22 results on '"Mohanty RR"'
Search Results
2. Comparative Study of Degree of Great Toe Movement after Complete and Partial Flexor Hallucis Longus Harvest in Free Fibula Flap.
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Agnihotri I, Nayak BB, Lakhotia P, Patnaik A, and Mohanty RR
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Background The flexor hallucis longus (FHL) muscle is crucial in fine motor control of the great toe but the muscle is often sacrificed in free fibula flap (FFF) reconstruction. The aim of this study was to compare great toe movement between complete and partial FHL resection during FFF harvest to see if FHL can be left behind (without undergoing fibrosis) in situ when bulk is not required at the recipient site. Methods A prospective, cross-sectional, observational study was performed including patients undergoing FFF harvest over a 2-year period. Movement of great toe interphalangeal joint was recorded of operated and unoperated legs in patients undergoing partial and complete FHL harvest and data analyzed. Results There was a statistically significant ( p < 0.05) difference between the two groups of patients. Conclusion FHL can be safely left in situ in patients not requiring bulk at the recipient site as blood supply, nerve supply, and muscle function are not compromised in partial FHL harvest. Further image-based and dye-based studies are warranted., Competing Interests: Conflict of Interest None declared., (Association of Plastic Surgeons of India. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. ( https://creativecommons.org/licenses/by-nc-nd/4.0/ ).)
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- 2024
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3. Acute ischaemic stroke and deep vein thrombosis following snakebite.
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Das DS, Mohapatra RK, Mohanty RR, and Patel RK
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- Humans, Female, Adult, Antivenins therapeutic use, Magnetic Resonance Imaging, Animals, Snake Bites complications, Venous Thrombosis etiology, Venous Thrombosis diagnostic imaging, Ischemic Stroke etiology
- Abstract
Snakebite envenomation remains a neglected tropical public health issue claiming thousands of lives every year. It is a common medical emergency and a threat to the impoverished populations of low-income and middle-income countries including India. A combination of ischaemic stroke and deep vein thrombosis is a devastating duo complication of snake bite, with no literature report to date. Here, the authors report an unusual case of a young woman developing ischaemic stroke and deep vein thrombosis following snakebite even after the use of antivenom. MRI brain showed right thalamic infarct with haemorrhagic transformation and, ultrasound Doppler revealed right lower limb deep vein thrombosis. The pathophysiology of deep vein thrombosis and ischaemic stroke is complex. It is believed that the activation of the coagulation cascade, complement system together with endothelial injury and immune activation leads to inflammation, thrombosis and occlusion of smaller and even larger vessels., Competing Interests: Competing interests: None declared., (© BMJ Publishing Group Limited 2024. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2024
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4. Effect of Virgin Coconut Oil (VCO) on Cardiometabolic Parameters in Patients with Dyslipidemia: A Randomized, Add-on Placebo-Controlled Clinical Trial.
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Maiti R, Mohanty RR, Dey A, Maji S, Padhan M, and Mishra A
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- Adult, Humans, Coconut Oil therapeutic use, Atorvastatin therapeutic use, Thiobarbituric Acid Reactive Substances, Dyslipidemias drug therapy, Atherosclerosis drug therapy
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Objective: Statin monotherapy for dyslipidemia is limited by adverse effects and limited effectiveness in certain subgroups like metabolic syndrome. Add-on therapy with an agent with a known safety profile may improve clinical outcomes, and virgin coconut oil (VCO) may be the candidate agent for improving the cardiometabolic profile. The present study was conducted to evaluate the effect of add-on VCO with atorvastatin in dyslipidemia in adults., Methods: A randomized, double-blind clinical trial was conducted on 150 patients with dyslipidemia who were randomized into control and test groups. The control group received atorvastatin monotherapy, whereas the test group received add-on VCO with atorvastatin for 8 weeks. At baseline, demographic, clinical, and biochemical parameters were assessed and repeated after 8 weeks of therapy. The main outcome measures were lipid profile, cardiovascular risk indices, 10-year cardiovascular risk, body fat compositions, and thiobarbituric acid reactive substances (TBARS)., Results: The increase in HDL in the test group was significantly greater than in the control group (MD: 2.76; 95%CI: 2.43-3.08; p < 0.001). The changes in the atherogenic index ( p = 0.003), coronary risk index ( p < 0.001), cardiovascular risk index ( p = 0.001), and TBARS ( p < 0.001) were significantly greater in the test group. The decrease in LDL, total cholesterol and lipoprotein(a), were significantly higher in the control group. There were no significant differences between the groups with respect to the changes in triglyceride, VLDL, and 10-year cardiovascular risk., Conclusions: Add-on VCO (1000 mg/day) with atorvastatin (10 mg/day) can achieve a better clinical outcome in patients with dyslipidemia by increasing HDL and improving oxidative stress cardiovascular risk indices.
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- 2024
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5. Review of Satralizumab for Neuromyelitis Optica Spectrum Disorder: A New Biologic Agent Targeting the Interleukin-6 Receptor.
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Meher BR, Mohanty RR, and Dash A
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Currently, three monoclonal antibodies (MABs) have received regulatory approval from the federal agency, the United States Food and Drug Administration (USFDA), for the medical management of neuromyelitis optica spectrum disorder (NMOSD). Satralizumab was the third approved therapy after MABs like eculizumab and inebilizumab for NMOSD, an uncommon but severe enfeebling autoimmune neurological disease. Satralizumab, a humanized monoclonal antibody, exerts its action in NMOSD by acting against cytokine interleukin-6 (IL-6), a foremost mediator in the pathological process of NMOSD. Two pivotal clinical trials carried out in NMOSD patients had established that satralizumab significantly decreased the rate of relapse in patients suffering from NMOSD as opposed to placebo. The trials also demonstrated that satralizumab is relatively safe. Thus, satralizumab provides an efficacious and safe treatment option for this rare, disabling central nervous system (CNS) disease. Our review aimed to elucidate the pharmacological characteristics of satralizumab and illustrate the available evidence regarding its safety and efficacy in patients with NMOSD., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2024, Meher et al.)
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- 2024
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6. Defining anthropometric thresholds (mid-arm circumference and calf circumference) in older adults residing in the community: a cross-sectional analysis using data from the population representative Longitudinal Aging Study in India (LASI DAD).
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Bhagwasia M, Rao AR, Banerjee J, Bajpai S, Khobragade PY, Raman AV, Talukdar A, Jain A, Rajguru C, Sankhe L, Goswami D, Shanthi GS, Kumar G, Varghese M, Dhar M, Gupta M, Koul PA, Mohanty RR, Chakrabarti SS, Yadati SR, Dey S, Lee J, and Dey AB
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- Aged, Female, Humans, Male, Aging, Body Mass Index, Cohort Studies, Cross-Sectional Studies, India epidemiology, Middle Aged, Reference Values, Anthropometry, Malnutrition diagnosis, Malnutrition epidemiology, Overnutrition
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Objectives: To identify factors associated with malnutrition (undernutrition and overnutrition) and determine appropriate cut-off values for mid-arm circumference (MAC) and calf circumference (CC) among community-dwelling Indian older adults., Design: Data from the first wave of harmonised diagnostic assessment of dementia for Longitudinal Ageing Study in India (LASI-DAD) were used. Various sociodemographic factors, comorbidities, geriatric syndromes, childhood financial and health status were included. Anthropometric measurements included body mass index (BMI), MAC and CC., Setting: Nationally representative cohort study including 36 Indian states and union territories., Participants: 4096 older adults aged >60 years from LASI DAD., Outcome Measures: The outcome variable was BMI, categorised as low (<18.5 kg/m
2 ), normal (18.5-22.9 kg/m2 ) and high (>23 kg/m2 ). The cut-off values of MAC and CC were derived using ROC curve with BMI as the gold standard., Results: 902 (weighted percentage 20.55%) had low BMI, 1742 (44.25%) had high BMI. Undernutrition was associated with age, wealth-quintile and impaired cognition, while overnutrition was associated with higher education, urban living and comorbidities such as hypertension, diabetes and chronic heart disease. For CC, the optimal lower and upper cut-offs for males were 28.1 cm and >31.5 cm, respectively, while for females, the corresponding values were 26 cm and >29 cm. Similarly, the optimal lower and upper cut-offs for MAC in males were 23.9 cm and >26.9 cm, and for females, they were 22.5 cm and >25 cm., Conclusion: Our study identifies a high BMI prevalence, especially among females, individuals with higher education, urban residents and those with comorbidities. We establish gender-specific MAC and CC cut-off values with significant implications for healthcare, policy and research. Tailored interventions can address undernutrition and overnutrition in older adults, enhancing standardised nutritional assessment and well-being., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)- Published
- 2023
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7. Dasiglucagon for the Treatment of Insulin-induced Hypoglycemia in Patients with Type 1 Diabetes Mellitus: A Meta-analysis
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Maji S, Mohanty RR, and Maiti R
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- Humans, Glucagon therapeutic use, Glucagon adverse effects, Hypoglycemic Agents adverse effects, Insulin adverse effects, Glucose therapeutic use, Diabetes Mellitus, Type 1 drug therapy, Hypoglycemia drug therapy, Hypoglycemia chemically induced
- Abstract
Background: The use of conventional glucagon for managing insulin-induced hypoglycemia is obscured by its chemical instability and the need for reconstitution of the lyophilized powder, leading to delayed rescue. Dasiglucagon, a glucagon analog, may potentially overcome these shortcomings., Aims: To evaluate the efficacy and safety of dasiglucagon in insulin-induced hypoglycemia in patients with type 1 diabetes mellitus (T1DM)., Study Design: Meta-analysis., Methods: PubMed/MEDLINE, Scopus, Embase, and Cochrane databases along with clinical trial registries were searched to include data from five randomized controlled trials conducted using dasiglucagon for the treatment of insulin-induced hypoglycemia in T1DM patients published until May 2023. We performed a risk of bias assessment to determine the quality of the included studies and a random-effects model analysis for determining the effect size. Subgroup analysis and meta-regression were done as applicable., Results: The time to recovery (in minutes) with dasiglucagon was earlier than placebo [mean difference (MD): -24.73; 95% confidence interval (CI): -30.94 to -18.52; p < 0.00001) or oral glucose (MD: -15.00; 95% CI: -20.33 to -9.67; p < 0.00001); however, the difference between dasiglucagon and glucagon was not statistically significant (MD: -0.76; 95% CI: -2.19 to 0.66; p = 0.29)., Conclusion: Dasiglucagon is safer and more effective than placebo or oral glucose for insulin-induced hypoglycemia in T1DM patients; however, it is not superior to conventional glucagon.
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- 2023
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8. Association Between Cognitive Performance and Nutritional Status: Analysis From LASI-DAD.
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Bhagwasia M, Rao AR, Banerjee J, Bajpai S, Raman AV, Talukdar A, Jain A, Rajguru C, Sankhe L, Goswami D, Shanthi GS, Kumar G, Varghese M, Dhar M, Gupta M, A-Koul P, Mohanty RR, Chakrabarti SS, Yadati SR, Dey S, and Dey AB
- Abstract
Malnutrition in low- and middle-income countries causes cognitive decline and other health problems. Harmonized Diagnostic Assessment of Dementia for Longitudinal Aging Study in India (LASI DAD) is an extensive study on late-life cognition and dementia. This study examines the link between nutrition and cognitive abilities in older adults using data from the LASI DAD. We conducted descriptive statistics on nutritional parameters (body-mass index, waist-hip ratio, and Mini-Nutritional Assessment), cognitive functions, and socio-demographic variables in 2,892 adults aged ≥60 years. Cognitive domains assessed included delayed recall, orientation, language, executive function, abstract reasoning, and attention. Cognitive impairment was defined as impaired performance in two or more domains. Mean age was 69.3 ± 7.1 years, 52.9% were female, and 57.5% were illiterate. Low body-mass index (adjusted OR: 1.88, p < .001), at risk of malnutrition (adjusted OR: 1.89, p < .001) and malnourished (adjusted OR: 2.86, p < .001) on Mini-Nutritional Assessment were associated with the presence of cognitive impairment. Better cognitive performance was associated with increased body mass index (adjusted OR: 0.74, p -.03), hemoglobin (adjusted OR: 0.91, p -.006), and serum albumin (adjusted OR: 0.38, p < .001). This study shows that nutritional status assessed by anthropometric measures and blood markers is strongly linked to cognitive performance in older adults., Competing Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2023.)
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- 2023
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9. Purpura fulminans complicating scrub typhus and acute hepatitis E coinfection.
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Das DS, Mohanty RR, Behera A, and Behera S
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- Humans, Purpura Fulminans etiology, Scrub Typhus complications, Scrub Typhus diagnosis, Coinfection, Hepatitis E complications, Hepatitis E diagnosis
- Abstract
Competing Interests: Competing interests: None declared.
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- 2023
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10. Prevalence of dementia in India: National and state estimates from a nationwide study.
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Lee J, Meijer E, Langa KM, Ganguli M, Varghese M, Banerjee J, Khobragade P, Angrisani M, Kurup R, Chakrabarti SS, Gambhir IS, Koul PA, Goswami D, Talukdar A, Mohanty RR, Yadati RS, Padmaja M, Sankhe L, Rajguru C, Gupta M, Kumar G, Dhar M, Chatterjee P, Singhal S, Bansal R, Bajpai S, Desai G, Rao AR, Sivakumar PT, Muliyala KP, Bhatankar S, Chattopadhyay A, Govil D, Pedgaonkar S, Sekher TV, Bloom DE, Crimmins EM, and Dey AB
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- Male, Female, Humans, Prevalence, Aging, Neuropsychological Tests, India epidemiology, Dementia epidemiology
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Introduction: Prior estimates of dementia prevalence in India were based on samples from selected communities, inadequately representing the national and state populations., Methods: From the Longitudinal Aging Study in India (LASI) we recruited a sample of adults ages 60+ and administered a rich battery of neuropsychological tests and an informant interview in 2018 through 2020. We obtained a clinical consensus rating of dementia status for a subsample (N = 2528), fitted a logistic model for dementia status on this subsample, and then imputed dementia status for all other LASI respondents aged 60+ (N = 28,949)., Results: The estimated dementia prevalence for adults ages 60+ in India is 7.4%, with significant age and education gradients, sex and urban/rural differences, and cross-state variation., Discussion: An estimated 8.8 million Indians older than 60 years have dementia. The burden of dementia cases is unevenly distributed across states and subpopulations and may therefore require different levels of local planning and support., Highlights: The estimated dementia prevalence for adults ages 60+ in India is 7.4%. About 8.8 million Indians older than 60 years live with dementia. Dementia is more prevalent among females than males and in rural than urban areas. Significant cross-state variation exists in dementia prevalence., (© 2023 The Authors. Alzheimer's & Dementia published by Wiley Periodicals LLC on behalf of Alzheimer's Association.)
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- 2023
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11. Comparison of Efficacy and Safety of Azilsartan and Amlodipine Combination Versus Telmisartan and Amlodipine Combination in Hypertensive Patients: A Non-inferiority Trial.
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Dash A, Meher BR, Padhy BM, Mohanty RR, and Tripathy A
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Introduction Hypertension (HTN) is one of the most common conditions encountered in daily practice in hospitals. Combination therapy is mostly initiated in the management of HTN when target blood pressure is not achieved with monotherapy. There are few studies comparing the antihypertensive effect of a combination of azilsartan and amlodipine with a combination of amlodipine and other angiotensin receptor blockers (ARBs), however, the results are contradictory. The objective of this study was to compare the efficacy and safety of the azilsartan and amlodipine combination versus the telmisartan and amlodipine combination in hypertensive patients. Methods The present study was a prospective, randomized, active-controlled, open-label, parallel-group clinical trial. Hypertensive patients were randomized into two groups of 25 patients each. Baseline evaluations of systolic blood pressure (SBP), diastolic blood pressure (DBP), and high-sensitivity troponin I (hsTnI) were done. Patients were reassessed after 12 weeks of drug therapy with azilsartan 40 mg and amlodipine 5 mg combination or telmisartan 40 mg once daily (QD) and amlodipine 5 mg combination QD. Results The response rate (defined as a reduction of more than 20 mm Hg in SBP or 10 mm Hg in DBP or both from baseline at 12 weeks) for HTN in the test group and control groups was found to be 88% and 96% respectively. The response rate of the azilsartan amlodipine group was found to be non-inferior to the telmisartan amlodipine group (odds ratio, OR, 0.31, p = 0.61) at the end of 12 weeks of drug therapy. At 12 weeks of follow-up, there was a significant decrease in SBP (p < 0.001), DBP (p < 0.001), and hsTnI levels (p < 0.001) in both groups from baseline values. However, differences between the test and control groups for blood pressure and hsTnI were found to be not statistically significant at 12 weeks of follow-up. The most commonly reported adverse effect in both groups was headache. Conclusion Azilsartan amlodipine combination had an 88% response rate, which was non-inferior to the telmisartan and amlodipine combination. Biomarkers such as hsTnI showed a significant decrease in both groups after 12 weeks of follow-up. However, there was no significant difference between the two groups., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2023, Dash et al.)
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- 2023
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12. Lethal Neurotoxicity in Lambda-Cyhalothrin Poisoning: A Rare Case Report.
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Naveen A, Sahu MR, Mohanty MK, Mohanty RR, Sethy M, and Velayutham B
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- Male, Humans, Middle Aged, Nitriles toxicity, Insecticides toxicity, Pyrethrins toxicity, Neurotoxicity Syndromes etiology, Poisoning
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Abstract: Agricultural poisons (insecticides and pesticides) are the most common types of poison implicated in the morbidity and mortality associated with acute poisoning. Suicidal ingestion is more frequent than accidental or homicidal poisonings. Pyrethroids are considered relatively safer than other insecticides. Lambda-cyhalothrin (LCH) belongs to the fourth-generation, type II synthetic pyrethroid. To the best of our knowledge, fatalities after LCH exposure have not yet been reported in the literature. Here, we describe a case of LCH poisoning in a 54-year-old male farmer after an accidental pipe burst in a sprayer while spraying in the field. The patient died 10 days after poisoning due to severe neurotoxicity resulting in bilateral parieto-occipital and brainstem infarcts. The histopathological features of the brain associated with LCH poisoning have been discussed in this report., Competing Interests: The authors report no conflict of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)
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- 2023
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13. An objective assessment for bone drilling: A pilot study on vertical drilling.
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Nigam A, Mohanty RR, Kellam JF, Ambrose CG, Krishnamurthy VR, and Tai BL
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- Pilot Projects, Bone and Bones surgery
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The purpose of this study is to propose a quantitative assessment scheme to help with surgical bone drilling training. This pilot study gathered and compared motion and force data from expert surgeons (n = 3) and novice residents (n = 6). The experiment used three-dimensional printed bone simulants of young bone (YB) and osteoporotic bone (OB), and drilling overshoot, time, and force were measured. There was no statistically significant difference in overshoot between the two groups (p = 0.217 for YB and 0.215 for OB). The results, however, show that the experts took less time (mean = 4.01 s) than the novices (mean = 9.98 s), with a statistical difference (p = 0.003 for YB and 0.0001 for OB). In addition, the expert group performed more consistently than the novices. The force analysis further revealed that experts used a higher force to drill the first cortical section and a noticeably lower force in the second cortex to control the overshoot (approximate reduction of 5.5 N). Finally, when drilling time and overshoot distance were combined, the motion data distinguished the skill gap between expert and novice drilling; the force data provided insight into the drilling mechanism and performance outcomes. This study lays the groundwork for a data-driven training scheme to prepare novice residents for clinical practice., (© 2022 Orthopaedic Research Society. Published by Wiley Periodicals LLC.)
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- 2023
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14. Deep phenotyping and genomic data from a nationally representative study on dementia in India.
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Lee J, Petrosyan S, Khobragade P, Banerjee J, Chien S, Weerman B, Gross A, Hu P, Smith JA, Zhao W, Aksman L, Jain U, Shanthi GS, Kurup R, Raman A, Chakrabarti SS, Gambhir IS, Varghese M, John JP, Joshi H, Koul PA, Goswami D, Talukdar A, Mohanty RR, Yadati YSR, Padmaja M, Sankhe L, Rajguru C, Gupta M, Kumar G, Dhar M, Jovicich J, Ganna A, Ganguli M, Chatterjee P, Singhal S, Bansal R, Bajpai S, Desai G, Bhatankar S, Rao AR, Sivakumar PT, Muliyala KP, Sinha P, Loganathan S, Meijer E, Angrisani M, Kim JK, Dey S, Arokiasamy P, Bloom DE, Toga AW, Kardia SLR, Langa K, Crimmins EM, and Dey AB
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- Aged, Humans, Aging, Genomics, Longitudinal Studies, India, Cognitive Dysfunction, Dementia genetics
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The Harmonized Diagnostic Assessment of Dementia for the Longitudinal Aging Study in India (LASI-DAD) is a nationally representative in-depth study of cognitive aging and dementia. We present a publicly available dataset of harmonized cognitive measures of 4,096 adults 60 years of age and older in India, collected across 18 states and union territories. Blood samples were obtained to carry out whole blood and serum-based assays. Results are included in a venous blood specimen datafile that can be linked to the Harmonized LASI-DAD dataset. A global screening array of 960 LASI-DAD respondents is also publicly available for download, in addition to neuroimaging data on 137 LASI-DAD participants. Altogether, these datasets provide comprehensive information on older adults in India that allow researchers to further understand risk factors associated with cognitive impairment and dementia., (© 2023. The Author(s).)
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- 2023
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15. Levothyroxine Therapy and Predictors of Cardiovascular Risk in Clinical Hypothyroidism: A Prospective Cohort Study.
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Maiti R, Mohanty RR, Mishra A, Dey A, and Verma N
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Background Hypothyroidism is associated with hypoadiponectinemia, insulin resistance, and increased cardiovascular risk. The association of adiponectin, insulin resistance, and future cardiovascular risk in clinical hypothyroidism and the effect of levothyroxine are non-conclusive because of the contradictory results. The present prospective cohort study has been conducted to evaluate the effect of levothyroxine on serum adiponectin, insulin resistance, and cardiovascular risk in patients with clinical hypothyroidism. Methods Sixty patients with clinical hypothyroidism who were prescribed levothyroxine were recruited following selection criteria and changes in Zulewski's score, glycemic parameters, homeostatic model assessment of insulin resistance (HOMA-IR), quantitative insulin sensitivity check index (QUICKI), lipid profile, serum adiponectin, serum high-sensitivity C-reactive protein (hs-CRP), cardiovascular risk indices, and Framingham risk score were assessed 12 weeks post-levothyroxine therapy. Receiver operating characteristic (ROC) analysis was done to detect the cut-off for adiponectin levels to differentiate between responders and non-responders. Neural network models were created to predict the risk of cardiovascular morbidity. Results Post-levothyroxine therapy, there was a significant improvement in body mass index (BMI) (p = 0.025), diastolic blood pressure (p = 0.021), Zulewski's score (p < 0.001), serum insulin (p = 0.005), fasting sugar (p < 0.001), serum adiponectin (p < 0.001), thyroid profile (p < 0.001), total cholesterol (p < 0.001), low-density lipoprotein (p < 0.001), high-density lipoprotein (p = 0.007), triglycerides (p = 0.002), and subcutaneous fat (p = 0.015). Serum adiponectin showed significant improvement in hypothyroid patients compared to euthyroid individuals (mean difference: -2.21; 95% CI: -2.52 to -1.91; p < 0.001). Mean difference in insulin resistance (HOMA-IR: 0.3, p < 0.001; QUICKI: -0.002, p < 0.001) and cardiovascular risk (atherogenic index: 0.12, p = 0.04; coronary risk index: 0.14, p = 0.038; Framingham risk score: 0.65, p = 0.041) also showed improvement. Serum adiponectin and thyroid-stimulating hormone levels were directly correlated with insulin resistance and cardiovascular risk scores. Conclusion The reduced serum adiponectin level and increased cardiovascular risk in clinical hypothyroidism were improved with hormone replacement, and serum adiponectin level was found to be a good prognostic marker for the treatment response., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2022, Maiti et al.)
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- 2022
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16. Efficacy and safety of abrocitinib for the treatment of moderate-to-severe atopic dermatitis: a meta-analysis of randomized clinical trials.
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Meher BR, Mohanty RR, and Padhy BM
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- Double-Blind Method, Humans, Immunoglobulin A, Pruritus drug therapy, Pyrimidines, Randomized Controlled Trials as Topic, Severity of Illness Index, Sulfonamides, Treatment Outcome, Dermatitis, Atopic drug therapy
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Background: Atopic dermatitis (AD) is a chronic relapsing inflammatory skin disorder. Though corticosteroids are the cornerstone of therapy, the Janus kinase inhibitor abrocitinib has shown promise in recent clinical trials for the treatment of AD., Objective: To assess the overall efficacy and safety of abrocitinib in moderate to severe AD., Methods: All randomized controlled trials (RCTs) evaluating the efficacy and safety of abrocitinib in moderate to severe AD were included in the meta-analysis., Results: The pooled analysis revealed a significant proportion of patients achieving Investigator's Global Assessment (IGA) response (RR = 3.52, 95% CI; 2.78-4.46, p < .00001), Eczema Area and Severity Index (EASI) response (RR = 3.35, 95% CI; 2.54-4.41, p < .00001), and Peak Pruritus Numerical Rating Score (PP-NRS) response (RR = 2.54,95% CI; 1.95-3.30, p < .00001) in abrocitinib arm compared to the placebo arm. Moreover, the pooled analysis also suggested that treatment-emergent adverse events (TAEs) were relatively higher with abrocitinib than placebo (R.R. = 1.17; 95% CI; 1.06-1.29, p = .002)., Conclusions: This meta-analysis showed that abrocitinib had a significant beneficial effect and tolerable adverse effect profile in patients of AD. Dose regimens of 200 and 100 mg seemed to have similar benefits. However, long-term trials are needed for corroboration.Key pointsAbrocitinib is emerging as a potential treatment option for moderate to severe atopic dermatitis.The pooled analysis from 4 RCTs demonstrated significant effectiveness of abrocitinib in both physician and patient-reported outcomes like IGA, EASI, and PP-NRS. The drug was also well-tolerated across the trials.The number needed to treat (NNT) for all efficacy outcomes was low suggesting clinically desirable benefits with the use of abrocitinib. Trial registration : Review registration number PROSPERO database: CRD42021255634.
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- 2022
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17. Awareness, attitude, and practice of materiovigilance among medical professionals at a tertiary care institute of national importance: A cross-sectional study.
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Meher BR, Padhy BM, Srinivasan A, and Mohanty RR
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Background: Medical faculty and residents have a key role in the reporting of adverse events associated with medical devices. However, at present, there are no published data regarding their knowledge, attitude, and practice about materiovigilance in India., Materials and Methods: This was a cross-sectional questionnaire-based survey done among medical faculty and residents of a tertiary care institution of national importance. The questionnaire consists of 15 questions pertaining to knowledge, attitude, and practice of materiovigilance., Results: The questionnaire was administered to 138 medical faculty and residents, out of which 105 responded constituting a 76% response rate. The mean knowledge score of medical faculty and residents was 2.09 ± 1.06 and 2.07 ± 1.02, respectively, and the difference between the two groups was not statistically significant ( P = 0.9). The majority of the participants (92.63%) believed that medical device can cause adverse events; however, very few of them (20.13%) have reported it during their practice., Conclusion: Requisite knowledge and appropriate attitude are essential for developing healthy practice toward reporting of adverse events associated with medical devices. Our study revealed that the knowledge gap exists among medical professionals about the reporting of adverse events and the materiovigilance program. A continuous effort is required to make them aware of the materiovigilance by conducting various training programs such as continuous medical education and workshops by the coordinators of the medical device adverse events monitoring center., Competing Interests: There are no conflicts of interest., (Copyright: © 2021 Perspectives in Clinical Research.)
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- 2022
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18. Comparative Study of the Effects of Azilsartan and Telmisartan on Insulin Resistance and Metabolic Biomarkers in Essential Hypertension Associated With Type 2 Diabetes Mellitus.
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Meher BR, Mohanty RR, Sahoo JP, Jena M, Srinivasan A, and Padhy BM
- Abstract
Introduction The complex interplay between the autonomic nervous system, renin-angiotensin-aldosterone system (RAAS), and immunity contributes to the pathogenesis of hypertension in diabetes mellitus. The objective of this study was to investigate and compare the effect of azilsartan and telmisartan on insulin resistance and metabolic biomarkers in patients with both hypertension and type 2 diabetes mellitus. Methods The present study was a prospective, randomized, active-controlled, open-label, parallel-group clinical trial. Patients with grade I or II essential hypertension with type 2 diabetes mellitus were randomized into two groups of 25 patients each. Baseline evaluation of homeostasis model assessment-insulin resistance (HOMA-IR), plasma glucose, insulin, leptin and adiponectin levels, and systolic and diastolic blood pressure (SBP and DBP) of patients was done. Patients were reassessed after 12 weeks of drug therapy with azilsartan 40 mg OD (once daily) or telmisartan 40 mg OD. Results The mean changes in HOMA-IR from the baseline at the end of 12 weeks of treatment were 0.15 (-0.64, 0.94.52) in the azilsartan group and 0.32 (-0.61, 1.26) in the telmisartan group. The mean difference in the changes from the baseline in HOMA-IR between the two groups was 0.3 (-0.87, 1.48), which was not statistically significant. No statistically significant changes were observed between the two groups in metabolic biomarkers (leptin: -0.84, CI: -4.83 to 3.14, and adiponectin: -0.12, CI: -0.62 to 0.37). Systolic (SBP) and diastolic blood pressure (DBP) decreased at the end of the 12-week treatment in both the groups; however, there was no significant difference between the two groups (SBP: -2.6, CI: -10.35 to 5.1, and DBP: -3.0, CI: -7.7 to 1.7). Conclusion Neither azilsartan nor telmisartan had any significant effects on insulin resistance and metabolic biomarkers after 12 weeks of drug therapy in hypertension patients associated with type 2 diabetes mellitus. However, they showed a comparable antihypertensive effect. The adverse effects observed were mild in nature, and their incidence was comparable between the two groups., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2022, Meher et al.)
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- 2022
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19. Cost of Ambulatory Care in Diabetes: Findings From a Non-Communicable Disease Clinic of a Tertiary Care Institute in Eastern India.
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Patro BK, Taywade M, Mohapatra D, Mohanty RR, Behera KK, and Sahoo SS
- Abstract
Background: This study was conducted to evaluate the cost of ambulatory care of diabetes in a non-communicable disease (NCD) clinic in eastern India., Methods: This hospital-based cross-sectional cost description study was conducted from July to August 2018. A total of 192 diagnosed cases aged 18-70 years with a minimum history of one year since diagnosis attending the NCD clinic for the first time were included. Information was collected using a pre-tested schedule based on the cost of illness approach that consisted of socio-demographic details, disease status, and cost of ambulatory care. Cost of the drugs was calculated using a standardized repository of drug costs. The estimated expenditure of previous three months was calculated and extrapolated to one year to calculate yearly expenditure., Results: The mean age of the study participants was 43.93±10.41 years and the mean duration of diabetes was 6.64±6.08 years. The median direct cost due to diabetes was Rs 9560 (136.57 USD) annually. It was higher in females (Rs 10,056, 143.45 USD) than in males (Rs 9020, 128.85 USD). In direct medical costs, a major part was constituted by the drugs, oral hypoglycemic agents, and/or insulin (approximately 70%)., Conclusions: In an ambulatory framework too, diabetes causes a substantial financial burden on the individual in India. In the wake of resource constraints in Indian health settings, the public health system needs to be adequately strengthened by policymakers to address the growing number of diabetics and long-standing complications., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2022, Patro et al.)
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- 2022
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20. Comparison of Clinical Outcome between Dexamethasone and Methyl Prednisolone in Treatment of Moderate to Severe COVID-19: A Systematic Review and Meta-Analysis.
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Mohanty RR, Das S, Padhy BM, and Meher BR
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- Dexamethasone, Humans, Methylprednisolone, SARS-CoV-2, COVID-19 Drug Treatment
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Objective: Though systemic corticosteroid is used for treatment of COVID 19, questions regarding the appropriate dose, duration and type of corticosteroid use still remain unanswered. This study aimed to address, whether choice of systemic corticosteroid significantly influences the clinical outcome of COVID 19 patients., Materials and Methods: Studies reporting the comparison between clinical outcome of dexamethasone and methylprednisolone in treatment of COVID 19 were searched from inception till April, 2021. Random-effect model was used. Odd's ratio (OR) and 95% confidence interval was expressed. I2 statistics used for test of heterogeneity., Result: Three studies with 373 patients (160 in dexamethasone group and 213 in methyl prednisolone group) were included. Though, statistically significant reduction in all-cause mortality with methyl prednisolone group in comparison to dexamethasone group (OR=1.80, 95%CI: 1.08 to 3.01, P=0.02) estimated, sub group analysis of observational studies did not support the finding (OR=1.60, 95% CI: 0.88 to 2.92, P=0.12). No significant difference in terms of need for invasive ventilator or intensive care unit (ICU) between the 2 groups. The grade of evidence was very low for both the outcomes. Conclusion and Relevance: In the present context, both dexamethasone and methyl prednisolone are equally effective in the management of COVID 19., (© Journal of the Association of Physicians of India 2011.)
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- 2022
21. Effectiveness of pulse dose methyl prednisolone in management of COVID 19: A systematic review and meta-analysis of observational studies.
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Mohanty RR, Biswa Mohan Padhy, and Meher BR
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- Adrenal Cortex Hormones, Humans, Methylprednisolone therapeutic use, COVID-19 Drug Treatment
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Purpose: Till date, only systemic corticosteroids have demonstrated definite mortality benefit in management of COVID 19 in various studies. Still certain questions regarding the appropriate dose, duration and timing of corticosteroids remain unanswered. For this reason, the study was planned to determine the efficacy and safety of the pulse dose methyl prednisolone in management of COVID 19 from the publicly available evidence., Methods: PubMed, the Cochrane library, ClinicalTrials.gov and medRxiv were searched for articles reporting the use of pulse dose methyl prednisolone in COVID 19 from inception till 31st May, 2021. Odds ratios (ORs) were calculated for estimation of pooled effect by using random effect model and heterogeneity was checked by using I2 statistics., Results: Twelve studies (11 observational and 1 RCT) were included in the systematic review. A total of 3110 patients from 9 studies were included in the meta-analysis. Though the use of pulse dose methyl prednisolone demonstrated statistically significant mortality benefit in comparison to usual care (OR=0.71, 95% CI: 0.51 to 0.97, [P=0.03]), (I2= 21%) with calculated Number needed to treat (NNT) of 23.5, there was no statistically significant difference between the use of pulse dose and low dose corticosteroid (OR=0.66, 95% CI: 0.44 to 1.01, [(P=0.05]), (I2= 25%) and the NNT is 23.5. Incidence of adverse events were similar across all the groups. The grade of evidence for primary outcome was of moderate certainty., Conclusion: This meta-analysis concurs with the previous reports regarding the use of corticosteroid in COVID 19 in comparison to usual care. However, for both the primary and secondary outcome, the study did not find any statistically significant difference between the use of pulse dose methyl prednisolone and low dose corticosteroid to treat COVID 19 patients.
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- 2022
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22. Identifying barriers to report adverse drug reactions using the Delphi method: Experience from an institute of national importance of India.
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Meher BR and Mohanty RR
- Abstract
Competing Interests: There are no conflicts of interest.
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- 2022
- Full Text
- View/download PDF
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