A Real-World Observational Study to Evaluate the Safety and Effectiveness of Fluticasone Furoate-Oxymetazoline Fixed Dose Combination Nasal Spray in Patients with Allergic Rhinitis.

Background: Allergic rhinitis (AR) has shown an increasing prevalence leading to a considerable medical and social burden. Nasal congestion is the cardinal symptom of AR, and the upper respiratory tract is most affected by this long-lasting ailment. Intranasal corticosteroids alleviate nasal congestion, along with other symptoms of AR, but their effect is not evident immediately.

Primary orbital squamous cell carcinoma treated with definitive radiotherapy.

Squamous cell carcinoma (SCC) arising from the orbit is a rare entity. Only a dozen of such cases are reported in the literature. Owing to its rarity, standard treatment is not defined, but most are treated with surgery.

Endoscopic cardiac surgery for redo tricuspid valve repairminimall.

We present an isolated endoscopic tricuspid repair in an 85-year-old man who presented with progressive dyspnoea and pedal oedema. He had coronary artery bypass grafting about 24 years ago and had significant comorbidities including atrial fibrillation, chronic obstructive pulmonary disease and upper gastrointestinal bleeding.

ARV1 Gene: A Novel Cause of Autosomal Recessive Cerebellar Ataxia with Elevated Alpha Fetoprotein.

ARV1 mutation is known to present as developmental and epileptic encephalopathy (DEE)-38. However, the phenotypic spectrum has been expanding ever since it was reported in 2016. Along with seizures and developmental delay, other unique clinical features include ophthalmological abnormalities and movement disorders in the form of ataxia and dystonia, especially in those with missense mutation.

Safety and immunogenicity of a new formulation of a pentavalent DTwP-HepB-Hib vaccine in healthy Indian infants-A randomized study.

Background: Pentavalent vaccines (DTP-HepB-Hib) have been introduced in many countries in their routine public immunization programmes to protect against diphtheria (D), tetanus (T), pertussis (P), hepatitis B (Hep B) and Hemophilus influenzae type b (Hib) diseases. This study compared the safety and immunogenicity of a new formulation of a whole-cell Bordetella pertussis (wP) based pentavalent vaccine (DTwP-HepB-Hib). The new formulation was developed using well-characterized hepatitis B and pertussis whole cell vaccine components.

Grafted tubularised incised plate: A right option in the management of failed mid-penile and distal hypospadias.

Introduction: Hypospadias is a common congenital anomaly of the urogenital system. The goal of the initial repair is to correct any curvature, ensuring that the penis is straight, allowing for successful intercourse, to create a functional neourethra to direct the urinary stream in a forward direction and to produce a cosmetically normal-appearing penis with a slit-like meatus at the tip of the glans. Failures and complications do occur.

Drug-induced Capillary Leak Syndrome.

Capillary leak syndrome is a disease with a high mortality rate. Its signs and symptoms are nonspecific. Generalized edema, hypotension, hypoproteinemia, and hemoconcentration are the characteristics of capillary leak syndrome.

Prognosticating Gross Tumor Volume in Head-and-Neck Cancer - Redefining Gross Tumor Volume Beyond Contouring.

Purpose: Precision radiotherapy (RT) requires accurate delineation of gross tumor volumes (GTVs) for targeted dose delivery. Volumetric measurement of this GTV can predict the treatment outcomes. This volume has been limited for mere contouring and its potential as the prognostic factor is less explored.

Hybrid Minimally Invasive Esophagectomy for Carcinoma Oesophagus: Experience at Tertiary Care Centre in North Karnataka.

Surgery remains the mainstay for curative treatment of carcinoma of midthoracic and lower thoracic oesophagus. In the twentieth century, open esophagectomy was the standard of care. In the twenty-first century, treatment for carcinoma oesophagus has revolutionized with incorporation of neoadjuvant treatment and application of various minimally invasive techniques for esophagectomy.

Neoadjuvant Chemotherapy Followed by Cystectomy: a Single-Center Experience.

Nearly 50% of patients with muscle-invasive bladder cancer treated with cystectomy alone will progress to metastatic disease. Surgery alone is not a sufficient therapy in a large number of patients with invasive bladder cancer. Systemic therapy with cisplatin-based chemotherapy has been shown to provide response rates in several bladder cancer studies.

Safety and immunogenicity of an indigenously developed tetanus toxoid, diphtheria toxoid, and acellular pertussis vaccine (Tdap) in adults, adolescents, and children in India.

Background: This study assessed safety and immunogenicity of Serum Institute of India Pvt Ltd (SIIPL)'s tetanus toxoid (TT), diphtheria toxoid (DT), and acellular pertussis booster vaccine (Tdap).

Research Design And Methods: In this Phase II/III, multicenter, randomized, active-controlled, open-label study, 1500 healthy individuals, aged 4-65 years, were randomized to receive a single dose of SIIPL Tdap or comparator Tdap vaccine (Boostrix®; GlaxoSmithKlines, India). Adverse events (AEs) during initial 30 minutes, 7-day, 30-day post-vaccination were assessed.

Submandibular gland extirpation during neck dissection, is it truly justified?

Background: There is no oncologic basis for the extirpation of the submandibular gland (SMG) in early oral squamous cell carcinomas (OSCC) unless the SMG is truly infiltrated by the tumor. The study aimed at assessing the true involvement of SMG in OSCC and to determine whether the gland extirpation in all cases is justified.

Methods: This study prospectively evaluated the pathological involvement of SMG by OSCC in 281 patients, who were diagnosed with OSCC and underwent wide local excision of the primary tumor with simultaneous neck dissection.

Status and Determinants of Early Detection of Oral Premalignant and Malignant Lesions in India.

It has been over four decades since the launch of the National Cancer Control Programme in India, yet the cancer screening rates for oral cancer remain unremarkable. Moreover, India is bracing a large burden of oral cancer with poor survival rates. An effective public health programme implementation relies on a multitude of factors related to cost-effective evidence-based interventions, the healthcare delivery system, public health human resource management, community behaviour, partnership with stakeholders, identifying opportunities and political commitment.

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.

Concurrent Weekly Cisplatin and Simultaneous Integrated Boost-IMRT in Locally Advanced Head and Neck Squamous Cell Carcinoma-An Institutional Experience.

 Concurrent chemoradiation with weekly cisplatin in locally advanced head and neck squamous cell carcinoma (LA-HNSCC) is widely practiced in India. Radiation with simultaneous integrated boost intensity-modulated radiotherapy (SIB-IMRT) has the advantage of executing IMRT in single phase with better dose distribution.  150 patients with LA-HNSCC treated between April 2015 and December 2019 were retrospectively evaluated.

Challenges of diabetes in elderly TB patients.

Diabetes mellitus (DM) and tuberculosis (TB) are worldwide health burdens post-COVID-19. TB is the second-leading cause of death by a single infectious microbe. There is much evidence around the world about the responsibility of TB-DM co-morbidity.

Safety, tolerability and immunogenicity of Biological E's CORBEVAX™ vaccine in children and adolescents: A prospective, randomised, double-blind, placebo controlled, phase-2/3 study.

Background: After establishing safety and immunogenicity of Biological-E's CORBEVAX™ vaccine in adult population (18-80 years) in Phase 1-3 studies, vaccine is further tested in children and adolescents in this study.

Methods: This is a phase-2/3 prospective, randomised, double-blind, placebo-controlled study evaluating safety, reactogenicity, tolerability and immunogenicity of CORBEVAX™ vaccine in children and adolescents of either gender between <18 to ≥12 years of age in Phase-2 and <18 to ≥5 years of age in Phase-Phase-2/Phase-3 with placebo as a control. This study has two age sub-groups; subgroup-1 with subjects <18 to ≥12 years of age and subgroup-2 with subjects <12 to ≥5 years of age.

Induction of Endometrial HOXA 10 Gene Expression by Vitamin D and its Possible Influence on Reproductive Outcome of PCOS Patients Undergoing Ovulation Induction Procedure.

Background And Objectives: Polycystic ovarian syndrome (PCOS) is one of the most common endocrinopathies in women frequently presenting with anovulatory infertility. Low successful pregnancy and live birth rates even after successful ovulation induction (OI) and fertilization (IVF) in these patients indicate that endometrial dysfunction may be another important factor contributing to infertility. Vitamin D acting through nuclear receptors induces the expression of various genes required for cell growth and differentiation and plays a crucial role in reproduction.

Comparison of efficacy of filter paper cyanmethemoglobin method with automated hematology analyzer for estimation of hemoglobin.

Background: Screening of hemoglobin (Hb) before blood donation is one among the vital tests. It is performed to select a blood donor to prevent the collection of blood from an anemic person. However, no accurate, cost-effective, reliable, and standardized method is available to estimate Hb.

Changing trends in assessment: Effectiveness of Direct observation of procedural skills (DOPS) as an assessment tool in anesthesiology postgraduate students.

Background And Aims: National Medical commission of India (NMC) has introduced Competency based Medical Education (CBME) following the international trend. Competency based assessment differs from traditional assessment and we need to adopt to newer work place-based assessments (WPBA). Direct Observation of Procedural Skills (DOPS) is one such assessment tool, which assesses procedural skills of a student.

Lot-to-lot consistency of a hexavalent DTwP-IPV-HB-PRP∼T vaccine and non-inferiority to separate DTwP-HB-PRP∼T and IPV antigen-matching vaccines at 6-8, 10-12, and 14-16 weeks of age co-administered with oral rotavirus vaccine in healthy infants in India: A multi-center, randomized, controlled study.

Background: Combination vaccines reduce the number of pediatric injections but must be as safe, immunogenic, and effective as each of the individual vaccines given separately. Additionally, consistency in manufacturing lots is essential for WHO prequalification. This study aimed to establish the lot-to-lot consistency of a fully liquid, hexavalent diphtheria (D)-tetanus (T)-whole-cell pertussis (wP)-inactivated poliovirus (IPV)-hepatitis B (HB)- b (PRP-T) (DTwP-IPV-HB-PRP∼T) vaccine and to demonstrate non-inferiority to licensed DTwP-HB-PRP∼T and IPV vaccines.

COVID 19 Associated Mucormycosis: Preventable Risk Factors Leading to a Better Prognosis: A Case Series.

India was severely affected by the second wave of coronavirus disease (COVID‑19), leading to sudden expansive spread of Mucormycosis, presenting with sinusitis, blackish mucus secretions, discolouration of palate, facial pain, swelling and blurring of vision. Hyperglycemia, hypercoagulable state and elevated levels of serum ferritin were the major contributing factors in progression of the deadly disease. To highlight the correlation between Diabetes Mellitus, hyperferritenimia and elevated levels of D-Dimer with increased rate of incidence and poor prognosis of the disease.

A Phase IV Study on Safety, Tolerability and Efficacy of Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate in Treatment Naïve Adult Indian Patients Living with HIV-1.

Purpose: WHO recommends dolutegravir (DTG) based regimens as first-line treatment for HIV-1 infection. However, few studies have been conducted in Indian population. Hence, our study evaluated the safety, tolerability, and efficacy of DTG 50 mg with Tenofovir and Lamivudine (300/300mg) fixed dose combination in treatment naïve adult Indian patients.