Prospective Observational Cohort Study of Tenecteplase: Results From the Indian Registry in Ischemic Stroke-Tenecteplase.

Background: Tenecteplase has been approved for acute ischemic stroke at a dose of 0.2 mg/kg by the Indian licensing authority. A registry to evaluate the safety of tenecteplase was mandated by the licensing authority.

Daratumumab in Indian patients with relapsed and refractory multiple myeloma: a prospective, multicenter, phase IV study.

To assess the safety and effectiveness of daratumumab monotherapy in Indian patients with relapsed/refractory multiple myeloma. In this prospective, multicenter, phase IV study, patients (aged ≥18 years) received intravenous daratumumab (16 mg/kg) in six cycles. Safety was the primary end point.

A Phase 3, randomized, non-inferiority study of a heterologous booster dose of SARS CoV-2 recombinant spike protein vaccine in adults.

Due to waning immunity following primary immunization with COVID-19 vaccines, booster doses may be required. The present study assessed a heterologous booster of SII-NVX-CoV2373 (spike protein vaccine) in adults primed with viral vector and inactivated vaccines. In this Phase 3, observer-blind, randomized, active controlled study, a total of 372 adults primed with two doses of ChAdOx1 nCoV-19 (n = 186) or BBV152 (n = 186) at least six months ago, were randomized to receive a booster of SII-NVX-CoV2373 or control vaccine (homologous booster of ChAdOx1 nCoV-19 or BBV152).

Viral co-infection, autoimmunity, and CSF HIV antibody profiles in HIV central nervous system escape.

Antiretroviral therapy (ART) suppresses plasma and cerebrospinal fluid (CSF) HIV replication. Neurosymptomatic (NS) CSF escape is a rare exception in which CNS HIV replication occurs in the setting of neurologic impairment. The origins of NS escape are not fully understood.

Effect of Oral Nutritional Supplementation on Adequacy of Nutrient Intake among Picky-Eating Children at Nutritional Risk in India: A Randomized Double Blind Clinical Trial.

Nutrient inadequacies among picky-eaters have adverse effects on growth and development. Oral nutritional supplements (ONS) along with dietary counseling (DC), rather than DC alone as reported in our earlier publication, promoted growth among picky-eating Indian children aged from >24 m to ≤48 m with weight-for-height percentiles lying between the 5th and 25th (based on WHO Growth Standards) over 90 days. This paper presents the contribution of ONS to nutrient adequacy, dietary diversity, and food consumption patterns in children (N = 321).

Topical Esmolol Hydrochloride as a Novel Treatment Modality for Diabetic Foot Ulcers: A Phase 3 Randomized Clinical Trial.

Importance: Preclinical and phase 1/2 studies with esmolol hydrochloride suggest its potential role in treatment of diabetic foot ulcers (DFUs).

Objective: To study the efficacy of topical esmolol for healing of uninfected DFUs.

Design, Setting, And Participants: A randomized, double-blind, multicenter, phase 3 clinical trial was conducted from December 26, 2018, to August 19, 2020, at 27 referral centers across India.

Leflunomide treatment for patients hospitalised with COVID-19: DEFEAT-COVID randomised controlled trial.

Objective: To evaluate the clinical efficacy and safety of leflunomide (L) added to the standard-of-care (SOC) treatment in COVID-19 patients hospitalised with moderate/critical clinical symptoms.

Design: Prospective, open-label, multicentre, stratified, randomised clinical trial.

Setting: Five hospitals in UK and India, from September 2020 to May 2021.

The 2022 outbreak and the pathobiology of the coxsackie virus [hand foot and mouth disease] in India.

Outbreaks of HFMD in children aged <5 years have been reported worldwide and the major causative agents are Coxsackievirus (CV) A16, enterovirus (EV)-A71 and recently CVA6. In India, HFMD is a disease that is not commonly reported. The purpose of the study was to identify the enterovirus type(s) associated with large outbreak of Hand, foot, and mouth disease during COVID-19 pandemic in 2022.

Noninvasive Respiratory Assist Devices in the Management of COVID-19-related Hypoxic Respiratory Failure: Pune ISCCM COVID-19 ARDS Study Consortium (PICASo).

Objective: To determine whether high-flow nasal oxygen (HFNO) or noninvasive ventilator (NIV) can avoid invasive mechanical ventilation (IMV) in COVID-19-related acute respiratory distress syndrome (ADRS), and the outcome predictors of these modalities.

Design: Multicenter retrospective study conducted in 12 ICUs in Pune, India.

Patients: Patients with COVID-19 pneumonia who had PaO/FiO ratio <150 and were treated with HFNO and/or NIV.

Safety and immunogenicity of SII-NVX-CoV2373 (COVID-19 vaccine) in adults in a phase 2/3, observer-blind, randomised, controlled study.

Background: NVX-CoV2373, a Covid-19 vaccine was developed in the USA with ∼90% efficacy. The same vaccine is manufactured in India after technology transfer (called as SII-NVX-CoV2373), was evaluated in this phase 2/3 immuno-bridging study.

Methods: This was an observer-blind, randomised, phase 2/3 study in 1600 adults.

Clinico-Epidemiologic Characteristics of Patients Reported in the Mycotic Infections in COVID-19 Registry.

We update results from the Mycotic Infections in COVID-19 (MUNCO) Registry, May-September 2021. Data collection from May to September 2021 yielded 728 cases from India, Nepal, Bangladesh, Thailand, and the United States. The cases consisted of mostly mucormycosis (97.

Factors Associated with Mortality in Coronavirus-Associated Mucormycosis: Results from Mycotic Infections in COVID-19 (MUNCO) Online Registry.

Background: COVID-19-associated mucormycosis (CAM) is associated with high morbidity and mortality. MUNCO is an international database used to collect clinical data on cases of CAM in real time. Preliminary data from the Mycotic Infections in COVID-19 (MUNCO) online registry yielded 728 cases from May to September 2021 in four South Asian countries and the United States.

A Comparison of Finger Pulse Oximeter and SET-Based Neonatal Pulse Oximeter in Neonates in Terms of SpO Values and Response Time.

Pulse oximetry is an imperative noninvasive tool to detect hypoxia. Signal extraction technology (SET)-based pulse oximeters recommended in neonates are expensive, while finger pulse oximeters are cheaper and widely available. Oxygen saturation (SpO) values and reliable saturation reading time of 30 neonates were obtained using MEDITIVE MPO-03 fingertip pulse oximeter and Masimo SET-Rad-97 pulse oximeter on the right hand and right foot.

Goals of Care for Patients with Severe Comorbid Illnesses Hospitalized for an Acute Deterioration.

Bande B. Goals of Care for Patients with Severe Comorbid Illnesses Hospitalized for an Acute Deterioration. Indian J Crit Care Med 2022;26(4):414-415.

Rhino-Orbito-Cerebral Mycosis and COVID-19: From Bad to Worse?

Background: There has been an increase an alarming rise in invasive mycoses during COVID-19 pandemic, especially during the second wave.

Aims: Compare the incidence of invasive mycoses in the last three years and study the risk factors, manifestations and outcomes of mycoses in the COVID era.

Methodology: Multicentric study was conducted across 21 centres in a state of western India over 12-months.

The Second- vs First-wave COVID-19: More of the Same or a Lot Worse? A Comparison of Mortality between the Two Waves in Patients Admitted to Intensive Care Units in Nine Hospitals in Western Maharashtra.

Background: India, along with the rest of the world, faced the challenging severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. The second wave in India lagged behind that in the Western world, due to different timing of seasons. There is scarce data about the differences between the two waves, for intensive care unit (ICU) patients.

Use of Tofacitinib in the Management of COVID-19 Pneumonia.

Bande BD. Use of Tofacitinib in the Management of COVID-19 Pneumonia. Indian J Crit Care Med 2021; 25(10):1089-1090.

Cerebrovascular Involvement in Mucormycosis in COVID-19 Pandemic.

Background: Many countries have seen an unprecedented rise of cases of coronavirus disease 2019 (COVID-19) associated mucormycosis (CAM). Cerebrovascular involvement in CAM has not been studied so far. We describe clinico-radiological manifestations of cerebrovascular complications observed in CAM.