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We report the clinical efficacy against COVID-19 infection of BBV152, a whole virion inactivated SARS-CoV-2 vaccine formulated with a toll-like receptor 7/8 agonist molecule adsorbed to alum (Algel-IMDG) in Indian adults. We did a randomised, double-blind, placebo-controlled, multicentre, phase 3 clinical trial in 25 Indian hospitals or medical clinics to evaluate the efficacy, safety, and immunological lot consistency of BBV152. Adults (age ≥18 years) who were healthy or had stable chronic medical conditions (not an immunocompromising condition or requiring treatment with immunosuppressive therapy) were randomised 1:1 with a computer-generated randomisation scheme (stratified for the presence or absence of chronic conditions) to receive two intramuscular doses of vaccine or placebo administered 4 weeks apart. Participants, investigators, study coordinators, study-related personnel, the sponsor, and nurses who administered the vaccines were masked to treatment group allocation; an unmasked contract research organisation and a masked expert adjudication panel assessed outcomes. The primary outcome was the efficacy of the BBV152 vaccine in preventing a first occurrence of laboratory-confirmed (RT-PCR-positive) symptomatic COVID-19 (any severity), occurring at least 14 days after the second dose in the per-protocol population. We also assessed safety and reactogenicity throughout the duration of the study in all participants who had received at least one dose of vaccine or placebo. This report contains interim results (data cutoff May 17, 2021) regarding immunogenicity and safety outcomes (captured on days 0 to 56) and efficacy results with a median of 99 days for the study population. The trial was registered on the Indian Clinical Trials Registry India, CTRI/2020/11/028976, and ClinicalTrials.gov, NCT04641481 (active, not recruiting). Between Nov 16, 2020, and Jan 7, 2021, we recruited 25 798 participants who were randomly assigned to receive BBV152 or placebo; 24 419 received two doses of BBV152 (n=12 221) or placebo (n=12 198). Efficacy analysis was dependent on having 130 cases of symptomatic COVID-19, which occurred when 16 973 initially seronegative participants had at least 14 days follow-up after the second dose. 24 (0·3%) cases occurred among 8471 vaccine recipients and 106 (1·2%) among 8502 placebo recipients, giving an overall estimated vaccine efficacy of 77·8% (95% CI 65·2–86·4). In the safety population (n=25 753), 5959 adverse events occurred in 3194 participants. BBV152 was well tolerated; the same proportion of participants reported adverse events in the vaccine group (1597 [12·4%] of 12 879) and placebo group (1597 [12·4%] of 12 874), with no clinically significant differences in the distributions of solicited, unsolicited, or serious adverse events between the groups, and no cases of anaphylaxis or vaccine-related deaths. BBV152 was highly efficacious against laboratory-confirmed symptomatic COVID-19 disease in adults. Vaccination was well tolerated with no safety concerns raised in this interim analysis. Bharat Biotech International and Indian Council of Medical Research.

Background The use of cutting seton (CS) for the management of cryptoglandular fistula-in-ano has remained controversial because of reports of fecal incontinence, postoperative pain, and extended healing time. The aim of this review was to provide the first synthesis of studies investigating the use of CS for the treatment of cryptoglandular fistula-in-ano. Methods MEDLINE, Embase, and CENTRAL were searched up to October 2022. Randomized controlled trials and observational studies comparing CS with alternative interventions were included, along with single-arm studies evaluating CS alone. The primary outcome was fistula-in-ano recurrence, and secondary outcomes included incontinence, healing time, proportion with complete healing, and postoperative pain. Inverse variance random-effects meta-analyses were used to pool effect estimates. Results After screening 661 citations, 29 studies were included. Overall, 1513 patients undergoing CS (18.8% female, mean age: 43.1 years) were included. Patients with CS had a 6% (95% CI: 3–12%) risk of recurrence and a 16% (95% CI: 5–38%) risk of incontinence at 6 months. CS patients had an average healing time of 14.6 weeks (95% CI: 10–19 weeks) with 73% (95% CI: 48–89%) of patients achieving complete healing at 6 months postoperatively. There was no difference in recurrence between CS and fistulotomy, advancement flap, two-stage seton fistulotomy, or draining seton. Conclusions Overall, this analysis shows that CS has comparable recurrence and incontinence rates to other modalities. However, this may be at the expense of more postoperative pain and extended healing time. Further comparative studies between CS and other modalities are warranted.

Succinate dehydrogenase (SDH)-deficient renal cell carcinoma (RCC) accounts for 0.05–2% of all RCCs. The majority of patients have germline mutations, most frequently in the SDHB gene. People with these mutations are predisposed to developing paragangliomas, phaeochromocytomas and gastrointestinal stromal tumours. Patients should be referred to genetic services for further workup and close surveillance imaging due to the risk of development of further tumours. We present a woman with SDH-deficient RCC and review the literature associated with this uncommon entity.

Regression analysis is extensively used for prediction and prognostication, and its use has substantial overlap with the domain of machine learning. The main objective of this paper is to compare the performance of two regression techniques namely Simple Linear Regression (SLR) and Multiple Linear Regression (MLR) algorithms by two cases: predicting the salary of employees after certain years and predicting the prices of real estates. An employee's salary depends on numerous factors, such as total employee experience, certifications, and overall experience as a lead and manager. The factors in predicting house prices are the area of land (sqft_living), condition, waterfront, number of bedrooms, and so on. The dataset used in this experiment is an open-source dataset from KaggleInc. The algorithms were compared using parameters like R-squared value, Mean absolute error (MAE), Mean Squared Error (MSE), Median Absolute Error (MDAE), Variance Score, and Root Mean Square Error (RMSE). Results have shown that MLR provides the better efficiency in comparison to SLR.

Background Carbohydrate antigen 19.9 (CA19.9), a tumor marker for malignancies of the hepatobiliary tract and pancreas, has frequently been shown to be deranged in a number of non-malignant conditions that are associated with jaundice. This study aims to demonstrate the correlation between CA19.9 and serum bilirubin concentration in patients with benign conditions and to determine the frequency of a false-positive increase in CA19.9 in patients being investigated for potential HPB malignancies. Methods This is a retrospective review of 83 consecutive patients presenting with an abnormal CA19.9 and radiological or clinical features suggestive of HPB malignancy subsequently shown to have benign disease. All patients were thoroughly investigated and followed up until the diagnosis of malignancy could be safely excluded. Results Serum bilirubin, sodium, lymphocyte count, neutrophil:lymphocyte ratio (NLR), β-human chorionic gonadotrophin (HCG), and age were found to correlate with CA19.9 by Pearson's correlation (P = 0.001, P = 0.006, P = 0.006, P < 0.001, P = 0.012, and P = 0.049, respectively). In multivariate regression analysis, bilirubin was identified as an independent variable that may predict CA19.9 level (P = 0.028). Conclusion CA19.9 level is significantly influenced by serum bilirubin and elevated levels have been observed in patients with non-malignant HPB conditions. Adjusting CA19.9 according to bilirubin levels is likely to improve the specificity of this antigen in the differential diagnosis of benign and malignant HPB diseases and its reliability in the monitoring of disease response to chemotherapy.

Despite the Introduction of Panchayat Raj Institution in rest of Sikkim, Lachen and Lachung, two villages in North Sikkim have still retained the traditional system of self-governance called Dzumsa. The article brings out how despite the penetration of forces of modernisation, the institution still persists as an effective mode of self-governance system fairly accommodating the developmental roles in the new democratic set up in the state. The article concludes by saying how the mechanical solidarity and collective consciousness in the Durkheimian an sense and Parsonian pattern variable of collective-orientation and particularism still remains intact although faint changes are being noticed in the institution.

PICCs are attractive, economical alternative for prolonged administration of chemotherapy in pediatric oncology kids. But there are few disadvantages also-infections, block, thrombosis etc. Here we describe our experience with regard to patients demographics and complications. Combined retrospective and prospective analysis of data of patients in whom PICCs were inserted at our center from January-2011 to November-2013. One hundred seventeen PICCs inserted in 82 patients admitted.73 PICCs analysed (35-inserted more than once, 8-lostto followup,1-causeforremoval of PICC not found were excluded).48-males (65 %),25-females(35 %). Median age-5.7 yr (0.4-18 yr).55 (75.3 %)--Hemato-lymphoid (ALL-most common), 18(24.7 %)-solid tumors (Neuroblastoma-most common). Majority basilic veins inserted (n=73,92 %). Total number of catheter days-4856 (median time-71.5 days; range-1-222 days). Causes for removal of PICCs-6(8.2 %)--completed treatment, 14(20 %)--fever, with no proven sepsis,46(63 %)-complications.7 (9.5 %) PICCs in situ. Catheter related blood stream infections (CRBSI)-23 (31.5 %)-5.01 episodes/1,000 catheter days, most common complication. Staphylococci, Acenetobacter, and Candida are the most commonly isolated organism. Other complications--line site infections(9),catheter thrombosis (5), accidental removal(5), line blocks(4) 1.96, 1.09, 1.0, 0.87 episodes/1,000 catheter days respectively CRBSI are major morbidity and a significant problem of developing countries, otherwise PICCS are safe and cost effective here. Pain relief was the major benefit and trade off for increased risk of infections.