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.

Clinical Profile and Endoscopic Management in Patients with Choledocholithiasis.

Background: Common bile duct stones is a common medical problem that are usually seen in association with gallstone disease. Endoscopic management of Common bile duct stones involves doing Endoscopic retrograde cholangiography for bile duct clearance which is the primary therapeutic modality of choice. This prospective study was done to identify the clinical characteristics and outcome of patients presenting with Common bile duct stones undergoing Endoscopic retrograde cholangiography.

Post-cholecystectomy clip migration: an unusual nidus of choledocholithiasis: a case report.

Introduction And Importance: Laparoscopic cholecystectomy is one of the common surgeries occurring worldwide and the gold standard for the management of gallstone disease. The non-absorbable surgical clips may slip and can migrate causing a variety of problems as such, choledocholithiasis.

Case Presentation: The authors report a case of 43-year-old female who presented with the complaint epigastric pain.

Comparison of Acute Physiology and Chronic Health Evaluation II, Bedside Index for Severity in Acute Pancreatitis and Modified Computed Tomography Severity Index Scores in Predicting the Outcome in Acute Pancreatitis in a Tertiary Care Centre in Nepal.

Background: It is important to identify the severity of acute pancreatitis in the early course of the disease.

Methods: This prospective observational study included 83 patients with acute pancreatitis. The Acute Physiology and Chronic Health Evaluation II and the Bedside Index for Severity in Acute Pancreatitis scores were assessed within 24 hours of admission, and the modified computed tomography severity index score was calculated in those patients who underwent contrast enhanced computed tomography.

Antimitochondrial antibody-negative primary biliary cirrhosis with secondary Sjogren syndrome: a case report.

Introduction And Importance: Primary biliary cholangitis (PBC) is a rare immune-mediated liver disease characterized by the destruction of intrahepatic bile ducts and a positive antimitochondrial antibody (AMA), which is considered a serological hallmark for the diagnosis. Rarely, AMA can be absent/nondetectable in a few cases and is referred to as 'AMA-negative'.

Case Presentation: The authors present such an uncommon case of AMA-negative PBC in a 39-year-female with Sjogren's syndrome who presented with fatigue, pruritus, and dry eyes.

Efficacy and Safety Comparison of Basic Fibroblast Growth Factor-Related Decapeptide 0.1% Solution (bFGFrP) Plus Oral PUVA Combination Therapy with Oral PUVA Monotherapy in the Treatment of Vitiligo.

Background: Phototherapy in its different forms, is mainstay of vitiligo management. Combining treatment modalities like topical calcipotriol (for quicker, more intense repigmentation), Low dose azathioprine with PUVA have proven to be beneficial in management of vitiligo due to different mechanisms of repigmentation and their synergistic effects. Topical bFGF-related decapeptide (bFGFrP) application followed by sun exposure/ UVA phototherapy yields effective repigmentation.

Genitofemoral peripheral nerve stimulator implantation for refractory groin pain: a case report.

Purpose: Genitofemoral neuralgia (GFN) is a chronic pain condition that may be refractory to commonly employed treatment modalities. Implantation of a peripheral nerve stimulator (PNS) may provide significant pain relief; however, few reports have described placement of and response to a GFN PNS implant.

Clinical Features: We implanted a StimRouter® PNS in a 42-yr-old male with severe GFN that did not respond to pharmacologic and interventional pain management modalities and impaired all aspects of his function and quality of life.

Hepatic Encephalopathy Induced Transient Cortical Blindness.

Hepatic encephalopathy describes a spectrum of potentially reversible neuropsychiatric abnormalities seen in a patient with severe liver dysfunction with porto-systemic shunting. Cortical blindness can be a rare presentation of hepatic encephalopathy and can even precede the onset of altered sensorium. We report a case of 57 years female with chronic liver disease who presented with bilateral loss of vision, with no focal neurological deficits.

Detection of Colonic Polyps During Colonoscopy in a Tertiary Care Center of Nepal.

Background: Colorectal cancer is the third leading cause of cancer death in the world. Most colon cancer develop from the polyps. Data on the prevalence of colorectal polyps in Nepal is lacking.

Symptomatic Hyponatremia following Bowel Preparation for Colonoscopy: A Case Report.

Colonoscopy is considered a gold standard tool for the diagnostic evaluation of colorectal diseases. Bowel preparation, a pre-requisite for colonoscopy, usually involves ingestion of purgatives for the cleansing of the bowel so that visualization is not obscured during the procedure. Commonly used preparations are sodium phosphate-based solutions, sodium picosulphate and polyethylene glycol.

The Assessment of Health-Related Quality of Life in Patients With Chronic Liver Disease: A Single-Center Study.

Aim The aim of this study was to investigate the factors affecting health-related quality of life (HRQOL) in Nepalese patients with chronic liver disease (CLD). Methods In this study, HRQOL was measured with validated Nepali versions of the short-form 36 (SF-36) survey. Socioeconomic factors, etiology, laboratory parameters, disease severity, and self-rated health perceptions on HRQOL were recorded for analysis.

Comparative Study of Slow Infusion versus Bolus Doses of Albumin and Furosemide Infusion to Mobilize Refractory Ascites in Decompensated Chronic Liver Disease.

Background: Combined use of furosemide with albumin is an approved therapy to overcome diuretic resistance in treatment of ascites in decompensated chronic liver disease. Bolus dosing of diuretics has its own limitations due to pre-existing hypotension, post diuretic sodium retention and braking phenomenon. Slow albumin and furosemide Infusion has been shown to mobilize large ascites with improved diuresis and hemodynamic stability in decompensated chronic liver disease.

Machine Learning Confirms Nonlinear Relationship between Severity of Peripheral Arterial Disease, Functional Limitation and Symptom Severity.

Background: Peripheral arterial disease (PAD) involves arterial blockages in the body, except those serving the heart and brain. We explore the relationship of functional limitation and PAD symptoms obtained from a quality-of-life questionnaire about the severity of the disease. We used a supervised artificial intelligence-based method of data analyses known as machine learning (ML) to demonstrate a nonlinear relationship between symptoms and functional limitation amongst patients with and without PAD.

Prevalence of Covert Hepatic Encephalopathy in A Tertiary Care Centre.

Introduction: Among patients with Hepatic Encephalopathy, prevalence of Minimal HE varies between 30-50%. Identifying patients with MHE has been shown to improve with medications and delay development of Overt HE, however only limited clinicians screen for MHE in patients due to time consuming neuropsychological and neurophysiological tests. The Number Connection Test is an easy way to evaluate patients to diagnose MHE.

Efficacy and safety of basic fibroblast growth factor (bFGF) related decapeptide solution plus Tacrolimus 0.1% ointment versus Tacrolimus 0.1% ointment in the treatment of stable vitiligo.

Vitiligo is common acquired pigmentary disorder affecting skin of 1% of the world population, India 3% to 8% incidences approximately. Treatment is tough challenge. The combination treatments have proven beneficial due to different mechanisms.

Inhibition of bacterial attachment and biofilm formation by a novel intravenous catheter material using an in vitro percutaneous catheter insertion model.

Introduction: Despite sterile barrier precautions and vigorous skin antisepsis, percutaneous insertion of intravenous catheters has been shown to result in attachment to the catheter surface of bacteria residing in the deep structures of the skin. Such attachment poses the risk of biofilm formation and eventual catheter-related bloodstream infection (CRBSI). This study was undertaken to assess whether the non-coated surface treatment of a unique catheter material (ChronoFlex C with BioGUARD™) could inhibit bacterial attachment and biofilm formation.

Assessment of Validity of SF 36 Questionnaire Using Nepali Language to Determine Health-related Quality of Life in Patients with Chronic Liver Disease: A Pilot Study.

Objectives: The main objective of this study was to translate and validate the short form 36 (SF-36) health survey questionnaire into the Nepali language using a standard protocol to determine health-related quality of life (HRQoL) in patients with chronic liver disease (CLD).

Methods: We conducted a cross-sectional study among 40 patients with CLD. A formal translation of SF-36 from English into the Nepali language was performed.

A vascular access and midlines program can decrease hospital-acquired central line-associated bloodstream infections and cost to a community-based hospital.

Background: We propose that substituting central lines with midlines can help reduce the total number of central line catheter-days as well as central line-associated bloodstream infections (CLABSIs), thereby reducing the associated costs and the resulting increased length of stay. A midline or vascular access program in a community hospital can bring about these positive changes.

Objectives: Our objective is to evaluate whether the institution of a midline program for vascular access at a community hospital can reduce the number of central line catheter-days and the associated CLABSI rate, incidence, and cost.

A comparison study of the detection of bloodstains on painted and cleaned surfaces with luminol.

There seems to be a limited amount of research about the detection of concealed bloodstains on painted surfaces. The bloodstains on walls and floors are often removed by cleaning, in some cases the surfaces are painted by the perpetrator after committing a violent crime in order to hide the crime that has occurred. The study hereafter extends and deepens on previous researches by investigating the detectability of horse bloodstains on painted ceramic tiles as a function of the number of layers of paint.

Prevalence of Hypertension in Boloor Diabetes Study (BDS-II) and its Risk Factors.

Introduction: Hypertension is a major public health problem in India and worldwide. Since hypertension is often asymptomatic, it commonly remains undetected, leading to serious complications if untreated. Hypertension is one of the leading causes of end stage renal disease.

The Incidence of Central Line-Associated Bacteremia After the Introduction of Midline Catheters in a Ventilator Unit Population.

Hypothesis: Our objective was to evaluate whether the use of midline venous catheters in place of central line venous catheters, when appropriate, decreased the overall incidence of central line-associated bacteremia in a ventilator unit.

Methods: The time interval between February 2012 and February 2013 was divided into 2 periods. Group A was the first half of the year, before the introduction of midline catheters, and group B was the second half of the year, 6 months after their introduction.

Radiofrequency ablation using BarRx for the endoscopic treatment of radiation proctopathy: a series of three cases.

Radiation proctopathy is a complication of pelvic radiotherapy, which occurs in patients treated for carcinoma of the prostate, rectum, urinary bladder, cervix, uterus, and testes. If it presents within 6 weeks to 9 months after therapy, it is called acute radiation proctitis/proctopathy (ARP), and if it occurs 9 months to a year after treatment, it is classified as chronic radiation proctitis/proctopathy (CRP). CRP occurs in 5%-20% of patients receiving pelvic radiation, depending on the radiation dose and the presence or absence of chemotherapy.

Treatment of relapsing Clostridium difficile infection using fecal microbiota transplantation.

Background: Clostridium difficile infection (CDI) has become a global concern over the last decade. In the United States, CDI escalated in incidence from 1996 to 2005 from 31 to 64/100,000. In 2010, there were 500,000 cases of CDI with an estimated mortality up to 20,000 cases a year.