A template tool for the evaluation of vaccines for emerging pathogens to be used for pregnant and breast-feeding women.

Vaccination during pregnancy provides effective protection against pathogens that increase the risk of maternal and infant morbidity and mortality for mothers and their infants. The SARS-CoV-2 pandemic demonstrated the need for the inclusion of pregnant and breast-feeding women in research and development of vaccines for emerging pathogens, such as Ebola, Zika, Lassa fever, Chikungunya, and influenza virus of pandemic potential. The COVID-19 Vaccines Global Access (COVAX) Maternal Immunization Working Group (MIWG), in collaboration with the Coalition for Epidemic Preparedness Innovation and the Safety Platform for Emergency Vaccines (CEPI-SPEAC) developed a standardized template with key considerations to guide the assessment of vaccines against emerging pathogens in pregnant and breast-feeding women.

Leveraging Data Locality in Quantum Convolutional Classifiers.

Quantum computing (QC) has opened the door to advancements in machine learning (ML) tasks that are currently implemented in the classical domain. Convolutional neural networks (CNNs) are classical ML architectures that exploit data locality and possess a simpler structure than a fully connected multi-layer perceptrons (MLPs) without compromising the accuracy of classification. However, the concept of preserving data locality is usually overlooked in the existing quantum counterparts of CNNs, particularly for extracting multifeatures in multidimensional data.

Generalized Quantum Convolution for Multidimensional Data.

The convolution operation plays a vital role in a wide range of critical algorithms across various domains, such as digital image processing, convolutional neural networks, and quantum machine learning. In existing implementations, particularly in quantum neural networks, convolution operations are usually approximated by the application of filters with data strides that are equal to the filter window sizes. One challenge with these implementations is preserving the spatial and temporal localities of the input features, specifically for data with higher dimensions.

Retinal Manifestations in High Altitude.

Dangi, Meenu, Arnab Sadhukhan, Poninder Kumar, S. Bandopadhayay, Vijay K. Sharma, V.

Bioequivalence of a biosimilar enoxaparin (Cloti-Xa™) and its innovator (Clexane ): A single-dose, randomized, double-blind, two-period, two-treatment, two-sequence, crossover, balanced study in healthy human subjects.

Currently, several biosimilars of low-molecular-weight heparins (LMWHs) with differing potencies are being developed and marketed globally. Thus, it is important that the potency of each biosimilar LMWH be compared with its innovator's molecule. The present study aimed to determine the bioequivalence of biosimilar (Cloti-Xa™) and innovator (Clexane ) formulations of enoxaparin sodium (40 mg/0.

Polymyxin B-Induced Kidney Injury Assessment of a Novel Formulation of Polymyxin B (VRP-034) in Rats.

Despite the crucial role of Polymyxin-B in treating life-threatening gram-negative infections, its clinical utility is limited due to the risk of acute kidney injury. In response, a novel formulation of polymyxin-B is being developed to mitigate drug-induced kidney injury. In this study, we have assessed the toxicity of four variants of that novel formulation (VRP034_F21-F24) in comparison with standard polymyxin-B using kidney injury biomarkers in rats.

An unreported case of septic arthritis of wrist in a neonate.

Septic Arthritis of the wrist is rare in the paediatric population due to its extraarticular metaphysis. We report here a case of wrist septic arthritis in a neonate caused by an uncommon causative organism, A 15 days old male child was referred with the complaint of swelling and decreased movement of the left wrist for 5 days. Local examination revealed warm, tender, erythematous and fluctuant swelling over the dorso-ulnar aspect of the left wrist.

A novel method for oxidative degradation of metanil yellow azo dye by hexacyanoferrate(III) ions.

In the present work, the degradation of metanil yellow, an azo dye, by hexacyanoferrate(III) ions (oxidant) in the aqueous alkaline medium has been investigated by kinetic-spectrophotometric method at λmax 435 nm of the reaction mixture. The effect of various parameters such as the concentration of dye, oxidant, and solution pH on the reaction rate has been determined. The results show that the rate of degradation increases linearly with the increase in concentrations of oxidant and dye at optimum pH of 9.

CSE-1034 versus Ceftriaxone: Efficacy and Safety Analysis from a Randomized, Open-labeled Phase III Study in Complicated Urinary Tract Infections.

Objective: The aim of this study was to determine the clinical outcome, microbiological outcome and safety profile of CSE-1034, a novel combination of Ceftriaxone, Sulbactam and EDTA in patients with complicated urinary tract infections (cUTI).

Materials And Methods: This was a randomized, controlled, open-labeled Phase-3 trial with the primary objective of assessing the efficacy and safety of CSE-1034 versus Ceftriaxone for the empirical treatment of cUTI. Adult cUTI patients were randomized to receive either intravenous dose of CSE-1034 or Ceftriaxone.

Comparative efficacy and safety analysis of CSE-1034: An open labeled phase III study in community acquired pneumonia.

Objective: CSE-1034 is a novel antibiotic adjuvant entity (AAE) with proven activity against broad range of multi-drug resistant (MDR) pathogens causing various bacterial infections. This phase 3 clinical trial was designed to evaluate the efficacy and safety of CSE-1034 therapy for the treatment of community-acquired pneumonia (CAP) patients of Pneumonia Outcomes Research Team (PORT) risk III-IV.

Methods: In this multi-centric, controlled, open-labeled phase 3 trial, adult patients with PORT risk III-IV CAP were randomized to receive either intravenous CSE-1034 (3g every 12h) or Ceftriaxone (2g every 12h) for 3-10 days.

Prevalence and Capsular Types of Group B Streptococci Colonizing Indian Women Living in the United States.

Group B streptococcal rectovaginal colonization prevalence in women of Indian descent living in the United States was 24.7% comparable with US rates but higher than rates reported from India. The capsular polysaccharide types were distinct in that type V was most common and 33% of group B streptococcal strains were nontypeable.

Safety and efficacy of a novel drug elores (ceftriaxone+sulbactam+disodium edetate) in the management of multi-drug resistant bacterial infections in tertiary care centers: a post-marketing surveillance study.

Objective: In India, Elores (CSE-1034: ceftriaxone+sulbactam+disodium edetate) was approved as a broad spectrum antibiotic in year 2011 and is used for management of Extended Spectrum Beta Lactamases/Metallo Beta lactamases infections in tertiary care centers. The objective of this study was to investigate the efficacy of this drug in patients with Extended Spectrum Beta Lactamases/Metallo Beta lactamases infections and identify the incidence of adverse events in real clinical settings.

Methods: This Post Marketing Surveillance study was conducted at 17 centers across India and included 2500 patients of all age groups suffering from various bacterial infections and treated with Elores (CSE1034).

Group B Streptococcal Colonization Among Pregnant Women in Delhi, India.

Background: Little is known regarding maternal group B streptococcal (GBS) colonization prevalence and capsular (CPS) serotype distribution among pregnant women in India. The objective of this prospective cohort study was to determine GBS recto-vaginal colonization prevalence in pregnant women at Dr. Ram Manohar Lohia Hospital in Delhi, India.

Comparison of different osmotic therapies in a mouse model of traumatic brain injury.

Background: Inflammation in the affected region, increased intracranial pressure, consequent oedema and congestion contribute to the negative outcome of traumatic brain injury. Osmotic therapies are recommended for improvement in cognitive and motor functions. Aim of the present study was to evaluate the effect of osmotic therapies in a mice model of traumatic brain injury.

An Hepatic Abscess in a Patient With Sickle Cell Anemia.

We present a case of hepatic abscess in a transfusion-dependent 16-year-old patient with sickle cell disease. There have been 10 such cases in sickle cell disease patients reported, with the last report published greater than a decade ago. The diagnosis of hepatic abscess merits consideration in sickle cell disease patients presenting with fever without a source and/or abdominal pain.

Population Pharmacokinetics of Fixed Dose Combination of Ceftriaxone and Sulbactam in Healthy and Infected Subjects.

Increased antibacterial resistance (ABR) and limited drug discovery warrant optimized use of available antibiotics. One option is to rationally combine two antibiotics (fixed dose combination (FDC)) that may delay or prevent emergence of ABR in notorious pathogen. Major concern with FDC is the mutual interaction of its components that might influence their pharmacokinetic (PK) profile, requiring reassessing of whole formulation (adding cost and time).

Molecular characterization and in vitro susceptibilities of β-lactamase producing Escherichia coli, Klebsiella species, Acinetobacter baumannii, Pseudomonas aeruginosa and Staphylococcus aureus to CSE1034 and other β-lactams.

Objective: To study the prevalence of extended-spectrum β-lactamases (ESBLs) among 663 clinical isolates obtained from various parts of India and to study the occurrence of different variants of ESBLs among these isolates.

Methods: Phenotypic characterization and susceptibility studies were performed according to the methods described in Clinical and Laboratory Standards Institute guidelines. The occurrence of ESBL variants was analyzed with PCR using the previously reported primers.

The impact of ethanol lock therapy on length of stay and catheter salvage in pediatric catheter-associated bloodstream infection.

Background: Ethanol lock therapy (ELT) with systemic antimicrobial therapy (SAT) is a treatment for catheter-associated bloodstream infections (CABSI). However, its impact on hospital length of stay (LOS) is unknown.

Objectives: Assess the impact of ELT on LOS, LOS attributable to CABSI (ALOS), and catheter salvage in pediatric hematology, oncology, stem cell transplant (HOSCT) CABSI.

Protective role of ceftriaxone plus sulbactam with VRP1034 on oxidative stress, hematological and enzymatic parameters in cadmium toxicity induced rat model.

We investigated the protective role of ceftriaxone plus sulbactam with VRP1034 (Elores) on hematological, lipid peroxidation, antioxidant enzymatic activities and Cd levels in the blood and tissues of cadmium exposed rats. Twenty-four male rats were divided into three groups of eight rats each. The control group received distilled water whereas group II received CdCl2 (1.

Comparative antibacterial activity of a novel semisynthetic antibiotic: etimicin sulphate and other aminoglycosides.

Etimicin is a novel fourth generation semisynthetic aminoglycoside. It has good antimicrobial activity against both gram-positive and gram-negative bacterial infections and also against aminoglycoside resistant strains. In the present study, in vitro antibacterial activity of etimicin was determined by minimum inhibitory concentration (MIC), minimum bactericidal concentration (MBC) and time kill curve tests against type strains and 407 clinical isolates (obtained in a surveillance study), in comparison to other aminoglycosides.

Sub-acute toxicity study of a new aminoglycoside etimicin sulphate in swiss albino mice.

Etimicin sulfate, an ethylization derivative of gentamicin, is a new soluble wide-spectrum synthetic aminoglycoside drug. It has wide antibacterial spectrum with high effect and less cross resistance as compared to other aminoglycosides. In order to further explore its safety and tolerance, we have conducted a subactute toxicity study on swiss albino mice.