal baseline PFT and negative MCT were identified. Thirteen patients (10.2%) had negative MCT and FEF50/FIF50 > 1 after testing. They were predominately obese (BMI, 31.3 ± 6.6), non-smoking (10), White (8) males (9) aged 51.3 ± 14.1 years (mean ± SD) referred for symptoms suggestive of asthma (n = 7) or for chronic cough (n = 6). Five had obstructive sleep apnea, three gastroesophageal reflux disease, and two chronic rhinosinusitis. FEF50/FIF50 increased significantly from 0.72 ± 0.21 after nebulized saline (vehicle) to 1.21 ± 0.13 after inhaled methacholine (p < 0.001). Median inhaled methacholine concentration eliciting these responses was 1.0 mg/mL (range, 0.25-16 mg/mL).

CONCLUSIONS: VEAL is observed in a subset of patients with a negative MCT. This phenomenon should be recognized and reported to the referring healthcare providers and its clinical significance addressed as indicated.

PMID:38031090 | DOI:10.1186/s13223-023-00860-w

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Master statistical analysis plan: attractive targeted sugar bait phase III trials in Kenya, Mali, and Zambia

Trials. 2023 Nov 29;24(1):771. doi: 10.1186/s13063-023-07762-7.

ABSTRACT

This manuscript is a master statistical analysis plan for each of three-cluster randomized controlled trials to evaluate the efficacy of attractive targeted sugar baits (ATSB) described in an already published protocol. The master SAP contains an overarching plan for all three trials, which can be adapted to trial-specific circumstances. The primary objective of the trials is to evaluate the efficacy of ATSB in the presence of universal vector control coverage with insecticide-treated nets (ITN) or indoor residual spraying (IRS) after two transmission seasons on clinical malaria incidence as compared with universal vector control coverage with ITN or IRS alone. The primary outcome measure is the incidence rate of clinical malaria, assessed in cohorts aged 12 months to less than 15 years (≥ 5 years to 15 years in Mali) during monthly follow-up visits. The primary unadjusted analysis will be conducted on the intention-to-treat analysis population without adjustment for any anticipated confounding variables. The primary outcome will be analyzed using a multi-level model constructed on a generalized linear model framework with a Poisson likelihood and a log link function. Random intercepts will be included for each study cluster and a fixed effect for study-arm. The analyst will be blinded to study arm assignment. Several secondary outcomes will be analyzed, as well as a pooled analysis (individual patient data meta-analysis) across the three trial sites. Additionally, a standard meta-analysis is expected to be conducted using combined data from all sites.

PMID:38031086 | DOI:10.1186/s13063-023-07762-7

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Quality of life and factors associated among caregivers of adolescent and young adult Ebola survivors in Democratic Republic of the Congo, a cross-sectional study

BMC Public Health. 2023 Nov 29;23(1):2362. doi: 10.1186/s12889-023-17222-1.

ABSTRACT

BACKGROUND: Ebola virus disease is a medical condition whose consequent effects on quality of life of patients. In the history of infectious diseases, there have been pathologies that have had significant repercussions for caregivers, healthcare providers and the community.

OBJECTIVES: This study investigate determinants of quality of life among caregivers of adolescent and young adult Ebola survivors in Democratic Republic of the Congo.

METHODS: This was a cross sectional study. The study sites were the two health districts of Beni and Katwa, in North-Kivu province in the Eastern part of Democratic Republic of the Congo. The study period was from April to August 2022. Participants of the study were caregivers of adolescents and young adult Ebola virus survivors. Simple random sampling technique was used to select the 68 study participants. A questionnaire was administered. Data was collected using pretested questionnaire of WHO quality of life Bref (WHOQOL-BREF) and CommCare by Dimagi.Inc. lastest Version 2.52.1 and a sum of score of 78 or higher indicated a high level of life quality. To determine the quality of life of caregivers of adolescents and young adult EVD survivors, descriptive analysis was used. The Pearson correlation coefficient was utilized to check whether the predictor variables are multicollinear. The regression analysis produced the crude odds ratio (COR), adjusted odds ratio (aOR), 95% confidence interval (CI), and p-value. Statistical significance was defined as a p-value 0.05. The final multivariate model contained variables that were significant in the bivariate analysis. Prior to data collection, a research permit from National Ethical Committee of Research in Democratic Republic of the Congo was obtained. Written informed consents from literate or illiterate caregivers of adolescent and young adult Ebola survivors were obtained. Throughout the study, participants’ privacy and confidentiality were respected.

RESULTS: A total of 68 care givers participated in the study, with a majority 54/68(79.41%) having poor quality of life. Men were 3.17 times more likely to record good quality of life than women (p = 0.02); OR:(95% CI), 3.17: (1.2 – 8.36), With regards to place of residence, caregivers who lived in town were less likely to have good quality of life compared to those in rural (p = 0.01); OR: (95%CI), 0.25: (0.09 – 0.72).

CONCLUSION: The quality of life of caregivers of adolescent and young adult Ebola survivors in Democratic Republic of the Congo is poor. To be woman caregiver and to live in town are determinants associated with poor quality of life among caregivers of adolescent and young adult Ebola survivors.

PMID:38031082 | DOI:10.1186/s12889-023-17222-1