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Background: Combination vaccines reduce the number of pediatric injections but must be as safe, immunogenic, and effective as each of the individual vaccines given separately. Additionally, consistency in manufacturing lots is essential for WHO prequalification. This study aimed to establish the lot-to-lot consistency of a fully liquid, hexavalent diphtheria (D)-tetanus (T)-whole-cell pertussis (wP)-inactivated poliovirus (IPV)-hepatitis B (HB)-Haemophilus influenzae b (PRP-T) (DTwP-IPV-HB-PRP∼T) vaccine and to demonstrate non-inferiority to licensed DTwP-HB-PRP∼T and IPV vaccines. Methods: A Phase III, randomized, active-controlled, and open-label study was conducted at multiple centers across India. Healthy infants who had received a birth dose of oral poliovirus vaccine and hepatitis B vaccine received one of three lots of DTwP-IPV-HB-PRP∼T or separate DTwP-HB-PRP∼T and IPV vaccines at 6-8, 10-12, and 14-16 weeks of age. Oral rotavirus vaccine was co-administered at 6-8 weeks of age and 10-12/14-16 weeks of age. DTwP-IPV-HB-PRP∼T lot-to-lot consistency and non-inferiority (pooled DTwP-IPV-HB-PRP∼T) versus DTwP-HB-PRP∼T and IPV post-third dose were assessed using seroprotection rates (anti-D, anti-T, anti-HBs, anti-PRP, anti-polio 1, 2, 3) and adjusted geometric mean concentrations (anti-PT, anti-FIM). Safety was assessed by parental reports. Results: Lot-to-lot consistency was demonstrated for DTwP-IPV-HB-PRP∼T and non-inferiority versus DTwP-HB-PRP∼T and IPV was confirmed with 95% CIs for seroprotection rate differences and adjusted geometric mean concentration ratios within pre-defined clinical margins. Pooled seroprotection rate was ≥ 99.7% for anti-D ≥ 0.01 IU/mL, anti-T ≥ 0.01 IU/mL, anti-HBs ≥ 10 mIU/mL, anti-PRP ≥ 0.15 µg/mL, and anti-polio 1, 2, and 3 ≥ 8 (1/dil) and vaccine response rate was 83.9% for anti-PT and 97.7% for anti-FIM. There were no safety concerns. Conclusions: Immunogenicity of three lots of the fully liquid DTwP-IPV-HB-PRP∼T vaccine was consistent and non-inferior to licensed comparators following vaccination at 6-8, 10-12, and 14-16 weeks of age. There were no safety concerns and no evidence of any effect of co-administration with rotavirus vaccine.

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Objectives: We evaluated the extent of consent declines and consent withdrawals during the COVID-19 pandemic as seen in published randomized controlled trials (RCTs) and compared it with non-COVID-19 RCTs published at the same time and two historical controls. Methods: PubMed/Medline only was searched using key-word "COVID-19" and "RCTs" separately, and filtered for COVID-19 RCTs and non-COVID-19 RCTs respectively, published during a nine-month period (1 Feb - 1 Nov 2020). Exclusions were study protocols, observational studies, interim analysis of RCT data and RCTs with missing data. Primary outcome measures were the proportion of consent declines and consent withdrawals as percentage of total participants screened and randomized respectively in COVID-19 RCTs. We compared consent declines and consent withdrawals of COVID-19 RCTs with non-COVID-19 RCTs and two earlier studies on the same topic that served as historical controls (non-pandemic setting). Results: The search yielded a total of 111 COVID-19 RCTs and 49 non-COVID-19 RCTs. Of these, 39 (35.13%) COVID-19 RCTs and 11 (22.45%) non-COVID-19 RCTs were finally analysed. A total of 770/17759 (4.3%) consent declines and 100/7607 (1.31%) consent withdrawals were seen in 39 COVID-19 RCTs. A significant difference was observed in consent declines between COVID-19 vs non-COVID-19 RCTs [4.3% vs 11.9%, p < 0.0001] and between COVID-19 RCTs vs two historical controls [(4.3% vs 8.6%, p < 0.0001) and (4.3% vs 21.1%, p < 0.0001), respectively]. Conclusion: RCTs conducted during the COVID-19 pandemic appear to have significantly lower consent declines relative to non-COVID-19 RCTs during pandemic and RCTs conducted in non-pandemic settings.

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BACKGROUND: Oral health is integral part of general health. In certain conditions especially among mentally disabled, oral health is neglected. Studies have shown that mentally disabled population has the risk of poor oral health. People with disabilities deserve the same opportunities for oral health and hygiene as those who are healthy, but sadly dental care is the most common unmet health care need of the disabled people. METHODOLOGY: This comparative, descriptive cross-sectional study was conducted among institutionalized mentally disabled and normal children of age group 6-13 years in Mysore city. RESULTS: Majority of mentally disabled children, that is, 36.73% (n = 180), had poor oral hygiene when compared with normal children, that is, 9.18% (n = 45). This difference was statistically highly significant (P < 0.000). The significant differences in the gingival status and severity of mental disability were seen (P < 0.001). The result showed that the gingival health worsens with increase in the severity of mental disability. CONCLUSION: The present study showed the dental negligence among mentally disabled children where the parents, caretakers, and dentists are responsible. Oral health promotion programs should be conducted for special group children, their parents, as well as caretakers.

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BACKGROUND: One of the widespread problems of oral health is bruxism and is defined as a parafunctional habit with involuntary grinding and gnashing of the teeth occurring during sleep. However, bruxism is connected to anxiety and stress, but the published literature on bruxism among prison inmates is scanty. Objective: The objective of the study was to determine the prevalence of active sleep bruxism and its impact on oral health-related quality of life (OHRQoL) among inmates in Central Penal Institution, Mysore. MATERIALS AND METHODS: The study was cross sectional and conducted among eligible male inmates at Central Penal Institution, Mysore. The information on active sleep bruxism and OHRQoL was collected using a predesigned structured questionnaire by means of personal interview by a trained investigator. The active sleep bruxism was assessed using the criteria of American Academy of Sleep Medicine and OHRQoL through modified oral health impact profile (OHIP-14). The data analysis was done using descriptive statistics, Chi-square test, t-test, analysis of variance, and linear regression model. RESULTS: A total of 212 male inmates aged between 18 and 80 years were considered for the study. The prevalence of active sleep bruxism among the study population was 31.6%. The mean OHIP-14 score was significantly higher (P < 0.001) among the inmates having active sleep bruxism (38.52 ± 12.8) suggesting a high oral health impact as compared to inmates without this disorder (31.67 ± 12). CONCLUSION: The prevalence of active sleep bruxism was higher among the inmates of penal institution as compared to the general population. The active sleep bruxism had a negative impact on OHRQoL.

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BACKGROUND: In pursuit of a more "holistic" dentistry and an increasing focus on promoting oral health, dental students are increasingly being trained to take a more active part in health promotion and education. In particular, this incorporates an emphasis on diet and educating people to eat in more healthy ways. AIM: This paper works from the premise that if dental students are to engage in oral health promotion, they will do so more effectively if they have first explored their own food choice motivations. SUBJECTS AND METHODS: A descriptive, cross-sectional questionnaire study. The food choice questionnaire (FCQ) was distributed to a comparative group of 1(st) and 5(th) year dental students in timetabled lecture slots. The FCQ is a previously validated measure designed to assess ten main factors relevant to peoples" food choices. The data was analyzed using SPSS version 18.0 (Chicago, IL, USA) using descriptive statistics and independent sample t-test. RESULTS: Nearly 77% (122/159) students responded. Findings were analyzed using independent sample t-test. Results indicated statistically significant differences in terms of food choice motivations between male and female students of 1(st) and 5(th) year. CONCLUSION: Awareness and an understanding of the differences in motivational factors affecting food choice between dental students is important as they are increasingly taught to play an active role in oral health promotion.

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Data-driven reconstruction of biological networks is a crucial step towards making sense of large volumes of biological data. Although several methods have been developed recently to reconstruct biological networks, there are few systematic and comprehensive studies that compare different methods in terms of their ability to handle incomplete datasets, high data dimensions and noisy data. The authors use experimentally measured and synthetic datasets to compare three popular methods - principal component regression (PCR), linear matrix inequalities (LMI) and least absolute shrinkage and selection operator (LASSO) - in terms of root-mean-squared error (RMSE), average fractional error in the value of the coefficients, accuracy, sensitivity, specificity and the geometric mean of sensitivity and specificity. This comparison enables the authors to establish criteria for selection of an appropriate approach for network reconstruction based on a priori properties of experimental data. For instance, although PCR is the fastest method, LASSO and LMI perform better in terms of accuracy, sensitivity and specificity. Both PCR and LASSO are better than LMI in terms of fractional error in the values of the computed coefficients. Trade-offs such as these suggest that more than one aspect of each method needs to be taken into account when designing strategies for network reconstruction.

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Quantitative modelling and analysis of biochemical networks is challenging because of the inherent complexities and nonlinearities of the system and the limited availability of parameter values. Even if a mathematical model of the network can be developed, the lack of large-scale good-quality data makes accurate estimation of a large number of parameters impossible. Hence, coarse-grained models (CGMs) consisting of essential biochemical mechanisms are more suitable for computational analysis and for studying important systemic functions. The central question in constructing a CGM is which mechanisms should be deemed 'essential' and which can be ignored. Also, how should parameter values be defined when data are sparse? A mixed-integer nonlinear-programming (MINLP) based optimisation approach to coarse-graining is presented. Starting with a detailed biochemical model with associated computational details (reaction network and mathematical description) and data on the biochemical system, the structure and the parameters of a CGM can be determined simultaneously. In this optimisation problem, the authors use a genetic algorithm to simultaneously identify parameter values and remove unimportant reactions. The methodology is exemplified by developing two CGMs for the GTPase-cycle module of M1 muscarinic acetylcholine receptor, Gq, and regulator of G protein signalling 4 [RGS4, a GTPase-activating protein (GAP)] starting from a detailed model of 48 reactions. Both the CGMs have only 17 reactions, fit experimental data well and predict, as does the detailed model, four limiting signalling regimes (LSRs) corresponding to the extremes of receptor and GAP concentration. The authors demonstrate that coarse-graining, in addition to resulting in a reduced-order model, also provides insights into the mechanisms in the network. The best CGM obtained for the GTPase cycle also contains an unconventional mechanism and its predictions explain an old problem in pharmacology, the biphasic (bell-shaped) response to certain drugs. The MINLP methodology is broadly applicable to larger and complex (dense) biochemical modules.

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Biochemical systems embed complex networks and hence development and analysis of their detailed models pose a challenge for computation. Coarse-grained biochemical models, called reduced-order models (ROMs), consisting of essential biochemical mechanisms are more useful for computational analysis and for studying important features of a biochemical network. The authors present a novel method to model-reduction by identifying potentially important parameters using multidimensional sensitivity analysis. A ROM is generated for the GTPase-cycle module of m1 muscarinic acetylcholine receptor, Gq, and regulator of G-protein signalling 4 (a GTPase-activating protein or GAP) starting from a detailed model of 48 reactions. The resulting ROM has only 17 reactions. The ROM suggested that complexes of G-protein coupled receptor (GPCR) and GAP--which were proposed in the detailed model as a hypothesis--are required to fit the experimental data. Models previously published in the literature are also simulated and compared with the ROM. Through this comparison, a minimal ROM, that also requires complexes of GPCR and GAP, with just 15 parameters is generated. The proposed reduced-order modelling methodology is scalable to larger networks and provides a general framework for the reduction of models of biochemical systems.

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Reaction of [Ru(eta4-C8H12) (CH3CN)2 Cl2] with 2-(2-pyridyl) benzimidazole or Schiff bases derived from 2-acetylpyridine and S-methyldithiocarbazate, S-benzyldithiocarbazate and thiosemicarbazide leads to form new complexes of the type [Ru(eta4-C8H12)(L)Cl2] (where L=ligand). In vitro, most of the compounds exhibited potent activity and the Ru derivatives 1a [Ru(eta4-C8H12)(2-Acpy-SMDT)Cl2], 2a [Ru(eta4-C8H12)(2-Acpy-SBDT)Cl2] and 3a [Ru(eta4-CsH12)(2-Acpy-TSC)Cl2] were found more active than metronidazole against (HK-9) strain of Entamoeba histolytica.

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A comprehensive field investigation in several parts of India has revealed that the presence of coliforms in drinking water is associated with hydrogen sulfide-producing organisms. This paper describes a simple, rapid, and inexpensive field test for the screening of drinking water for faecal pollution, based on the detection of hydrogen sulfide. The new test showed good agreement with the standard most probable number (MPN) test. It proved highly successful in the field when it was used to detect faecal pollution and to monitor water quality during an outbreak of water-borne hepatitis A infection in the city of Gwalior. The test is reliable and simple to perform, and will be especially useful for screening rural water supplies and for large-scale screening of urban water supplies where resources, time, manpower, and laboratory facilities are limited.

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