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Introduction- Acute pancreatitis exhibits a significant mortality rate, making early identification crucial for effective care and risk stratification. Harmless acute pancreatitis score (HAPS) is one such score that is easy to calculate and is done at the time of admission, bedside index of severity in acute pancreatitis (BISAP) is another one requiring more parameters. The present study was done to do a comparative evaluation of Harmless Acute Pancreatitis Score (HAPS) and Bedside Index of Severity in Acute Pancreatitis (BISAP) Scoring System in the Stratification of Prognosis in Acute Pancreatitis. Material and methods- The present prospective observational study was conducted among 150 patients of acute pancreatitis at department of medicine, GMC, Jammu for a study period of one year. The patient was evaluated using the BISAP and HAP scores. Analysis was conducted using Statistical Package for Social Sciences (SPSS) version 25.0. Results- The mean age of patients was 36.45 years. Out of 150 patients 42.6% were male and 57.4% were female. HAPS was positive in 50 % (75) patients. BISAP score was positive in 86% (129) of patients while negative in 14% (21) of patients. BISAP has a sensitivity of 63% and high specificity of 100%. The diagnostic accuracy of BISAP is also high, at around 94%. However, the diagnostic accuracy of HAPS stands at around 66%. Conclusion- HAPS is a highly sensitive metric for predicting the severity of acute pancreatitis. HAPS appears to be an effective tool for assisting physicians in evaluating the severity of AP. HAPS may be regarded as the benchmark for predicting AP for prompt and economical treatment. [ABSTRACT FROM AUTHOR]

Background: Fenugreek plant (Trigonella foenum-graecum) constitutes a traditionally acclaimed herbal remedy for many human ailments including diabetes, obesity, neurodegenerative diseases, and reproductive disorders. It is also used as an effective anti-oxidative, anti-inflammatory, antibacterial, and anti-fungal agent. The seed of the plant is especially enriched in several bioactive molecules including polyphenols, saponins, alkaloids, and flavonoids and has demonstrated potential to act as an antidiabetic phytotherapeutic. A novel patented formulation (Fenfuro®) was developed in our laboratory from the fenugreek seeds which contained >45% furostanolic saponins (HPLC). Objective: A placebo-controlled clinical compliance study was designed to assess the effects of complementing Fenfuro® on a randomized group of human volunteers on antidiabetic therapy (Metformin and sulphonylurea) in controlling the glycemic index along with simultaneous safety assessment. Study methodology and trial design: In a randomized double-blind, placebo-controlled trial, 42 individuals (21 male and 21 female volunteers) in the treatment group (out of 57 enrolled) and 39 individuals (17 male and 22 female volunteers) in the placebo group (out of 47 enrolled), all on antidiabetic therapy with Metformin/Metformin with sulphonyl urea within the age group of 18–65 years were administered either 1,000 mg (500 mg × 2) (Fenfuro®) capsules or placebo over a period of 12 consecutive weeks. Fasting and postprandial glucose along with glycated hemoglobin were determined as primary outcomes to assess the antidiabetic potential of the formulation. Moreover, in order to evaluate the safety of the formulation, C-peptide and Thyroid Stimulating Hormone (TSH) levels as well as immunohematological parameters were assessed between the treatment and placebo groups at the completion of the study. Results: After 12 weeks of administration, both fasting as well as postprandial serum glucose levels decreased by 38 and 44% respectively in the treatment group. Simultaneously, a significant reduction in glycated hemoglobin by about 34.7% was also noted. The formulation did not have any adverse effect on the study subjects as there was no significant change in C- peptide level and TSH level; liver, kidney, and cardiovascular function was also found to be normal as assessed by serum levels of key immunohematological parameters. No adverse events were reported. Conclusion: This clinical compliance study re-instated and established the safety and efficacy of Fenfuro® as an effective phytotherapeutic to treat hyperglycemia.

Purpose: Patients with abdominal rectus diastasis (ARD) may have muscular functional impairments, but clinics lack appropriate objective assessment tools. The aim was to establish the relative and absolute reliability, and convergent validity, of muscular activity using Surface Electromyography (SEMG) during isometric abdominal muscle strength testing in patients with ARD and controls without ARD. Methods: Twenty-six patients with ARD were matched for age, sex and BMI with controls without ARD. Participants were tested twice during isometric muscular contractions using SEMG located on six abdominal sites. Mean amplitude, fatigue, and recruitment order were analyzed. Relative reliability was evaluated with Intraclass Correlation Coefficients (ICC), while absolute reliability was estimated by calculating the Standard Error of Measurement and Minimal Detectable Change. Convergent validity was addressed in relation to participant characteristics, functional ability, and symptoms. Results: Mean SEMG amplitude for all abdominal wall muscle contractions showed moderate to excellent relative test–retest reliability, with ICC values ranging from 0.46 to 0.97. In contrast, fatigue and recruitment order displayed poor to moderate relative reliability in both groups. Absolute reliability measures were generally high. A moderate to high convergent validity (ARD: rho-value 0.41–0.70; Controls: rho-value 0.41–0.75) was observed for mean amplitude in relation to a functional sit-to-stand test, abdominal circumference, BMI, back pain, and quality-of-life. Conclusions: The results of applying SEMG during isometric abdominal muscle support practicing the method in clinics, although additional development is needed with further standardization and more functional testing. Furthermore, the method demonstrates construct validity in patients with ARD and in age- and sex-matched controls. [ABSTRACT FROM AUTHOR]

Objective: Combining clinical investigations with usability studies provides valuable information for medical devices evaluation. But both types of study are very different in terms of objectives and methodologies. How are usability studies integrated into clinical investigations in practice? Methods: We searched the ClinicalTrials.gov database for clinical investigation protocols that included usability outcome(s) and analyzed them. Results: 77 study protocols were identified for the analysis, including 102 outcomes related to usability in total. The most frequently assessed outcomes were satisfaction (53/102) and ease of use (33/102). The questionnaire was the most frequently planned technique (85/102) followed by interviews (24/102). Other methods were used, such as observation (9/102), mostly when the end users was a healthcare professional, and diary (6/102), mostly with patients. Conclusion: Our study results showed that the collection of usability data can be included in a clinical investigation, with various levels of investment. Resource-light, rapid integration via a questionnaire will enable the collection of subjective data on the users' perceptions. When more resources are available, observation in accessible environments can be set up (especially during use by healthcare professionals in hospital) or interviews and/or diaries for home-based environments (especially by patients). [ABSTRACT FROM AUTHOR]

Severe hypo- and hypercalcemia are common and urgent treatment is recommended. Free calcium (fCa) is the gold standard but needs blood gas tests with challenging preanalytics. Total calcium (tCa) and calculated adjusted calcium (aCa) are readily available, but their interpretation is hampered by identical tCa and aCa cutoffs, laborious local aCa calculation and difficult comparability of calcium biomarkers. Laboratory results from University Medicine Leipzig were evaluated over a five-year period (236,274 patients). A local aCa equation was derived by linear least squares regression, the agreement between fCa, tCa and aCa assessed with Cohen's κ and decision thresholds derived by this indirect method. The local aCa equation was created from data of 9,756 patients, each with one paired measurement of tCa, fCa and albumin. Derived aCa cutoffs (1.95/3.15 mmol/L) differ markedly from derived tCa cutoffs (1.6/2.9 mmol/L) and severe hypo- and hypercalcemia can be more accurately assessed by aCa (κ=0.489, 0.812) than by tCa (κ=0.445, 0.744). Comparing our approach to standard care (tCa, literature cutoff), a total 3,250 of 3,680 (88.3 %) misclassified measurements were correctly classified when using aCa with evidence-based cutoffs. Optimized cutoffs for aCa and tCa hold great potential for improved patient care. Locally derived aCa equations differ mostly in the chosen mean normal calcium and provide minimal overall improvement, but entail a close examination of the used cutoffs before application. [ABSTRACT FROM AUTHOR]

Objective: This study aims to explore the training mode for brain death determination to ensure the quality of subsequent brain death determination. Methods: A four-skill and four-step (FFT) training model was adopted, which included a clinical neurological examination, an electroencephalogram (EEG) examination, a short-latency somatosensory evoked potential (SLSEP) examination, and a transcranial Doppler (TCD) examination. Each skill is divided into four steps: multimedia theory teaching, bedside demonstration, one-on-one real or dummy simulation training, and assessment. The authors analyzed the training results of 1,577 professional and technical personnel who participated in the FFT training model from 2013 to 2020 (25 sessions), including error rate analysis of the written examination, knowledge gap analysis, and influencing factors analysis. Results: The total error rates for all four written examination topics were < 5%, at 4.13% for SLSEP, 4.11% for EEG, 3.71% for TCD, and 3.65% for clinical evaluation. The knowledge gap analysis of the four-skill test papers suggested that the trainees had different knowledge gaps. Based on the univariate analysis and the multiple linear regression analysis, among the six factors, specialty categories, professional and technical titles, and hospital level were the independent influencing factors of answer errors (p < 0.01). Conclusion: The FFT model is suitable for brain death (BD) determination training in China; however, the authors should pay attention to the professional characteristics of participants, strengthen the knowledge gap training, and strive to narrow the difference in training quality. [ABSTRACT FROM AUTHOR]

Purpose: In recent years, ceramic implants made of zirconia have secured a niche position next to established titanium implants, due partly to new scientific findings and positive clinical experience with the handling of ceramic implants. The aim of this study was to assess the clinical and radiographic data for monotype ceramic implants that have remained in place for 60 months under masticatory loading. Materials and Methods: In 2011, this prospective clinical study included patients with a single-tooth gap in the maxilla and mandible. Monotype ceramic implants (Straumann) were used according to a standard protocol. Provisional prostheses were placed after 3 months, followed by final prostheses 3 months later. Patients were invited for a 60-month follow-up. Implant survival was analyzed from lifetime data. Success rates and crestal bone levels were evaluated from implant placement to 6, 12, 36, and 60 months after surgery. Results: From the initial 44 patients recruited, 36 were analyzable for the 60-month follow-up. With one implant lost before the 6-month followup, the survival rate after 60 months was 97.7%, and the mean survival time was 58.7 months. Sixty months after implant placement, the success rate was 97.2% (95% confidence interval = 84.6% to > 99.9%). Mean bone loss after 60 months was 0.99 (± 0.59) mm. Conclusion: After 60 months, monotype ceramic implants made of zirconia achieved success and survival rates comparable with those reported for titanium implants in selected patient populations. Ceramic implants can be used as an alternative to titanium implants at the request of patients and if specifically indicated, for example, due to titanium intolerance. [ABSTRACT FROM AUTHOR]

This article discusses the impact of viral co-infection on cellular or human health and its clinical outcome. Co-infection occurs when a host is infected by two or more pathogens, such as viruses, bacteria, fungi, and protozoa. This phenomenon can lead to complications, including altered viral pathogenicity and disrupted host defense. The article explores different patterns of interaction between viruses in co-infection, such as interference, synergy, non-interference, dependence assistance, and host-parasite relationship. It also examines specific cases of co-infection, including tuberculosis with HIV co-infection, co-infections with SARS-CoV-2, human polyomavirus, influenza virus, and human T-cell leukemia virus type 1. The research aims to uncover new insights into viral pathogenesis and improve understanding of the complex interplay between viral pathogens and human health. [Extracted from the article]

The human factors engineering (HFE) process supports the design and development of medical devices, especially novel devices requiring clinical investigation. The typical culmination of the HFE process prior to market approval is a human factors (HF) validation study, with specific requirements of participant, environment and task representation that carry a financial and temporal burden for medical device manufacturers. Whilst strongly recommended ahead of clinical investigations by regulators (and the authors), the prescribed methodology for HF validation studies required for pre-market approval may be excessive ahead of a clinical investigation during the development process. However, the stringent nature of HF validation studies will support effective clinical investigation design and minimise risks of poor clinical outcome or compliance. This paper provides recommendations in what to consider when determining what type of HF study to conduct ahead of each clinical investigation phase as well as insights into the symbiotic benefits of HFE and clinical investigations. [ABSTRACT FROM AUTHOR]

Several high‐risk medical devices for children have become unavailable in the European Union (EU), since requirements and costs for device certification increased markedly due to the EU Medical Device Regulation. The EU‐funded CORE‐MD project held a workshop in January 2023 with experts from various child health specialties, representatives of European paediatric associations, a regulatory authority and the European Commission Directorate General Health and Food Safety. A virtual follow‐up meeting took place in March 2023. We developed recommendations for investigation of high‐risk medical devices for children building on participants' expertise and results of a scoping review of clinical trials on high‐risk medical devices in children. Approaches for evaluating and certifying high‐risk medical devices for market introduction are proposed. [ABSTRACT FROM AUTHOR]

The recent COVID-19 pandemic has hit humanity very hard in ways rarely observed before. In this digitally connected world, the health informatics and investigation domains (both public and private) lack a robust framework to enable rapid investigation and cures. Since the data in the healthcare domain are highly confidential, any framework in the healthcare domain must work on real data, be verifiable, and support reproducibility for evidence purposes. In this paper, we propose a health informatics framework that supports data acquisition from various sources in real-time, correlates these data from various sources among each other and to the domain-specific terminologies, and supports querying and analyses. Various sources include sensory data from wearable sensors, clinical investigation (for trials and devices) data from private/public agencies, personnel health records, academic publications in the healthcare domain, and semantic information such as clinical ontologies and the Medical Subject Heading ontology. The linking and correlation of various sources include mapping personnel wearable data to health records, clinical oncology terms to clinical trials, and so on. The framework is designed such that the data are Findable, Accessible, Interoperable, and Reusable with proper Identity and Access Mechanisms. This practically means to tracing and linking each step in the data management lifecycle through discovery, ease of access and exchange, and data reuse. We present a practical use case to correlate a variety of aspects of data relating to a certain medical subject heading from the Medical Subject Headings ontology and academic publications with clinical investigation data. The proposed architecture supports streaming data acquisition and servicing and processing changes throughout the lifecycle of the data management. This is necessary in certain events, such as when the status of a certain clinical or other health-related investigation needs to be updated. In such cases, it is required to track and view the outline of those events for the analysis and traceability of the clinical investigation and to define interventions if necessary. [ABSTRACT FROM AUTHOR]

The management of adult spinal deformity (ASD) relies upon retrospective data, but there have been calls for prospective trials to improve the evidentiary base. This study sought to define the state of the spinal deformity clinical trials and highlight trends to guide future research. The ClinicalTrials.gov database was queried for all ASD trials initiated since 2008. ASD was defined as adults (>18 years) and defined by the trial. All identified trials were categorized by enrollment status, study design, funding source, start and completion dates, country, outcomes examined, among many other study characteristics. Sixty trials were included, of which 33(55.0%) started within the past 5 years of the query date. Most trials were sponsored by academic centers (60.0%) followed by industry (48.3%). Notably, 16 (27%) trials had multiple funding sources, all included collaboration with an industry entity. Only one trial had funding from a government agency. There were 30 (50%) interventional and 30 (50%) observational studies. The average time to completion was 50.8 ± 49.1 months. A total of 23 (38.3%) studies investigated a new procedural innovation, while 17 (28.3%) studies examined the safety or efficacy of a device. Study publications were associated with 17 (28.3%) trials in the registry. The number of trials has increased significantly over the past 5 years, with the bulk of trials being funded by academic centers and industry and a notably lack by government agencies. Most trials focused on device or procedural investigation. Despite growing interest in ASD clinical trials, there remain many points for improvement in the current evidentiary base. [ABSTRACT FROM AUTHOR]

The widespread accessibility of commercial/clinically‐viable electrochemical diagnostic systems for rapid quantification of viral proteins demands translational/preclinical investigations. Here, Covid‐Sense (CoVSense) antigen testing platform; an all‐in‐one electrochemical nano‐immunosensor for sample‐to‐result, self‐validated, and accurate quantification of the severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) nucleocapsid (N)‐proteins in clinical examinations is developed. The platform's sensing strips benefit from a highly‐sensitive, nanostructured surface, created through the incorporation of carboxyl‐functionalized graphene nanosheets, and poly(3,4‐ethylenedioxythiophene) polystyrene sulfonate (PEDOT:PSS) conductive polymers, enhancing the overall conductivity of the system. The nanoengineered surface chemistry allows for compatible direct assembly of bioreceptor molecules. CoVSense offers an inexpensive (<$2 kit) and fast/digital response (<10 min), measured using a customized hand‐held reader (<$25), enabling data‐driven outbreak management. The sensor shows 95% clinical sensitivity and 100% specificity (Ct<25), and overall sensitivity of 91% for combined symptomatic/asymptomatic cohort with wildtype SARS‐CoV‐2 or B.1.1.7 variant (N = 105, nasal/throat samples). The sensor correlates the N‐protein levels to viral load, detecting high Ct values of ≈35, with no sample preparation steps, while outperforming the commercial rapid antigen tests. The current translational technology fills the gap in the workflow of rapid, point‐of‐care, and accurate diagnosis of COVID‐19. [ABSTRACT FROM AUTHOR]

Abstract The widespread accessibility of commercial/clinically‐viable electrochemical diagnostic systems for rapid quantification of viral proteins demands translational/preclinical investigations. Here, Covid‐Sense (CoVSense) antigen testing platform; an all‐in‐one electrochemical nano‐immunosensor for sample‐to‐result, self‐validated, and accurate quantification of the severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) nucleocapsid (N)‐proteins in clinical examinations is developed. The platform's sensing strips benefit from a highly‐sensitive, nanostructured surface, created through the incorporation of carboxyl‐functionalized graphene nanosheets, and poly(3,4‐ethylenedioxythiophene) polystyrene sulfonate (PEDOT:PSS) conductive polymers, enhancing the overall conductivity of the system. The nanoengineered surface chemistry allows for compatible direct assembly of bioreceptor molecules. CoVSense offers an inexpensive (

The intention of this 5-year prospective cohort investigation was to clinically and radiographically investigate the outcomes of a one-piece zirconia implant system for single tooth replacement. Sixty-five patients received a total of 66 single-tooth implants. All implants immediately received temporary restorations and were finally restored with all-ceramic crowns. Follow-ups were performed at the prosthetic delivery, after 1, 3, and 5 years. Peri-implant and dental soft-tissue parameters were evaluated and patient-reported outcomes recorded. To monitor peri-implant bone remodelling, standardised radiographs were taken at the implant insertion and at the 1-, 3-, and 5-year follow-ups. In the course of 5 years, 14 implants were lost, resulting in a cumulative implant survival rate of 78.2%. The mean marginal bone loss from the implant insertion to the 5-year follow-up amounted to 1.12 mm. Probing depth, clinical attachment level, bleeding, and plaque index increased over time. In 91.5% of the implants, the papilla index showed levels of 1 or 2, respectively. At the end of the study, the patient satisfaction was higher compared to the pre-treatment measurements. Due to the low survival rate after five years and the noticeably high frequency of advanced bone loss observed in this study, the implant has not met the launch criteria, as it would have not been recommended for routine clinical use. [ABSTRACT FROM AUTHOR]

Simple Summary: It was found that long-established tumor-derived cell lines do not adequately reproduce drug sensitivity and behavior of a real human cancers. Therefore, more reliable tumor models that recapitulate the heterogeneity and patho-physiology of patient tumors are under development. The aim of our review is to describe the current patient-derived models of cancer, discuss their advantages and disadvantages, and provide information about clinical trials and inventions in this field. This work provides a comprehensive overview of the strong and weak sides of patient-derived models, as well as the latest achievements in data collection, creation of repositories and biobanks. Cancer is a heterogeneous disease. Each individual tumor is unique and characterized by structural, cellular, genetic and molecular features. Therefore, patient-derived cancer models are indispensable tools in cancer research and have been actively introduced into the healthcare system. For instance, patient-derived models provide a good reproducibility of susceptibility and resistance of cancer cells against drugs, allowing personalized therapy for patients. In this article, we review the advantages and disadvantages of the following patient-derived models of cancer: (1) PDC—patient-derived cell culture, (2) PDS—patient-derived spheroids and PDO—patient-derived organoids, (3) PDTSC—patient-derived tissue slice cultures, (4) PDX—patient-derived xenografts, humanized PDX, as well as PDXC—PDX-derived cell cultures and PDXO—PDX-derived organoids. We also provide an overview of current clinical investigations and new developments in the area of patient-derived cancer models. Moreover, attention is paid to databases of patient-derived cancer models, which are collected in specialized repositories. We believe that the widespread use of patient-derived cancer models will improve our knowledge in cancer cell biology and contribute to the development of more effective personalized cancer treatment strategies. [ABSTRACT FROM AUTHOR]

The objective was to investigate the clinical and radiological outcome of one-piece zirconia oral implants to support three-unit fixed dental prostheses (FDP) after three years in function. Twenty-seven patients were treated with a total of 54 implants in a one-stage surgery and immediate provisionalization. Standardized radiographs were taken at implant placement, after one year and after three years, to evaluate peri-implant bone loss. Soft-tissue parameters were also assessed. Linear mixed regression models as well as Wilcoxon Signed Rank tests were used for analyzing differences between groups and time points (p < 0.05). At the three-year evaluation, one implant was lost, resulting in a cumulative survival rate of 98.1%. The mean marginal bone loss amounted to 2.16 mm. An implant success grade I of 52% (bone loss of ≤2 mm) and success grade II of 61% (bone loss of ≤3 mm) were achieved. None of the evaluated baseline parameters affected bone loss. The survival rate of the zirconia implants was comparable to market-available titanium implants. However, an increased marginal bone loss was observed with a high peri-implantitis incidence and a resulting low implant success rate. [ABSTRACT FROM AUTHOR]

Objective: To develop the clinical questions and outcomes of Clinical Practice Guideline of Fire Needling Therapy for Herpes Zosters based on Norms of Formulation and Evaluation for the Clinical Guideline on Acupuncture and Moxibustion released by World Federation of Acupuncture and Moxibustion Societies., Methods: Combined the investigation with expert consultation and consensus method, and taken clinicians (members) of Chinese Association of Acupuncture and Moxibustion as the subjects, the clinical questions concerned were collected and the two-round consultation was conducted among expert group by letter. In the first round questionnaire, using the voting method, the relevant clinical questions in intervention measures were collected; and in the second round, with the Delphi method adopted, the importance of clinical questions and outcomes in the investigation was scored., Results: A total of 200 structured clinical questions proposed by 153 clinicians and the clinical experience with 13 kinds of combined therapies involved and fire needling as the key measure were collected. The authority coefficient ( Cr ) of the Delphi questionnaire was >0.70, and the coefficient of variation for the importance scores of alternative clinical questions and outcomes was 0.06-0.26 and 0.12-0.47, respectively. The top 10 clinical questions and 12 outcomes (6 outcomes referred to the patients either in the acute stage or the post-neuralgia stage) were included, with the importance score of clinical questions>4, the importance score of outcomes>6, and the coefficient of variation ≤0.25., Conclusion: The clinical questions and outcomes of Clinical Practice Guideline of Fire Needling Therapy for Herpes Zosters are formulated, which provides the research basis for the recommendation development of the guideline.

Purpose: After unsatisfactory results in a first-in-human clinical investigation with an anatomically shaped medial meniscus prosthesis, the prosthesis and its fixation technique were altered. This interim analysis of a prospective single-arm clinical investigation aims to evaluate safety and clinical performance in a first-in-human study with the redesigned meniscus prosthesis system., Methods: Ten patients suffering from medial postmeniscectomy pain syndrome were treated with the meniscus prosthesis. Patient-reported outcome measures were obtained at baseline and at 6-week, 3-, 6-, and 12-month follow-up. Radiographs and magnetic resonance imaging scans were obtained to evaluate joint degeneration and prosthesis location., Results: The device alterations resolved the issues occurring with the previous design, but four prostheses were explanted after fixation failure or subluxation of the prosthesis. Five out of six patients who reached 1-year follow-up reported a clinically significant improvement of the knee injury and osteoarthritis outcome score pain subscale. Imaging revealed no adverse effects on joint degeneration., Conclusion: The failure mechanisms that occurred with the previous design have been resolved, but the new fixation technique introduced new safety issues. Improvement of positioning and fixation techniques are considered essential future adaptations to reduce the risk of failure. The good clinical outcomes reported by the patients reaching 1-year follow-up indicate that the medial meniscus prosthesis is a potential solution for patients suffering from postmeniscectomy pain syndrome., Level of Evidence: Level II., (© 2024 The Author(s). Knee Surgery, Sports Traumatology, Arthroscopy published by John Wiley & Sons Ltd on behalf of European Society of Sports Traumatology, Knee Surgery and Arthroscopy.)

Favoring innovation by making timely medical technology available to people and by securing patients' safety is a challenge. The new European Medical Device Regulation (MDR) will have a central implication in the development of new devices and could affect their innovation and availability, as well as discourage investment in research within Europe. Start-ups and small companies might not be able to cope with the increasing complexity and the required changes of perspective. Health-care institutions are facing an increasing availability of complex technologies, while data on their clinical efficacy and cost-effectiveness are rarely provided. A partnership/collaboration between health-care institutions, academia, and private industries will enhance their own specific interests with the common goal of improving overall health and quality of life. The complexity of the subject combined with the variety of specialists and stakeholders involved requires the implementation, in hospital centers of clinical excellence, of units dedicated to the whole path of the medical device innovation. Stakeholders should quickly provide adequate measures to facilitate the complex medical device innovation path under the more stringent MDR aimed to increase safety and quality of care. [ABSTRACT FROM AUTHOR]

Fowl adenovirus (FAdV) associated diseases have emerged as major viral diseases in all types of poultry around the globe. These diseases have been re-emerging as outbreaks throughout Pakistan in recent years, therefore, the purpose of the current study was to conduct molecular epidemiology of Fowl Adenovirus in commercial poultry depending upon different variables. The study is based on n=675 farm samples (each sample represents organ collection of 5 birds per farm) from commercial poultry around division Faisalabad, Pakistan during years 2018-2020. Type of chicken affected, age groups, shed types, seasons and regions were assumed as risk factors associated with the prevalence of FAdVs which were analyzed using non-parametric tests. For molecular studies, liver tissues were subjected to polymerase chain reaction (PCR) by targeting hexon gene. The current study showed higher prevalence in layer type chicken among commercial chicken types, younger birds showed higher FAdV prevalence due to possible vertical transmission and higher prevalence of FAdV infection was observed in commercial poultry kept in semi-environment control sheds due to inconsistent control over the biosecurity and internal environment of the shed. This study also reported shed type and season to be significantly associated (P<0.05) with risk of FAdV infection. [ABSTRACT FROM AUTHOR]

Over the past few decades, there has been extensive research on the use of vitamin D as an adjunctive therapy in the treatment and prevention of tuberculosis. In vitro studies have provided valuable insights into the mechanisms by which vitamin D activates the immune response to combat Mycobacterium tuberculosis. These encouraging findings have spurred clinical investigations globally to assess the effectiveness of vitamin D as a preventive measure and as an adjunctive treatment for tuberculosis. However, the results from these clinical studies have been contradictory, with some demonstrating clear efficacy while others report only modest or no activity. In this review, we aim to analyze the clinical studies on vitamin D and examine the possible discrepancies observed in their outcomes. [ABSTRACT FROM AUTHOR]

Background: Autoantibody specificity in autoimmune diseases is variable due to each patient's individual spectrum of autoantibodies and the inherent differences between detection methods and tests. Since false-positive results have downstream consequences, we conducted a comprehensive assessment of anti-double stranded DNA (anti-dsDNA) specificity from published studies of systemic lupus erythematosus (SLE). Methods: A systematic review (MEDLINE, Embase, Cochrane Central Register of Controlled Trials, and Database of Abstracts of Reviews of Effects) identified cross-sectional or case-control studies published January 2004 to August 2019, reporting anti-dsDNA test accuracy data in SLE. Study quality was assessed using Quality Assessment Tool for Diagnostic Accuracy Studies, version 2. A meta-analysis was conducted to estimate specificity by test method or named test where feasible. Results: Thirty studies were included covering 43 different tests. The Crithidia luciliae indirect immunofluorescence test (CLIFT) and fluorescence enzyme immunoassay methods are likely to be ≥ 90% specific (Euroimmun 97.8% (95% CI 96.2%–98.7%) 4 studies; EliA 94.7% (95% CI 91.7%–96.7%), 6 studies; CLIFT 98.7% (95% CI 96.7%–99.5%), 8 studies/7 tests]. For other test methods, specificity was not fully demonstrated to be ≥ 90% and/or the control group included healthy patients possibly overestimating specificity. More studies are required for NOVA Lite [96.0% (95% CI 87.2%–98.9%), 5 studies], chemiluminescence immunoassays [92.3% (95% CI 83.6%–96.6%), 6 studies/4 tests], multiplex immunoassays [89.3% (95% CI 86.1%–91.8%), 4 studies/2 tests], and Farr fluorescent immunoassays (no estimate, 2 studies). Specificity data reported for Farr radioimmunoassays [93.8% (95% CI 85.4–97.5%), 11 studies, 9 tests] and enzyme-linked immunosorbent assays [93.4% (95% CI 89.9%–95.7%), 15 studies/16 tests] lacked consistency. Conclusion: Anti-dsDNA testing shows considerable variation in test specificity, with potential impact on the management of SLE patients. This review may help laboratory specialists and clinicians choose and interpret the appropriate anti-dsDNA test for their setting. [ABSTRACT FROM AUTHOR]

Abstract Background Lymphedema is a public health problem in countries with lymphatic filariasis (LF) including Mali. We studied the epidemiology and clinical presentation of lymphedema in three previously LF-endemic health districts of Mali after at least five consecutive rounds of mass drug administration (MDA) with albendazole and ivermectin. Methods From 2016 to 2018, we used passive and active case finding methods to identify lymphedema cases in three health districts with high pre-MDA LF prevalence: Kolondieba (66%), Bougouni (44%) and Kolokani (34%). Results Three hundred and thirty nine cases of lymphedema were identified, 235 (69.32%) through active case finding. Their median age was 56 years (range 2–90) and 286 (84.36%) were women. Lymphedema was reported in 226 (78.5%) people aged 41 years and older compared to 73 (21.5%) people below the age of 41 years (Chi2 = 17.28, df = 5, p = 0.004). One hundred and seventy five cases of lymphedema were found in Kolondieba (66 per 100,000 people), 116 in Bougouni (19 per 100,000) and 48 in Kolokani (16 per 100,000). Stage III lymphedema was observed in 131 (38.64%), stage II in 108 (31.86%), stage IV in 46 (13.57%), stage I in 23 (6.78%), stage V in 21 (6.19%) and stage VI in ten (2.95%). In the three study districts, lymphedema affected the legs in 281 (82.89%), the arms in 42 (12.39%) and both in 16 (4.72%) (Chi2 = 13.63, p = 0.008). Conclusion Health districts in Mali with the highest pre-MDA LF prevalences had the highest prevalence of lymphedema. Efforts to actively identify lymphedema cases should be scaled up in previous LF-endemic areas, and should be supplemented by a morbidity management and disability prevention plan at the peripheral health system level.

The intention of this 5-year prospective cohort investigation was to clinically and radiographically investigate the outcomes of a one-piece zirconia implant system for single tooth replacement. Sixty-five patients received a total of 66 single-tooth implants. All implants immediately received temporary restorations and were finally restored with all-ceramic crowns. Follow-ups were performed at the prosthetic delivery, after 1, 3, and 5 years. Peri-implant and dental soft-tissue parameters were evaluated and patient-reported outcomes recorded. To monitor peri-implant bone remodelling, standardised radiographs were taken at the implant insertion and at the 1-, 3-, and 5-year follow-ups. In the course of 5 years, 14 implants were lost, resulting in a cumulative implant survival rate of 78.2%. The mean marginal bone loss from the implant insertion to the 5-year follow-up amounted to 1.12 mm. Probing depth, clinical attachment level, bleeding, and plaque index increased over time. In 91.5% of the implants, the papilla index showed levels of 1 or 2, respectively. At the end of the study, the patient satisfaction was higher compared to the pre-treatment measurements. Due to the low survival rate after five years and the noticeably high frequency of advanced bone loss observed in this study, the implant has not met the launch criteria, as it would have not been recommended for routine clinical use.

The objective was to investigate the clinical and radiological outcome of one-piece zirconia oral implants to support three-unit fixed dental prostheses (FDP) after three years in function. Twenty-seven patients were treated with a total of 54 implants in a one-stage surgery and immediate provisionalization. Standardized radiographs were taken at implant placement, after one year and after three years, to evaluate peri-implant bone loss. Soft-tissue parameters were also assessed. Linear mixed regression models as well as Wilcoxon Signed Rank tests were used for analyzing differences between groups and time points (p < 0.05). At the three-year evaluation, one implant was lost, resulting in a cumulative survival rate of 98.1%. The mean marginal bone loss amounted to 2.16 mm. An implant success grade I of 52% (bone loss of ≤2 mm) and success grade II of 61% (bone loss of ≤3 mm) were achieved. None of the evaluated baseline parameters affected bone loss. The survival rate of the zirconia implants was comparable to market-available titanium implants. However, an increased marginal bone loss was observed with a high peri-implantitis incidence and a resulting low implant success rate.

Background: Fenugreek plant ( Trigonella foenum-graecum ) constitutes a traditionally acclaimed herbal remedy for many human ailments including diabetes, obesity, neurodegenerative diseases, and reproductive disorders. It is also used as an effective anti-oxidative, anti-inflammatory, antibacterial, and anti-fungal agent. The seed of the plant is especially enriched in several bioactive molecules including polyphenols, saponins, alkaloids, and flavonoids and has demonstrated potential to act as an antidiabetic phytotherapeutic. A novel patented formulation (Fenfuro ® ) was developed in our laboratory from the fenugreek seeds which contained >45% furostanolic saponins (HPLC)., Objective: A placebo-controlled clinical compliance study was designed to assess the effects of complementing Fenfuro ® on a randomized group of human volunteers on antidiabetic therapy (Metformin and sulphonylurea) in controlling the glycemic index along with simultaneous safety assessment., Study Methodology and Trial Design: In a randomized double-blind, placebo-controlled trial, 42 individuals (21 male and 21 female volunteers) in the treatment group (out of 57 enrolled) and 39 individuals (17 male and 22 female volunteers) in the placebo group (out of 47 enrolled), all on antidiabetic therapy with Metformin/Metformin with sulphonyl urea within the age group of 18-65 years were administered either 1,000 mg (500 mg × 2) (Fenfuro ® ) capsules or placebo over a period of 12 consecutive weeks. Fasting and postprandial glucose along with glycated hemoglobin were determined as primary outcomes to assess the antidiabetic potential of the formulation. Moreover, in order to evaluate the safety of the formulation, C-peptide and Thyroid Stimulating Hormone (TSH) levels as well as immunohematological parameters were assessed between the treatment and placebo groups at the completion of the study., Results: After 12 weeks of administration, both fasting as well as postprandial serum glucose levels decreased by 38 and 44% respectively in the treatment group. Simultaneously, a significant reduction in glycated hemoglobin by about 34.7% was also noted. The formulation did not have any adverse effect on the study subjects as there was no significant change in C- peptide level and TSH level; liver, kidney, and cardiovascular function was also found to be normal as assessed by serum levels of key immunohematological parameters. No adverse events were reported., Conclusion: This clinical compliance study re-instated and established the safety and efficacy of Fenfuro ® as an effective phytotherapeutic to treat hyperglycemia., Competing Interests: No potential conflict of interest was reported by the author(s). Partially funded by Chemical Resources, Panchkula, Haryana, India., (© 2024 Rajinder Singh Gupta et al.)

The U.S. Food and Drug Administration (FDA) provides guidance for expanded access to experimental therapies, which in turn plays an important role in the Twenty-first Century Cures Act mandate to advance cell-based therapy. In cases of incurable diseases where there is a lack of alternative treatment options, many patients seek access to cell-based therapies for the possibility of treatment responses demonstrated in clinical trials. Here, we describe the use of the FDA’s expanded access to investigational new drug (IND) to address rare and emergency conditions that include stiff-person syndrome, spinal cord injury, traumatic brain stem injury, complex congenital heart disease, ischemic stroke, and peripheral nerve injury. We have administered both allogeneic bone marrow-derived mesenchymal stem cell (MSC) and autologous Schwann cell (SC) therapy to patients upon emergency request using Single Patient Expanded Access (SPEA) INDs approved by the FDA. In this report, we present our experience with 10 completed SPEA protocols.

Objectives: Recently, the area of Enterprise Risk Management (ERM) has received considerable attention both from the academic and professional communities. The empirical evidence seems to support the enabling role of the ERM in improving firms’ operating and financial performance, focusing on metrics such as equity values, cost of capital, and debt ratings. However, companies are still struggling with the development, implementation, and evaluation of ERM-based processes. In particular, this problem has been significantly more challenging for companies in emerging economies. Method: In this paper, we provide a clinical study detailing the institutional and functional risk management steps (identification, assessment, mitigation, implementation, and review) and processes undertaken to develop and implement ERM for a major investment banking company in Iran. Results: Overall, we found that the company has been exposed to fourteen categories of top risk sources including competition, political, human resource, market, liquidity, regulations, credit, reputation, and corporate governance. Furthermore, we have chosen a subset of more quantifiable categories of risk and recommended mitigation strategies and developed metrics to evaluate their performance.

Introduction: Clinical investigation is a critical component of clinical medicine. Yet, other than mentorship by an experienced senior physician, young physicians have few formal training opportunities that fit into their clinical training and convey the pre-requisite clinical investigator competencies. To address this training gap, we designed the Clinical Investigator Training Program (CITP); a practical and pragmatic curriculum weaved into the constant pressures of balancing patient care with academic pursuit required of the academic practitioner. Methods: Between January 2016 and December 2018, we conducted four CITP courses, with each comprised of four 4-h sessions that included didactic lectures, group projects including the development of a mock clinical protocol, and expert's panel discussions. Each course enrolled 15 participants from an average of 28 applicants. We assessed the knowledge acquired following each course via a pre- and post-course test (t-test with positive scores indicating improvement in knowledge base). In addition, we also tracked which participants became first time principal investigator following completion of CITP. Results: A total of 60 participants enrolled in the 4 CITP courses, and there was a statistically significant improvement in mean post-test scores (p

Recent success stories in automated object or face recognition, partly fuelled by deep learning artificial neural network (ANN) architectures, have led to the advancement of biometric research platforms and, to some extent, the resurrection of Artificial Intelligence (AI). In line with this general trend, inter-disciplinary approaches have been taken to automate the recognition of emotions in adults or children for the benefit of various applications, such as identification of children's emotions prior to a clinical investigation. Within this context, it turns out that automating emotion recognition is far from being straightforward, with several challenges arising for both science (e.g., methodology underpinned by psychology) and technology (e.g., the iMotions biometric research platform). In this paper, we present a methodology and experiment and some interesting findings, which raise the following research questions for the recognition of emotions and attention in humans: (a) the adequacy of well-established techniques such as the International Affective Picture System (IAPS), (b) the adequacy of state-of-the-art biometric research platforms, (c) the extent to which emotional responses may be different in children and adults. Our findings and first attempts to answer some of these research questions are based on a mixed sample of adults and children who took part in the experiment, resulting in a statistical analysis of numerous variables. These are related to both automatically and interactively captured responses of participants to a sample of IAPS pictures.

Recent success stories in automated object or face recognition, partly fuelled by deep learning artificial neural network (ANN) architectures, have led to the advancement of biometric research platforms and, to some extent, the resurrection of Artificial Intelligence (AI). In line with this general trend, inter-disciplinary approaches have been taken to automate the recognition of emotions in adults or children for the benefit of various applications, such as identification of children's emotions prior to a clinical investigation. Within this context, it turns out that automating emotion recognition is far from being straightforward, with several challenges arising for both science (e.g., methodology underpinned by psychology) and technology (e.g., the iMotions biometric research platform). In this paper, we present a methodology and experiment and some interesting findings, which raise the following research questions for the recognition of emotions and attention in humans: (a) the adequacy of well-established techniques such as the International Affective Picture System (IAPS), (b) the adequacy of state-of-the-art biometric research platforms, (c) the extent to which emotional responses may be different in children and adults. Our findings and first attempts to answer some of these research questions are based on a mixed sample of adults and children who took part in the experiment, resulting in a statistical analysis of numerous variables. These are related to both automatically and interactively captured responses of participants to a sample of IAPS pictures. [ABSTRACT FROM AUTHOR]

Background: Lymphedema is a public health problem in countries with lymphatic filariasis (LF) including Mali. We studied the epidemiology and clinical presentation of lymphedema in three previously LF-endemic health districts of Mali after at least five consecutive rounds of mass drug administration (MDA) with albendazole and ivermectin.Methods: From 2016 to 2018, we used passive and active case finding methods to identify lymphedema cases in three health districts with high pre-MDA LF prevalence: Kolondieba (66%), Bougouni (44%) and Kolokani (34%).Results: Three hundred and thirty nine cases of lymphedema were identified, 235 (69.32%) through active case finding. Their median age was 56 years (range 2-90) and 286 (84.36%) were women. Lymphedema was reported in 226 (78.5%) people aged 41 years and older compared to 73 (21.5%) people below the age of 41 years (Chi2 = 17.28, df = 5, p = 0.004). One hundred and seventy five cases of lymphedema were found in Kolondieba (66 per 100,000 people), 116 in Bougouni (19 per 100,000) and 48 in Kolokani (16 per 100,000). Stage III lymphedema was observed in 131 (38.64%), stage II in 108 (31.86%), stage IV in 46 (13.57%), stage I in 23 (6.78%), stage V in 21 (6.19%) and stage VI in ten (2.95%). In the three study districts, lymphedema affected the legs in 281 (82.89%), the arms in 42 (12.39%) and both in 16 (4.72%) (Chi2 = 13.63, p = 0.008).Conclusion: Health districts in Mali with the highest pre-MDA LF prevalences had the highest prevalence of lymphedema. Efforts to actively identify lymphedema cases should be scaled up in previous LF-endemic areas, and should be supplemented by a morbidity management and disability prevention plan at the peripheral health system level. [ABSTRACT FROM AUTHOR]

Aim: To assess whether changes in diagnoses and management of temporomandibular joint disorder (TMJD) patients are influenced by radiographic findings and if there is an association between specific radiologic alterations and management strategy changes. Methods: A total of 204 patients with TMJ symptoms were examined using the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). Diagnoses and management were first decided without the aid of radiographs. Management categories were: pharmacology, physiotherapy, counseling and behavioral treatment, occlusal stabilization, surgery, additional examinations, and referrals, each with subcategories. Sagittal TMJ tomograms were assessed for the presence of flattening, erosion, osteophyte, and sclerosis in the TMJ components. Diagnoses and management were reevaluated after gaining access to the radiographs and radiographic classifications. Logistic regression analyses were performed with changes in management as the dependent variable and age and radiographic findings as the independent variables. Results: Diagnosis was changed for 56 patients, mainly from arthralgia to osteoarthritis. Management was changed for 55 patients. Most changes occurred in pharmacology and physiotherapy followed by counseling and behavioral treatment, occlusal stabilization, referrals, additional examinations, and surgery. Changes were mostly within the categories, and the highest number of changes was seen in pharmacology, physiotherapy, and counseling and behavioral treatment. Radiographic degenerative findings increased the chance of change (any change) (odds ratio [OR] ? 2.03) and the chance of change in pharmacology (OR ? 2.56) and physiotherapy (OR = 2.48) separately. No other significant associations were found. Conclusion: Radiographic degenerative findings increased the chance of changes in management strategy. However, 73% of the TMJD patients had no changes in management after radiographic examination. In cases with changes, these were mainly adjustments within management categories. [ABSTRACT FROM AUTHOR]

Objectives: To analyze the diagnostic value of the clinical and radiographic investigation of the interface of two-piece implant systems under the variables crevice size of the microgap, clinical experience, radiograph exposure time, prosthesis design, and type of evaluation. Method and Materials: A simulated mandibular cast with five screw-retained implants (Straumann) providing three different prosthesis designs displayed artificially created proximal, visually inaccessible microgaps of unequal sizes or junctions without any measurable gap formation. Three groups of 15 investigators each with a different degree of clinical experience evaluated the implant-abutment interfaces of the cast clinically and radiographically. The investigation was conducted on the basis of a scoring form adapted from the receiver operating characteristic (ROC) 5-choice method. Radiographs were prepared in two exposure times (0.1 second, 0.2 second) for each junction. Radiographs of the initial situation without any measurable gap formation were shown as a control and to detect false-positive scores for each gap size. A 10-point SEM measurement of the junctions served for standardization purposes. Statistical methods included ROC analysis, kappa analysis, and a regression analysis (α = .05). Results: Gaps greater than 150.9 μm (P < .001) were detected 227% more frequently and gaps greater than 189.7 μm 292% more frequently via radiographic examination. Kappa values were adequate for the radiographic examination and unsatisfactory for clinical examination. Prosthetic superstructure and exposure time did not adversely affect the diagnosis. Clinical experience improved the detection of microgaps significantly. Conclusion: A relationship between the size of microgaps and the examiners' ability to detect them can be established. Whereas tactile examination alone is not accurate enough, radiographic analysis affiliated with a certain degree of clinical experience possesses features for an adequate clinical management of restoration defects. [ABSTRACT FROM AUTHOR]

Aim: To identify associations between clinical symptoms of temporomandibular joint disorders and radiographic findings. Methods: Two hundred four adult patients (156 women, 48 men, mean age 40 years) with temporomandibular joint (TMJ) pain/sounds or changes in mandibular motion were examined according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). Bilateral sagittal corrected TMJ tomograms in closed and open positions were assessed for the presence of flattening, erosion, osteophytes, and sclerosis in the joint components and the range of mandibular motion. Logistic regression analyses were performed with the radiographic findings as the dependent variables and the following clinical variables as independent variables: opening pattern, maximal jaw opening, TMJ sounds, number of painful muscle/TMJ sites, duration of pain, presence of arthritic disease, depression and somatization scores, graded chronic pain, and age and gender. Results: Coarse crepitus on opening/closing (odds ratio [OR] ≥ 3.12), on lateral excursions (odds ratio ≥ 4.06), and on protrusion (OR ≥ 5.30) was associated with increased risk of degenerative findings in tomograms. A clinical diagnosis of osteoarthritis increased the risk of radiographic findings (OR ≥ 2.95) and so did increasing age (OR ≥ 1.03 per year) and the female gender (OR ≥ 2.36). Maximal assisted opening and maximal opening without pain (< 40 mm) was associated with a posterior condyle-to-articular tubercle position (OR ≥ 2.60). No other significant associations were observed. Conclusion: Age, gender, and coarse crepitus, but no pain-related variables, were associated with increased risk of degenerative findings in TMJ tomograms. Maximal opening < 40 mm was associated with a posterior condyle-to-articular tubercle relation on opening. [ABSTRACT FROM AUTHOR]

Objective: The aim of this multicenter study was to evaluate the clinical efficacy of a strontium chloride-containing desensitizer, Hyposen (Lege Artis), over 6 months. Method and Materials: A total of 142 patients with hypersensitivity in 9 dental practices and 2 clinical departments were included in the double-blind, randomized, placebo-controlled study. Each patient exhibited at least 2 hypersensitive and caries-free teeth with exposed dentin surfaces. One tooth was treated with strontium chloride (SR) as recommended by the manufacturer, another with a placebo. Levels of hypersensitivity were assessed after 2, 8, 12, and 24 weeks by cold air and tactile stimuli. After 6 months 132 patients could be reexamined. Results: A reduction of discomfort and pain was observed in 95 patients (72%) after treatment with SR. Statistical analysis showed a significant positive effect of SR compared to the placebo group (P < .05, McNemar test). Conclusion: Use of SR for desensitizing hypersensitive dentin is an effective alternative to existing desensitizing agents. [ABSTRACT FROM AUTHOR]

Purpose: The quality of fillings consisting of a hybrid composite was compared with fillings consisting of two different microfilled composites in a clinical examination. Material and Methods: Within the design of a clinically controlled two-year study conducted under practice-relevant conditions, the composites C-Fill MH (Megadenta), Helio Progress (Vivadent), and Visio-Dispers (ESPE) were examined in anterior-tooth cavities in 134 patients by means of the split-mouth technique. The clinical examinations were performed based on modified Ryge criteria (marginal integrity, anatomical form, secondary caries, color, marginal discoloration, surface roughness) after 12 and 24 months. Results: Immediately following filling application, all evaluation criteria except color were assessed as level A. After 12 and 24 months, C-Fill MH was found to be significantly superior to the other materials with regard to marginal integrity, color, and marginal discoloration. Conclusion: The hybrid composite C-Fill MH seems to be superior to the microfilled composites and should therefore be preferred as a restorative filling material. [ABSTRACT FROM AUTHOR]