LOCAL HYPOXIA AND IMMUNODEFICIENCY. EFFECT OF OBESITY ON REDUCING THE EFFECTIVENESS OF TREATMENT FOR BACTERIAL VAGINOSIS

Проведен анализ результатов обследования 143 больных бактериальным вагинозом с учетом наличия у них алиментарного ожирения. Все женщины, принимавшие участие в нашем исследовании, дали письменное информированное согласие на участие в нем. Исследование проводили до начала лечения бактериального вагиноза. В зависимости от наличия алиментарного ожирения больных разделили на 2 группы. В I группу вошли 97 с нормальным весом телом, без признаков алиментарного ожирения. Во II группе у 46 больных отмечалось увеличение массы тела, соответствующее алиментарному ожирению II степени. Критериями для анализа являлись результатами бактериоскопического исследования мазков из влагалища, окрашенных по Грамму и выявления в них количественных показателей «ключевых клеток» и показатели оксиметрии, определение интегративного коэффициента Кслиз%, отражающий содержание кислорода в слизистой оболочке, по отношению к показателям, зарегистрированным на II пальце кисти, позволяющего прогнозировать результативность лечения. Таким образом, на фоне алиментарного ожирения еще до начала лечения интенсивность патологического процесса при бактериальном вагинозе была более выражена, чем без него. При этом локальные гипоксия и иммунодефицит свидетельствовали о риске снижения эффективности лечения The analysis of the results of examination of 143 patients with bacterial vaginosis, taking into account the presence of alimentary obesity, was carried out. All women who took part in our study gave written informed consent to participate in it. The study was carried out before starting treatment for bacterial vaginosis. Depending on the presence of alimentary obesity, the patients were divided into 2 groups. Group I included 97 people with normal body weight, without signs of alimentary obesity. In group II, 46 patients showed an increase in body weight corresponding to alimentary obesity of the II degree. The criteria for the analysis were the results of bacterioscopic examination of vaginal smears stained according to Gram and the identification of quantitative indicators of "key cells" in them and oximetry indicators, determination of the integrative coefficient Cmucous membrane% , reflecting the oxygen content in the mucous membrane, in relation to the indicators recorded on the second finger of the hand, which allows predicting the effectiveness of treatment. Thus, amid alimentary obesity, even before the start of treatment, the intensity of the pathological process with bacterial vaginosis was more pronounced than without it. At the same time, local hypoxia and immunodeficiency indicated the risk of a decrease in the effectiveness of treatment.

The effects of virtual reality telemedicine a single pediatric use case patient with PTSD, post COVID-19: Exploratory research method. (Preprint)

UNSTRUCTURED This paper is an exploratory research comparison between using standard tele psych over 2D devices with HMD ( Head Mounted Device) using the Thera VRTM software. The single case example is with the pediatric mental health subject, and was specifically used to treat PTSD and co morbid symptoms related to the impact of COVID-19. The case usage was all delivered as telemedicine, and was conducted in private practice. Interventions used on all devices were Trauma Focused CBT. Results suggested a positive improvement on both patient engagement and outcome in treatment after continuous use of Virtual Reality as telehealth with avatar technology. Written informed consent was obtained from the minor’s legal guardian under the THERA VR™ agreement, for the publication of any potentially identifiable images or data included in this article.

A study of postnatal assessment of gestational age of neonates by new Ballards and Parkins score

Background: The aim, of the study was to find the correlation between new Ballard score and Parkin’s score and whether they correlate with obstetric gestational age estimated by LMP and/or 1st-trimester USG.Methods: A cross-sectional clinical study for 6 months duration was carried out at tertiary care NICU and postnatal ward of a teaching hospital. Any intramural neonate admitted in NICU and neonates examined after randomized selection in postnatal ward within the first 24 hours of life were included in the study after written informed consent. Their demographic profile was documented using preset Performa and gestational age was assessed using both New Ballard score and Parkins score.Results: Total 387 new-borns were screened with mean age of 12.86±11 hours. Out of which 209 (54.0%) were males and 178 (46.0%) were females. The 259 (66.0%) new-borns were normal vaginal delivered and 128 (33.0%) new-borns were delivered by caesarean section. In the study it was found that the obstetric gestational age strongly correlates to gestational age by new Ballard score (r=0.880, p<0.001), and to gestational age by Parkins score (r=0.880, p<0.001). The gestational age by new Ballard score also strongly correlates to gestational age by Parkins score (r=0.937, p<0.001). Scatter diagram shows that there is strong positive linear correlation between gestational age assessed by LMP and NBS. While that gestational age accessed by Parkins having weak positive relationship compared to NBS.Conclusions: New Ballard score predicts new-born gestational age better in preterm and term new-borns, but Parkin’s Score, being simpler assessment method, takes very less time and has the advantage of no subjective neurological criteria and lesser interpersonal variation.

Exercise as an Emerging Factor Effecting Cardiovascular Health (An Experimental Approach)

This resaerch study was basically carried out for the purpose to assess the effect of moderate intensity exercise on cardiovascular health. Ten (10) participants were voluntarily selected and thus they were randomly divided into two (02) groups i.e. (Experimental Group (EG)=05+ Control Group (CG)=05.A self-made eight weeks’ self-made moderate intensity exercise protocol was applied on all the subjects. Pre and post test data were collected through Harvard Step Test. A written informed consent was taken from each subject before participation in the study. All participants were informed about the benefits and risk factors of the study. After fulfilling all the ethical protocols, eight weeks self-made moderate intensity exercise protocol was applied on all the subjects. Pre and post test data were collected through Harvard Step Test. The collected data were tabulated and analyzed by using various statistical tools. On the basis of analysis the researcher arrived at conclusion that exercise has a significant effect on cardiovascular health.

To Study the Electroencephalogram Changes in Children with Acute Encephalitis

Aim: To study the electroencephalogram changes in children with acute encephalitis. Study design: Cross-sectional study. Place and duration of study: The cases were admitted from OPD and emergency over duration of 10 months from May2009 to March 2010 in Children Hospital PIMS, Islamabad. Method: Patients with Cerebral Palsy, Degenerative Brain disease, Cerebral Malaria and Meningitis were excluded. Written informed consent was taken from parents /guardians. All patients, from both genders, age varying from 4 months to 12 years, fitting the criteria of Acute Encephalitis according to ICD 9 & 10 were included in the study, which were 56 in total. All cases had Lumbar puncture and Cerebro Spinal Fluid examination. The findings of pleocytosis (WBC count more than5 u/l), protein and sugar were recorded. EEG (Electroencecephlogram) was done in 52 patients, frequencies and percentages were calculated of the findings. Results: The mean age was 4. 6 years, (varying from 4 months to 12 years) with a standard deviation of 3. 2. From a total of fifty six patients, 38(68%) were males and 18(32%) females. All cases presented with fever (100%). Cerebro Spinal Fluid examination, showed Pleocytosis in 30(54%) while 46(46%) had normal cell count. Cerebro Spinal Fluid protein content was normal in 45(80%) and increased in 11(20%). Cerebro Spinal Fluid sugar was normal in 50(89%) and 6(11%) had low. Electroencephalogram was done in fifty-two patients out of which 30(58%) were normal, 22(42%) were abnormal. Intermittent slowing was found in 17(77%) and 5(23%) cases had focal discharges along with intermittent slowing, out of which three were unilateral temporo-frontal discharges, two cases had other focal discharges on EEG. Conclusion: In patients with Acute Encephalitis, slowing of the rhythm was the most frequent abnormal Electroencephalogram finding, followed by focal discharges in children admitted in Children’s Hospital PIMS, Islamabad. Keywords: Acute Encephalitis, Electroencephalogram (electro encephalogram), Cerebro Spinal Fluid Pleocytosis, Fever

EVALUATION OF LIPID PROFILE AND THYROID HORMONE LEVELS IN PATIENTS WITH CHRONIC PANCREATITIS COMBINED WITH HYPOTHYROIDISM

With hypothyroidism (HТ) there is a change in homeostasis in tissues sensitive to thyroidhormones, which in its turn leads to a violation of fat metabolism. HT induces a significantincrease in lipid peroxidation and reduces the activity of antioxidant enzymes, oxidativestress, which is formed in HT, can play a key role in the progression of pancreaticdysfunction (PD).Purpose – to study the indicators of the lipid profile and the level of thyroid hormones inpatients with CP and CP, combined with HT.Material and methods 107 people were examined, including 29 patients with CP (group1), 30 patients with HT (group 2), 28 patients with CP on the associated with HT (group3), 20 almost healthy individuals (AHI) (group 4). The age of the examined patientsranged from 44 to 72 years, the main percentage (53%) was dominated by people ofworking age from 49 to 58 years (mean age - 54.26 ± 1.87). The gender distribution wascomparable across all groups. According to the local ethics committees for biomedicalresearch, guided by Ukrainian health legislation and the 2000 a. declaration of Helsinki,all patients and AHI surveyed gave written informed consent to participate in the study.All patients were hospitalized at the Chernivtsi Regional Clinical Hospital and theChernivtsi Regional Endocrinology Center.The results. According to the results of the study of the lipid profile in all groups of patientsthere were manifestations of dyslipidemia, but they were more pronounced in patientswith combined pathology: total cholesterol increased 36.04% (p <0.05) compared withAHI; 21.37% compared with the group of patients with CP and by 15.06% compared withthe group of patients with CP. The level of triglycerides increased in the group of patientswith CP, associated with HT in 2.2 times compared with AHI group, in comparison ofthe groups of the combined pathology with CP patients and with HT patients it is higher 34.51% and 9.4% (p <0, 05). Patients in all 3 groups had an increase in very low-densitylipoprotein cholesterol compared with AHI, with a tendency to increase in patients inwhom CP was combined with HT.Conclusion. The most pronounced signs of dyslipidemia were found in patients with CPcombined with HT, which confirms the close pathogenetic link between these nosologies- a marker of thyroid insufficiency (increased TSH levels, decreased T4), manifestationsof dyslipidemia, which is a predictor of pancreatic lesions. The study of comorbidity ofthese nosologies is a promising area of clinical gastroenterology and endocrinology. Theresults prove the need for more detailed and in-depth study of the clinical course andinteraction of these diseases, in order to optimize the therapeutic treatment regimens, thatwill allow to avoid the development of complications and disability.

Secondary attack rate among high-risk contacts of COVID-19 paediatric index cases: a study at the beginning of the pandemic in Pune city of Western Maharashtra, India

Background: The COVID-19 was the emerging disease caused by SARS-COV2. Efficient transmission of this disease occurs through droplets and fomites. The susceptibility of children to coronavirus disease-19 (COVID-19) and transmission of COVID-19 from children to others is a relatively unexplored area. The aim of this study was to understand the transmission dynamics of severe acute respiratory syndrome coronavirus 2 in children. Study objectives were to estimate secondary attack rate of COVID-19 from paediatric index case during the early phase of pandemic in Pune city and to identify factors associated with transmission and development of the COVID-19 disease.Methods: This was a retrospective cohort study conducted in the month of June 2020. The sample includes 58 contacts of 11 laboratory confirmed pediatric index cases of COVID-19 from Pune municipal corporation after written informed consent. A confidential telephonic interview of parents was taken by using a prestructured questionnaire which includes socio-demographic data, family background, type of house, development of symptoms, outcome etc.Results: The mean age of primary pediatric case was 12.7±5.1 years. All of them were symptomatic. The SAR estimated was 55.2%. The factors significantly affecting SAR were comorbidity, no. of family members, type of family, overcrowding, no. of rooms, bedroom attached with toilet.Conclusions: The household SAR from paediatric patients is high and is closely associated with family size and other household characteristics. Hence, home quarantine should be advocated in smaller families with appropriate isolation facilities; more emphasis is given to co-morbid individuals.

Sampling site for SARS-CoV-2 RT-PCR—An intrapatient four-site comparison from Tampere, Finland

Background SARS-CoV-2 diagnosis relies on the performance of nasopharyngeal swabs. Alternative sample sites have been assessed but the heterogeneity of the studies have made comparing different sites difficult. Objectives Our aim was to compare the performance of four different sampling sites for SARS-CoV-2 samples with nasopharynx being the benchmark. Study design COVID-19 positive patients were recruited prospectively, and samples were collected and analysed for SARS-CoV-2 with RT-PCR from all four anatomical sites in 43 patients, who provided written informed consent. Results All anterior nasal and saliva samples were positive, while two oropharyngeal samples were negative. There was no significant difference in the cycle threshold values of nasopharyngeal and anterior nasal samples while saliva and oropharynx had higher cycle threshold values. Conclusions Anterior nasal swab performs as good as nasopharynx swab with saliva also finding all the positives but with higher cycle threshold values. Thus, we can conclude that anterior nasal swabs can be used for SARS-CoV-2 detection instead of nasopharyngeal swabs if the situation would require so.

Informed consent in pragmatic trials: results from a survey of trials published 2014–2019

ObjectivesTo describe reporting of informed consent in pragmatic trials, justifications for waivers of consent and reporting of alternative approaches to standard written consent. To identify factors associated with (1) not reporting and (2) not obtaining consent.MethodsSurvey of primary trial reports, published 2014–2019, identified using an electronic search filter for pragmatic trials implemented in MEDLINE, and registered in ClinicalTrials.gov.ResultsAmong 1988 trials, 132 (6.6%) did not include a statement about participant consent, 1691 (85.0%) reported consent had been obtained, 139 (7.0%) reported a waiver and 26 (1.3%) reported consent for one aspect (eg, data collection) but a waiver for another (eg, intervention). Of the 165 trials reporting a waiver, 76 (46.1%) provided a justification. Few (53, 2.9%) explicitly reported use of alternative approaches to consent. In multivariable logistic regression analyses, lower journal impact factor (p=0.001) and cluster randomisation (p<0.0001) were significantly associated with not reporting on consent, while trial recency, cluster randomisation, higher-income country settings, health services research and explicit labelling as pragmatic were significantly associated with not obtaining consent (all p<0.0001).DiscussionNot obtaining consent seems to be increasing and is associated with the use of cluster randomisation and pragmatic aims, but neither cluster randomisation nor pragmatism are currently accepted justifications for waivers of consent. Rather than considering either standard written informed consent or waivers of consent, researchers and research ethics committees could consider alternative consent approaches that may facilitate the conduct of pragmatic trials while preserving patient autonomy and the public’s trust in research.

88 Evidence of enhanced immune activation within the tumor microenvironment and the circulation of female patients with high-risk melanoma compared to males

BackgroundSex differences in tumor immunity and response to immunotherapy were shown in murine models and descriptive analyses from recent clinical trials. We recently reported that female gender is a favorable prognostic marker for survival benefit following ipilimumab and high dose interferon-alfa (HDI) adjuvant therapy of high-risk melanoma in the ECOG-ACRIN E1609 trial (N=1670). Therefore, we investigated differences in candidate immune biomarkers in the circulation and tumor microenvironment (TME) of female and male patients.MethodsGene expression profiling (GEP) was performed on the tumor biopsies of 718 (454 male, 264 female) patients. The primary endpoint was mRNA expression profiling using U133A 2.0 Affymetrix gene chips. Raw microarray data sets were normalized by using the Robust Multi-array Average (RMA) method using Affymetrix Power Tools (APT) as previously published. Multiple probe sets representing the same genes were collapsed by using the probe with maximum gene expression. Gene set enrichment analysis (GSEA) was performed by comparing the female and male tumor samples, and gene sets with FDR q-value <0.1 were deemed as significant. Similarly, peripheral blood (serum and PBMC) samples were tested for soluble (Luminex) and cellular (multicolor flow cytometry) prognostic biomarkers in a subset of patients (N=321; 109 female and 212 male). All patients provided an IRB-approved written informed consent.ResultsAmong the subset of patients tested for circulating biomarkers, females were significantly younger than males (P=0.03). Testing PBMCs, the percentages of CD3+ T cells (P=0.04) and CD3+CD4+ helper T cells (P=0.0005) were significantly higher in female patients compared to males. Also, there were trends toward higher levels of proinflammatory cytokines IL1beta (P=0.07) and IL6 (P=0.06) in females. On the other hand, males had significantly higher percentages of monocytes (P=0.03). Further, there were trends toward higher percentages of CD3+/CD4+/CD25hi+/Foxp3+ (P=0.1) and CD3+/CD4+/CD25+/CD127low+ (P=0.1) T-reg in male patients compared to females. Among the cohort of patients (N=718) with tumor GEP data, females were significantly younger than males (P=0.0009). GEP identified pathways and genes related to immune cell infiltration and activation that were significantly enriched in the tumors of females compared to males (table 1).Abstract 88 Table 1Immune pathways significantly enriched in tumors of femalesConclusionsFemale gender was associated with adjuvant immunotherapeutic benefits and female patients were more likely to have evidence of immune activation within the TME and the circulation, supporting a potentially important role for female related factors in the immune response against melanoma, and these require further investigation.AcknowledgementsWe are grateful to the patients and family members who participated in the E1609 trial and the E1609 trial investigators. This study was conducted by the ECOG-ACRIN Cancer Research Group (Peter J. O’Dwyer, MD and Mitchell D. Schnall, MD, PhD, Group Co-Chairs) and supported by the National Cancer Institute of the National Institutes of Health under the following award numbers: U10CA180794, U10CA180820, U10CA180888, UG1CA233180, UG1CA233184. Biomarkers studies were supported under the following award number: P50CA12197310 (Tarhini and Kirkwood). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.Trial RegistrationNCT01274338Ethics ApprovalThe E1609 study protocol was approved by the institutional review board of each participating institution and conducted in accordance with Good Clinical Practice guidelines as defined by the International Conference on Harmonization. All patients provided an IRB-approved written informed consent.ConsentNot applicable.