Dynamic Assessment of Hematological Parameters as Predictive Biomarkers for Disease Severity and Prognosis in COVID-19 Patients: A Longitudinal Study.

Background: The coronavirus disease 2019 (COVID-19) pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has led to substantial morbidity and mortality worldwide. Hematological abnormalities are common in COVID-19 patients and play a significant role in disease pathogenesis and prognosis.

Objective: This study aimed to longitudinally monitor hematological parameters in COVID-19 patients and investigate their predictive value for disease severity and prognosis.

Outcomes of Deep Inferior Epigastric Artery Perforator (DIEP) Flap in Indian Population-A Prospective Single-Institute Study.

 Breast reconstruction has become integral part of breast cancer treatment. Deep inferior epigastric perforator (DIEP)-based flap is considered the gold standard in autologous breast reconstruction.  The aim of this study was to evaluate the patient satisfaction and the incidence of complications in DIEP flaps in an Indian setup for breast reconstruction.

Fetal cardiac teratoma and pericardiocentesis: A case report.

Fetal pericardial teratomas are rare. They present with pericardial effusion and hydrops. The definitive management is postnatal resection of the tumor.

Population Pharmacokinetics of MYL-1402O, a Proposed Biosimilar to Bevacizumab and Reference Product (Avastin) in Patients with Non-squamous Non-small Cell Lung Cancer.

Background And Objectives: MYL-1402O is a bevacizumab (Avastin) biosimilar. Pharmacokinetic and safety similarity of MYL-1402O and reference Avastin authorized in the European Union (EU-Avastin) and the US (US-Avastin) was demonstrated in healthy subjects (phase I, NCT02469987). The key objectives of this study were to establish a population pharmacokinetic (PopPK) model on pooled data from the phase I and phase III clinical studies to assess pharmacokinetic linearity of MYL-1402O and Avastin across dose ranges, to assess the pharmacokinetic similarity of MYL-1402O and Avastin in patients with non-squamous non-small cell lung cancer (nsNSCLC), and to explore potential covariates to account for systematic sources of variability in bevacizumab exposure.

covery and vival of patients with moderate to severe acute spiratory distress syndrome (ARDS) due to OVID-19: a multicenter, single-arm, Phase IV itolizumab rial: .

Background: Itolizumab, an anti-CD6 monoclonal antibody, down-regulates COVID-19-mediated inflammation and the acute effects of cytokine release syndrome. This study aimed to evaluate the safety and efficacy of itolizumab in hospitalized COVID-19 patients with PaO/FiO ratio (PFR) ≤200 requiring oxygen therapy.

Research Design And Methods: This multicenter, single-arm, Phase 4 study enrolled 300 hospitalized adults with SARS-CoV-2 infection, PFR ≤200, oxygen saturation ≤94%, and ≥1 elevated inflammatory markers from 17 COVID-19 specific tertiary Indian hospitals.

Nodal Yield <15 Is Associated With Reduced Survival in Esophagectomy and Is a Quality Metric.

Background: Surgical resection after neoadjuvant therapy remains the cornerstone of curative management of esophageal adenocarcinoma and is frequently used for squamous cell carcinoma. The optimal extent of lymphadenectomy and whether increasing lymph node yields confer a survival benefit remains unclear. Guidelines suggest resecting and examining a minimum of 15 lymph nodes at esophagectomy.

Comparative clinical efficacy and safety of insulin glargine 300 U/ml (Toujeo) versus insulin glargine 100 U/ml in type 2 diabetes and type 1 diabetes: A systematic literature review and meta-analysis.

Aim: To compare the clinical efficacy and safety of glargine-U100 (Lantus/Gla-100) with glargine-U300 (Toujeo/Gla-300) in adult patients with type 2 diabetes (T2D) and type 1 diabetes (T1D).

Materials And Methods: A literature search on Gla-300/Gla-100 in diabetes management was conducted using the MEDLINE/Embase/Cochrane databases from inception to 10 January 2021. Eligible studies considered for inclusion were parallel-design, randomized controlled trials (RCTs).

The Role of Dermal Regeneration Template in Anterior Abdominal Wall Defect after Burst Abdomen: A Case Report in Acute Graft Versus Host Disease of the Gastrointestinal Tract in Aplastic Anemia.

Acute graft-versus-host disease of the gastrointestinal tract (GI-aGVHD) is a rare condition, often requiring multiple laparotomies, ultimately leading to a burst abdomen. We report the successful use of a dermal regeneration template (DRT), combined with negative pressure wound therapy (NPWT) and skin grafts, to reconstruct the abdominal skin in an 11-year-old boy. The patient was a case of aplastic anemia, who underwent bone marrow transfers, the first of which failed and the second one was successful.

Pharmacokinetic and pharmacodynamic equivalence of Biocon's biosimilar insulin N with US-licensed Humulin® N formulation in healthy subjects: Results from the RHINE-2 (Recombinant Human INsulin Equivalence-2) study.

Aim: To establish the pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of proposed biosimilar Insulin N (Biocon's Insulin-N; Biocon Biologics Ltd., Bangalore, India) and US-licensed Humulin® N (Humulin-N; Eli Lilly and Company, Indianapolis, IN, USA) in healthy subjects.

Materials And Methods: This was a phase-1, single-centre, double-blind, randomized, three-period, six-sequence, partially replicated, crossover, 24-h euglycaemic clamp study.

Estimating the size of the monkeypox virus outbreak in Nigeria and implications for global control.

Background: A multi-country outbreak caused by monkeypox virus (MPXV) has been unfolding across endemic and non-endemic countries since May 2022. Throughout April and May 2022, Nigeria reported 31 MPXV cases, of which 11 were confirmed via testing. In May 2022, three internationally exported cases of MPXV, presumed to have originated in Nigeria, were reported, suggesting that a larger than reported outbreak might be occurring in the country.

Efficacy and safety of Tregopil, a novel, ultra-rapid acting oral prandial insulin analog, as part of a basal-bolus regimen in type 2 diabetes: a randomized, active-controlled phase 2/3 study.

Background: Efficacy and safety of ultra-rapid acting oral prandial insulin Tregopil was compared with insulin aspart (IAsp) in patients with type 2 diabetes (T2D) on insulin glargine and metformin.

Research Design And Methods: In this open-label, active-controlled trial, patients with T2D, HbA ≥7%-≤9% and 2-h postprandial glucose (PPG) ≥180 mg/dL were randomized 1:1:1 to Tregopil (30 mg, = 30; 45 mg, = 31) and IAsp, = 30. Primary outcome was change from baseline (CFB) in HbA at week 24.

Analysis of Saliva Composition: Parathyroid Hormone-Related Protein, Total Protein, and Secretory Immunoglobulin A (sIgA) in Rattus norvegicus with Stunted Growth.

Objective:  This study aimed to determine total protein, secretory immunoglobulin A (sIgA) and parathyroid hormone-related protein (PTHrP) levels in the saliva of rats with stunted growth.

Materials And Methods:  Experimental laboratory research with a pre-and posttest control group design was conducted. Seventeen albino rats () were divided into the control group (eight rats) and the treatment group (nine rats).

Pharmacokinetic and pharmacodynamic equivalence of Biocon's biosimilar Insulin 70/30 with US-licensed HUMULIN® 70/30 formulation in healthy subjects: Results from the RHINE-3 (Recombinant Human INsulin Equivalence-3) study.

Aim: To establish the pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of proposed biosimilar insulin 70/30 (Biocon's Insulin-70/30) and HUMULIN® 70/30 (HUMULIN-70/30; Eli Lilly and Company, IN).

Materials And Methods: In this phase 1, automated euglycaemic glucose clamp study, 78 healthy subjects were randomized (1:1) to receive a single dose of 0.4 IU/kg of Biocon's Insulin-70/30 and HUMULIN-70/30.

Evaluating diagnostic utility of PAS stained skin scrape cytology smear in clinically suspected superficial cutaneous mycoses: A simple yet unpracticed technique.

Background And Objectives: For fungal dermatitis, a wet Potassium Hydroxide (KOH) preparation of the skin scrapings forms the routine practice for diagnosis. This study was carried out to determine the diagnostic accuracy and to evaluate the value-added information of PAS-stained scrape cytology smear in evaluating the presence of fungal elements.

Methods: This prospective study was carried out on the patients clinically diagnosed with superficial cutaneous mycoses.

Pharmacokinetic and pharmacodynamic equivalence of Biocon's biosimilar Insulin-R with the US-licensed Humulin® R formulation in healthy subjects: Results from the RHINE-1 (Recombinant Human INsulin Equivalence-1) study.

Aim: To establish equivalence in the pharmacokinetic (PK) and pharmacodynamic (PD) endpoints between proposed biosimilar Insulin-R (Biocon's Insulin-R) and Humulin® R using the euglycaemic clamp technique in healthy subjects.

Materials And Methods: In this phase-1 automated euglycaemic glucose clamp study, 42 healthy subjects were randomized (1:1) to receive a single dose of 0.3 IU/kg of Biocon's Insulin-R and Humulin-R.

Physicochemical and functional characterization of trastuzumab-dkst, a trastuzumab biosimilar.

Preclinical comparative similarity studies of trastuzumab-dkst, a Herceptin biosimilar, are reported. Primary sequence and higher order structure and pharmacological mechanisms of action were compared using multiple techniques. Pharmacokinetics and repeat-dose toxicity were assessed in cynomolgus monkeys.

Final overall survival analysis of the phase 3 HERITAGE study demonstrates equivalence of trastuzumab-dkst to trastuzumab in HER2-positive metastatic breast cancer.

Purpose: The phase 3 HERITAGE trial demonstrated that the biosimilar trastuzumab-dkst is well tolerated with similar efficacy (measured by overall response rate [ORR] and progression-free survival [PFS]) compared with originator trastuzumab combined with taxane followed by monotherapy in patients with HER2-positive metastatic breast cancer (MBC). Herein, we present final overall survival (OS) from HERITAGE.

Methods: HERITAGE is a multicenter, double-blind, randomized, parallel-group study.

Correlation between week 24 trastuzumab-dkst response and week 48 progression-free survival: the HERITAGE trial.

Background: Trastuzumab-dkst is a biosimilar of trastuzumab. The phase 3 HERITAGE trial demonstrated equivalent overall response rate (ORR) with trastuzumab-dkst or originator trastuzumab at 24 weeks in patients with HER2-positive metastatic breast cancer receiving chemotherapy. We now present the correlation of ORR with progression-free survival (PFS) for maintenance monotherapy with trastuzumab-dkst vs trastuzumab at 48 weeks of treatment, and the safety, tolerability, and immunogenicity.

A two-arm, randomized, controlled, multi-centric, open-label phase-2 study to evaluate the efficacy and safety of Itolizumab in moderate to severe ARDS patients due to COVID-19.

: Efficacy and safety of Itolizumab, an immunomodulatory mAb, in treating moderate-to-severe acute respiratory distress syndrome (ARDS) due to cytokine release in COVID-19 patients was evaluated in a multi-centric, open-label, two-arm, controlled, randomized, phase-2 study.: Patients were randomized (2:1) to Arm-A (best supportive care [BSC]+Itolizumab) and Arm-B (BSC). Primary outcome of interest was reduction in mortality 30-days after enrollment.

Indian Guidelines for Indications and Timing of Intervention for Common Congenital Heart Diseases: Revised and Updated Consensus Statement of the Working Group on Management of Congenital Heart Diseases. Abridged Secondary Publication.

Justification: A number of guidelines are available for management of congenital heart diseases from infancy to adult life. However, these guidelines are for patients living in high income countries. Separate guidelines, applicable to Indian children, are required when recommending an intervention for congenital heart diseases, as often these patients present late in the course of the disease and may have co-existing morbidities and malnutrition.

Factors Influencing Participation Of Healthy Volunteers In Clinical Trials: Findings From A Cross-Sectional Study In Delhi, North India.

Purpose: To identify the specific motivations that drive healthy volunteers to consent for their participation in clinical studies. Additionally, the study aimed to document the socio-demographic determinants of participation in the trial related solely to the intention of securing financial gains.

Patients And Methods: This cross-sectional study was conducted among subjects who participated as healthy volunteers in clinical trials conducted by Contract Research Organizations (CROs) of Delhi.

Study of Awareness and Practice of Informed Consent Process Among Clinical Trial Participants and Their Motives Behind Participation.

Process to obtain informed consent is an essential component in research involving human subjects. However, much is not known about the level of awareness participants have about optimal consenting process and the motives that drive their participation in the trials. A cross-sectional study was conducted among volunteers who had been participating in clinical trials in contract research organizations of Delhi.

Guidelines for the management of common congenital heart diseases in India: A consensus statement on indications and timing of intervention.

Introduction: A number of guidelines are available for management of congenital heart diseases from infancy to adult life. However, these guidelines are for patients living in high-income countries. Separate guidelines, applicable to Indian children, are required when recommending an intervention for congenital heart diseases, as often these patients present late in the course of the disease and may have co-existing morbidities and malnutrition.