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Introduction: Pregnancy increases the risk of periodontitis due to the increase in progesterone and estrogen. Moreover, periodontitis during pregnancy is associated with development of pregnancy and birth related complications. The aim of this study is to determine, whether periodontal treatment during pregnancy can reduce systemic inflammation and lower the risk of adverse pregnancy and birth related outcomes. Methods and analysis: The PROBE study is a non-randomized controlled intervention study conducted among 600 pregnant women with periodontitis. The women will be recruited among all pregnant women at two Danish hospitals in Region Zealand during their nuchal translucency scan and will subsequently be screened for periodontitis. The intervention group includes 300 pregnant women, who will be offered state-of-the-art periodontal treatment during pregnancy. The control group includes additional 300 pregnant women, who will be offered periodontal treatment after giving birth. Outcome measures include periodontal measures, inflammatory, hormonal and glycaemic markers as well as the prevalence of preterm birth risk, low birth weight and risk markers of gestational diabetes mellitus (GDM) and preeclampsia that will be collected from all screened women and further during pregnancy week 20 and pregnancy week 35 for women enrolled in the intervention. Ethics and dissemination: The study's findings will be published in peer reviewed journals and disseminated at national and international conferences and through social media. The PROBE study is designed to provide important new knowledge as to whether periodontal treatment during pregnancy can reduce the prevalence of complications related to pregnancy and birth. Clinical trials registration: The study was registered on clinicaltrials.gov (NCT06110143). [ABSTRACT FROM AUTHOR]

Copyright of Canadian Journal of Dental Hygiene is the property of Canadian Dental Hygienists Association and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

The article comments on a research which examined the use of respiratory waveform analysis for the enhanced efficacy of mechanical insufflation-exsufflation in patients with amyotrophic lateral sclerosis.

Introduction: Reports of consensus conferences are usually valued less than reports of clinical trials even when rigorous methodology is used. However, limited data are available comparing the impact of these 2 methods of shaping clinical practice. Objective: Compare the publication impact of consensus conferences and clinical trials. Methods: Consensus publications from the Acute Disease Quality Initiative (ADQI) from 2002 through 2017 were identified and classified by subject matter. Randomized trials were identified in the same publication year and subject in journals, starting with the highest impact factor. Both publication types were matched, and total citations were determined for each using Google Scholar. A secondary analysis compared total costs for each publication type. Results and Conclusions: Seventeen ADQI consensus conference reports and 17 randomized trials were identified. ADQI reports received a similar number of citations per paper (median, interquartile range) compared to randomized trials (132, 54–228; vs. 159, 60–340, p = ns). Similarly, 10 (58.8%) ADQI reports and 10 randomized trials were cited >100 times. On average, ADQI reports appeared in journals with lower impact factors compared to clinical trials (5.4 ± 4.6 vs. 25.4 ± 27.1; p < 0.01). The median cost per citation (USD 2017) for ADQI reports was USD 606.01 compared to almost twice this figure, USD 1,182.59, for clinical trials on the same topics (p = 0.09). Despite being published in lower impact factor journals, consensus reports on topics in critical care nephrology, received similar citations to randomized controlled trials published the same year. [ABSTRACT FROM AUTHOR]

Background and Objectives: Given the fact that randomized controlled clinical trials are more valid than other research methods to determine the therapeutic effects of treatment, proper design and accurate reporting is of particular importance. This study was conducted with the aim of evaluating the quality of writing the title and abstract of randomized clinical trials of Iranian medical universities journals in 2016 using the Consolidated Standards of Reporting Trials (CONSORT) checklist. Materials and Methods: In this descriptive study, information gathering through internet search was limited to Persian language journals affiliated to the medical universities of the country. Based on the CONSORT checklist, which contains 18 questions, all randomly controlled clinical trials, consisting of 262 papers published in these magazines in 2016, were reviewed. Statistical analysis was performed using descriptive statistics and Chi-square and Fisher’s exact tests. Results: Only 34 (13%) of the articles refered to “randomized” word in the title of the article. Regarding the proportion of cases observed in the articles, based on the gender of the author, only two "mentioning the place of data collection" (p=0.009) and "mentioning clinical trial registration number" (p=0.020) and based on the scientific rank two cases, namely, “mentioning the full details of the responsible author” (p=0.002) and "mentioning the randomized method" (p=0.039) were significantly different. Conclusion: The need to follow CONSORT criteria and eliminate the deficiencies mentioned for conducting these studies in the country seems necessary. Therefore, it is recommended to the authors to use the CONSORT clinical checklist while writing randomized controlled clinical trials. [ABSTRACT FROM AUTHOR]

The article presents reporting the results of a clinical trial across multiple papers. Topics discussed include the trial was prospectively registered on the clinicaltrials.gov registry and the protocol published in BMC public health; and according to the trial registry entry, the primary outcome was ‘Mediterranean diet compliance' which is discrepant with the protocol where the authors state the ‘first objective of the study is increase physical activity.

Background : The number of papers published by an institution is acknowledged as an easy-to-understand research outcome. However, the quantity as well as the quality of research papers needs to be assessed. Methods: To determine the relation between the number of published papers and paper quality, a survey was conducted to assess publications focusing on interventional clinical trials reported by 11 core clinical research hospitals. A score was calculated for each paper using Système d'interrogation , de gestionet d'analyse des publications scientifiques scoring system, allowing for a clinical paper quality assessment independent of the field. Paper quality was defined as the relative Journal impact factor (IF) total score/number of papers. Results: We surveyed 580 clinical trial papers. For each of the 11 medical institutions (a–k), respectively, the following was found: number of published papers: a:66, b:64, c:61, d:56, e:54, f:51, g:46, h:46, i:46, j:45, k:45 (median: 51, maximum: 66, minimum: 45); total Journal IF: a:204, b:252, c:207, d:225, e:257, f:164, g:216, h:190, i:156, j:179, k:219 (median: 207, maximum: 257, minimum: 156); relative Journal IF total score: a:244, b:272, c:260, d:299, e:268, f:215, g:225, h:208, i:189, j:223, k:218 (median: 225, maximum: 299, minimum: 189); and paper quality (relative Journal IF total score/number of papers): a:3.70, b:4.25, c:4.26, d:5.34, e:4.96, f:4.22, g:4.89, h:4.52, i:4.11, j:4.96, k:4.84 (median: 4.52, maximum: 5.34, minimum: 3.70). Additionally, no significant relation was found between the number of published papers and paper quality (correlation coefficient, −0.33, P = 0.32). Conclusions: The number of published papers does not correspond to paper quality. When assessing an institution's ability to perform clinical research, an assessment of paper quality should be included along with the number of published papers. [ABSTRACT FROM AUTHOR]

While conducting a coordinated set of repeat runs of human evaluation experiments in NLP, we discovered flaws in every single experiment we selected for inclusion via a systematic process. In this squib, we describe the types of flaws we discovered, which include coding errors (e.g., loading the wrong system outputs to evaluate), failure to follow standard scientific practice (e.g., ad hoc exclusion of participants and responses), and mistakes in reported numerical results (e.g., reported numbers not matching experimental data). If these problems are widespread, it would have worrying implications for the rigor of NLP evaluation experiments as currently conducted. We discuss what researchers can do to reduce the occurrence of such flaws, including pre-registration, better code development practices, increased testing and piloting, and post-publication addressing of errors. [ABSTRACT FROM AUTHOR]

Introduction and aim Diabetic foot ulcer (DFU) is a chronic condition that affects an increasing number of people each year[1]. Healing the ulceration requires cooperation between patients, specialists and scientists in order to achieve satisfactory results. Treating this type of wound is not only a therapeutic challenge[1,2,3,4,5,6], but also an economic one, which is why so much scientific research has already been made on this phenomenon[2,3]. Still scientists continue their quest for new cost-effective alternatives to current therapeutic options that would be consistent with contemporary knowledge and available engineering capabilities in pursuance of creating techniques and new dressings that will accelerate the healing of DFUs[2,3,7,8]. Factors such as stress, obesity, certain medications, and chronic diseases appear to negatively affect the process of repair [1,9,10,4,6,11]. Studies prove that aloe vera gel due to its healing properties, can be considered as a potential dressing that will expedite the mending process of diabetic foot ulceration[12,13,14]. In this paper, we performed a literature review of the applicability of aloe vera in the healing process of DFUs. Materials and methods Searching the available literature, including randomized clinical trials and systematic reviews, we drew on databases focusing on the effects of treatment for diabetic foot ulceration using Aloe vera. Conclusion: The current scientific research on the use of Aloe vera gel in diabetic foot ulcer treatment indicates that this method is safe, effective and inexpensive[2,3]. However the difficulty of treatment and the increasing prevalence of this type of wound pose a challenge to finding new solutions and exploring mechanisms in which aloe vera can have a possible role in the wound healing process. Nevertheless, this paper presents a promising impact of Aloe vera gel applicability in the healing process of diabetic foot ulcer. [ABSTRACT FROM AUTHOR]

Despite the introduction of targeted vaccines and screening protocols, locally advanced cervical cancer represents a median proportion of 37% among all cervical carcinomas. Compared to early stages, it presents significantly lower cure rates, with a 5-year disease-free survival rate of 68% and a 5-year overall survival rate of 74%. According to current guidelines, definitive radiotherapy with concomitant chemotherapy represents the gold standard for locally advanced cervical cancer treatment. However, a significant number of patients relapse and die from metastatic disease. The aim of this narrative review is to examine the recent advancements in treating locally advanced cervical cancer, exploring new frontiers in therapeutic approaches. The PubMed database and clinical trial registries were searched to identify relevant articles published on locally advanced cervical cancer treatment up to March 2024, mainly focusing on papers published in the last decade. Abstracts presented at major international congresses that bring relevant evidence were included. Progress achieved in refining radiotherapy techniques, recent evidence regarding neoadjuvant treatment preceding surgery or concurrent chemoradiotherapy, and key findings concerning adjuvant treatment are thoroughly explored. Furthermore, a comprehensive review of prominent phase II and phase III trials examining the integration of immune checkpoint inhibitors is conducted, analyzing the various contexts in which they are applied. In light of the new evidence that has emerged in recent years and is discussed in this article, the appropriate selection of the most suitable therapeutic approach for each patient remains a complex but crucial issue. [ABSTRACT FROM AUTHOR]

Background: The lower limb motor dysfunction caused by stroke is one of the main sequelae affecting patients' ability to live normally in the later period. Acupuncture treatment of limb movement dysfunction after stroke has been recommended by authoritative guidelines for reducing limb spasticity, enhancing limb strength and so on. However, the efficacy of different acupuncture methods in treating lower limb motor dysfunction after stroke remains controversial. Objective: In this paper, network meta-analysis (NMA) was used to prioritize various acupuncture intervention combinations commonly used in clinical practice, try to screen the acupuncture intervention scheme with the highest clinical efficacy and safety, and explore its rationality in guiding clinical practice. Methods: We searched a total of 4,312 studies from 8 databases and 2 clinical trial registries, and selected 43 articles for systematic review. We used pairwise meta-analysis and network meta-analysis to evaluate the efficacy and ranking of various acupuncture interventions. At the same time, the risk of bias, publication bias, and sensitivity of included randomized controlled trials were analyzed. The main outcome indicator was Fugl-Meyer assessment of lower extremity (FMA-LE), and the secondary outcome indicators were Modified Barthel Index (MBI), Berg balance scale (BBS) and Modified Ashworth scale (MAS). Results: A total of 4,134 patients in 43 studies were included. The intervention included 9 acupuncture-related treatments, of which 20.9% were classified as high-risk. Among the four outcome indicators in pairwise meta-analysis, the effect of body acupuncture combined with conventional rehabilitation has the highest comprehensive credibility in terms of efficacy and safety comparing with conventional rehabilitation [SMD= 1.14, 95%CI (0.81, 1.46)], [SMD= 1.35, 95%CI (0.97, 1.72)], [SMD= 1.22, 95%CI (0.39, 2.05)], [SMD= 1.21, 95%CI (0.74, 1.44)]. In addition, multiple intervention methods, for example, warm acupuncture plus rehabilitation treatment for MBI and electroacupuncture plus body acupuncture plus rehabilitation treatment for BBS, may increase certain additional effects on different outcome indicators. Conclusion: This study proves that body acupuncture combined with rehabilitation treatment is the most widely used intervention method with the highest evidence quality in the treatment of lower limb motor dysfunction after stroke. However, for some other acupuncture methods, large samples and high-quality clinical randomized controlled trials are still needed to be fully verified. [ABSTRACT FROM AUTHOR]

Background: Stroke survivors with aphasia want to improve their everyday talking (discourse). In current UK practice, 90% of speech and language therapists believe discourse assessment and treatment is part of their role but are hampered by barriers in resources, time and expertise. There is a clinical need for well-articulated discourse assessment and treatments. LUNA is a multi-level treatment targeting words, sentences and discourse macrostructure in personal stories that addresses this clinical need. Objectives: This study aimed to assess the feasibility and acceptability of LUNA trial procedures in a randomised waitlist-controlled trial; and to evaluate preliminary efficacy. Methods: This paper reports a phase II, waitlist-controlled, proof-of-concept feasibility trial. Participants with chronic aphasia (n = 28) were recruited from the community and randomised to an Immediate (n = 14) or Delayed (n = 14) group. LUNA treatment was delivered twice weekly for 10 weeks via the videoconferencing technology, Zoom. Feasibility was assessed in terms of participant recruitment and retention, adherence, missing data, and treatment fidelity. Preliminary treatment efficacy was assessed in terms of between group differences in outcome measures relating to discourse, language, and psychosocial state. Results: The remote LUNA trial was feasible: 85% of those eligible consented to the trial; trial retention was 86%; 87% of treatment sessions were delivered as scheduled, and 79% of participants completed 80%+ of the treatment programme; data was missing only for participants who withdrew; treatment fidelity was high at 92% adherence; and only one clinical outcome measure demonstrated ceiling effects. ANCOVA analysis of the clinical outcome measures revealed group differences with medium and large effect sizes, indicating, improvements in the production of words, sentences, discourse macrostructure, overall language functioning (WAB-R), and psychosocial state (VAMS) following LUNA treatment. For most outcomes measured, similar treatment benefits were suggested in a secondary, non-parametric analysis. Conclusions: Large-scale evaluation of the clinical efficacy and cost-effectiveness of LUNA is warranted and supported by these findings. Trial registration: Clinical trials registration: NCT05847023 (clinical trials.gov). [ABSTRACT FROM AUTHOR]

Background: When performing nail surgery, clinicians must choose from a multitude of procedures and variations within each procedure. Much has been published to guide this decision making, but there are a lack of up to date robust systematic reviews to assess the totality of this evidence. Methods: Five databases (MEDLINE, Embase, CINAHL, Web of Science and CENTRAL) and two registers (Clinicaltrials.gov and ISRCTN) were searched to January 2022 for randomised trials evaluating the effects of a surgical intervention(s) for ingrown toenails. Two independent reviewers screened records, extracted data, assessed risk of bias and certainty of evidence. Data on co-primary outcomes of symptom relief and symptomatic regrowth were presented in our first paper. This paper presents data for the secondary outcomes and further discussion. Results: Of 3,928 records identified, 36 randomised trials were included in the systematic review. Healing time appears to be reduced with shorter application of phenol. A reduced healing time was also apparent was with the addition of curettage, although this may also increase the risk of post-operative bleeding and pain. Post operative bleeding was also reportedly lower in people who received local anaesthetic with epinephrine but no tourniquet. Use of phenol with nail bed excision may decrease the risk of infection. Lower pain scores were reported when using partial matrixectomy and surgical interventions with phenol. Shorter duration of pain was reported with phenolisation and wedge resection. Participant satisfaction was high overall. Conclusion: This second paper reports secondary outcomes from a robust systematic review of randomised trials on surgical treatment of ingrown toenails. Despite the large volume of clinical trials conducted on the topic, few clinical conclusions can be drawn due to the poor quality of these studies. Further high-quality clinical trials are needed to answer fundamental questions in the surgical treatment of ingrown toenails. [ABSTRACT FROM AUTHOR]

Copyright of Acta Pediátrica Española is the property of Ediciones Mayo and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

A questionnaire which provides desirable reliability and validity has been previously developed to assess the disease awareness of diagnosed chronic kidney disease (CKD) patients. However, conventional paper questionnaires often have disadvantages, including recall bias. To substantially improve this, we therefore aimed to explore the feasibility of developing a smartphone-based electronic version (e-version) based upon its original paper version and subsequently tested its validity, reliability, and applicability. A pilot study was conducted at Guangdong Provincial Hospital of Chinese Medicine in Guangzhou, China, during August 2019. The e-version had identical content to the paper version and was adapted in terms of layout and assisted functions via the Wechat-incorporated Wen-Juan-Xing platform. Eligible patients with diagnosed CKD were invited to participate and were assigned the e-version. Randomly selected respondents received a test-retest of the same e-version 2 weeks after their first completion. In some instances, psychometric properties, including validity and reliability of the e-version, were examined. In others, its clinical application was also tested, which included comparisons among the clinical profiles of patients who had/had not responded to the questionnaire as well as patients with above or below average questionnaire scores. Of the 225 patients screened, 217 were enrolled to participate, with a response rate of 52.5%. Desirable reliability (Cronbachα = 0.962, ICC for total scores = 0.948), while good convergent validity (Cronbachα = 0.962) and low discriminant validity (one extracted component), of the e-version were detected. Performing inter-group comparisons highlighted statistical differences in terms of higher education level (z = −2.436, P = 0.015) and earlier CKD stages (z = −1.978, P = 0.048), with these patients often preferring to respond. No significant differences were detected in the clinical profiles between respondents who obtained an above or below average questionnaire score. The e-version is reliable but was not shown to be a valid approach. Audiences with higher education levels and less advanced disease condition may prefer to respond to the e-version. Adaptation of this e-questionnaire, from its original paper version, may not be a direct transition and meticulous modifications may be required during the transition process. Chinese Clinical Trial Registry (ChiCTR1900024633). [ABSTRACT FROM AUTHOR]

Thyroid disease classification plays a crucial role in early diagnosis and effective treatment of thyroid disorders. Machine learning (ML) techniques have demonstrated remarkable potential in this domain, offering accurate and efficient diagnostic tools. Most of the real-life datasets have imbalanced characteristics that hamper the overall performance of the classifiers. Existing data balancing techniques process the whole dataset at a time that sometimes causes overfitting and underfitting. However, the complexity of some ML models, often referred to as "black boxes," raises concerns about their interpretability and clinical applicability. This paper presents a comprehensive study focused on the analysis and interpretability of various ML models for classifying thyroid diseases. In our work, we first applied a new data-balancing mechanism using a clustering technique and then analyzed the performance of different ML algorithms. To address the interpretability challenge, we explored techniques for model explanation and feature importance analysis using eXplainable Artificial Intelligence (XAI) tools globally as well as locally. Finally, the XAI results are validated with the domain experts. Experimental results have shown that our proposed mechanism is efficient in diagnosing thyroid disease and can explain the models effectively. The findings can contribute to bridging the gap between adopting advanced ML techniques and the clinical requirements of transparency and accountability in diagnostic decision-making. [ABSTRACT FROM AUTHOR]

The amount of grey literature and 'softer' intelligence from social media or websites is vast. Given the long lead‐times of producing high‐quality peer‐reviewed health information, this is causing a demand for new ways to provide prompt input for secondary research. To our knowledge, this is the first review of automated data extraction methods or tools for health‐related grey literature and soft data, with a focus on (semi)automating horizon scans, health technology assessments (HTA), evidence maps, or other literature reviews. We searched six databases to cover both health‐ and computer‐science literature. After deduplication, 10% of the search results were screened by two reviewers, the remainder was single‐screened up to an estimated 95% sensitivity; screening was stopped early after screening an additional 1000 results with no new includes. All full texts were retrieved, screened, and extracted by a single reviewer and 10% were checked in duplicate. We included 84 papers covering automation for health‐related social media, internet fora, news, patents, government agencies and charities, or trial registers. From each paper, we extracted data about important functionalities for users of the tool or method; information about the level of support and reliability; and about practical challenges and research gaps. Poor availability of code, data, and usable tools leads to low transparency regarding performance and duplication of work. Financial implications, scalability, integration into downstream workflows, and meaningful evaluations should be carefully planned before starting to develop a tool, given the vast amounts of data and opportunities those tools offer to expedite research. [ABSTRACT FROM AUTHOR]

Background: Endometrial cancer (EC) is the most common gynecological malignancy in both Europe and the USA. Approximately 3–5% of cases occur in women of reproductive age. Fertility-sparing treatment (FST) options are available, but very limited evidence regarding grade 2 (G2) ECs exists in the current literature. This systematic review aimed to comprehensively evaluate reproductive and oncologic outcomes among young women diagnosed with stage IA or G2EC disease who underwent FST. Methods: A comprehensive search of the literature was carried out on the following databases: MEDLINE, EMBASE, Global Health, The Cochrane Library (Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Cochrane Methodology Register), the Health Technology Assessment Database, and Web of Science. Only original studies that reported the oncologic and reproductive outcomes of patients with stage IA and G2EC tumors who underwent FST were considered eligible for inclusion in this systematic review (CRD42023484892). Studies describing only the FST for endometrial hyperplasia or G1 EC were excluded. Results: Twenty-two papers that met the abovementioned inclusion criteria were included in the present systematic review. Preliminary analysis suggested encouraging oncologic and reproductive outcomes after FST. Conclusions: The FST approach may represent a feasible and safe option for women of childbearing age diagnosed with G2EC. Despite these promising findings, cautious interpretation is warranted due to inherent limitations, including heterogeneity in study designs and potential biases. Further research with standardized methodologies and larger sample sizes is imperative for obtaining more robust conclusions. [ABSTRACT FROM AUTHOR]

Journal Activities and Accomplishments In order to make comparisons to prior editorial terms, I summarize data concerning the submissions and papers published during my editorial term, and when possible, have included comparison data from the last editor ([9]). Journal of Pediatric Psychology (JPP), 2008-2012: Editor's Vale Dictum. Journal of Pediatric Psychology (JPP), 1998-2002: Editor's Vale Dictum. Journal of Pediatric Psychology (JPP), 2003-2007: Editor's Vale Dictum. [Extracted from the article]

A limited number of studies have directly examined the effects of liposomal encapsulated phytochemicals and their anti-obesity effects in adults. This study aimed to summarize the evidence on the effect of liposomal encapsulated phytochemicals and their role in regulating major pathways involved in the anti-obesity mechanism. A systematic search was performed using several search engines like Science Direct, Google Scholar, and other online journals, focusing on laboratory research, systematic reviews, clinical trials, and meta-analysis that focused on liposomal encapsulated phytochemicals with anti-obesity properties, and followed the preferred reporting terms for this systematic review. An initial search provided a result of 1810 articles, and 93 papers were selected after the inclusion and exclusion criteria. Very few studies have been conducted on the liposomal encapsulation of phytochemicals or its synergistic study to combat obesity; hence this review paves the way for future obesity research and is mainly helpful for the pediatric obesity population. Liposomal encapsulation of phytochemicals has improved the efficiency of freely administered phytochemicals. Targeted delivery improved drug utilization and regulated the anti-obesity pathways. PPARƔ is a major therapeutic target for obesity as it inhibits adipocyte differentiation and maintains energy homeostasis. [ABSTRACT FROM AUTHOR]

Patient engagement is currently considered the cornerstone of a revolution in healthcare for its positive impact on health outcomes, health behaviors and healthcare costs. Patient engagement is focused on personalized care to consumers through providing knowledge, skills and confidence. Mobile health (mHealth) applications are an innovative means to facilitate patient engagement. Nevertheless, the extent to which the current mHealth applications are designed to engage patients in managing their chronic diseases is unclear. This paper aims to identify the Persuasive System Design (PSD) features present in current mHealth applications that increased the engagement of patients with chronic diseases. This review also aims to identify patient engagement-related outcomes of these features. This paper conducted a systematic literature review and meta-analysis to find relevant studies published from all years up to 2020 through six databases: PubMed, Scopus, Web of Science, Cinahl plus with full text, MEDLINE with full text, and Cochrane Library (Central register of controlled trials). The database search returned 4939 articles; after applying the inclusion and exclusion criteria, the number of included articles for the final review was 13. A qualitative content analysis was performed to identify PSD model features and their patient engagement-related outcomes. The quality assessment has been done through the Cochrane Risk of Bias tool for RCTs. The systematic literature review and meta-analysis identified eleven PSD features that can increase patient engagement through using mHealth applications. The identified PSD features have been shown to have various patient engagement-related outcomes. Behavior Change Techniques (BCTs) were combined with the identified PSD features. This paper identified persuasive features of mHealth application design that influence the engagement of patients with chronic diseases toward changing their behavior. The impact of these features is also analyzed in this review. The results show that an mHealth technology-mediated patient engagement model is needed. [ABSTRACT FROM AUTHOR]

Introduction: Unsafe abortion is the cause of a substantial number of maternal mortalities and morbidities globally, but specifically in low- and middle-income countries. Medical abortion methods provided by non-physicians may be a way to reduce the burden of unsafe abortions. Currently, only one systematic review comparing non-physicians with physicians for medical abortion exists. However, the review does not have any setting restrictions and newer evidence has since been published. Therefore, this review aims to evaluate the effectiveness, acceptability, and safety of first-trimester abortion managed by non-physicians compared with physicians in low- and middle-income countries.Material and Methods: The databases PubMed, Cochrane Library, Global Health Library, and EMBASE were searched using a structured search strategy. Further, the trial registries clinicaltrials.gov and The International Clinical Trial Registry Platform were searched for published and unpublished trials. Randomized controlled trials comparing provision of medical abortion by non-physicians with that by physicians in low- or middle-income countries were included. Risk of bias was assessed using the Cochrane Risk of Bias tool. Trials that reported effect estimates on the effectiveness of medical methods on complete abortion were included in the meta-analysis. The protocol was prospectively registered in the PROSPERO database, ID: CRD42020176811.Results: Six papers from four different randomized controlled trials with a total of 4021 participants were included. Two of the four included trials were assessed to have overall low risk of bias. Four papers had outcome data on complete abortion and were included in the meta-analyses. Medical management of first-trimester abortion and medical treatment of incomplete abortion were found to be equally effective when provided by a non-physician as when provided by a physician (risk ratio 1.00; 95% CI 0.99-1.01). Further, the treatment was equally safe, and women were equally satisfied when a non-physician provided the treatment compared with a physician.Conclusions: Provision of medical abortion or medical treatment for incomplete abortion in the first trimester is equally effective, safe, and acceptable when provided by non-physicians compared with physicians in low- and middle-income countries. We recommend that the task of providing medical abortion and medical treatment for incomplete abortion in low- and middle-income countries should be shared with non-physicians. [ABSTRACT FROM AUTHOR]

Background: The new European Medicines Agency (EMA) Clinical Trials Information System (CTIS), based on the Clinical Trials Regulation (CTR EU 536/2014), came into full effect on 31 January 2022 and was intended to provide an easier, more streamlined approach to the registration of clinical trials taking place in Europe. Using the experience gained on the new regulatory framework from three multi-national European clinical research studies of outbreak-prone infectious diseases, this article describes the advantages and shortcomings of the new clinical trial submission procedure. Methods: We report the time to approval, size of the application dossier, and number of requests for information (RFIs) for each study. We also explore the experience of each study within the regulatory framework and its use of CTIS to document the real-world, practical consequences of the system on individual studies. The study assesses the experience of three multi-country studies conducted in Europe working within the EU and non-EU regulatory environments. Results: While the time to regulatory and ethical approval has improved since the implementation of the new regulation, the timelines for approvals are still unacceptably slow, particularly for studies being conducted in the context of an evolving outbreak. Within the new regulatory approval procedure, there is evidence of conflicting application requirements, increased document burden, barriers to submitting important modifications, and debilitating technical hurdles. Conclusions: CTIS promised to lower the administrative bar, but unfortunately this has not been achieved. There are challenges that need to be urgently confronted and addressed for international research collaborators to effectively manage health crises in the future. While the value of multi-national outbreak research is clear, the limitations and delays imposed by the system, which raise challenging ethical questions about the regulation, are prejudicial to all clinical research, especially publicly funded academic studies. This report is relevant to both regulators and clinical researchers. It is hoped that these findings can help improve pan-European clinical trials, especially for the purpose of epidemic preparedness and response. Trial registration: This paper references experiences gained during management of three pan-European trials: EU-SolidAct's Bari-SolidAct (CT No. 2022-500385-99-00 - 15 March 2022) and AXL-SolidAct (CT No. 2022-500363-12-00 - 19 April 2022), and MOSAIC (CT No. 2022-501132-42-00 - 22 June 2022). [ABSTRACT FROM AUTHOR]

This paper examines the role of nurseries in the Green Revolution. Nurseries were sets of seeds assembled to test particular traits and sent to breeders around the world to trial. Focusing on wheat nurseries of the 1960s and 70s, I highlight the materials that were central to their distribution, as well as the breeders who planted them. Through this analysis, I trouble the common narrative of the Green Revolution as emerging from centers of international agricultural science, showing the networks of expertise, seed transfer, field trials, and data collection that underpinned this process of agricultural transformation. [ABSTRACT FROM AUTHOR]

The Letter to the Galatians is a polemical correspondence about the course of gospel mission that is at stake in the view of the apostle Paul. When Paul represents his own contacts with the Jerusalem church, he defends "our freedom which we have in Christ Jesus" (Gal 2:4). In his aim to focus on the unity of all in Christ, Paul even goes at lengths to state that there is no difference between slave and free (Gal 3:28), while polemically associating both a former state of unbelievers (Gal 4:8) and the emphasis by missionary opponents on circumcision and the covenant of the law (Gal 4:12–31) with bondage and slavery. Yet, what did freedom (ἐλευθερία, Gal 2:4) and its opposite, slavery (δουλεία, Gal 4:24, 5:1), exactly mean in the ancient world in which Paul and his readers lived and communicated? Jews, Greeks, and Romans did not necessarily mean the same by these terms, nor did freedom necessarily mean exactly the same as modern conceptions of the term. This paper aims to contextualize Paul's imagery with a view to biblical traditions, early Jewish notions of freedom, and Graeco-Roman registers of discourse, taking into account historical, literary, linguistic, and rhetorical-critical contexts of interpretation and revisiting the language of freedom and slavery with a view to insights from linguistic anthropology. The paper then revisits the Pauline position of "freedom in Christ" in relation to previous hypotheses of Paul's gospel mission. [ABSTRACT FROM AUTHOR]

Face authentication is an important biometric authentication method commonly used in security applications. It is vulnerable to different types of attacks that use authorized users' facial images and videos captured from social media to perform spoofing attacks and dynamic movements for penetrating security applications. This paper presents an innovative challenge-response emotions authentication model based on the horizontal ensemble technique. The proposed model provides high accurate face authentication process by challenging the authorized user using a random sequence of emotions to provide a specific response for every authentication trial with a different sequence of emotions. The proposed model is applied to the KDEF dataset using 10-fold cross-validations. Several improvements are made to the proposed model. First, the VGG16 model is applied to the seven common emotions. Second, the system usability is enhanced by analyzing and selecting only the four common and easy-to-use emotions. Third, the horizontal ensemble technique is applied to enhance the emotion recognition accuracy and minimize the error during authentication processes. Finally, the Horizontal Ensemble Best N-Losses (HEBNL) is applied using challenge-response emotion to improve the authentication efficiency and minimize the computational power. The successive improvements implemented on the proposed model led to an improvement in the accuracy from 92.1% to 99.27%. [ABSTRACT FROM AUTHOR]

Background: Surgical resection for Bismuth‐Corlette type IV (BC‐IV) hilar cholangiocarcinomas, also termed Klatskin tumours are technically challenging and were once considered unresectable tumours. Following advances in hepatobiliary imaging and surgical techniques, emerging evidence suggests that surgical resection is a viable avenue for long‐term survival. We aimed to identify factors affecting survival outcomes of hepatic resections for BC‐IV cholangiocarcinomas. Method: A systematic review was performed across multiple databases and several clinical trial registries. Two reviewers independently screened and selected papers that contained survival data on BC‐IV cholangiocarcinoma after hepatic resections. Results: Of 13 499 papers from our search result, 21 papers satisfied the inclusion criteria. The median post‐operative survival was 30.8 months. The average 1‐ and 5‐year post‐operative survivals were 61.6 and 33.3%, respectively. Predictors of long‐term survival included achievement of R0 margins, minimisation of operative time and reduction intra‐operative blood loss. Conclusion: Our analysis demonstrates improving post‐operative outcomes and survival in surgical resection of BC‐IV cholangiocarcinoma and suggests that radical surgical resection is a valid treatment option for the disease. [ABSTRACT FROM AUTHOR]

Introduction: Tenofovir alafenamide (TAF) is approved for paediatric use in fixed‐dose combination tablets, but efficacy and safety data in children are limited. We conducted a systematic review on the efficacy/effectiveness and safety of TAF in infants, children and adolescents living with HIV. Methods: We searched MEDLINE, Embase, the Cochrane Library, clinical trial registries, reference lists and relevant conferences to identify literature published January 2009–March 2021. We included clinical trials and observational studies assessing the efficacy/effectiveness or safety of TAF through ≥6 months of treatment in participants aged 0–19 years. Results and discussion: Overall 3626 abstracts and 371 full papers were screened. Four single‐arm, innovator‐funded trials (341 participants) and a pooled analysis of those trials were identified. All four trials included treatment‐experienced and virally suppressed children or adolescents. One trial also included treatment‐naïve adolescents with baseline viral load >1000 copies/ml. The risk of bias was rated as low in one study and unclear in the other three owing to missing data on study design (all conference presentations). At 48 weeks, 92% (46/50) of treatment‐naïve participants were virally suppressed (one trial). Among treatment‐experienced participants with viral load at 48 weeks, 214 of 224 participants were virally suppressed. Across the studies, one grade 3/4 adverse event was considered drug‐related (intermediate uveitis). There were three discontinuations for adverse events (grade 2 anxiety and insomnia, grade 1 iridocyclitis [drug‐related] and grade 1 pulmonary tuberculosis [unrelated to treatment]). One accidental death occurred across the four studies. In the pooled analysis of 223 participants, the median change in bone mineral density z‐score (height‐ and age‐adjusted) from baseline to 48 weeks was −0.12 (interquartile range [IQR] −0.46, 0.17) to 0.05 (IQR not reported) for spine, and −0.09 (IQR −0.33, 0.07) to 0.09 (IQR not reported) for total body less head. Weight‐for‐age z‐scores increased by 0.25 from baseline to 48 weeks. Conclusions: Four single‐arm trials were identified in this systematic review, with initial evidence suggesting good viral suppression and no obvious safety concerns in children and adolescents on TAF‐containing regimens over 24–48 weeks. However, further comparative and longer‐term safety data are needed in children and adolescents, including on weight and metabolic changes. [ABSTRACT FROM AUTHOR]

Background: The advent of computer‐guided surgery removed the need for complex surgical interventions such as extensive flap elevations, second stage implant exposure, and complications usually associated with conventional protocols. Purpose (a) Analyze available literature reporting on applicability, accuracy, clinical outcome of flapless surgery with or without computer guidance. (b) Evaluate quality of studies, in terms of scientific level of evidence and ethical committee approval. Materials and methods: A PUBMED search was performed in July 2018. A first search was based on a general search string limited to "Dental Implants" and "flapless surgery." A second search focused on accuracy of computer‐guided surgery using search string "Surgery, Computer‐Assisted" or "guided surgery," and "Dental implants." The following inclusion criteria were applied: (a) studies in English; (b) human studies (excluding cadaver); (c) systematic reviews; (d) systematic reviews with meta‐analysis. Reviews not mentioning accuracy were excluded in search 2. Results: Nine reviews included in total. Implant survival ranged between 89% and 100%. Early surgical and prosthetic complications reported in 9.1% to 36.4% of reviewed papers. Tooth‐supported guides show more accuracy than bone or mucosa‐supported guides. Fully guided surgery yields higher accuracy, with lower values for horizontal coronal, horizontal apical and angular deviation (1.00, 1.23, and 3.13°mm, respectively) than those placed with half guided surgery (1.44, 1.91, and 4.30 mm, respectively). Thirty‐four of 71 human studies included in nine reviews, mentioned ethical committee approval or compliance with Declaration of Helsinki. Conclusions: Guided flapless surgery is comparable to free‐hand surgery in terms of implant survival, marginal bone remodeling, and peri‐implant variables. Clinicians advised to take care in all steps of the protocol, and include safety margins around virtually planned implants. Regarding compliance with research ethics, we should question whether scientific reports of clinical trials performed without an ethical umbrella are trustworthy. Compliance of ethics standards is imperative for submitted research papers. [ABSTRACT FROM AUTHOR]

The number of rheumatology journals, and papers related to this specialty, is expanding every day. Careful consideration for ethical aspects of such published work is mandatory for authors, readers, reviewers, editors, and all stakeholders. Recent instances of lack of appropriate research ethics committee overview, or participant consent for inclusion in the research study, or a case report, resulting in retractions, emphasize the need for greater awareness regarding these ethical aspects. Authors should strive to avoid redundancy, especially for review articles, both systematic and narrative. Clinical trial registration before commencing enrolment is mandatory as per contemporary norms. Transparent declaration of authorship contributions as well as appropriate attribution of authorship are recommended, since these may help avoid subsequent authorship conflicts. Authors, reviewers, and editors should disclose conflicts of interest, both financial and non-financial. Unbiased peer review is a critical part of editorial decision making; recent instances of peer review fraud have resulted in numerous retractions of scientific papers. Any reproduction of text, figures, or tables should be with due attribution to source, and after seeking permission of the copyright holder. Citations to published work should be relevant and diverse. Research assessment should rely on the assessment of quality of published work, rather than mere citation analyses. Authors should beware predatory, low-quality journals, and utilize social media channels to ethically promote their research with due consideration to privacy and copyright. Rheumatology societies should collaborate to develop guidelines for ethical research reporting, and educate young scientists regarding these principles. [ABSTRACT FROM AUTHOR]

Objective: To systematically evaluate the risk factors for perimenopausal depression in Chinese women and to provide a basis for screening perimenopausal women at high-risk for depression. Methods: A computer search of seven databases, including SinoMed, PubMed, Web of Science, and so on, and two clinical trial registries on the risk factors for depression in Chinese women during perimenopause was conducted for metaanalysis. The search time limit was from the establishment of the database to December 2022. The included case-control and cross-sectional studies were evaluated using the Newcastle-Ottawa scale (NOS) and criteria developed by the Agency for Healthcare Research and Quality (AHRQ). Results: A total of 15 papers with 12,168 patients and 18 risk factors were included. Meta-analysis results showed that the risk factors for depression in perimenopausal women were relationship quality [OR = 1.23, 95% confidence intervals (1.03, 1.46)], marital status [OR = 2.49, 95% CI (1.77, 3.50)], family income [OR = 1.48 95% CI (1.10, 2.00)], comorbid chronic diseases [OR = 2.39, 95% CI (1.93, 2.95)], exercise status [OR = 1.63, 95% CI (1.26, 2.11)], perimenopausal syndrome [OR = 2.36, 95% CI (2.11, 2.63)], age [OR = 1.04, 95% CI (1.01, 1.07)], and stressful events [OR = 12.14, 95% CI (6.48, 22.72)], and social support was a protective factor [OR = 0.76, 95% CI (0.63, 0.91), p < 0.05]. Conclusion: Based on the exploration of risk factors for perimenopausal depression in Chinese women, we aimed to provide guidance for the screening of risk factors for depression in perimenopausal women and thereby reduce the incidence of depression. [ABSTRACT FROM AUTHOR]

Background: To systematically summarize and categorize the Chinese herbal medicine in the domestic traditional Chinese medicine (TCM) literature on type 2 diabetes mellitus (T2DM), in this paper, we mine traditional Chinese medicine data for relationships and provide for future practitioners and researchers. Methods: Taking randomized controlled trials on the treatment of T2DM in TCM as the research theme, we searched for full-text literature in three major clinical databases, including CNKI, Wan Fang, and VIP, published between 1990 and 2020. We then conducted frequency statistics, cluster analysis, association rules extraction, and principal component analysis based on a corpus of medical academic words extracted from 1116 research articles. Results: The most frequently used is Astragali Radix, and the most commonly used two-herb combination in T2DM treatment consisted of Coptidis Rhizoma and Moutan Cortex. Moutan Cortex, Alismatis Rhizoma, and Dioscoreae Rhizoma were the most frequently used three-herb combination. We found a "lung" and "liver" and "kidney" model and confirmed the value of classical meridian tropism theory and pattern identification. The treatment is mainly to fill deficiency and clear heat and consider water infiltration, dampness, blood circulation, and silt. Conclusion: This study provides an in-depth perspective on the TCM medication rules for T2DM and offers practitioners and researchers valuable information about the current status and frontier trends of TCM research on T2DM in terms of diagnosis and treatment. [ABSTRACT FROM AUTHOR]

Background: This paper examines the events and conditions that led to the creation of the International Clinical Trials Registry Platform (ICTRP) in 2006 by the World Health Organization (WHO), and how the WHO addressed the issue of transparency in global pharmaceutical research. Using historical textual analysis, I trace the scientific debates that advocated for the establishment of official clinical trial registries in medical journals, and the sequence of actions following the GSK Paxil scandal in 2004, identifying the major ethical and scientific arguments that led to the involvement of the WHO as a key actor in trial registration in the context of the Big Pharma business model. Results: Through the questions "Why register?" and "Why registries?" as a roadmap, I examine the issues of publication bias and selective reporting by the industry, scrutinizing two ways in which the practice of publication bias damaged transparency in industry-sponsored research. The first involved ethical concerns regarding human subject exploitation and concealing of negative results. The second addresses the deterioration of the certainty of evidence due to incomplete access to trials results. By reviewing the series of events that occurred between 2004 and 2006 –between the Paxil scandal and the launch of the ICTRP—, I analyze the actions taken by the different actors involved: (1) the International Committee of Medical Journal Editors (ICMJE) and the creation of the Ottawa Group; (2) the WHO, beginning with the Ministerial Summit on Health Research held in November of 2004, and (3) the responses of the pharmaceutical industry and specifically GSK to the call for transparency and trial registration. Conclusions: The history of trial registration through the ICTRP as a dataveillance apparatus shows the difficulty of regulating a health enterprise turned into a global business. Moreover, it shows the challenges of globalization and how easier and faster it is to globalize business compared to good practices, raising the question of why it has been so hard to undo these trends. Indeed, the history of the movement for trial registration is not a history of regulation success, or at least not yet. [ABSTRACT FROM AUTHOR]

Background: Obesity and rapid weight gain are established risk factors for noncommunicable diseases and have emerged as independent risk factors for severe disease following Coronavirus Disease 2019 (COVID-19) infection. Restrictions imposed to reduce COVID-19 transmission resulted in profound societal changes that impacted many health behaviours, including physical activity and nutrition, associated with rate of weight gain. We investigated which clinical and sociodemographic characteristics were associated with rapid weight gain and the greatest acceleration in rate of weight gain during the pandemic among adults registered with an English National Health Service (NHS) general practitioner (GP) during the COVID-19 pandemic. Methods and findings: With the approval of NHS England, we used the OpenSAFELY platform inside TPP to conduct an observational cohort study of routinely collected electronic healthcare records. We investigated changes in body mass index (BMI) values recorded in English primary care between March 2015 and March 2022. We extracted data on 17,742,365 adults aged 18 to 90 years old (50.1% female, 76.1% white British) registered with an English primary care practice. We estimated individual rates of weight gain before (δ-prepandemic) and during (δ-pandemic) the pandemic and identified individuals with rapid weight gain (>0.5 kg/m2/year) in each period. We also estimated the change in rate of weight gain between the prepandemic and pandemic period (δ-change = δ-pandemic—δ-prepandemic) and defined extreme accelerators as the 10% of individuals with the greatest increase in their rate of weight gain (δ-change ≥1.84 kg/m2/year) between these periods. We estimated associations with these outcomes using multivariable logistic regression adjusted for age, sex, index of multiple deprivation (IMD), and ethnicity. P-values were generated in regression models. The median BMI of our study population was 27.8 kg/m2, interquartile range (IQR) [24.3, 32.1] in 2019 (March 2019 to February 2020) and 28.0 kg/m2, IQR [24.4, 32.6] in 2021. Rapid pandemic weight gain was associated with sex, age, and IMD. Male sex (male versus female: adjusted odds ratio (aOR) 0.76, 95% confidence interval (95% CI) [0.76, 0.76], p < 0.001), older age (e.g., 50 to 59 years versus 18 to 29 years: aOR 0.60, 95% CI [0.60, 0.61], p < 0.001]); and living in less deprived areas (least-deprived-IMD-quintile versus most-deprived: aOR 0.77, 95% CI [0.77, 0.78] p < 0.001) reduced the odds of rapid weight gain. Compared to white British individuals, all other ethnicities had lower odds of rapid pandemic weight gain (e.g., Indian versus white British: aOR 0.69, 95% CI [0.68, 0.70], p < 0.001). Long-term conditions (LTCs) increased the odds, with mental health conditions having the greatest effect (e.g., depression (aOR 1.18, 95% CI [1.17, 1.18], p < 0.001)). Similar characteristics increased odds of extreme acceleration in the rate of weight gain between the prepandemic and pandemic periods. However, changes in healthcare activity during the pandemic may have introduced new bias to the data. Conclusions: We found female sex, younger age, deprivation, white British ethnicity, and mental health conditions were associated with rapid pandemic weight gain and extreme acceleration in rate of weight gain between the prepandemic and pandemic periods. Our findings highlight the need to incorporate sociodemographic, physical, and mental health characteristics when formulating research, policies, and interventions targeting BMI in the period of post pandemic service restoration and in future pandemic planning. Miriam Samuel and team analyzed health records of 17 million adults in England, examining patterns of weight change before and during COVID-19 and identifying groups most prone to rapid weight gain. Author summary: Why was this study done?: Restrictions imposed during the Coronavirus Disease 2019 (COVID-19) pandemic may have led to lifestyle changes that are associated with weight gain. Some studies have suggested that women, younger adults (18 to 29 years), and those living in more deprived areas were at greatest risk of weight gain during the pandemic, but these were limited by small sample size. There are currently no large-scale analyses of how the pandemic impacted preexisting patterns of weight gain, and how this varied by sociodemographic and clinical characteristics. What did the researchers do and find?: We used data from the routinely collected health records of 17 million adults living in England to investigate patterns of weight change before and during the pandemic and describe which groups were most likely to have experienced unhealthy patterns of weight gain. We found that, among adults with measures of weight recorded in their healthcare records, women, younger adults (18 to 29 years), those living in the most deprived areas, and those of white British ethnicity were most likely to have gained weight rapidly before and during the pandemic. The same groups were also most likely to have experienced extreme acceleration in their rate of weight gain during the pandemic. Almost all the long-term conditions (LTCs) increased the risk of unhealthy patterns of weight gain, with mental health conditions, such as depression, having the greatest estimated effect. What do these findings mean?: The COVID-19 pandemic appears to have had the greatest impact on women, young adults, and those living in the most deprived areas in terms of unhealthy patterns of weight gain. We present, to our knowledge, new evidence that people with mental health conditions were more likely to have unhealthy patterns of weight gain during the pandemic, highlighting the need to consider sociodemographic, physical, and mental health characteristics in research, policies, and interventions around weight. We recommend that future pandemic planning should consider how to mitigate the unequal indirect impact of a pandemic on patterns of weight gain to prevent preexisting health inequalities being further exacerbated. Changes in healthcare activity during the pandemic affected patterns of weight monitoring in primary care, which may have introduced new bias to the analyses. [ABSTRACT FROM AUTHOR]

Highlights from the article: Clinical researchers can now share initial versions of their manuscripts through a free preprint server modeled after websites where physicists and biologists post papers before they appear in a peer-reviewed journal. Co-sponsored by Cold Spring Harbor Laboratory (CSHL) in New York, which created the bioRxiv preprint server in 2013, Yale University, and publisher The BMJ, the site aims to address concerns about posting draft papers on health science research involving human subjects by screening them carefully for select criteria and prominently labeling the papers as unreviewed.

Up to 50% of autistic people experience co-occurring anxiety, which significantly impacts their quality of life. Consequently, developing new interventions (and/ or adapting existing ones) that improve anxiety has been indicated as a priority for clinical research and practice by the autistic community. Despite this, there are very few effective, evidence-based therapies available to autistic people that target anxiety; and those that are available (e.g., autism adapted Cognitive Behavioural Therapy; CBT) can be challenging to access. Thus, the current study will provide an early-stage proof of concept for the feasibility and acceptability of a novel app-based therapeutic approach that has been developed with, and adapted for, autistic people to support them in managing anxiety using UK National Institute for Health and Care Excellence (NICE) recommended adapted CBT approaches. This paper describes the design and methodology of an ethically approved (22/LO/0291) ongoing non-randomised pilot trial that aims to enrol approximately 100 participants aged ≥16-years with an existing autism diagnosis and mild-to-severe self-reported anxiety symptoms (trial registration NCT05302167). Participants will be invited to engage with a self-guided app-based intervention—'Molehill Mountain'. Primary (Generalised Anxiety Disorder Assessment, Hospital Anxiety and Depression Scale) and secondary outcomes (medication/ service use and Goal Attainment Scaling) will be assessed at baseline (Week 2 +/- 2), endpoint (Week 15 +/- 2) and three follow-ups (Weeks 24, 32 and 41 +/- 4). Participants will also be invited to complete an app acceptability survey/ interview at the study endpoint. Analyses will address: 1) app acceptability/ useability and feasibility (via survey/ interview and app usage data); and 2) target population, performance of outcome measures and ideal timing/ duration of intervention (via primary/ secondary outcome measures and survey/ interview)–with both objectives further informed by a dedicated stakeholder advisory group. The evidence from this study will inform the future optimisation and implementation of Molehill Mountain in a randomised-controlled trial, to provide a novel tool that can be accessed easily by autistic adults and may improve mental health outcomes. [ABSTRACT FROM AUTHOR]

Copyright of Chinese Journal of Tissue Engineering Research / Zhongguo Zuzhi Gongcheng Yanjiu is the property of Chinese Journal of Tissue Engineering Research and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Introduction: Fibroblast activation protein (FAP) is highly overexpressed in stromal tissue of various cancers. While FAP has been recognized as a potential diagnostic or therapeutic cancer target for decades, the surge of radiolabeled FAP-targeting molecules has the potential to revolutionize its perspective. It is presently hypothesized that FAP targeted radioligand therapy (TRT) may become a novel treatment for various types of cancer. To date, several preclinical and case series have been reported on FAP TRT using varying compounds and showing effective and tolerant results in advanced cancer patients. Here, we review the current (pre)clinical data on FAP TRT and discuss its perspective towards broader clinical implementation. Methods: A PubMed search was performed to identify all FAP tracers used for TRT. Both preclinical and clinical studies were included if they reported on dosimetry, treatment response or adverse events. The last search was performed on July 22 2022. In addition, a database search was performed on clinical trial registries (date 15th of July 2022) to search for prospective trials on FAP TRT. Results: In total, 35 papers were identified that were related to FAP TRT. This resulted in the inclusion of the following tracers for review: FAPI-04, FAPI-46, FAP-2286, SA.FAP, ND-bisFAPI, PNT6555, TEFAPI-06/07, FAPI-C12/C16, and FSDD. Conclusion: To date, data was reported on more than 100 patients that were treated with different FAP targeted radionuclide therapies such as [177Lu]Lu-FAPI-04, [90Y]Y-FAPI-46, [177Lu]Lu-FAP-2286, [177Lu]Lu-DOTA.SA.FAPI and [177Lu]Lu-DOTAGA.(SA.FAPi)2. In these studies, FAP targeted radionuclide therapy has resulted in objective responses in difficult to treat end stage cancer patients with manageable adverse events. Although no prospective data is yet available, these early data encourages further research. [ABSTRACT FROM AUTHOR]

Thanks to advances in care, most children with congenital heart disease nowadays survive into adulthood. The majority of patients remain at high risk for future complications. Hence, life-long follow-up is mandatory. Care needs of patients evolve, especially when reaching adulthood. A structured transition period to adult care is advocated. Currently, a fully detailed and structured transition program is not available for patients with congenital heart disease. The aim is to describe the development and design of a multicomponent transition program for adolescents with congenital heart disease, called "Transition with a heart." Transition with a heart was developed based on the Dutch program "On your own feet," starting at the age of 12 years and continuing after transfer. The most vital core components include a general and individualized flowchart, adolescent-centered communication, a joined transfer consultation, and an appointed transition coordinator. Adolescents are gradually informed about their condition and potential late consequences in adult life and stimulated to take medical care in their own hands.Conclusion: Transition with a heart is a practical, multicomponent, comprehensive transition program developed to cover the essential aspects of transitional care for adolescents with congenital heart disease (i.e., continuity of care, disease knowledge, and self-management skills). Interventions were selected from the highest sources of scientific evidence currently available.Clinical trial registration: Not applicableWhat is Known:• Transition towards adult life and health care is a complex process, requiring careful patients' guidance. Various task forces have described the need and potential benefits of transition programs in young people with chronic conditions. Details about the practical development and content of such programs in congenital heart disease are, however, currently lacking.What is New:• This method paper presents the development and design of a person-centered multicomponent transition program for adolescents with congenital heart disease comprising interventional components covering the most important aspects of transitional care: promoting autonomy, disease knowledge, and continuity of care. [ABSTRACT FROM AUTHOR]

Copyright of Journal of Medical Residency Review is the property of Journal of Medical Residency Review and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Gastroesophageal reflux disease (GERD) is a common concern following laparoscopic sleeve gastrectomy (LSG). This paper aimed to assess the incidence of reflux disease following these bariatric procedures. A literature search was conducted to identify observational studies and clinical trials reporting patients developed GERD disease after LSG. Twenty-two studies included in the analysis, involve 20,495 participants, indicated that the estimated proportion of patients who developed post-surgery GERD was 0.35 (95% CI 0.30–0.41). Subgroup analysis revealed a proportion of 0.33 (95% CI 0.27–0.38) in observational studies and 0.58 (95% CI 0.39–0.75) in clinical trials. High heterogeneity was noted across studies (I2 = 98%). Sensitivity analyses and publication bias assessments were performed to enhance the robustness of the results. Our findings highlight a moderate to high risk of developing GERD following LSG surgery. [ABSTRACT FROM AUTHOR]

Non-timely reporting, selective reporting, or non-reporting of clinical trial results are prevalent and serious issues. WHO mandates that summary results be available in registries within 12 months of study completion and published in full text within 24 months. However, only a limited number of clinical trials in infectious diseases, including those done during the COVID-19 pandemic, have their results posted on ClinicalTrials.gov. An analysis of 50 trials of eight antiviral drugs tested against COVID-19 with a completion date of at least 2 years ago revealed that only 18% had their results published in the registry, with 40% not publishing any results. Non-timely and non-reporting practices undermine patient participation and are ethically unacceptable. Strategies should include obligatory reporting of summary results within 12 months in clinical trial registries, with progress towards peer-reviewed publication within 24 months indicated. Timely publication of research papers should be encouraged through an automated flagging mechanism in clinical trial registries that draws attention to the status of results reporting, such as a green tick for trials that have reported summary results within 12 months and a red tick in case of failure to do so. We propose the inclusion of mandatory clinical trial reporting standards in the International Conference on Harmonization Good Clinical Practice guidelines, which should prohibit sponsor contract clauses that restrict reporting (referred to as gag clauses) and require timely reporting of results as part of the ethics committees' clearance process for clinical trial protocols. [ABSTRACT FROM AUTHOR]

Background: Migraine is often comorbid with other disorders. People with migraine may be prescribed one or more concomitant medications. This post hoc analysis assessed the safety and efficacy of lasmiditan in Japanese people with migraine comorbidities or using concomitant medications. Patients and Methods: The MONONOFU study was a Phase 2, randomized, placebo-controlled, multicenter study of lasmiditan for acute migraine treatment in Japanese adults. Patients reported comorbidities (pre-existing or coexisting conditions) during screening. Concomitant medications (any drugs taken ± 48 hours of the study drug) and treatment-emergent adverse events (TEAEs) were recorded in a paper diary. Study drug efficacy (pain freedom 2 hours after administration of study drug) was reported in an eDiary. Logistic regression models were used for subgroup analyses of safety (incidence of TEAEs) and efficacy (pain freedom at 2 hours post dose) of lasmiditan in relation to presence/absence of comorbidities, and safety in relation to concomitant medications. Results: Common comorbidities (occurring in ≥ 10% of any lasmiditan dose group) were seasonal allergies, allergic rhinitis, tension-type headache, cervicobrachial syndrome, dysmenorrhea, nasopharyngitis, musculoskeletal stiffness, chronic gastritis, constipation, and insomnia. There was no significant interaction of treatment with comorbidity for safety or efficacy. There was also no significant interaction between treatment and concomitant medication groups of special interest (acetaminophen/nonsteroidal anti-inflammatory drugs, triptans, antiemetics, central nervous system depressant medications, serotonergic medications, antiepileptics, antihypertensive medications, Chinese herbal medicines, and contraceptives) for incidence of TEAEs. Conclusion: In Japanese people with migraine, the safety of lasmiditan appeared to be independent of common comorbidities and concomitant medications; efficacy appeared to be independent of comorbid conditions. Clinical Trials Registration: NCT03962738 (ClinicalTrials.gov). [ABSTRACT FROM AUTHOR]

Latest advances in non-small cell lung cancer (NSCLC) therapies have revolutionized the treatment regimens utilized for NSCLCs with or without a driver mutation. Molecular targeted treatments such as tyrosine kinase inhibitors (TKIs) are utilized to prevent tumor progression and improve survival. Despite the great benefit of immunotherapy in NSCLC tumors with no driver mutation, the use of immune checkpoint inhibitors (ICIs) in NSCLC tumors harboring a driver mutation has been under debate. Furthermore, several trials have been conducted investigating the use of these therapies with TKIs. A few trials were halted due to growing concerns of increased toxicity with the combination of TKI and immunotherapy. The adverse events ranged from low grade dermatologic complaints to fatal interstitial lung diseases. These toxicities occur with both concurrent and sequential administration of treatment. Thus, recommendations for the safest method of combination treatment have not yet been described. This review paper discusses recent views on combination treatment, previous clinical trials reporting grade 3-4 toxicities, and guidelines for a safe timeline of administration of treatment based on past evidence. [ABSTRACT FROM AUTHOR]

Simple Summary: Peritoneal metastases have a poor prognosis, and one potential treatment option is cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC). The specific role of HIPEC is still poorly defined. In this cross-sectional study, we systematically analyzed all HIPEC trials registered on ClinicalTrials.gov to identify current research areas and to provide a perspective on expected outcomes. Only 11% (n = 26) of HIPEC trials registered on ClinicalTrials.gov (n = 234) have been published. The registered trials are very heterogeneous regarding methodological approaches and study designs. Currently, research is being conducted on 20 different drugs. The most studied cancers in HIPEC trials are peritoneal metastatic colorectal tumors, gastric cancer, and ovarian cancer. Introduction: Over the past two decades, cytoreductive surgery and HIPEC has improved outcomes for selected patients with peritoneal metastasis from various origins. This is a cross-sectional study with descriptive analyses of HIPEC trials registered on ClinicalTrials.gov. This study aimed to characterize clinical trials on HIPEC registered on ClinicalTrials.gov with the primary objective of identifying a trial focus and to examine whether trial results were published. Methods: The search included trials registered from 1 January 2001 to 14 March 2022. We examined the associations of exposure variables and other trial features with two primary outcomes: therapeutic focus and results reporting. Results: In total, 234 clinical trials were identified; 26 (11%) were already published, and 15 (6%) trials have reported their results but have not been published as full papers. Among ongoing nonpublished trials, 81 (39%) were randomized, 30 (14%) were blinded, n = 39 (20%) were later phase trials (i.e., phases 3 and 4), n = 152 (73%) were from a single institution, and 91 (44%) had parallel groups. Most of the trials were recruiting at the time of this analysis (75, 36%), and 39 (20%) were completed but had yet to publish results. In total, 68% of the trials focused on treatment strategies, and 53% investigated the oncological outcome. The most studied neoplasms for HIPEC trials were peritoneally metastasized colorectal cancer (32%), gastric cancer (29%), and ovarian cancer (26%). Twenty different drugs were analyzed in these clinical trials. Conclusions: Many study results are awaited from ongoing HIPEC trials. Most HIPEC trials focused on gastric, colorectal, or ovarian cancer. Many clinical trials were identified involving multiple entities and chemotherapeutic agents. [ABSTRACT FROM AUTHOR]

Systematic reviews rank at the top of the evidence hierarchy. Concise writing implies drafting the systematic review article succinctly, i.e. using as few words to express as full an extent of the research effort as possible. Precise writing means drafting the text with accuracy especially with respect to the methodological and statistical aspects. The Abstract ought to be succinct and structured to allow for editors, peer reviewers and readers to get the gist of the key aspects of the systematic review with a quick read. The readership needs to be able to critically appraisal systematic reviews for their internal and external validity rapidly. The Abstract also needs to be standalone, representing an independent summary that can be fully understood without the need for reading the full paper. The standard structure of the main text of a scientific article called IMRaD (Introduction, Methods, Results and Discussion) applies equally to systematic reviews in the same way as it does to any other kinds of research manuscripts whether related to laboratory experiments or clinical trials. Restricting the word count limits to those imposed by journals may at first seem difficult, even unfair, to systematic reviewers. However, with the availability of online appendices to transparently and fully report the details of the methods, results and other aspects of the work undertaken allows for a succinct print or PDF article. Writing a shorter manuscript is more effortful than writing a longer report. This commentary is aimed at novice systematic reviewers to help them learn the written and unwritten writing rules in order to assist them in producing impactful publications to support evidence-based medicine. [ABSTRACT FROM AUTHOR]

Background Few studies have assessed participant safety in human challenge trials (HCTs). Key questions regarding HCTs include how risky such trials have been, how often adverse events (AEs) and serious adverse events (SAEs) occur, and whether risk mitigation measures have been effective. Methods A systematic search of PubMed and PubMed Central for articles reporting on results of HCTs published between 1980 and 2021 was performed and completed by 7 October 2021. Results Of 2838 articles screened, 276 were reviewed in full. A total of 15 046 challenged participants were described in 308 studies that met inclusion criteria; 286 (92.9%) of these studies reported mitigation measures used to minimize risk to the challenge population. Among 187 studies that reported on SAEs, 0.2% of participants experienced at least 1 challenge-related SAE. Among 94 studies that graded AEs by severity, challenge-related AEs graded "severe" were reported by between 5.6% and 15.8% of participants. AE data were provided as a range to account for unclear reporting. Eighty percent of studies published after 2010 were registered in a trials database. Conclusions HCTs are increasingly common and used for an expanding list of diseases. Although AEs occur, severe AEs and SAEs are rare. Reporting has improved over time, though not all papers provide a comprehensive report of relevant health impacts. We found very few severe symptoms or SAEs in studies that reported them, but many HCTs did not report relevant safety data. This study was preregistered on PROSPERO as CRD42021247218. [ABSTRACT FROM AUTHOR]