Gestational diabetes mellitus diagnosed with single test glucose screening test and its outcome in a tertiary hospital in South India

Background: 1) To assess maternal and neonatal outcomes after screening, diagnosing and treating GDM. 2) Role of single test glucose screening test (GST) in diagnosing gestational diabetes mellitus (GDM) in our population.Methods: A one year retrospective study of women diagnosed with and treated for GDM from Jan 2014 to Dec 2014   at SDM medical college and hospital, Dharwad, Karnataka, India. Case records were retrieved to collect data on maternal and neonatal outcome, glycemic control and diabetic management. Single test GST, as per the latest DIPSI guideline was the test used to diagnose GDM i.e. 75 gm of glucose was given to all pregnant women between 24- 34 weeks of pregnancy, irrespective of the last meal and time of the day and after two hours, plasma glucose was estimated. Women with a 2-hr plasma glucose value of >140 mg/ dl were diagnosed to have GDM and were not subjected further for oral glucose tolerance test (OGTT). In women with high risk factors for GDM, the test was performed in the Ist trimester or at their first visit to the hospital.Results: All booked women in the study period underwent GST i.e. we could do universal screening .The incidence of GDM was 4.8%. 147 women were diagnosed to have GDM out of 3050 women screened for GDM. Of the affected women, 74.1% were managed with diet alone and 24.9% received insulin treatment. Good glycemic control improved both maternal and neonatal outcome. Poor glycemic control and presence of preeclampsia were risk factors for   maternal and neonatal complications.Conclusions: Single test GST is a patient friendly and effective approach to screen women for GDM especially in high risk ethnic population. Timely and aggressive management helps improve maternal and neonatal outcomes and also decrease the future risk of development of diabetes both in the mother and the fetus

Human papilloma virus vaccination: knowledge, awareness and acceptability among medical and paramedical students

Background: Cervical cancer is the second leading cause of death in india. it is also one of the few malignancies where an infectious etiological agent human papilloma virus (HPV) has been identified. With the advent of HPV vaccination, it is possible to reduce the morbidity and mortality associated with carcinoma cervix. But biggest hurdle to achieve this is the lack of awareness about the availability and use of HPV vaccine. This study was conducted to know knowledge and awareness of HPV infection and vaccination among medical and paramedical students. We also evaluated the acceptability and coverage of HPV vaccine among these students.Methods: This study was conducted among a total of 520 female students of the Sri Dharmasthala Manjunatheshwara University with the help of a questionnaire. The study group included 207 MBBS students, 167 BDS students, 89 nursing students and 57 physiotherapy students.Results: Most of the students were in 18-20 years’ age group. Nearly 40.57% of the students knew that HPV is sexually transmitted and 29.80% were aware that this infection can be prevented. Availability of HPV vaccine was known to 75% of the students and the main source of their information was through their college teachings. Nearly 43.75% of the students knew HPV vaccine protects against cervical cancer and 26.73% of the students were vaccinated. Overall knowledge and awareness were better among medical students.Conclusions: A lot of work needs to be done so as to make the target population accept HPV vaccine. There is a great difference between awareness of availability of the vaccine and its use. This emphasizes the need for health care professionals to take special interest in promoting this vaccine in the general population

A Cross-sectional study on Out-of-Pocket expenditure towards Immunization and its consequences faced by families with under-five Children Residing at one of the Cities of Western India

Background: When immunization of under-five children results in Out-of-Pocket Expenditure (OOPE), it affects motivation of parents for vaccination inversely. Objectives: To assess determinants affecting preference for specific/mixed type of health facilities and to estimate out-of-pocket expenditure towards immunization of under-five children. To assess opinion of participants for prevention/decreasing OOPE towards immunization. Methods: A community-based cross-sectional study was conducted at one of zones of Ahmedabad city, selected by simple random sampling. Following technique of “30×7 cluster survey” with necessary house-hold information received from Municipal Corporation, selection of 7 children was pursued from each cluster reaching to sample-size of 210 (30 X 7). Results: Of 211 children included in study, 124(58.77%), 68(32.23%) and 19(9%) had taken immunization services from government, private and mixed variety respectively. Majority of families (110, 88.71%) preferring government healthcare-facility for immunization incurred expenses <5000 INR/child as while in other two groups, all beneficiaries had expensed>5000 INR/child. Conclusions: Determinants like child’s gender, parents’ education, Type of family, Socio-economic status, delivery place of child and occupation of father had statistically significant association with preferred place of vaccination. Fixation of upper ceiling-limit of vaccines which are recommended by pediatricians but not covered in government run program was one of suggestions

Evaluation of trigger tool method for adverse drug reaction reporting by nursing staff at a tertiary care teaching hospital

Background: To sensitize nurses about Trigger Tool Method (TTM) and to evaluate the impact of TTM on adverse drug event (ADE) reporting by nurses at a tertiary care teaching hospital in India.Methods: This was prospective, interventional, single center study conducted among nursing health professionals of Civil Hospital Ahmedabad (CHA) posted in Medicine Department. They were sensitized about ADE reporting, pharmacovigilance, methods of ADRs reporting and details about TTM. Also, a list of 17 triggers was prepared by the investigator and given to nurses. They were educated to report ADEs using TTM. At the initiation and end of study, questionnaires were given to evaluate knowledge, attitude and practice of ADR reporting among participant nurses. All triggers and ADEs reported were analyzed in terms of association between them, effectiveness of trigger in detecting an ADR and in terms of Positive Predictive Value (PPV). Reported ADRs were also assessed for causality, severity and preventability.Results: A total 758 patients were admitted during the study period in the respective medicine department. List of 17 triggers consists of 9 drug triggers (DT), 1 laboratory trigger (LT) and 7 patient triggers (PT). Of these 17 triggers, 14 triggers were identified by nurses. These 14 triggers were noticed 130 times. These included DT (100 times), LT (0 times) and PT (30 times). Of the various triggers observed, 7 DT and 4 PT were related to ADRs. Hence, 11 triggers (64.70%) were positive (related to ADRs), out of 17 total triggers under evaluation. 21 ADRs were observed using TTM by nurses.Conclusions: The TTM helps to detect and report ADRs by nurses. Educational interventions about TTM help in better detection and reporting of ADRs

Tributyltin (TBT) biodegradation induces oxidative stress of Cunninghamella echinulata

Tributyltin (TBT) is one of the most deleterious compounds introduced into natural environment by humans. The ability of Cunninghamella echinulata to degrade tributyltin (TBT) (5 mg l-1) as well as the effect of the xenobiotic on fungal amino acids composition and proteins profile were examined. C. echinulata removed 91% of the initial biocide concentration and formed less hazardous compounds dibutyltin (DBT) and monobutyltin (MBT). Moreover, the fungus produced a hydroxylated metabolite (TBTOH), in which the hydroxyl group was bound directly to the tin atom. Proteomics analysis showed that in the presence of TBT, the abundances of 22 protein bands were changed and the unique overexpressions of peroxiredoxin and nuclease enzymes were observed. Determination of free amino acids showed significant changes in the amounts of 19 from 23 detected metabolites. A parallel increase in the level of selected amino acids such as betaine, alanine, aminoisobutyrate or proline and peroxiredoxin enzyme in TBT-containing cultures revealed that TBT induced oxidative stress in the examined fungus.National Science Centre, Poland (Project No. UMO-2014/13/N/NZ9/00878)

Evaluation of Critical Quality Attributes of a Pentavalent (A, C, Y, W, X) Meningococcal Conjugate Vaccine for Global Use

Towards achieving the goal of eliminating epidemic outbreaks of meningococcal disease in the African meningitis belt, a pentavalent glycoconjugate vaccine (NmCV-5) has been developed to protect against Neisseria meningitidis serogroups A, C, Y, W and X. MenA and X polysaccharides are conjugated to tetanus toxoid (TT) while MenC, Y and W polysaccharides are conjugated to recombinant cross reactive material 197 (rCRM197), a non-toxic genetic variant of diphtheria toxin. This study describes quality control testing performed by the manufacturer, Serum Institute of India Private Limited (SIIPL), and the independent control laboratory of the U.K. (NIBSC) on seven clinical lots of the vaccine to ensure its potency, purity, safety and consistency of its manufacturing. In addition to monitoring upstream-manufactured components, samples of drug substance, final drug product and stability samples were evaluated. This paper focuses on the comparison of the vaccine’s critical quality attributes and reviews key indicators of its stability and immunogenicity. Comparable results were obtained by the two laboratories demonstrating sufficient levels of polysaccharide O-acetylation, consistency in size of the bulk conjugate molecules, integrity of the conjugated saccharides in the drug substance and drug product, and acceptable endotoxin content in the final drug product. The freeze-dried vaccine in 5-dose vials was stable based on molecular sizing and free saccharide assays. Lot-to-lot manufacturing consistency was also demonstrated in preclinical studies for polysaccharide-specific IgG and complement-dependent serum bactericidal activity for each serogroup. This study demonstrates the high quality and stability of NmCV-5, which is now undergoing Phase 3 clinical trials in Africa and India

Finishing the euchromatic sequence of the human genome

The sequence of the human genome encodes the genetic instructions for human physiology, as well as rich information about human evolution. In 2001, the International Human Genome Sequencing Consortium reported a draft sequence of the euchromatic portion of the human genome. Since then, the international collaboration has worked to convert this draft into a genome sequence with high accuracy and nearly complete coverage. Here, we report the result of this finishing process. The current genome sequence (Build 35) contains 2.85 billion nucleotides interrupted by only 341 gaps. It covers ∼99% of the euchromatic genome and is accurate to an error rate of ∼1 event per 100,000 bases. Many of the remaining euchromatic gaps are associated with segmental duplications and will require focused work with new methods. The near-complete sequence, the first for a vertebrate, greatly improves the precision of biological analyses of the human genome including studies of gene number, birth and death. Notably, the human enome seems to encode only 20,000-25,000 protein-coding genes. The genome sequence reported here should serve as a firm foundation for biomedical research in the decades ahead

Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK.

BACKGROUND: A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. METHODS: This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674. FINDINGS: Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0-75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4-97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction=0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8-80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3-4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation. INTERPRETATION: ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials. FUNDING: UK Research and Innovation, National Institutes for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, Bill & Melinda Gates Foundation, Lemann Foundation, Rede D'Or, Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca

Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK

Background A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. Methods This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674. Findings Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0–75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4–97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction=0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8–80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3–4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation. Interpretation ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials