Unlocking the benefits of Drug Master File filing in the Indian pharmaceutical industries.

Ensuring the safety and quality of drugs is a crucial component for the development of any pharmaceutical industry. This requires stringent regulation in the process of drug manufacturing and marketing. A Drug Master File (DMF) serves as a comprehensive document containing information about the quality, safety, and manufacturing procedure/facility of a drug or drug substance.

Reduced guanidinoacetate in plasma of patients with autosomal dominant Fanconi syndrome due to heterozygous P341L variant and study of organoids towards treatment.

Autosomal dominant Fanconi syndrome due to a variant (GATM-FS), causes accumulation of misfolded arginine-glycine amidinotransferase (AGAT) in proximal renal tubules leading to cellular injury. GATM-FS presents during childhood and progresses to end-stage kidney disease (ESKD) in adults. We study creatine metabolism in two individuals of unrelated families with a known variant and the effect of creatine supplementation in kidney organoids.

Myofibrosarcoma of Maxilla - Case Report and Review of Literature.

Myofibrosarcoma is a distinct mesenchymal malignancy which commonly occurs in head and neck region. It has a high tendency for local recurrence and distant metastasis. 39-year-old male presented with epistaxis, nasal obstruction and left sided complete loss of vision.

Transoral Robotic Surgery for a Rare Case of Venolymphatic Malformation in Parapharyngeal Space.

Venous malformations are low flow endothelial malformations with aberrant and ectatic venous channels. They are defects in vascular growth which causes functional and cosmetic impairment. Gradual growth in size of the lesion occurs due to venous congestion or thrombosis.

A Rare Case Report of Osteosarcoma of Maxilla with Double Free-Flap Reconstruction.

Osteosarcomas are rare and highly malignant bone tumours which are composed of malignant mesenchymal cells producing osteoid or immature bone. Maxillary osteosarcomas are rare tumours accounting for less than 1% of head and neck malignancies. Aggressive surgical resection is the main modality of treatment with good reconstruction.

Extraskeletal Myxoid Chondrosarcoma of Floor of Mouth-A Rare Case Report and Review of Literature.

Introduction: Chondrosarcomas are rare malignancies of the cartilage and myxoid chondrosarcoma is its variant which commonly occurs in soft tissue of extremities. Extraskeletal chondrosarcoma is a rare malignant neoplasm of bone or soft tissue origin and is characterized by the presence of spindle cells admixed with well differentiated cartilage or chondroid stroma. They are mostly radioresistant tumours and surgical resections with adequate margins is considered as the ideal treatment modality with adjuvant radiotherapy in high grade tumours and add on chemotherapy, in case of presence of poor prognostic factors.

Incidentally Detected 131-Iodine Avid Parotid Oncocytoma Coexistent with Papillary Carcinoma Thyroid.

131-I radioactive iodine (RAI) scan is an important modality in the management of differentiated thyroid cancer to detect recurrent or residual disease. Thus it is important to have knowledge about the possibility of false positive findings in these scans to avoid wrongful diagnosis and unnecessary treatment. We here by present a patient who underwent total thyroidectomy with lymph node dissection and followed by radioactive iodine therapy for papillary thyroid cancer.

A Rare Case of Extraosseous Osteosarcoma (EOS) of Parotid Gland.

Extraosseous osteosarcoma is a rare malignant soft tissue neoplasm, and extraosseous osteosarcoma of the parotid gland is very rare. It has a very aggressive course, and there are no standardized treatment guidelines. We report the case of a 20 year old male patient who presented with history of right neck swelling since 6 years for which he had undergone right parotid surgery 5 years ago.

Trigeminal Schwannoma - Case Report of a Rare Tumour.

Schwannomas are benign nerve tumours arising from the Schwann cells. Approximately 25-45% of schwannomas occurs in the head and neck region. Majority of schwannomas in the head and neck region arise from the vagus nerve.

Uncommon Manifestation of Oligometastatic Prostate Cancer: Sister Mary Joseph Nodule.

A 76-year-old man with a history of prostate cancer diagnosed in 2008 developed biochemical recurrence in 2010 and started intermittent androgen deprivation therapy. In 2021, due to rising prostate-specific antigen, an 18 F-piflufolastat PSMA PET/CT was performed. It showed a radiotracer-avid sclerotic lesion in the right iliac bone and an indeterminate radiotracer-avid nodule in the umbilical region, demonstrating progressive enlargement and increased uptake on subsequent imaging.

Long-term survival and quality of life after extracorporeal membrane oxygenation.

Objectives: Long-term data on patient survivors after extracorporeal membrane oxygenation (ECMO) support remains limited. This study sought to examine the 5-year survival and health-related quality of life (HRQoL) of patients treated with venoarterial (VA)- or venovenous (VV)-ECMO.

Methods: A single-center retrospective chart review and survival analysis was conducted on all patients who required ECMO from December 2007 to June 2019.

Safety and efficacy of nivolumab plus ipilimumab in patients with advanced non-clear cell renal cell carcinoma: results from the phase 3b/4 CheckMate 920 trial.

Background: CheckMate 920 (NCT02982954) is a multicohort, phase 3b/4 clinical trial of nivolumab plus ipilimumab treatment in predominantly US community-based patients with previously untreated advanced renal cell carcinoma (RCC) and clinical features mostly excluded from phase 3 trials. We report safety and efficacy results from the advanced non-clear cell RCC (nccRCC) cohort of CheckMate 920.

Methods: Patients with previously untreated advanced/metastatic nccRCC, Karnofsky performance status ≥70%, and any International Metastatic Renal Cell Carcinoma Database Consortium risk received up to four doses of nivolumab 3 mg/kg plus ipilimumab 1 mg/kg every 3 weeks followed by nivolumab 480 mg every 4 weeks for ≤2 years or until disease progression/unacceptable toxicity.

An online Sexual Health and Rehabilitation eClinic (TrueNTH SHAReClinic) for prostate cancer patients: a feasibility study.

Purpose: The primary objective was to determine the feasibility of implementing the TrueNTH SHAReClinic as a pan-Canadian sexual health and rehabilitation intervention for patients treated for localized prostate cancer.

Methods: The feasibility study was designed to evaluate the accessibility and acceptability of the intervention. Participants from five institutions across Canada were enrolled to attend one pre-treatment and five follow-up online clinic visits over 1 year following their prostate cancer (PC) treatment.

Effect of Continuous Electrocardiogram Monitoring on Detection of Undiagnosed Atrial Fibrillation After Hospitalization for Cardiac Surgery: A Randomized Clinical Trial.

Importance: Postoperative atrial fibrillation (POAF) occurring after cardiac surgery is associated with adverse outcomes. Whether POAF persists beyond discharge is not well defined.

Objective: To determine whether continuous cardiac rhythm monitoring enhances detection of POAF among cardiac surgical patients during the first 30 days after hospital discharge compared with usual care.

Supply the demand: Assessment of the feasibility of local nonurologists in relieving the burden of chronic indwelling catheters in a low-income country.

Introduction: Despite the high prevalence rates of urinary retention in sub-Saharan Africa, regional deficiencies in urological care have culminated in inadequate medical management and a backlog of urology cases. Our study examined the efficacy and safety of a surgical camp enlisting local non-urologists performing simple open prostatectomy on the rate of chronic catheter usage secondary to urinary retention.

Methods: We reported on a prospective case series of patients with chronic indwelling catheters who underwent open simple prostatectomy during a one-week urology camp in the Machinga District of Malawi.

Quantifying the "Assistant Effect" in Robotic-Assisted Radical Prostatectomy (RARP): Measures of Technical Performance.

Purpose: Surgeons are reliant on the bedside assistant during robotic surgeries. Using a modified global rating scale (GRS), we aim to assess the association between an assistant's technical skill on surgeon performance in Robotic-Assisted Radical Prostatectomy (RARP).

Methods: Prospective, intraoperative video from RARP cases at three centers were collected.

Supply the demand: Assessment of the feasibility of local non-urologists in relieving the burden of chronic indwelling catheters in a low-income country.

Introduction: Despite the high prevalence rates of urinary retention in sub-Saharan Africa, regional deficiencies in urological care have culminated in inadequate medical management, and a backlog of urology cases. Our study examined the efficacy and safety of a surgical camp enlisting local non-urologists performing simple open prostatectomy on the rate of chronic catheter usage secondary to urinary retention.

Methods: We reported on a prospective case series of patients with chronic indwelling catheters who underwent open simple prostatectomy during a one-week urology camp in the Machinga District of Malawi.

Costs of surgical ablation of atrial fibrillation in Ontario, Canada from 2006 to 2017.

Background: International guidelines currently recommend concomitant surgical ablation of atrial fibrillation (AF) in patients with AF undergoing cardiac surgery. However, a systematic review and meta-analysis of 23 randomized controlled trials (RCTs) showed no significant difference in mortality or stroke in patients who underwent surgical AF ablation compared with those who did not (moderate-quality evidence).

Methods: We estimated the Ontario-wide costs of surgical AF ablation between 2006 and 2017 using data from a systematic review and meta-analysis of RCTs, estimates of case volumes from Ontario Health Insurance Plan fee codes, the ongoing left atrial appendage occlusion study III trial (NCT01561651), institutional costs from large academic centers in Ontario, as well as professional fees based on the Ontario fee schedule.

Delirium definition influences prediction of functional survival in patients one-year postcardiac surgery.

Background: Delirium after cardiac surgery is associated with prolonged intensive care unit (ICU) and hospital length of stay and elevated rates of mortality. The Society of Thoracic Surgery National Database (STS-ND) includes delirium in routine data collection but restricts its definition to hyperactive symptoms. The objective is to determine whether the Confusion Assessment Method for ICU (CAM-ICU), which includes hypo- and hyperactive symptoms, is associated with improved prediction of poor 1-year functional survival following cardiac surgery.

CSF cell-free DNA EGFR testing using DdPCR holds promise over conventional modalities for diagnosing leptomeningeal involvement in patients with non-small cell lung cancer.

Background: EGFR mutant NSCLC patients have leptomeningeal (LM) involvement in more than 9% cases.

Material & Methods: We conducted a study evaluating the diagnostic utility of cfDNA EGFR testing in CSF using DdPCR while comparing it against MRI and CSF cytology. We also looked for known EGFR mutations in the CSF sample.