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In this randomized, open-label, 2-part, 2 × 2 crossover, phase 1 study, the effect of a low-fat low-calorie (LFLC) meal on the relative bioavailability of a trametinib 2-mg tablet or dabrafenib 150-mg capsule was evaluated in healthy participants. Trametinib adjusted geometric mean ratios (90%CI) of fed : fasted for area under the concentration-time curve (AUC) from time 0 to the last quantifiable concentration and AUC from time 0 extrapolated to infinity were 0.76 (0.71-0.82) and 0.82 (0.77-0.88), respectively. For dabrafenib, the adjusted geometric mean ratios of AUC from time 0 to the last quantifiable concentration and AUC from time 0 extrapolated to infinity (90%CI) for fed:fasted were 0.85 (0.79-0.91) and 0.86 (0.80-0.92), respectively. Consumption of an LFLC meal delayed trametinib and dabrafenib absorption, with an increase in time to maximum concentration of ≈15 and ≈30 minutes, respectively, compared to the fasted state. These findings indicate that consumption of an LFLC meal reduced the bioavailability and delayed the absorption of trametinib and dabrafenib, supporting current recommendations to administer both drugs in the fasting state; however, an occasional LFLC meal is unlikely to affect the pharmacokinetics of the drugs once steady state is reached and, by consequence, not likely to alter the overall intended efficacy.
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Fasting , Humans , Biological Availability , Healthy VolunteersABSTRACT
Background: COVID 19 has two-way interaction with Type II Diabetes Mellitus. First, patient with DM are more prone for developing severe COVID 19. Second, moderate to severe COVID 19 can present with new onset DM or may lead to hyperglycaemia and hyperglycaemic complications in Type II DM patients. In this report we present 4 cases of COVID 19 associated Hyperglycaemic Complication (3 with Diabetic Ketoacidosis and 1 with Hyperglycaemic hyperosmolar state). Method(s): Case Series of patients admitted to Thumbay Hospital, Ajman. Result(s): We report 4 cases of COVID 19 patients who presented to us with hyperglycaemic complications. There of them had features of Diabetic Ketoacidosis and one had Hyperglycaemic hyperosmolar state. All were treated with IV Insulin infusion and IV Fluids. COVID 19 infection was managed as per MOH protocol. All patients recovered well and were discharged in stable condition. Discussion(s): COVID 19 is associated with new onset DM or may lead to hyperglycaemic complications in patients with Type II DM. There are three pathophysiological processes which may be responsible for this finding. One, SARS-CoV-2 virus is known to enter the body through angiotensin-converting enzyme (ACE) II receptors in the pulmonary pneumocytes leading to infection and inflammation. Similar ACE-II receptors are also expressed in key metabolic organs and tissues, including pancreatic beta cells, adipose tissue, the small intestine, and the kidneys. Direct infection of pancreatic beta-cells with SARS-CoV-2 virus with beta-cell cell injury is likely the underlying mechanism for development of new onset diabetes and hyperglycaemia in existing diabetic patients. Such direct beta cell infection can cause hyperglycaemic complications in asymptomatic or mild COVID 19 as well. Two, moderate to severe COVID 19 is associated with hyperinflammatory immune response leading to marked rise in inflammatory mediators such as C-reactive protein and ferritin. Such hyperinflammatory response can also lead to hyperglyacemia in patients with diabetes mellitus. Three, corticosteroids are mainstay treatment of patients with moderate to severe COVID 19 and would definitely contribute to worsening of hyperglycaemia in these patients. Our patients presented to us with hyperglycaemic complications before initiation of any treatment. It is likely that such a situation would be due to direct infection and destruction of beta cells with SARS-CoV-2 virus infection. Conclusion(s): Type II Diabetes Mellitus patients are high risk of developing hyperglycaemic complications due to COVID 19. This can lead to increased morbidity and mortality. Patients with Type II DM should seek medical attention even if they have mild to asymptomatic COVID 19 to monitor for hyperglycaemic complication which can develop irrespective of severity of stage of illness.
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Background Fulminant myocarditis can cause biventricular dysfunction with a mortality rate over 40%. We report a case with severe biventricular failure due to fulminant myocarditis that was successfully supported by left and right ventricular assist devices. Case A 65-year-old woman presented with chest pain, abdominal pain and diarrhea. She was hypotensive and labs revealed elevated troponin-T of 13.5 ng/mL and lactate of 4.3 mmol/L. She was positive for COVID by antigen testing. She was started on multiple vasopressor infusions and admitted to the intensive care unit. Echocardiogram revealed a severely reduced left ventricular ejection fraction of 15% and severe global hypokinesis. The following day, she developed a wide complex tachycardia that was refractory to amiodarone, lidocaine and multiple defibrillation attempts. She was transferred emergently to the cardiac cath lab where coronary angiography revealed an isolated 70% stenosis of the distal left circumflex artery. A Swan-Ganz catheter was placed that yielded a cardiac index by Fick of 1.2 L/min/m2, systemic vascular resistance of 1270 dynesseccm-5 and mixed venous oxygen saturation of 35%. Decision was made to emergently insert an Impella CP device. That evening, she developed complete heart block and transvenous pacing wire was inserted. Due to frequent suction alarms, decision was made to insert ProtekDuo device, which resulted in hemodynamic stabilization. A temporary coronary sinus pacing lead for atrial capture was inserted to improve atrioventricular synchrony. After several days of monitoring, repeat echocardiogram showed complete recovery of biventricular function and Impella CP and ProtekDuo devices were removed. Decision-making The decision of early implantation of ProtekDuo device was made to provide adequate blood flow to the left ventricular assist device for hemodynamic support. In addition, increased atrioventricular synchrony via insertion of temporary coronary sinus pacing wire improved cardiac output. Conclusion Fulminant myocarditis involving biventricular dysfunction can be supported by the use of simultaneous left and right ventricular assist devices.Copyright © 2023 American College of Cardiology Foundation
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Background and Objectives: Concerns have been expressed about the possible adverse impact of increased screen time on the psychological well-being of students during the COVID-19 pandemic. The current study aimed to assess the relationship between screen time and mental well-being among college students. Methods: This cross-sectional online survey-based study was conducted among Indian college students. Details regarding sociodemographics and the amount and pattern of screen time usage and mental well-being (assessed using World Health Organization Well-Being Index;5) were collected. Furthermore, personality traits were assessed using a validated questionnaire. Results: The final study sample comprised of 731 medical and engineering undergraduate students with a mean age of 20.7 years. The total screen time across different devices among the study participants for both weekdays and weekends was comparable, with a median value of 540 min. Poor mental well-being was significantly associated with higher total screen time (P = 0.03). Furthermore, screen time use predominantly to access social media for noncommunication purposes was associated with significantly lower mental well-being scores (P = 0.03). Conclusions: The current study highlights the impact of screen time on the mental well-being of students. The higher total screen time use was associated with poor mental well-being. Various types of screen time could have a differential relation with the mental well-being of students. Increased screen time use predominantly to access social media for noncommunication purposes was associated with a higher risk of poor mental well-being. © 2022 Medknow. All rights reserved.
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Introduction: Covid-19 pandemic has had severe impact on mental health and well-being of people around the globe. The uncountable loss of life, disruption of face-to-face health services and the uncertainty that followed raised concerns over mental health of all people. The impact was much worse in hospitalised covid-19 individuals. Most of the studies done on Covid-19 and mental health were focused on general population and health care workers. In our clinical practise, we observed an increased level of anxiety, stress and depression among hospitalised covid-19 individuals. Hence, we aim to assess the prevalence of psychological distress in these patients and there by validate our observation. Aims and Objectives: To assess the psychological impact of mild to moderate covid-19 disease in hospitalised patients. Material(s) and Method(s): A cross-sectional study was conducted in mild to moderate Covid-19 patients admitted to the tertiary care centre. A total of 501 patients filled 2 questionnaires - Depression, Anxiety, and Stress Scale-21(DASS-21) and Psycho-Social Assessment scale (PSA), a self-structured questionnaire. Result(s): In the depression subscale of DASS-21, 141(28.1%) had mild depression, 101(20.2%) had moderate depression, and 8 (1.6%) had severe depression. In the anxiety subscale, 105(20.9%) had mild anxiety, 198 (39.5%) had moderate anxiety, 35 (7.0%) had severe anxiety and 3 (0.6%) had extremely severe anxiety. In the stress subscale, 132(26.4 %) had mild stress, 161(32.1%) had moderate stress and 51 (10.2%) had severe stress. Patients above 30 years of age had moderate anxiety and stress, with stress being statistically significant among all age groups and gender. There were about 70% prevalence rate in all subgroups in PSA scale with anxiety being highest with 78%. Conclusion(s): The present study is a frontrunner in exploring the spectrum of psychological distress in hospitalised individuals due to Covid-19 disease. The uncertainty that the pandemic has inflicted upon us and its associated social stigma and economic recession has led to widespread increase in stress, anxiety and depression on people, including youngsters. Government, policy-makers and treating physicians should continue to provide mental health evaluation as an essential health service in all covid-19 affected individuals for early risk stratification and prevention of any unfavourable outcome. Copyright © 2022 Ubiquity Press. All rights reserved.
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Hyaluronic acid is a naturally occurring polysaccharide of extracellular matrix of connective tissues, synovial fluid, and other body tissues. It has an important role in regulating interactions intra and extracellularly between different growth factors, in addition to regulating osmotic pressure, maintaining tissue volume and lubrication. Periodontitis is an multifactorial inflammatory disease that affects teeth supporting structures which results in teeth loss. It is considered a wide world cause of teeth loss in adults. In addition to its local effect, teeth loss, it can have systemic impacts on many systemic organs. Although its main cause is bacteria, exaggerated host response and risk factors such as smoking, diabetes mellitus, HIV/AIDS, family history, and certain medications increase the disease progress. Hence teeth supporting structures are connective tissues and hyaluronic acid is a main component of connective tissues, a correlation of both in health and disease is explained in this article. Copyright © 2022 Wolters Kluwer Medknow Publications. All rights reserved.
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Background: COVID-19 pandemic has highlighted the importance of telemedicine in health care delivery worldwide. However, the true success of telemedicine depends on patients' acceptance, which in turn is decided by their interest in telemedicine. In this study, we aim to assess the population interest in telemedicine services across India during the COVID-19 pandemic. Methods: We measured national-level public interest in "telemedicine” using terms related to telemedicine in Google Trends during the years 2019 and 2020. The relationship between population search volume for telemedicine (composite score) and the number of COVID-19 cases during the early phase of COVID-19 was analyzed. The literacy rate and relative interest in telemedicine in the states were analyzed to assess the impact of education on telemedicine interest. Results: The interest in telemedicine in the year 2020 is higher compared to the year 2019 (U = 269.5, z = -7.043, p < 0.001). The search trends for telemedicine increased consistently during the early phase of the COVID-19 pandemic. The greatest search volume was seen in Andhra Pradesh. There was a strong correlation (r = 0.65, p < 0.001) between the initial increase in the number of COVID-19 cases and population-level interest in telemedicine over time. The relative interest in telemedicine for the year 2019 showed a significant direct relationship with the literacy rate (r = 0.47, p = 0.04). However, the relative interest in telemedicine for the year 2020 showed no relationship with the state's literacy rate signifying the spread of telemedicine across literacy barriers. Conclusion: Population interest in telemedicine was higher in the year 2020 compared to the previous year and remained high even after the easing of lockdown. The COVID-19 pandemic has played an important role in increasing the Indian public's interest in telemedicine. © The Author(s). 2022Open Access This article is distributedunder the terms ofthe Creative Commons Attribution 4.0InternationalLicense (https://creativecommons.org/licenses/by-nc/4.0/)
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The COVID-19 outbreak has caused disarray in the country's formal school education system (Ministry of Education in Initiatives by School Education Sector in 2020–21 for Continuing Teaching and Learning. https://dsel.education.gov.in/sites/default/files/update/covid_initiatives.pdf, 2021). While some children had engaged in learning from home using digital devices, television, radio and also with the guidance of volunteers and peers, dropouts and out of school children have become a major concern as a result of school closures, with other areas of concern also including teaching and learning for children with no access to digital gadgets, continuing learning for children with special needs, teacher’s reach/unavailability, access to engaging learning material, internet connectivity, etc., and in this frame of reference, digital divide-free online and blended learning has become a much-needed demand of the hour. Addressing these challenges for a diverse nation, however, necessitates an effective policy and implementation framework to ensure its reach at the grass-roots level while accepting the challenges of operationalization. This paper discusses the challenges of effective digital learning and recommendations for overcoming the barriers of Online and Blended Learning, with a focus on how technology would then take over and shoot through the roof of learning in the future.
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In this study, we assessed the impact of the COVID-19 pandemic on the amount and pattern of screen time among college students. The relationship between increased screen time and quality of life (QoL), COVID-related stress, and personality traits were also explored. A cross-sectional online survey-based study was conducted among Indian college students who were recruited by purposive sampling. Details regarding socio-demographics, amount and pattern of screen time usage, change in screen time patterns during the COVID-19 pandemic, and COVID-related stress were collected. In addition, personality traits and QoL were assessed with validated questionnaires. A total of 731 responses (51% female, mean age 20.7 years) were analysed. Of the participants, 93.2% self-reported an increase in daily screen time during COVID-19. The predominant reasons for the increased screen time were educational screen time (89.6%), streaming or watching videos for entertainment (82.8%), use of social media for non-communication purposes (78.1%), communication with friends and/or family members (76.2%), reading or watching news (65.9%), and interactive recreational screen time (44.7%). A small but significant negative correlation between increased screen time and QoL (rs =-0.154, p o .001) was found. Increased screen time due to the use of social media for non-communication purposes was associated with poorer QoL (U = 32947.50;p = .02) and greater COVID stress (U = 32381.50;p = .01). Educational screen time was the most common cause for increased screen time among college students and was not associated with negative effects on QoL. The context and purpose of screen time appears to be important in ascertaining the impact of screen time on QoL. © 2022, Centre for Addiction and Mental Health. All rights reserved.
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Aatma Nirbhar Bharat is the strategy of the Central Government to make our Nation self-sustained by breaking all the turbulence and constraints caused by the Covid-19 pandemic. The vision of Aatma Nirbhar Bharat intends development from the grass root level ensuring flawless, stabilized and rapid growth. Corporate Governance has a far reaching impact not only in the ambit of any particular entity, but also for the nation at large. Professionals are recognized as the conscience keepers of the nation's progress and they have a predominant role in ensuring ethical and virtuous principles are abided in all the initiatives of the Government. Good Corporate Governance would enable the Government to detect growth opportunities and risk mitigating measures as a gap bridging mechanism to improve efficiency in the operations for achieving the objectives of Aatma Nirbhar Bharat.
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Background : SARS-CoV-2 virus infection (COVID-19) is associated with high rates of venous thromboembolism (VTE). Immune mediated thrombosis has been implicated as a driving factor. Aims : To characterize coagulopathy by assessing thrombin generation kinetics and Von Willebrand Factor (VWF) and to characterize thromboinflammation through neutrophil extracellular trap (NET) formation in COVID-19 patients (pts). Methods : We collected plasma samples from 67 COVID-19 pts in the Emergency Department (ED) and 38 healthy volunteers (HV). Plasma thrombin generation kinetics were assessed using Calibrated Automated Thrombogram (CAT) and expressed as lag time (LT), peak height (PH), time to peak (ttPeak), and endogenous thrombin potential (ETP-total thrombin generated). NET formation was quantified through citrullinated nucleosome ELISA (H3NUC). VWF antigen/activity levels were determined by latex immunoassay. Factor VIII levels were performed using one-stage optical clot detection. VTE events were tracked through electronic medical records. This study was approved by the Institutional Review Board and patients were consented. Mann-Whitney test was performed, P < 0.05 considered significant. Results : Subject characteristics are described in Table 1. Of the 67 pts, 50.7% required admission and 31.3% supplemental oxygen. COVID-19 pts had longer LT and ttPeak, greater H3NUC, VWF antigen and activity level, and Factor VIII levels as compared to HV (Table 2). Admitted pts had longer LT (4.33 min [3.67, 5.67];3.33 min [3.00, 4.00], P < 0.001), ttPeak (7.73 min [6.84, 8.50];7.15 min [6.05, 7.75], P = 0.011), greater VWF antigen (247 IU/dL [208, 298];168 IU/ dL [103, 222], P < 0.001), activity (196 IU/dL [164, 238];130 IU/dL [94, 172], P < 0.001), and Factor VIII (159 IU/dL [129, 194];119 IU/dL [88, 169], P = 0.023) as compared to those not admitted. Conclusions : Symptomatic COVID-19 pts have prolonged initiation of thrombin generation, especially those requiring admission. Greater VWF activity and NETosis suggest systemic thromboinflammation in COVID-19 associated coagulopathy.
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Background: Patients with cancer and COVID-19 are at risk for poor clinical outcomes. An established multi-site remote patient monitoring (RPM) service was rapidly adapted to support a novel, interdisciplinary COVID-19 program for outpatient management of patients at high-risk for severe illness. The goal of this study was to assess the impact of the RPM program on clinical outcomes and acute care utilization in cancer patients diagnosed with COVID-19. Methods: This is a crosssectional analysis following a multi-site prospective observational study performed at Mayo Clinic Cancer Center (MCCC). All adult patients with active cancer - defined as currently receiving cancer-directed therapy or in recent remission on active surveillance - and PCR-confirmed SARS-CoV-2 infection between March 18 and July 31, 2020 were included. RPM was comprised of in-home technology to assess symptoms and physiologic data with centralized nurse and physician oversight. Results: During the study timeframe 224 cancer patients were diagnosed with COVID-19 at MCCC. Initial management included urgent hospitalization (within 48 hours of diagnosis) in 34 patients (15%). Of the remaining 190 patients (85%) initially managed in the outpatient setting, those who did not receive RPM were significantly more likely to experience hospitalization than those receiving RPM (OR 3.6, 95% CI 1.036 to 12.01, P = 0.044). Following balancing of patient characteristics by inverse propensity weighting, rates of hospital admission for RPM and non-RPM patients were 3.1% and 11% respectively, implying that RPM was associated with an 8% reduction in hospital admission rate (-0.077;95% CI: -0.315 to -0.019, P = 0.009). Use of RPM was also associated with lower rates of prolonged hospitalization, ICU admission, and mortality, though these trends did not reach statistical significance. Conclusions: In the midst of a global pandemic associated with inpatient bed, ventilator, and PPE shortages, the RPM program provided an effective strategy for outpatient clinical management and was associated with decreased rates of hospitalization, ICU admission, and mortality in cancer patients with COVID-19. This care model enabled simultaneous opportunity to mitigate the increased risks of exposure, transmission, and resource utilization associated with conventional care.
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The 2019 COVID-19 pandemic has thrown the global health-care system into a chaotic flux. Consolidating and reviewing all available knowledge will be crucial to combating the spread of this novel coronavirus. Prevention is paramount, but health care workers are at increased risk, and protective supplies are being limited and being rationed. Common symptoms include fever, cough, and shortness of breath. Hospitalizations are estimated to occur in about 20% of cases and are mostly due to pneumonia. While multiple promising treatments are being reported in the medical literature;there is limited, reliable clinical data are available. To minimize exposure of medical staff to contagious patients and to provide rapid escalation of care to these patients, a telehealth strategy could be leveraged. Such a strategy would entail the use of both telemedicine visits for communication and digital health platforms for monitoring.