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Formulation and sensory evaluation of nutrient-dense complementary food mixes for infants and young children aligned with national nutritional standards in India: A D-optimal mixture design approach

Indian J Med Res. 2026 Jun;163(6):829-837. doi: 10.25259/IJMR_256_2026.

ABSTRACT

Background and objectives In India, national nutrition programmes emphasise age-appropriate, nutrient-dense complementary foods for young children. This study aimed to optimise nutrient-dense complementary foods for children aged 12-35 months using locally sourced ingredients and a mixture design approach, in alignment with the Nutrition Norms of the Poshan 2.0 Programme under Schedule II of the National Food Security Act, 2013 (NFSA 2013), revised in 2023. Methods D-optimal mixture design is an advanced statistical design of experiments method used to determine the ideal proportions of ingredients in a mixture, where components sum to 100%. We used this design to optimise the proportions of cereals, pulses, milk powder, nuts, seeds, and oil to maximise iron, calcium, and zinc content while minimising phytate-to-mineral molar ratios. The optimised complementary base mix was standardised into three variants: one with reduced refined sugar and two without added refined sugar (one savoury-based mix and one dates powder-based mix). Mineral and phytic acid contents were analysed using standard analytical methods. Sensory evaluation was conducted using a nine- point hedonic scale with a semi-trained institutional panel. Results All optimised formulations met revised NFSA, 2013 nutrient standards for energy, protein, fat, carbohydrates, and key essential micronutrients, while reducing phytate-to-mineral molar ratios within practical formulation limits. Sensory evaluation showed good overall acceptability for all variants, with a mean score above 7.0. The savoury-based mix achieved the highest overall acceptability, followed by the reduced refined sugar-based mix and the dates powder-based mix. Interpretation and conclusions The findings demonstrate that a systematic formulation approach can be used to develop nutrient-dense, complementary food mixes with reduced or no added refined sugar using locally available ingredients without compromising micronutrient adequacy and sensory acceptability, supporting their potential relevance for public nutrition programmes.

PMID:42295725 | DOI:10.25259/IJMR_256_2026

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Prevalence of hypothyroidism among pregnant women and associated feto-maternal outcomes in India: Systematic review and meta-analysis

Indian J Med Res. 2026 Jun;163(6):745-762. doi: 10.25259/IJMR_2554_2025.

ABSTRACT

Background and objectives Hypothyroidism is the most common thyroid disorder during pregnancy and, if not managed adequately, increases the risk of adverse foeto-maternal outcomes. The present systematic review and meta-analysis was conducted to assess the prevalence of hypothyroidism among Indian pregnant women and related foeto-maternal outcomes. Methods A systematic search was conducted across PubMed, Google Scholar, and preprint servers to identify observational studies reporting the prevalence of hypothyroidism and associated foeto-maternal outcomes among Indian pregnant women. A random-effects model was utilised to pool effect sizes, and heterogeneity was assessed using I2 statistic. Funnel plots, along with Begg’s and Egger’s tests, were used to assess publication bias. Data were analysed using STATA version 17. Results A total of 60 studies were included. The pooled prevalence of hypothyroidism among pregnant women was 17% [95% confidence interval (CI): 14%, 19%] with subclinical hypothyroidism at 15% (95% CI: 12%, 18%) and overt hypothyroidism at 3% (95% CI: 3%, 4%). In women with subclinical hypothyroidism, the pooled prevalence of adverse maternal outcomes was 9% (95% CI: 6%, 11%), while the prevalence of adverse foetal outcomes was 11% (95% CI: 9%, 14%). The pooled prevalence was 18% for preterm birth (95% CI: 11%, 25%), 17% for low birth weight (95% CI: 10%, 25%), 7% for intrauterine death (95% CI: 2, 14%), and 2% for stillbirth (95% CI: 0, 4%). Among women with overt hypothyroidism, the prevalence of adverse maternal and foetal outcomes was 12% (95% CI: 10%, 15%) and 14% (95% CI: 11%, 17%), respectively. The pooled prevalence was 22% for low birth weight (95% CI: 13%, 31%), 16% for preterm birth (95% CI: 9%, 24%), 16% for intrauterine death (95% CI: 7%, 27%), and 6% for stillbirth (95% CI: 1%, 13%). Most studies used trimester-specific TSH cut-offs based on the American Thyroid Association guidelines. One fourth (n=15) of the 60 studies applied alternative thresholds, with upper limits for normal TSH varying from 4.0-10.0 mIU/L. Interpretation and conclusions The rising burden and adverse consequences of hypothyroidism in pregnancy demand urgent attention. Uniform, evidence-based screening and management practices must be implemented at all levels of care. There is a pressing need for India-specific diagnostic cut-offs and large-scale prospective studies to inform treatment thresholds and long-term outcomes.

PMID:42295724 | DOI:10.25259/IJMR_2554_2025

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Viral hepatitis co-infections with tuberculosis in India: A systematic review and meta-analysis

Indian J Med Res. 2026 Jun;163(6):770-777. doi: 10.25259/IJMR_3570_2025.

ABSTRACT

Background and objectives Tuberculosis (TB) and viral hepatitis (hepatitis B and C) co-infection is a significant threat in low-and middle-income countries like India. To optimise treatment protocols and prevent liver-related complications, it is essential to estimate the burden of these co-infections. This systematic review and meta-analysis were conducted to determine the prevalence of hepatitis B and C co-infection with tuberculosis in India. Methods In line with PRISMA guidelines, a systematic search of PubMed, Scopus, Embase, CINAHL, and Web of Science was conducted for English-language observational studies published up to January 6, 2026, that reported hepatitis B or C co-infection among TB patients in India. Pooled prevalence estimates were calculated using a random-effects model, heterogeneity was assessed using the I2 statistic, and risk of bias was evaluated using the Joanna Briggs Institute (JBI) critical appraisal tool. Results A total of 11 studies with 4502 participants reporting hepatitis B or C co-infections in among TB patients in India were included. The pooled prevalence of hepatitis B was 10% [95% Confidence Interval (CI):5%-16%], while the pooled prevalence of hepatitis C was 6% (95% CI:5%-7%). Among TB patients co-infected with HIV, the pooled prevalence of hepatitis B was 17% and pooled prevalence of hepatitis B among drug-resistant TB patients was 11%. Higher rates were reported in Southern and Western India. Interpretation and conclusions High prevalence of hepatitis B and C co-infections among TB patients in India suggests the need for integrated screening and management of these co-infections within the national programme strategies.

PMID:42295712 | DOI:10.25259/IJMR_3570_2025

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Household food insecurity in urban slums and its association with nutritional status of under-five children in Salem District, Tamil Nadu

Indian J Med Res. 2026 Jun;163(6):838-846. doi: 10.25259/IJMR_2123_2025.

ABSTRACT

Background and objectives Household food security is defined as physical and economic access to sufficient, safe, and nutritious food for an active and healthy life. Evidence suggests that urban poor are more food insecure (51%-Delhi and 74.6%-Vellore) than rural poor. Food insecurity adversely affects under-five children’s nutritional status. This study aimed to assess prevalence, determinants, and its association with child-nutrition in urban slums of Salem district, Tamil Nadu. Methods A community-based cross-sectional study was conducted among 363 randomly selected households between January to September 2023 using multi-stage random sampling. Data were collected from primary-care-givers using a validated-semi-structured-questionnaire (USAID-HFIAS) followed by measurement of daily raw food consumption and anthropometry of under-five children. Statistical analysis was performed in SPSSv16.0 using Chi-square/Fisher’s test, ANOVA and regression with P<0.05 taken as significant. Results Household food insecurity prevalence was 82.1%, with 20.1% severe. Mean food consumption was significantly lower among insecure households. Determinants included age/gender of household head, single earning member, dependents, and irregular use of public distribution system. Children with normal nutrition had 2.75 [P<0.05;95% confidence interval (C.I):1.31-5.75] times odds of belonging to secure households. Interpretation and conclusions Food insecurity was closely linked to under-five malnutrition, underscoring the need for interventions addressing affordability and structural factors such as housing, healthcare access, and resource distribution.

PMID:42295709 | DOI:10.25259/IJMR_2123_2025

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A Phase 1 Open-Label Study Assessing the Safety and Pharmacokinetics of TV-46000, an Extended-Release Injectable Suspension of Risperidone for Subcutaneous Use

CNS Drugs. 2026 Jun 15. doi: 10.1007/s40263-026-01302-y. Online ahead of print.

ABSTRACT

BACKGROUND: TV-46000 (Uzedy®) is a long-acting injectable antipsychotic for subcutaneous use that combines risperidone and an innovative, copolymer-based drug delivery technology in a suspension that was approved as a treatment for schizophrenia and bipolar I disorder by the US Food and Drug Administration (FDA) in April 2023 and October 2025, respectively. It is a risperidone injectable that can be administered once monthly or once every 2 months. As part of the clinical development of TV-46000, a Phase 1 open-label dose escalation study (TV46000-SAD-10055) was conducted to evaluate the safety and pharmacokinetics (PK) of TV-46000 in participants with schizophrenia or schizoaffective disorder.

METHODS: Individuals diagnosed with schizophrenia or schizoaffective disorder were assigned to 1 of 8 cohorts, which consisted of single escalating doses (50 to 225 mg) or 3 multiple doses (75 mg or 150 mg) administered every month for 3 months. Every cohort was preceded by a run-in period of 7 days with daily oral risperidone (2-6 mg) followed by a 7-day washout period before the TV-46000 injection. TV-46000 was administered in the abdomen in all but one cohort, where 225 mg was administered in the upper arm, to assess interchangeability between injection sites. Outcome measures reported were adverse events (AEs), local tolerability, changes in neurological and clinical assessments, and PK measures (determined by risperidone and 9-OH risperidone total active moiety [TAM] concentrations).

RESULTS: Of the 194 participants screened, 99 were included in the study. Of the 99 participants, 13 discontinued the study, but none of the discontinuations were related to the treatment. Most participants were Black or African American men, with a mean age of 44.2 years and a mean body mass index of 28.53 kg/m2. Treatment-emergent AEs after TV-46000 administration included injection-site reactions, increased blood creatine phosphokinase, and weight gain. There were two serious AEs; one death due to suicide and one exacerbation of schizophrenia requiring hospitalization that were both unrelated to TV-46000. After a single dose injection of TV-46000 50 to 225 mg, TAM concentrations reached clinically relevant plasma concentrations of 10 ng/mL within 24 hours for all doses and remained within therapeutic range for 28-56 days, depending on dose. The systemic exposure parameters (maximum, minimum, and average plasma concentration) after the third monthly TV-46000 injections of 75 and 150 mg were comparable with the corresponding steady-state exposure of 3-5-mg/day oral risperidone.

CONCLUSIONS: Overall, TV-46000 was well tolerated with no new safety signals detected compared with other formulations of risperidone. The PK profile of TV-46000 exhibited favorable characteristics of an extended-release formulation, including rapid initial release for fast onset of action and prolonged systemic exposure adequate for monthly administration.

PMID:42295697 | DOI:10.1007/s40263-026-01302-y

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Echocardiographic Findings in Small-Breed Dogs With Myxomatous Mitral Valve Disease and the Severity of Mitral Regurgitation, Heart Size and Clinical Signs Myxomatous Mitral Valve Disease in Dogs

Vet Med Sci. 2026 Jul;12(4):e70922. doi: 10.1002/vms3.70922.

ABSTRACT

BACKGROUND: The main goal of this study was to identify various brightness, motion and Doppler echocardiographic variables in small-breed dogs with myxomatous mitral valve disease.

ANIMALS: Sixty client-owned small-breed dogs with mitral regurgitation murmurs.

METHODS: Echocardiography was performed in brightness, motion and Doppler modality from the right parasternal view. On the basis of thoracic radiographs, the dogs were categorized into two groups: those with cardiomegaly and those without cardiomegaly. Additionally, on the basis of the jet area signal to left atrium ratio in colour Doppler echocardiography, the canines were divided into three groups: mild, moderate and severe mitral regurgitation. Furthermore, the dogs were classified into preclinical and clinical groups on the basis of the presence or absence of clinical signs, and various variables were compared across these groups.

RESULTS: This difference was statistically significant and more prevalent in intact dogs than in spayed/neutered dogs. Significant differences were observed in variables including LAmax, LA:Ao, LVIDd, LVIDs, VMA, VMG, VMV, GMV, VMA-GMVT, LVOT and GLVOT in dogs with myxomatous mitral valve disease of varying mitral regurgitation severity and between normal and enlarged hearts. Significant differences were also found in the FS, GMV, VLVOT and GLVOT variables between the clinical and preclinical groups. A moderate and statistically significant correlation was observed between LA:Ao and VMA, VMV and LVOT. Weak and mostly insignificant correlations were found between the Doppler and motion-mode variables.

CONCLUSIONS: Varying mitral regurgitation severity, heart size and the presence of clinical signs can significantly affect certain brightness, motion and Doppler echocardiographic variables in dogs with myxomatous mitral valve disease (valvular heart disease).

PMID:42295688 | DOI:10.1002/vms3.70922

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Benchmark Survey on Content Development and Key Performance Indicators: A phactMI Benchmarking Survey Update

Ther Innov Regul Sci. 2026 Jun 15. doi: 10.1007/s43441-026-00999-9. Online ahead of print.

ABSTRACT

OBJECTIVE: Medical Information plays a critical role in delivering accurate, evidence-based responses to unsolicited requests. At the heart of the response is the content developed by Medical Information. Additionally, the metrics and key performance indicators (KPIs) surrounding content development and delivery are necessary to gauge the utilization and impact of the content. Because the landscape has evolved significantly since the last survey in 2018, the need to re-examine content development approaches and KPIs is warranted. The objective of this benchmarking survey was to assess the evolving approach and tactics of content development and utilization of KPIs of phactMI member companies with a comparison to 2018 where applicable.

METHODS: In May 2024, an electronic survey containing 71 closed and open-ended questions was distributed to 36 phactMI member companies. The survey included demographics, development of specific content, scientific response documents (SRDs), custom response documents, and metrics and KPI. Results were analyzed with descriptive statistics.

RESULTS: Medical Information teams primarily develop content for HCPs (90%) versus patients (10%). Disease state content creation was more common among small/midsize companies (36%) than large companies (18%), though requests for such content were infrequent. Similar to 2018, SRDs remain predominantly traditional written documents (66%), with emerging use of frequently asked questions, infographics, HTML, and slide decks. Most companies (85%) maintain centralized SRD development, but the proportion without target timelines for SRD development increased from 37% in 2018 to 72% in 2024. AI adoption is in early stages, with 3 companies actively using it and 18 exploring applications, primarily for writing and paraphrasing. Omnichannel integration is reported by 59% of companies, and custom response documents account for 25% of inquiries. Similar to 2018, the most common KPIs in medical information departments include inquiry volume, turnaround time, and document updates. There is a growing emphasis on customer satisfaction and digital engagement. HCPs most frequently use email (52%) and phone (29%) for information, while digital channels remain underutilized.

CONCLUSION: This benchmarking survey highlights the need for ongoing innovation, strategic alignment, and robust quality assurance in Medical Information content development and KPI reporting. While many things are similar to 2018, customer expectations continue to evolve and technology has advanced. Organizations must balance operational efficiency with personalized engagement, while ensuring compliance and ethical standards. For the future, the three areas to prioritize are establishing non-traditional content development formats, processes, and workflows; expanding digital and mobile optimization; and strengthening governance around AI and content reuse.

PMID:42295686 | DOI:10.1007/s43441-026-00999-9

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Prediction of intensive care unit requirement and in-hospital mortality in Fournier’s gangrene: a comparative analysis of conventional statistical and machine learning models

Updates Surg. 2026 Jun 15. doi: 10.1007/s13304-026-02715-6. Online ahead of print.

ABSTRACT

This study aimed to evaluate the need for intensive care unit (ICU) admission and identify factors associated with in-hospital mortality (IHM) in patients with Fournier’s gangrene (FG) using traditional statistical methods complemented by machine learning-based models. This retrospective cohort study included surgically treated FG patients at a tertiary referral center. Demographic, clinical, laboratory, and perioperative variables were analyzed. Established prognostic indices, including the Fournier’s Gangrene Severity Index, Uludağ Fournier’s Gangrene Severity Index, Laboratory Risk Indicator for Necrotizing Fasciitis, Systemic Immune-Inflammation Index, platelet-to-lymphocyte ratio (PLR), and neutrophil-to-lymphocyte ratio, were evaluated. Patients were stratified according to ICU requirement and survival status. Multivariable logistic regression was performed to identify independent predictors. In addition, exploratory machine learning models, including k-Nearest Neighbors (KNN), Random Forest (RF), Support Vector Machine, and Decision Tree algorithms, were applied to assess predictive performance. Multivariable logistic regression analysis revealed that PLR and heart failure (HF) were independent predictors of ICU requirement. Regarding IHM, PLR remained the only independent predictor. In the exploratory ML analysis, KNN and RF showed AUC values of 0.886 and 0.873 for ICU prediction, and 0.787 and 0.765 for IHM prediction, respectively. However, given the limited sample size and low number of outcome events, these performance estimates should be interpreted cautiously. This study highlights the prognostic relevance of inflammatory markers, particularly PLR, and comorbid conditions including HF, chronic kidney disease, cerebrovascular disease and concurrent malignancy, in disease severity and IHM in FG. Machine learning-based models showed promising performance, although these findings should be considered preliminary and require validation in larger, multicenter cohorts.

PMID:42295668 | DOI:10.1007/s13304-026-02715-6

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A New Insight into the Threshold and Oscillatory Regimes in Plant-Pathogen Models: A Nutrient-Driven Approach

Bull Math Biol. 2026 Jun 15;88(7):118. doi: 10.1007/s11538-026-01682-8.

ABSTRACT

Across ecosystems, autotroph growth and susceptibility to disease are strongly constrained by the availability of essential nutrients such as nitrogen and phosphorus. Understanding how nutrient availability influences disease transmission is important for predicting disease persistence, outbreak risk, and long-term ecosystem dynamics under changing environmental conditions. At the same time, infectious diseases in autotrophs can reshape ecosystem processes by altering elemental recycling and the nutrient supply available to hosts. Here, we formulate a five-dimensional deterministic system of nonlinear ordinary differential equations within a disease-mediated nutrient dynamic framework. We incorporate novel nutrient-driven transmission and nonlinear resource uptake kinetics to capture the bidirectional relationships linking elemental cycles with infectious disease in a natural forest ecosystem. Using a combination of qualitative mathematical analysis, including proofs of solutions boundedness and derivations of basic reproductive number, and numerical bifurcation analyses, we evaluate the system’s long-term behavior. Our results show that nutrient-disease feedbacks strongly regulate the distribution of host densities and nutrients between autotrophs and the abiotic environment. Incorporating nutrient-driven transmission reveals bifurcation structures distinct from frameworks with constant transmission, highlighting high sensitivity to nutrient availability and stronger nonlinear feedbacks. Bifurcation analyses indicate that nutrient enrichment lowers the transmission threshold for disease persistence and accelerates the onset of oscillatory dynamics with greater amplitude under high nutrient levels. Similarly, higher transmission rates reduce the nutrient threshold for disease persistence and shift oscillatory dynamics to emerge at lower nutrient levels. We further show that even small differences in infected host uptake rates strongly influence dynamics: lower uptake dampens oscillations and weakens feedbacks, whereas higher uptake amplifies bottom-up nutrient effects on disease and reinforces top-down effects on nutrient cycling, producing pronounced limit cycles in hosts, nutrients, and prevalence. Overall, nutrient-driven transmission alters thresholds and oscillatory regimes in ecosystem disease models, leading to dynamics that are not captured under constant transmission assumptions. This work advances applied ecosystem and ecological disease sciences by improving our understanding of disease transmission processes in plant communities.

PMID:42295654 | DOI:10.1007/s11538-026-01682-8

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Differential expression of NEAT1 and miR-506-3p in triple-negative breast cancer: potential tissue-based diagnostic biomarkers

Clin Transl Oncol. 2026 Jun 15. doi: 10.1007/s12094-026-04455-w. Online ahead of print.

ABSTRACT

OBJECTIVES: Triple-negative breast cancer (TNBC) is an aggressive subtype of breast cancer (BC) characterized by the absence of estrogen receptor (ER), progesterone receptor (PR), and HER2 expression, and is one of the most challenging cancers to treat. Non-coding RNAs have been identified as potential biomarkers for various diseases, including cancer. Identifying these biomarkers may facilitate early diagnosis and improve treatment strategies. Therefore, this study aimed to evaluate the non-coding RNAs NEAT1 and miR-506-3p expression levels in TNBC patients.

METHODS: Formalin-fixed, paraffin-embedded (FFPE) tumor tissues and paired adjacent non-tumor tissues were obtained from 35 TNBC patients. Total RNA was extracted, and the expression levels of NEAT1 and miR-506-3p were quantified by qPCR using GAPDH and U6 as internal controls, respectively. Relative expression was analyzed by the 2-ΔΔCt method. Statistical analyses included comparison of gene expression fold changes, assessment of associations with clinicopathological features, Spearman correlation analysis, and receiver-operating characteristic (ROC) curve analysis.

RESULTS: NEAT1 was significantly upregulated (≈eightfold, P < 0.0001) and miR-506-3p was markedly downregulated (≈fivefold, P < 0.0001) in tumor tissues compared to adjacent non-tumor samples. Elevated NEAT1 expression was significantly associated with the younger age group, necrosis, calcification status, larger tumor size, and vascular invasion, whereas no significant associations were observed with BMI, tumor grade, or lymph-node involvement (P > 0.05). MiR-506-3p expression showed no significant clinicopathological differences in subgroup analysis. A significant inverse correlation was observed between NEAT1 and miR-506-3p levels (rs = -0.33, P < 0.05). ROC curve analysis showed promising discriminatory performance for NEAT1 in the present cohort (AUC = 0.9563, 95% CI 0.9165-0.9961; estimated sensitivity = 1.00, specificity = 0.77) and moderate discriminatory performance for miR-506-3p (AUC = 0.7971, 95% CI 0.6946-0.8997). A logistic regression model combining both markers showed improved discrimination in this dataset (AUC = 0.9739).

CONCLUSION: Our findings suggest that NEAT1 and miR-506-3p exhibit opposite expression patterns in TNBC tissues and may serve as complementary tissue-based candidate diagnostic biomarkers. Their combined use showed improved discriminatory performance in this cohort; however, larger independent validation studies are required before a clinical diagnostic application can be proposed.

PMID:42295648 | DOI:10.1007/s12094-026-04455-w