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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]

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.

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.

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]

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]

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]

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]

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]

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]

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]

Background: The majority of surgical interventions are performed in day care and patients are discharged after the first critical postoperative period. At home, patients have limited options to contact healthcare providers in the hospital in case of severe pain and nausea. A smartphone application for patients to self-record pain and nausea when at home after day care surgery might improve patient's recovery. Currently patient experiences with smartphone applications are promising; however, we do not know whether remote monitoring with such an application also improves the patient's recovery. This study aims to evaluate the experienced quality of recovery after day care surgery between patients provided with the smartphone application for remote monitoring and patients receiving standard care without remote monitoring. Methods: This non-blinded randomized controlled trial with mixed methods design will include 310 adult patients scheduled for day care surgery. The intervention group receives the smartphone application with text message function for remote monitoring that enables patients to record pain and nausea. An anaesthesia professional trained in empathetic communication, who will contact the patient in case of severe pain or nausea, performs daily monitoring. The control group receives standard care, with post-discharge verbal and paper instructions. The main study endpoint is the difference in perceived quality of recovery, measured with the QoR-15 questionnaire on the 7th day after day care surgery. Secondary endpoints are the overall score on the Quality of Recovery-15 at day 1, 4 and 7-post discharge, the perceived quality of hospital aftercare and experienced psychological effects of remote monitoring during postoperative recovery from day care surgery. Discussion: This study will investigate if facilitating patients and healthcare professionals with a tool for accessible and empathetic communication might lead to an improved quality of the postoperative recovery period. Trial registration: The 'Quality of recovery after day care surgery with app-controlled remote monitoring: a randomized controlled trial' is approved and registered on 23 February 2022 by Research Ethics Committees United with registration number R21.076/NL78144.100.21. The protocol NL78144.100.21, 'Quality of recovery after day care surgery with app-controlled remote monitoring: a randomized controlled trial', is registered at the ClinicalTrials.gov public website (registration date 16 February 2022; NCT05244772) [ABSTRACT FROM AUTHOR]

When a lien is established by entry in a specific public register (registry), it is a registered lien – a mortgage. According to the method of establishment, the right of lien, which is established by entry in the public register (registry), is called a mortgage. In modern real law insurance systems, an important place is occupied by lien law insurance, which allows the creditor, upon maturity of the claim, if it is not settled, to be settled from the value of the pledged thing, regardless of whether the thing at the time of settlement is owned by the pledge debtor or not. In this sense, the arrangement of lien insurance on things that are restricted in circulation for social, political and security reasons is particularly important. Thus, for weapons, a special regulation has determined the regime of legal circulation characterized by various restrictions, approvals and records of possession and ownership. Possession of weapons in the Republic of Croatia is governed by the Act on the Acquisition and Possession of Weapons by Citizens. However, the assumptions, effects and procedure for registration of a registered lien on weapons as movable property are governed by the Act on the Register of Court and Public Notary Security of Claims on Movable Property and Rights. In this regard, there are various registers in which different actual rights to weapons are registered, and which are kept by different state bodies. The paper analyses the actual legal significance (declaratory and constitutive) of the registration of weapons in various registers, the procedure and legal consequences of the registration. Open issues of establishment and transfer of lien rights, satisfaction of the lien creditor, right to possession and use of weapons as pledge are highlighted. The adequacy of the existing types of entries in the Register of Court and Public-Notary Security of Claims on Movable Property and Rights is analysed. The paper offers to provide guidelines and possible solutions for the regulation of these issues de lege ferenda that would meet the general, political and legal interests, as well as interests in private law of real rights holders on weapons. [ABSTRACT FROM AUTHOR]

Background: Selective publication of studies has important scientific, ethical, and public health implications. Aim: We studied selective publication among mood disorder research protocols registered in the Clinical Trials Registry of India (CTRI) database. We also examined the frequency and nature of protocol deviations among the published articles. Methods: Using a systematic search strategy, we examined the publication status of all mood disorder-related research protocols registered in the CTRI database from inception till December 31, 2019. Logistic regression analysis was used to identify variables associated with selective publication. Results: Of 129 eligible protocols identified, only a third (n = 43, 33.3%) were published in literature; among those published, only 28 (21.7%) were placed in MEDLINE indexed journals. Protocol deviations were observed in more than half of the published papers (n = 25, 58.1%); many of these (41.9%) were related to sample size deviations, though, importantly, deviations in primary and secondary outcomes were also noted (16.2%). Retrospective registration of trials (odds ratio, 2.98, 95% confidence interval, 1.32--6.71) was significantly associated with publication; other variables, such as funding status or multicentric sampling, were not associated with eventual publication. Conclusions: Two out of three mood disorder research protocols registered in India do not translate into published research. These findings from a low- and middle-income country with limited spending on health care research and development represent wastage of resources and raise scientific and ethical concerns about unpublished data and futile patient participation in research. [ABSTRACT FROM AUTHOR]

The systematic cadastral work in Romania involves the identification and measurement of buildings and their owners, their registration in the technical cadastral documents and their representation on cadastral plans, in order to be entered in the land register. Theseworks are carried out within the National Program, a program whose purpose is the free registration of buildings in the integrated cadastre and land book system, the realization of the cadastral plan of buildings and the opening of land books at the level of all UATs. The paper presents the situation of the systematic registration of properties in Mure county. [ABSTRACT FROM AUTHOR]

Increasing farmers' income has always been the core task of China's land reform. In 2017, a nationwide pilot project on the use of collective construction land for the construction of rental housing was launched. This study employed the synthetic difference-in-differences method to examine whether the reform contributed to the growth of farmers' property income. It was found that, compared with non-pilot areas, the property income of farmers in the pilot reform of collective construction land rental housing has increased by about 0.4334% on average, and this conclusion is still valid after a series of robustness tests. The role of the reform in promoting farmers' property income is more evident in Western China, Southern China and non-major grain-producing areas. By revealing the impact of the reform on farmers' property income, this paper enriches the literature related to the field of farmers' income increase and provides a policy reference for narrowing the urban–rural gap and achieving the development of rural revitalization and common prosperity. [ABSTRACT FROM AUTHOR]

Introduction: A bone fracture is a break in the continuity of bone tissue, caused by the action of an external or internal force on the bone. Ankle sprains are one of the most common injuries among athletes. Physically active people who participate in activities that require jumping, changing direction, and turning have an increased risk of ankle sprains. Ankle sprains and the repetitive trauma often associated with this condition can lead to long-term disability, lost time from activity, and financial burdens for athletes. Methods: The work is non-experimental (qualitative research), i.e. a review of scientific literature. The search included an overview of the relevant databases: Medline, PubMed, Google Scholar, Research Gate. The literature review includes 4 randomized clinical trials and 1 randomized single-blind trial. The mentioned databases were searched with the help of keywords: athletes, injury, ankle joint, rehabilitation. Results: Through a scientific review of the literature, the results of the significance and productivity of the application of rehabilitation in athletes with an ankle injury are presented. The results include the presentation and analysis of five published scientific papers in the period 2018-2020. The studies used for this review were published in India, Saudi Arabia, Iran, United States, Austria. Conclusion: By reviewing the scientific literature, it can be concluded that there are improvements in the quality of life of athletes after an ankle injury. The greatest improvements were noted in strength, balance and functional task performance. The application of the rehabilitation program plays an important role in reducing pain and stabilizing the knee joint. [ABSTRACT FROM AUTHOR]

Purpose: Rural community-based organizations (CBOs) serving immigrant communities are critical settings for implementing evidence-based interventions (EBIs). The Implementation Studio is a training and consultation program focused on facilitating the selection, adaptation, and implementation of cancer prevention and control EBIs. This paper describes implementation and evaluation of the Implementation Studio on CBO's capacity to implement EBIs and their clients' knowledge of colorectal cancer (CRC) screening and intention to screen. Methods: Thirteen community health educators (CHEs) from two CBOs participated in the Implementation Studio. Both CBOs selected CRC EBIs during the Studio. The evaluation included two steps. The first step assessed the CHEs' capacity to select, adapt, and implement an EBI. The second step assessed the effect of the CHEs-delivered EBIs on clients' knowledge of CRC and intention to screen (n = 44). Results: All CHEs were Hispanic and women. Pre/post-evaluation of the Studio showed an increase on CHEs knowledge about EBIs (pre: 23% to post: 75%; p < 0.001). CHEs' ability to select, adapt, and implement EBIs also increased, respectively: select EBI (pre: 21% to post: 92%; p < 0.001), adapt EBI (pre: 21% to post: 92%; p < 0.001), and implement EBI (pre: 29% to post: 75%; p = 0.003). Pre/post-evaluation of the CHE-delivered EBI showed an increase on CRC screening knowledge (p < 0.5) and intention to screen for CRC by their clients. Conclusion: Implementation Studio can address unique needs of low resource rural CBOs. An implementation support program with training and consultation has potential to build the capacity of rural CBOs serving immigrant communities to implementation of cancer prevention and control EBIs. Clinical Trials Registration Number: NCT04208724 registered. [ABSTRACT FROM AUTHOR]

Background: Research on clinical trials that employ stem cells to treat children's diseases is limited. The clinical trial registry database provides a unique window to us to get known about clinical trial researches with different statuses. However, few studies aimed to perform a comprehensive and thorough analysis of those registered trials in the aforementioned field based on ClinicalTrials.gov and the ICTRP portal site. Methods: Our study covered the clinical researches about stem cell therapy enrolling subjects aged under 18 years old registered on ClinicalTrials.gov and WHO ICTRP before May 18, 2021. A cross-sectional study was implemented to comprehensively describe and analyze the included trials that met the criteria. Results were available on ClinicalTrials.gov, and publications related to the included trials were identified. All analyses were performed utilizing the SPSS 25.0 software. Results: Eventually, 202 clinical trials were included and evaluated. The participant number of trials tended to be small; 71.3% were enrolled < 50. And 93.5% of the subjects were without gender restrictions. Till May 2020, 112 trials had been preliminary completed, of which only 39 trials had published papers or uploaded results. Most (73.6%) of 186 interventional trials were in phase 1 and phase 2, where 131 (70.4%) trials were conducted without masking, and 26.3% trials were randomized; 55.4% trials were performed single group assignment. Of 16 observational trials, case-only/series took up 37.5%. Hematopoietic stem cells (37.1%) and mesenchymal stem cells (36.1%) were mostly employed, while umbilical cord blood (UCB)-derived cells (24.3%) and bone marrow (BM)-derived cells (20.8%) were the major sources. Conclusions: This study provided an overall picture of utilizing stem cells for treatment and management of childhood diseases. Since clinical trials in this area are insufficient in quantity and quality, there is an urgent need of larger, better-designed trials. Increased investment in clinical research of stem cell treatment products should be carried out to achieve the transformation of results as soon as possible. Moreover, it is important to optimize the management of the registration platform and shorten the time it takes for research results to be published. [ABSTRACT FROM AUTHOR]

Copyright of Tarih İncelemeleri Dergisi is the property of Tarih Incelemeleri Dergisi 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.)

Purpose: To evaluate the impact of removable partial dentures (RPDs) on masticatory performance (MP) of partially edentulous subjects. Materials and Methods: Electronic database and hand searches were conducted to explore clinical trials reporting the evidence of the effect of metal- and acrylic-based RPDs on mastication. The validated objective and subjective measures of assessment of mastication were included. The article selection, data extraction, and assessment of risk of bias were conducted by two reviewers independently. Results: Out of 11,200 studies, 1 randomized controlled trial and 23 clinical trials met the inclusion criteria. Positive impact on different parameters of masticatory function after RPD treatment was reported in 14 studies. Subjective evaluation of chewing ability (CA) displayed an improvement in 83.3% of studies, while improvement was evidenced only in 69.5% of studies upon objective evaluation. Most studies reported data on free-end saddles. Of the 13 studies associated with bilateral free-end saddle dentures, 9 studies showed a positive effect on masticatory efficiency. Various factors were found to have an impact on the MP of RPDs. Conclusions: Subjective evaluation displays higher positive impact of RPDs in MP than objective evaluation. Assessment of patients' perspectives is important in clinical decision-making. Multiple factors affect the MP with RPD treatment. [ABSTRACT FROM AUTHOR]

Background: Digital health technologies (DHTs) can facilitate the execution of de-centralized trials that can offer opportunities to reduce the burden on participants, collect outcome data in a real-world setting, and potentially make trial populations more diverse and inclusive. However, DHTs can also be a significant source of electronic waste (e-waste). In recognition of the potential health and environmental impact from DHT use in trials, private and public institutions have recently launched initiatives to help measure and manage this e-waste. But in order to develop sound e-waste management policies, it will be necessary to first estimate the current volume of e-waste that results from the use of DHTs in trials. Materials and Methods: A Web Ontology Language (OWL)-compliant ontology of DHTs was created using a list of 500 DHT device names derived from a mixture of public and private sources. The U.S. clinical trials registry, ClinicalTrials.gov, was then queried to identify and classify trials using any of the devices in the ontology. The ClinicalTrials.gov records from this search were then analyzed to characterize the volume and properties of trials using DHTs, as well as estimating the total volume of individual DHT units that have been provisioned (or are planned to be provisioned) for clinical research. Results: Our ontology-driven search identified 2326 unique clinical trials with a reported "actual" enrollment of 200,947 participants and a "planned" enrollment of an additional 4,094,748 participants. The most-used class of DHTs in our ontology was "wearables," (1852 trials), largely driven by the use of smart watches and other wrist-worn sensors (estimated to involve 149,391 provisioned devices). The most-used subtype of DHTs in trials was "subcutaneous" devices (367 trials), driven by the prevalent use and testing of glucose monitors (estimated to involve 17,666 provisioned devices). Conclusion: Thousands of trials, involving hundreds of thousands of devices, have already been completed, and many more trials (potentially involving millions more devices) are planned. Despite the great opportunities that are afforded by DHTs to the clinical trial enterprise, if the industry lacks the ability to track DHT use with sufficient resolution, the result is likely to be a great deal of e-waste. A new ontology of DHTs, combined with rigorous data science methods like those described in this paper, can be used to provide better information across the industry, and in turn, help create a more sustainable and equitable clinical trials enterprise. [ABSTRACT FROM AUTHOR]

Background: Clinical trial registries allow assessment of deviations of published trials from their protocol, which may indicate a considerable risk of bias. However, since entries in many registries can be updated at any time, deviations may go unnoticed. We aimed to assess the frequency of changes to primary outcomes in different historical versions of registry entries, and how often they would go unnoticed if only deviations between published trial reports and the most recent registry entry are assessed. Methods and findings: We analyzed the complete history of changes of registry entries in all 1746 randomized controlled trials completed at German university medical centers between 2009 and 2017, with published results up to 2022, that were registered in ClinicalTrials.gov or the German WHO primary registry (German Clinical Trials Register; DRKS). Data were retrieved on 24 January 2022. We assessed deviations between registry entries and publications in a random subsample of 292 trials. We determined changes of primary outcomes (1) between different versions of registry entries at key trial milestones, (2) between the latest registry entry version and the results publication, and (3) changes that occurred after trial start with no change between latest registry entry version and publication (so that assessing the full history of changes is required for detection of changes). We categorized changes as major if primary outcomes were added, dropped, changed to secondary outcomes, or secondary outcomes were turned into primary outcomes. We also assessed (4) the proportion of publications transparently reporting changes and (5) characteristics associated with changes. Of all 1746 trials, 23% (n = 393) had a primary outcome change between trial start and latest registry entry version, with 8% (n = 142) being major changes, that is, primary outcomes were added, dropped, changed to secondary outcomes, or secondary outcomes were turned into primary outcomes. Primary outcomes in publications were different from the latest registry entry version in 41% of trials (120 of the 292 sampled trials; 95% confidence interval (CI) [35%, 47%]), with major changes in 18% (54 of 292; 95% CI [14%, 23%]). Overall, 55% of trials (161 of 292; 95% CI [49%, 61%]) had primary outcome changes at any timepoint over the course of a trial, with 23% of trials (67 of 292; 95% CI [18%, 28%]) having major changes. Changes only within registry records, with no apparent discrepancy between latest registry entry version and publication, were observed in 14% of trials (41 of 292; 95% CI [10%, 19%]), with 4% (13 of 292; 95% CI [2%, 7%]) being major changes. One percent of trials with a change reported this in their publication (2 of 161 trials; 95% CI [0%, 4%]). An exploratory logistic regression analysis indicated that trials were less likely to have a discrepant registry entry if they were registered more recently (odds ratio (OR) 0.74; 95% CI [0.69, 0.80]; p<0.001), were not registered on ClinicalTrials.gov (OR 0.41; 95% CI [0.23, 0.70]; p = 0.002), or were not industry-sponsored (OR 0.29; 95% CI [0.21, 0.41]; p<0.001). Key limitations include some degree of subjectivity in the categorization of outcome changes and inclusion of a single geographic region. Conclusions: In this study, we observed that changes to primary outcomes occur in 55% of trials, with 23% trials having major changes. They are rarely transparently reported in the results publication and often not visible in the latest registry entry version. More transparency is needed, supported by deeper analysis of registry entries to make these changes more easily recognizable. Protocol registration: Open Science Framework (https://osf.io/t3qva; amendment in https://osf.io/qtd2b). In this meta-research study, Martin Holst and colleagues investigate changes to prespecified primary outcomes in the historic registries of clinical trials. Author summary: Why was this study done?: Clinical trial registries are a key tool to increase the trustworthiness of clinical trials. They allow assessment of how closely a published trial follows its original plan. However, registry entries can be updated at any time, which creates a trail of historical versions. If the latest registry entry version matches with the published trial report, important preceding changes might thus be unapparent to assessors at first glance. Our objective was to investigate how often primary outcomes are changed in the trial registry over the course of a trial, and how often outcome changes are unapparent if one compares only the latest registry entry version to the publication. What did the researchers do and find?: We assessed all 1746 randomized controlled trials completed at German university medical centers between 2009 and 2017, that have a results publication. We determined the frequency of outcome changes between different versions of a registry entry, as well as the latest registry entry and the results publication. We defined adding or dropping primary outcomes, changing them to secondary outcomes, or turning secondary outcomes into primary outcomes, as major changes. We found that approximately 55% of trials had primary outcome changes at any timepoint over the course of a trial; 23% of trials had major changes. We observed changes that can be easily identified by comparing the published results to the latest registry entry in 41% of trials. In 14% of trials, however, the changes would require an in-depth look within the historical versions of that trial's registry entry. Only 1% of trials with changes (2 trials) reported this in the corresponding publications. What do these findings mean?: Our analysis suggests that changes to primary outcomes of a clinical trial are common, are often major, and have a potential to go unnoticed. More transparency is needed, supported by deeper analysis of registry entries to reveal these outcome changes. [ABSTRACT FROM AUTHOR]

Pharmacovigilance studies based on spontaneous reporting systems use disproportionality analysis methods to identify drug‐event combinations with higher‐than‐expected reporting. Enhanced reporting is deemed as a proxy for a detected signal and is used to generate drug safety hypotheses, which can then be tested in pharmacoepidemiologic studies or randomized controlled trials. Higher‐than‐expected reporting means that the reporting rate of a drug‐event combination of interest is disproportionately higher than the rate in a specific comparator or reference set. Currently, it is unclear which comparator is the most appropriate for use in pharmacovigilance. Moreover, it is also unclear how the selection of a comparator may affect the directionality of the various reporting and other biases. This paper reviews commonly used comparators chosen for signal detection studies (active comparator, class‐exclusion comparator, and full data reference set). We give an overview of the advantages and disadvantages of each method based on examples from the literature. We also touch upon the challenges related to the derivation of general recommendations for the selection of comparators when mining spontaneous reports for pharmacovigilance. [ABSTRACT FROM AUTHOR]