Background/Aim:Alcohol is the most common substance abused in Nepal. Liver disease caused by alcohol abuse, including its end stage, cirrhosis, is a major health care problem, which is difficult to treat.Objectives:To study the demographic profile, laboratory parameters, complications and their prognostic implications among patients of alcoholic liver disease (ALD).Materials and Methods:Records of all patients of ALD admitted from January 1' 2005 to December 31' 2006 were studied and followed up to December 31, 2007. A total of 181 patients were analyzed. Their clinical profile and laboratory parameters were noted and analyzed using SPSS-10.0 software.Results:Among the 181 patients, 80.7% were male, 30.9% were army/ex-army and 65.2% were documented smokers. The mean age of presentation was 52.08 years. Jaundice (57.5%) was the most common presentation followed by hepatomegaly (51.4%). Hypoalbuminemia (50.3) followed by ascites (48.1) were common complications. Death occurred in 19.1% of the patients, the most common cause being hepatic encephalopathy (72.2%) followed by variceal bleeding and hepatorenal syndrome. Jaundice, ascites and hepatic encephalopathy at presentation and female sex were significantly associated with increased mortality along with discriminant score >32, aspartate aminotransferase (AST): Alanine aminotranferase (ALT) ≥ 2, ultrasonography (USG)-proven cirrhosis, rise in prothrombin time ≥5 s, total bilirubin ≥ 4mg/dL and ESR ≥34.Conclusion:ALD was predominantly seen among the productive age group with a high morbidity and mortality. Jaundice, ascites, hepatic encephalopathy at presentation and female sex are poor prognostic indicators along with discriminant score > 32, AST:ALT ≥ 2, USG-proven cirrhosis, coagulopathy, hyperbilirubenemia and high ESR.

An educational initiative looks critically at the drug industry's promotional tactics.

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Background Typhoid fever is an endemic disease in many low-income and middle-income countries. The 2018 WHO position paper recommends that countries should consider typhoid vaccination in high-risk groups and for outbreak control. To address the typhoid vaccine supply and demand gap, a typhoid Vi polysaccharide-diphtheria toxoid (Vi-DT) conjugate vaccine development effort was undertaken to achieve WHO prequalification and contribute to the global supply of typhoid conjugate vaccine. The main aim of this study was to show immune non-inferiority of the Vi-DT vaccine compared with the WHO prequalified Vi polysaccharide-tetanus toxoid (Vi-TT) conjugate vaccine (Typbar TCV; Bharat Biotech India, Hyderabad, India) in participants of various ages from an endemic country. Methods We did an observer-blind, active-controlled, randomised, non-inferiority, phase 3 trial at four hospitals in Kathmandu, Dhulikhel, Dharan, and Nepalgunj in Nepal. Eligible participants were healthy individuals aged 6 months to 45 years for whom informed consent was obtained, were willing to follow the study procedures and were available for the duration of the study. Patients with an acute or chronic illness that could interfere with interpretation of the study endpoints, or who were involved in any other clinical trial were excluded. Participants were randomly assigned (1:1:1:1) by block randomisation (block size of four and eight), stratified by age (6 months to <2 years, 2 years to <18 years, and 18 years to 45 years), into one of four groups (A-D). Participants in groups A-C received a single dose (25 μg; 0•5 mL) of Vi-DT test vaccine via intramuscular injection from one of three good manufacturing practice lots (group A received lot 1, group B received lot 2, and group C received lot 3), and those in group D received a single dose (25 μg; 0•5 mL) of the Vi-TT vaccine via intramuscular injection. All participants, site staff (except for those who administered the study vaccines), and those assessing the outcomes were masked to group assignment. The co-primary endpoints were: (1) non-inferiority of immunogenicity of the Vi-DT vaccine (pooled groups A-C) versus the Vi-TT vaccine (group D), measured by the anti-Vi IgG seroconversion rate at 4 weeks after vaccination; and(2) the lot-to-lot consistency of the Vi-DT vaccine, measured by immune equivalence of the anti-Vi IgG geometric mean titre (GMT) at 4 weeks after receipt of the three Vi-DT vaccine lots (lot 1 vs lot 2, lot 1 vs lot 3, and lot 2 vs lot 3). Non-inferiority of the Vi-DT vaccine compared with the Vi-TT vaccine was shown if the lower limit of the 97•5% CI for the difference between the seroconversion rates in Vi-DT vaccine groups A-C combined versus Vi-TT vaccine group D was above the predefined non-inferiority margin of -10%. Lot-to-lot immune equivalence was shown if the upper and lower bounds of the two-sided 99•17% CI around the GMT ratio for each pairwise lot-to-lot comparison was between 0•67 and 1•50, which is the predefined equivalence margin recommended by WHO. The co-pri...

Background: Scrub typhus, an important cause of undifferentiated fever, is grossly neglected and often misdiagnosed in low and middle income countries like Nepal. The main aim of this study was to describe the clinico-laboratory profile, drug used in treatment, predictor of PICU admission and therapeutic outcome of serologically confirmed scrub typhus among Nepalese children.Methods: A prospective observational study was carried out in children aged up to 14 years with serologically (IgM ELISA) diagnosed Scrub typhus, admitted in a tertiary care hospital of central Nepal between Jan 2019 to Dec 2019.Results: All 100 children with scrub typhus presented with fever. Other symptoms and sign were cough (29%), abdominal distension (22%) hepatomegaly (45%), splenomegaly (28%), crepitation (10%) and eschar (6%). Similarly, thrombocytopenia (72%), and increased liver enzymes SGPT (51%) and SGOT (62%) were found. Co-infection with dengue (5%) brucella (5%) and UTI (5%) were seen. Thirty six percent has some form of complication. Fifty eight percent of children were treated with azithromycin and 25% treated with doxycycline. The mean length of hospital stay was 6.68 ±2.97 days with a mean duration of defervescence being 30.07 ± 26.65 hours. The increased risk of PICU admission was found in those children with crepitation in chest (OR: 15.17, 95% CI: 3.4-66.8) during presentation and those children not getting azithromycin as treatment (OR: 3.8, 95% CI: 1.2-11.7)Conclusions: Scrub typhus should be considered as a differential diagnosis in any community acquired acute undifferentiated febrile illness regardless of the presence of an eschar. Sepsis, meningitis and pneumonia are important complications. Child having crepitation on presentation has an increased chance admission in critical care unit. The child receiving azithromycin has less chance to land in PICU.Keywords: Clinico-laboratory profile; complications; fever; scrub typhus.

BackgroundEarthquakes impact child health in many ways. Diseases occurring immediately following an earthquake have been studied in field based hospitals but studies on the inpatient disease pattern among children without trauma in a permanent hospital setup is lacking.MethodsWe examined the diagnoses of all children without trauma, admitted to Kanti Children’s Hospital, Kathmandu for fifteen-week duration (from 4th week to end of the 18th week) following the 7.8 magnitude Nepal earthquake on 25th April 2015. The admitted children were grouped based on direct effect of earthquake on their family (house damaged or family member injured or dead) and on whether their place of residence was located in an earthquake affected district. Most common diagnoses were identified and their distribution between the aforementioned groups analyzed to examine differences, if any, in disease occurrence or presentation. The fifteen weeks study duration was divided into three parts of five weeks each, to study trends in illness presentation. Variables were compared among various groups using appropriate statistical tests (p < 0.05).ResultsA total of 1057 patients were admitted. The proportion of patients requiring admission for pneumonia, acute gastroenteritis and acute or poststreptococcal glomerulonephritis (AGN/PSGN) was significantly higher among children belonging to earthquake affected districts. Proportion of patients with any infective condition was also significantly higher in this group. Acute gastroenteritis and any infective condition were significantly higher among children from substantially affected families.The proportion of AGN/PSGN among admitted patients increased in successive time categories among patients from affected districts and from substantially affected families. Urinary Tract Infection, bronchiolitis, tuberculosis, pleural effusion, protein energy malnutrition/failure to thrive, nephrotic syndrome, meningitis/meningoencephalitis, epilepsy or seizure disorders, leukemia/malignancies, enteric fever, infective hepatitis and congenital heart disease were not significantly different among children from affected and not affected districts or between substantially affected and not affected families. Patients from substantially affected families were admitted to semi-intensive care ward or ICU in significantly higher proportions (12.6% vs 7.8%, p = 0.014).ConclusionChildren seeking care for certain diseases were more likely to be from earthquake affected families and districts. Those from affected families required critical care more often.Electronic supplementary materialThe online version of this article (10.1186/s12887-018-1008-z) contains supplementary material, which is available to authorized users.

Introduction:Methods: Results:Conclusions:

Clinical trials are complicated, time-consuming and costly. From the initial screening, informed consent and recruitment of the participants' to study completion, the sponsor must undertake a wide array of complex and closely monitored operations, complying with international standards for human subject research and local requirements. Conducting these studies in an underdeveloped country, with limited resources, infrastructure, and experience with regulated clinical trials adds to this complexity. The initial site selection, set up and preparatory activities for the clinical trial are crucial to minimizing the risks to both participants and to successful completion during the subsequent study execution.In this paper, we describe the experience and lessons learned of building clinical trial site capacity in terms of infrastructure and human resource development for a Phase III vaccine clinical trial. We believe that sharing the experience of setting up a clinical trial in a resource-limited country will enable other entities contemplating clinical research in these countries, to prepare and plan ahead, to minimize the impact of barriers, and to contribute to bringing more studies to the countries where people live with the burden of vaccine-preventable, poverty-associated diseases.