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Indian Academy of Pediatrics Consensus Guidelines on Preconception Care.
Singh, H, Nair, MKC, Kariya, P, Bhatt, S, Janardhanan, D, Shanthi, BL, Sodhi, M, Elizebath, KE, Ratna Kumari, TL, Kinjawadekar, U, et al
Indian pediatrics. 2024;(4):305-320
Abstract
JUSTIFICATION The preconception period is the earliest window of opportunity to ensure optimal human development. Pregnancy and childbirth outcomes can be improved by interventions offered to support the health and well-being of women and couples prior to conception. Thus, preconception care is essential in preparing for the first thousand days of life. Adolescence, the stage of life that typically comes before the preconception stage, is characterized by various high-risk behaviors like substance abuse, sexual experimentation, injuries, obesity, and mental health issues which can adversely affect their health in adult life. Thus, a Consensus Guideline for pediatricians on providing preconception care to adolescents and young adults can go a long way in making the generations to come, healthier and more productive. OBJECTIVES The purpose of these recommendations is to formulate an evidence-based Consensus Statement that can serve as a guidance for medical professionals to provide preconception care for young adults and adolescents. INTENDED USERS All obstetric, pediatric, and adolescent health care providers. TARGET POPULATION Adolescents and young adults. PROCESS A large proportion of adolescents seek care from pediatricians and there is a lack of Consensus Guidelines on preconception care. Therefore, the Indian Academy of Pediatrics called an online National Consultative Meeting on April 03, 2023, under the chairmanship of Dr MKC Nair and the National Convenor Dr Himabindu Singh. A group of pediatricians with wide experience and expertise in adolescent health care were assigned the task of formulating evidence-based guidelines on preconception care. The group conducted a comprehensive review of existing evidence by searching resources including PubMed and Cochrane databases. Subsequently, a physical meeting was held at Amritsar on October 07, 2023 during which the consensus was reached through discussions and voting. The level of evidence (LoE) of each recommendation was graded as per the Oxford Centre for Evidence-Based Medicine (OCEBM) 2011. RECOMMENDATIONS Every woman planning a pregnancy needs to attain and maintain a eumetabolic state. Prospective couples need to be counselled on the importance of a healthy lifestyle including a nutritious diet, avoidance of substance abuse, and timely screening for genetic disorders. Screening for and management of sexually transmitted diseases in males and females, appropriate vaccination and addressing mental health concerns are also recommended.
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Optically active two-dimensional MoS2-based nanohybrids for various biosensing applications: A comprehensive review.
Ghosh, S, Yang, CJ, Lai, JY
Biosensors & bioelectronics. 2024;:115861
Abstract
Following the discovery of graphene, there has been a surge in exploring other two-dimensional (2D) nanocrystals, including MoS2. Over the past few decades, MoS2-based nanocrystals have shown great potential applications in biosensing, owing to their excellent physico-chemical properties. Unlike graphene, MoS2 shows layer-dependent finite band gaps (∼1.8 eV for a single layer and ∼1.2 for bulk) and relatively strong interaction with the electromagnetic spectrum. The tunability of the size, shape, and intrinsic properties, such as high optical absorption, electron mobility, mechanical strength and large surface area, of MoS2 nanocrystals, make them excellent alternative probe materials for preparing optical, photothermal, and electrical bio/immunosensors. In this review, we will provide insights into the rapid evolutions in bio/immunosensing applications based on MoS2 and its nanohybrids. We emphasized the various synthesis, characterization, and functionalization routes of 2D MoS2 nanosheets/nanoflakes. Finally, we discussed various fabrication techniques and the critical parameters, including the limit of detection (LOD), linear detection range, and sensitivity of the biosensors. In addition, the role of MoS2 in enhancing the performance of biosensors, the limitations associated with current biosensing technologies, future challenges, and clinical implications are addressed. The advantages/disadvantages of each biosensor technique are also summarized. Collectively, we believe that this review will encourage resolute researchers to follow up further with the state-of-the-art MoS2-based biosensing technology.
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Harnessing the power of biological macromolecules in hydrogels for controlled drug release in the central nervous system: A review.
Ghosh, S, Ghosh, S, Sharma, H, Bhaskar, R, Han, SS, Sinha, JK
International journal of biological macromolecules. 2024;(Pt 1):127708
Abstract
Hydrogels have immense potential in revolutionizing central nervous system (CNS) drug delivery, improving outcomes for neurological disorders. They serve as promising tools for controlled drug delivery to the CNS. Available hydrogel types include natural macromolecules (e.g., chitosan, hyaluronic acid, alginate), as well as hybrid hydrogels combining natural and synthetic polymers. Each type offers distinct advantages in terms of biocompatibility, mechanical properties, and drug release kinetics. Design and engineering considerations encompass hydrogel composition, crosslinking density, porosity, and strategies for targeted drug delivery. The review emphasizes factors affecting drug release profiles, such as hydrogel properties and formulation parameters. CNS drug delivery applications of hydrogels span a wide range of therapeutics, including small molecules, proteins and peptides, and nucleic acids. However, challenges like limited biodegradability, clearance, and effective CNS delivery persist. Incorporating 3D bioprinting technology with hydrogel-based CNS drug delivery holds the promise of highly personalized and precisely controlled therapeutic interventions for neurological disorders. The review explores emerging technologies like 3D bioprinting and nanotechnology as opportunities for enhanced precision and effectiveness in hydrogel-based CNS drug delivery. Continued research, collaboration, and technological advancements are vital for translating hydrogel-based therapies into clinical practice, benefiting patients with CNS disorders. This comprehensive review article delves into hydrogels for CNS drug delivery, addressing their types, design principles, applications, challenges, and opportunities for clinical translation.
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Mechanism of Protease Resistance of D-Amino Acid Residue Containing Cationic Antimicrobial Heptapeptides.
Sarkar, T, Ghosh, S, Sundaravadivelu, PK, Pandit, G, Debnath, S, Thummer, RP, Satpati, P, Chatterjee, S
ACS infectious diseases. 2024;(2):562-581
Abstract
Antimicrobial peptides (AMPs) have been an alternate promising class of therapeutics in combating global antibiotic resistance threat. However, the short half-life of AMPs, owing to protease degradability, is one of the major bottlenecks in its commercial success. In this study, we have developed all-D-amino acid containing small cationic peptides P4C and P5C, which are completely protease-resistant, noncytotoxic, nonhemolytic, and potent against the ESKAPE pathogens in comparison to their L analogues. MD simulations suggested marginal improvement in the peptide-binding affinity to the membrane-mimetic SDS micelle (∼ 1 kcal/mol) in response to L → D conversion, corroborating the marginal improvement in the antimicrobial activity. However, L → D chirality conversion severely compromised the peptide:protease (trypsin) binding affinity (≥10 kcal/mol). The relative distance between the scissile peptide carbonyl and the catalytic triad of the protease (H57, D102, and S195) was found to be significantly altered in the D-peptide:protease complex (inactive conformation) relative to the active L-peptide:protease complex. Thus, the poor binding affinity between D-peptides and the protease, resulting in the inactive complex formation, explained their experimentally observed proteolytic stability. This mechanistic insight might be extended to the proteolytic stability of the D-peptides in general and stimulate the rational design of protease-resistant AMPs.
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Enhancing Bone Implants: Magnesium-Doped Hydroxyapatite for Stronger, Bioactive, and Biocompatible Applications.
Bhatnagar, D, Gautam, S, Sonowal, L, Bhinder, SS, Ghosh, S, Pati, F
ACS applied bio materials. 2024;(4):2272-2282
Abstract
Hydroxyapatite (HAp) with the chemical formula Ca10(PO4)6(OH)2 is an inorganic material that exhibits morphology and composition similar to those of human bone tissues, making it highly desirable for bone regeneration applications. As one of the most biocompatible materials currently in use, HAp has undergone numerous attempts to enhance its mechanical strength. This research focuses on investigating the influence of magnesium (Mg) incorporation on the structural and mechanical properties of synthesized magnesium-doped hydroxyapatite (MgHAp) samples. Apart from its biocompatibility, Mg possesses a density and elasticity comparable to those of human bone. Therefore, incorporating Mg into HAp can be pivotal for improving bone formation. Previous studies have not extensively explored the structural changes induced by Mg substitution in HAp, which motivated us to revisit this issue. Hydrothermal synthesis technique was used to synthesize MgHAp samples with varying molar concentrations (x = 0, 0.5, 1.0, and 1.5). Theoretical simulation of HAp and MgHAp for obtaining 3D structures has been done, and theoretical X-ray diffraction (XRD) data have been compared with the experimental XRD data. Rietveld analysis revealed the alteration and deviation of lattice parameters with an increase in the Mg content, which ultimately affect the structure as well the mechanical properties of prepared samples. The findings revealed an increase in compressive stress and fracture toughness as the Mg concentration in the composition increased. Furthermore, using a finite-element analysis technique and modeling of the mechanical testing data, the von Mises stress distribution and Young's modulus values were calculated, demonstrating the similarity of the prepared samples to human cortical bone. Biocompatibility assessments using NIH-3T3 fibroblast cells confirmed the biocompatible and bioactive nature of the synthesized samples. MgHAp exhibits great potential for biomedical applications in the dental, orthopedic, and tissue engineering research fields.
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A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy of Individualized Homeopathic Medicines in Pre-diabetes.
Guha, N, Ghosh, S, Mandal, S, Das, AD, Palanisamy, C, Maiti, S, Ghosh, P, Singh, NK, Koley, M, Saha, S
Homeopathy : the journal of the Faculty of Homeopathy. 2024;(2):67-79
Abstract
BACKGROUND Pre-diabetes (PD) contributes importantly to the disease burden worldwide and is a precursor to stroke, cardiovascular diseases, as well as type-2 diabetes mellitus. OBJECTIVE In this project, the efficacy of individualized homeopathic medicines (IHMs) was explored against placebos in the treatment of PD. METHODS A 6-month, double-blind, randomized, placebo-controlled trial was conducted at the outpatient departments of a homeopathic medical college and hospital in India. Sixty participants with PD were randomized to receive either IHMs (n = 30) or identical-looking placebos (n = 30). Concomitant care measures were advised to both groups of participants in terms of dietary advice, yoga, meditation and exercise. The primary outcome measures were fasting blood sugar (FBS) and the oral glucose tolerance test (OGTT); the secondary outcome was the Diabetes Symptom Checklist-Revised (DSC-R) score. All the outcomes were measured at baseline and after 3 and 6 months of treatment. Inter-group differences and effect sizes (Cohen's d) were calculated using two-way repeated measures analysis of variance models after adjusting baseline differences using analysis of co-variance on the intention-to-treat data. RESULTS Between-group differences for FBS were statistically significant, favoring IHMs against placebos (F 1,58 = 7.798, p = 0.007), but not for OGTT (F 1,58 = 1.691, p = 0.199). The secondary outcome, DSC-R total score, favoring IHMs significantly compared with placebos (F 1,58 = 15.752, p < 0.001). Calcarea Carbonicum, Thuja occidentalis and Sulphur were the most frequently prescribed medicines. No harm or serious adverse events were recorded from either of the participant groups. CONCLUSION IHMs produced significantly better results than placebos in FBS and in DSC-R scores but not in OGTT. Independent replications with larger sample sizes are warranted to substantiate the findings. TRIAL REGISTRATION CTRI/2019/10/021711.
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Insulin Glargine in Type 1 Diabetes Mellitus: A Review of Clinical Trials and Real-world Evidence Across Two Decades.
Saboo, B, Chandalia, H, Ghosh, S, Kesavadev, J, Kochar, IPS, Prasannakumar, KM, Sarda, A, Bantwal, G, Mehrotra, RN, Rai, M
Current diabetes reviews. 2024;(1):e100323214554
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Abstract
BACKGROUND Over the past two decades, insulin glargine 100 U/mL (Gla-100) has emerged as the "standard of care" basal insulin for the management of type 1 diabetes mellitus (T1DM). Both formulations, insulin glargine 100 U/mL (Gla-100) and glargine 300 U/mL (Gla- 300) have been extensively studied against various comparator basal insulins across various clinical and real-world studies. In this comprehensive article, we reviewed the evidence on both insulin glargine formulations in T1DM across clinical trials and real-world studies. METHODS Evidence in T1DM for Gla-100 and Gla-300 since their approvals in 2000 and 2015, respectively, were reviewed. RESULTS Gla-100 when compared to the second-generation basal insulins, Gla-300 and IDeg-100, demonstrated a comparable risk of overall hypoglycemia, but the risk of nocturnal hypoglycemia was higher with Gla-100. Additional benefits of Gla-300 over Gla-100 include a prolonged (>24- hours) duration of action, a more stable glucose-lowering profile, improved treatment satisfaction, and greater flexibility in the dose administration timing. CONCLUSION Both glargine formulations are largely comparable to other basal insulins in terms of glucose-lowering properties in T1DM. Further, risk of hypoglycemia is lower with Gla-100 than Neutral Protamine Hagedorn but comparable to insulin detemir.
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Improving adolescents' dietary behavior through teacher-delivered cancer prevention education: a school-based cluster randomized intervention trial in urban Rajasthan.
Mittal, A, Rustagi, N, Thirunavukkarasu, P, Ghosh, S, Raghav, P
BMC public health. 2024;(1):630
Abstract
BACKGROUND Dietary practices are one of the most common modifiable risk factors for cancers. Foods rich in dietary fibers are considered protective, meanwhile fast & junk foods are risk for common cancers. Adolescence period is marked by habit formation and is thus suited for delivering behavioral intervention. Schools offer an optimal setting for planning and executing these interventions to a large number of adolescents. OBJECTIVE To assess the effectiveness of a teacher-delivered cancer-prevention education in changing dietary behaviors of school going adolescents. METHODS A cluster randomized trial was conducted in government secondary and senior secondary schools with schools as clusters. A minimum required sample of 1032 students was estimated from 16 schools with 1:1 allocation in intervention and non-intervention groups. Dietary behaviors were recorded as dichotomous variable. The determinants were recorded as per theory of planned behavior framework using Likert-scale. Two teachers from each intervention school were trained to deliver cancer prevention education with focus on role of dietary behavior. Pre-post training assessment of teachers' knowledge towards common cancers was done using a self-administered questionnaire. Gender adjusted difference-in-difference analysis was done to assess intervention effect on both healthy and unhealthy behaviors. RESULTS In selected schools all students from classes 8 to 10 were approached and a total of 1224 students were enrolled, of whom 1096 completed the study. The study recorded significant improvement in scores of students from intervention group compared to non-intervention group for their attitude, subjective norms, perceived behavioral control and intention towards consuming healthy and avoiding unhealthy foods. The intervention was effective in significantly improving the proportion of students limiting fried/fast/packed food & sugar sweetened beverages (OR:1.51, 95%CI:1.08,2.12,p:0.017), and consuming fruits & vegetables daily (OR:1.55, 95%CI:1.08,2.22, p:0.017) while adjusting effect of gender. CONCLUSION Classroom-based cancer prevention education delivered through teachers during regular working hours is effective in improving dietary behaviors and its determinants among adolescent students. Thus, we recommend integrating a section focusing on the role of diet in cancer prevention and other lifestyle diseases in the existing school curriculum. TRIAL REGISTRATION The trial was registered under Clinical Trial Registry-India with registration number CTRI/2018/12/016586, dated-10/12/2018.
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Prognostic and Diagnostic Utility of Serum Biomarkers in Pediatric Traumatic Brain Injury.
Munoz Pareja, JC, de Rivero Vaccari, JP, Chavez, MM, Kerrigan, M, Pringle, C, Guthrie, K, Swaby, K, Coto, J, Kobeissy, F, Avery, KL, et al
Journal of neurotrauma. 2024;(1-2):106-122
Abstract
Traumatic brain injury (TBI) remains a major cause of morbidity and death among the pediatric population. Timely diagnosis, however, remains a complex task because of the lack of standardized methods that permit its accurate identification. The aim of this study was to determine whether serum levels of brain injury biomarkers can be used as a diagnostic and prognostic tool in this pathology. This prospective, observational study collected and analyzed the serum concentration of neuronal injury biomarkers at enrollment, 24h and 48h post-injury, in 34 children ages 0-18 with pTBI and 19 healthy controls (HC). Biomarkers included glial fibrillary acidic protein (GFAP), neurofilament protein L (NfL), ubiquitin-C-terminal hydrolase (UCH-L1), S-100B, tau and tau phosphorylated at threonine 181 (p-tau181). Subjects were stratified by admission Glasgow Coma Scale score into two categories: a combined mild/moderate (GCS 9-15) and severe (GCS 3-8). Glasgow Outcome Scale-Extended (GOS-E) Peds was dichotomized into favorable (≤4) and unfavorable (≥5) and outcomes. Data were analyzed utilizing Prism 9 and R statistical software. The findings were as follows: 15 patients were stratified as severe TBI and 19 as mild/moderate per GCS. All biomarkers measured at enrollment were elevated compared with HC. Serum levels for all biomarkers were significantly higher in the severe TBI group compared with HC at 0, 24, and 48h. The GFAP, tau S100B, and p-tau181 had the ability to differentiate TBI severity in the mild/moderate group when measured at 0h post-injury. Tau serum levels were increased in the mild/moderate group at 24h. In addition, NfL and p-tau181 showed increased serum levels at 48h in the aforementioned GCS category. Individual biomarker performance on predicting unfavorable outcomes was measured at 0, 24, and 48h across different GOS-E Peds time points, which was significant for p-tau181 at 0h at all time points, UCH-L1 at 0h at 6-9 months and 12 months, GFAP at 48h at 12 months, NfL at 0h at 12 months, tau at 0h at 12 months and S100B at 0h at 12 months. We concluded that TBI leads to increased serum neuronal injury biomarkers during the first 0-48h post-injury. A biomarker panel measuring these proteins could aid in the early diagnosis of mild to moderate pTBI and may predict neurological outcomes across the injury spectrum.
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Efficacy and Safety of Approximately 3 Years of Continuous Ozanimod in Moderately to Severely Active Ulcerative Colitis: Interim Analysis of the True North Open-label Extension.
Danese, S, Panaccione, R, Abreu, MT, Rubin, DT, Ghosh, S, Dignass, A, Afzali, A, Wolf, DC, Chiorean, MV, Vermeire, S, et al
Journal of Crohn's & colitis. 2024;(2):264-274
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Abstract
BACKGROUNDS AND AIMS This interim analysis from the True North open-label extension [OLE] study examines efficacy and safety of approximately 3 years of continuous ozanimod treatment in patients with moderately to severely active ulcerative colitis. METHODS Clinical responders after 52 weeks of ozanimod during the phase 3 True North study, who continued treatment in the OLE, were evaluated. Efficacy, including endoscopic and histological endpoints, was assessed during the OLE for approximately 2 additional years through OLE Week 94, using observed case [OC] and nonresponder imputation [NRI] analyses. Adverse events were monitored from True North baseline through OLE data cutoff and expressed as exposure-adjusted incidence rates. RESULTS This analysis included 131 patients; 54% had achieved corticosteroid-free remission at True North Week 52. In OC analyses, clinical response, clinical remission, and corticosteroid-free remission were achieved by 91.4%, 69.1%, and 67.9% of patients, respectively, at OLE Week 94 [146 weeks of total treatment]. Similarly, endoscopic improvement, histological remission, and mucosal healing were achieved by 73.3%, 67.3%, and 56.3% of patients, respectively, at OLE Week 94. Efficacy rates were lower using NRI analyses, but maintenance of efficacy was demonstrated through OLE Week 94. No new safety signals emerged from this analysis. Serious infections, malignancy, cardiovascular events, and hepatic events occurred infrequently. CONCLUSIONS Among patients who achieved clinical response after 1 year of ozanimod treatment during True North, a high percentage sustained clinical and mucosal efficacy over 2 additional years in the OLE. No new safety signals were observed with long-term ozanimod use.