bluuebunny/crossref_metadata_2025_split huggingface dataset:
Safety and efficacy of the mRNA BNT162b2 vaccine against SARS-CoV-2 in five groups of immunocompromised patients and healthy controls in a prospective open-label clinical trial
Authors: Bergman Peter , Blennow Ola , Hansson Lotta , Mielke Stephan , Nowak Piotr , Chen Puran , Söderdahl Gunnar , Österborg Anders , Edvard Smith C. I. , Wullimann David , Vesterbacka Jan , Lindgren Gustaf , Blixt Lisa , Friman Gustav , Wahren-Borgström Emilie , Nordlander Anna , Gomez Angelica Cuapio , Akber Mira , Valentini Davide , Norlin Anna-Carin , Thalme Anders , Bogdanovic Gordana , Muschiol Sandra , Nilsson Peter , Hober Sophia , Loré Karin , Chen Margaret Sällberg , Buggert Marcus , Ljunggren Hans-Gustaf , Ljungman Per , Aleman Soo ,   the COVAXID-collaborator group (shown separately)
Published: September 2021

AbstractBackgroundPatients with immunocompromised disorders have mainly been excluded from clinical trials of vaccination against COVID-19. Thus, the aim of this prospective clinical trial was to investigate the safety and efficacy after two doses of BNT162b2 mRNA vaccination in five selected groups of immunocompromised patients and healthy controls.Methods539 study subjects (449 patients and 90 controls) were included in the clinical trial. The patients had either primary (n=90), or secondary immunodeficiency disorders due to human immunodeficiency virus infection (n=90), allogeneic hematopoietic stem cell transplantation/chimeric antigen receptor T cell therapy (n=90), solid organ transplantation (SOT) (n=89), or chronic lymphocytic leukemia (CLL) (n=90). The primary endpoint was seroconversion rate two weeks after the second dose. The secondary endpoints were safety and documented SARS-CoV-2 infection.FindingsAdverse events were generally mild, but one case of fatal suspected unexpected serious adverse reaction occurred. 72·2% of the immunocompromised patients seroconverted compared to 100% of the controls (p=0.004). Lowest seroconversion rates were found in the SOT (43·4%) and CLL (63·3%) patient groups with observed negative impact of treatment with mycophenolate mofetil and ibrutinib, respectively.InterpretationThe results showed that the mRNA BNT162b2 vaccine was safe in immunocompromised patients. The rate of seroconversion was substantially lower than in healthy controls, with a wide range of rates and antibody titres among predefined patient groups and subgroups. This clinical trial highlights the need for additional vaccine doses in certain immunocompromised patient groups and/or subgroups to improve immunity.FundingKnut and Alice Wallenberg Foundation, Nordstjernan AB, Region Stockholm, Swedish Research Council, Karolinska Institutet, and organizations for PID/CLL-patients in Sweden.
Young onset diabetes in Asian Indians is associated with lower measured and genetically determined beta-cell function: an INSPIRED study
Authors: Siddiqui Moneeza K , Anjana RM , Dawed Adem Y , Martoeau Cyrielle , Srinivasan Sundararajan , Saravanan Jebarani , Madanagopal Sathish K , Veluchamy Abirami , Pradeepa Rajendra , Sattar Naveed , Venkatesan Radha , Palmer Colin N A , Pearson Ewan R , Mohan Viswanathan 
Published: September 2021

AbstractBackgroundSouth Asians have higher risk of type 2 diabetes compared to white Europeans and a younger age of onset. Reasons for the younger age of onset in relation to beta-cell function and insulin sensitivity are under-explored.MethodsTwo cohorts of Asian Indians, ICMR-INDIAB (Indian Council of Medical Research-INdia DIABetes Study) and DMDSC (Dr. Mohan’s Diabetes Specialties Centre) and one of white Europeans, ESDC (East Scotland Diabetes Cohort) were used. We examined the comparative prevalence of healthy, overweight, and obese BMI in young onset diabetes. We explored the role of clinically measured beta-cell function in diabetes onset in Asian Indians. Finally, the comparative distribution of a partitioned polygenic score (pPS) for risk of diabetes due to poor beta cell function was examined.ResultsPrevalence of young onset with normal BMI was 9.3% amongst white Europeans and 24%-39% amongst Asian Indians. In young diagnosed Asian Indians, after adjustment for family history of T2DM, sex, insulin sensitivity and HDL-c, stimulated C-peptide was 492pmol/mL (IQR: 353,616,P<0.0001) lower in lean compared to obese individuals. Asian Indians have lower genetically determined beta-cell function than white Europeans(P <0.0001). The pPS was associated with age of diagnosis in Asian Indians but not in white Europeans. The pPS explained 2% of variation in clinically measured beta cell function and 1.2%, 0.97%, and 0.36% of variance in age of diabetes amongst Asian Indians with normal, overweight, and obese BMI respectively.ConclusionsAsian Indians have over two times the prevalence of lean BMI in young onset diabetes compared to white Europeans. This phenotype of lean, young onset diabetes appears driven in part by lower beta cell function. We demonstrate that Asian Indians with diabetes also have lower genetically determined beta cell function.
Serial evaluation of anti-SARS-CoV-2 IgG antibody and breakthrough infections in BNT162b2 Vaccinated migrant workers from Bangladesh
Authors: Hoque Ashraful , Rahman Md Marufur , Das Anindita 
Published: September 2021

AbstractBackgroundWhile Bangladesh has started its mass COVID-19 vaccination drive, it is struggling to cover its huge population similar to other low- and middle-income countries due to the lack of vaccine availability. One of the major remittance sources for Bangladesh is its migrant workers who are required to receive mRNA vaccines to return to their jobs. Despite reports of higher efficacy of mRNA vaccine against COVID-19, breakthrough infection cases are arising especially with the emergence of Delta variant. It is highly important to understand the post-vaccination immune response and breakthrough infections in different populations so that the necessity of booster dosage can be assessed properly.MethodsWe observed post BNT162b2 full vaccination immune response in a small older group (mean age= 59.5±5.44 years) of migrant workers (n=10) for six months at the Sheikh Hasina National Institute of Burn and Plastic Surgery, Dhaka, Bangladesh. The plasma samples from the participants were collected after 14 days, 2 months, 3 months, 4 months, 5 months, and 6 months of receiving the 2nd dose of the BNT162b2 vaccine. Anti S1 RBD IgG responses were measured as optical density ratios using a commercially available ELISA kit.ResultsAll 10 of the participants were male migrant workers and none of them had a history of previous COVID-19 infection. The median antibody response [IQ1:IQ3] was 9.05 [7.53; 10.0] on day 14 then it increases to 13.6 [12.0; 14.0] at the second month which gradually decreased to a median of 8.63 [8.34; 9.37] on the 6th-month post-vaccination. There were two breakthrough infection cases after receiving the second dose and the antibody responses were highly increased in the following months. Two of the breakthrough cases were diagnosed with mild COVID-19 as the symptom duration was less than 3 days with no respiratory complications and no hospital admission were required.ConclusionsThe BNT162b2 mRNA vaccine produces a strong immune response that sustains at least 6 months after getting fully vaccinated. But even after getting fully vaccinated people are susceptible to breakthrough infections that are not severe and boost the immune response greatly offering a hybrid immunity from both vaccine and natural infection. Hence, it is still important to fully vaccinate a greater number of people rather than thinking of offering booster dosage to a privileged population out of the fear of breakthrough cases. If the LMICs can quickly cover at least 80% of their population with usual priority targets (healthcare workers, migrant workers, older people, etc.) then a global risk reduction and pandemic control would be possible that will allow additional variant-specific boosters for targeted populations if evidence support.
Low linoleic acid foods with added DHA given to Malawian children with severe acute malnutrition improves cognition: a randomized, triple blinded, controlled clinical trial
Authors: Stephenson Kevin , Callaghan-Gillespie Meghan , Maleta Kenneth , Nkhoma Minyanga , George Matthews , Park Hui Gyu , Lee Reginald , Humpheries-Cuff Iona , Lacombe R J Scott , Wegner Donna R , Canfield Richard L , Brenna J Thomas , Manary Mark J 
Published: September 2021

AbstractBackgroundThere is concern that the PUFA composition of ready-to-use therapeutic food (RUTF) for treatment of severe acute malnutrition (SAM) is suboptimal for neurocognitive recovery.ObjectiveWe tested the hypothesis that RUTF made with reduced amounts of linoleic acid, achieved using high oleic (HO) peanuts, with or without added DHA, improves cognition when compared to standard RUTF (S-RUTF).MethodsA triple-blind, randomized, controlled clinical feeding trial was conducted among children with uncomplicated SAM in Malawi with 3 types of RUTF; DHA-HO-RUTF, HO-RUTF and S-RUTF. The primary outcomes, measured in a subset of subjects, were the Malawi Developmental Assessment Tool (MDAT) global and 4 domain (gross motor, fine motor, language and social) z-scores and a modified Willatts problem solving assessment (PSA) intention score for 3 standardized problems, measured 6 months and immediately after completing RUTF therapy, respectively. Plasma fatty acid content, anthropometry and eye tracking were secondary outcomes. Comparisons were made between the novel PUFA RUTFs and S-RUTF.ResultsAmong the 2565 SAM children enrolled, global MDAT z-score was -0.69 ± 1.19 and - 0.88 ± 1.27 for children receiving DHA-HO-RUTF and S-RUTF, respectively (difference 0.19, 95% CI 0.01 to 0.38). The gross motor and social domains had higher z-scores among children receiving either DHA-HO-RUTF than S-RUTF. The PSA problem 3 scores did not differ by dietary group (Odds ratio 0.92, 95% CI 0.67 to 1.26 for DHA-HO-RUTF). After 4 weeks of treatment, plasma phospholipid EPA and α-linolenic acid were greater in children consuming DHA-HO-RUTF or HO-RUTF when compared to S-RUTF (for all 4 comparisons P values < 0.001), but only plasma DHA was greater in DHA-HO-RUTF than S-RUTF (P <0.001).ConclusionsTreatment of uncomplicated SAM with DHA-HO-RUTF resulted in an improved MDAT score, conferring a cognitive benefit six months after completing diet therapy. This treatment should be explored in operational settings.
Prevalence and incidence of stress, depression, and anxiety symptoms among Brazilians in quarantine across the early phases of the COVID-19 crisis
Authors: Blacutt Miguel , Filgueiras Alberto , Stults-Kolehmainen Matthew 
Published: September 2021

AbstractObjectiveThe present study aimed to measure the prevalence and incidence of stress, depression, and anxiety symptoms in Brazilians during the COVID-19 pandemic.MethodWe assessed 103 (54 women, 49 men) participants online in three periods of the pandemic: March 2020 (T1), April 2020 (T2), and June 2020 (T3). Prevalence and incidence were identified when mental health scores were two standard deviations above the mean compared to normative data. Mental health indicators were measured using the Perceived Stress Scale, the Filgueiras Depression Index, and the State-Trait Anxiety Inventory – State Subscale.ResultsAt T1, 89% of individuals were below cut-off scores for stress, anxiety, and depression, which dropped to 35% by T3. Stress prevalence was 1.9% at T1, 7.8% at T2, and 28.2% at T3. Depression prevalence was 0% at T1, 23.3% at T2, and 25.2% at T3. State anxiety prevalence was 10.7% at T1, 11.7% at T2, and 45.6% at T3. Stress incidence increased by 7.8% from T1 to T2, and 23.3% from T2 to T3. Depression incidence increased by 23.3% from T1 to T2, and 15.5% from T2 to T3. Anxiety incidence increased by 9.7% from T1 to T2, and 39.8% from T2 to T3. Stress severity scores significantly increased from 16.1±8.7 at T1 to 23.5±8.4 at T2, and 30.3±6.0 at T3. Depression severity scores significantly increased from 48.5±20.5 at T1 to 64.7±30.2 at T2, and 75.9±26.1 at T3. Anxiety increased from 49.0±13.4 at T1 to 53.5±12.5 at T2 and 62.3±13.4 at T3. Females had significantly higher anxiety scores than males by T3 (66.7±11.8 vs. 57.4±13.5).ConclusionPrevalence and incidence of stress, depression, and anxiety significantly increased throughout the pandemic. The largest increase in stress and anxiety occurred between T2 and T3, and between T1 and T2 for depression. Severity of stress, depression, and anxiety increased throughout the study.
Expanding The Use Of Friedewald Equation In Lipid Profile Testing Among HIV Positive And Negative Elderly Persons
Authors: Jude Emunyu , Brian Semigga , Stephen Kisembo , Brenda Namukwaya , Bridget Namubiru , Charles Bakyayita , Omony Emmanuel 
Published: September 2021

ABSTRACTHypercholesterolemia and hypocholesterolemia are associated with mortality which warrants routine lipid profile testing. This financially burdens the already overwhelmed health sector especially in developing countries. Additionally, lipid profile test reagent stock-out or failure to afford all tests affects result interpretation. In 1972, James Friedewald published a statistical model to calculate low density lipo-protein. The study aim was to determine the percentage error of the James Friedewald equation in calculating all lipid profile test parameters. A retrospective study from 2018 was performed at Mildmay Uganda involving lipid profile results of 103 persons (48 HIV-positive and 55 HIV-negative) 50 years and older enrolled in a previous cross-sectional study. The Friedewald equation was used to calculate total cholesterol, high density lipoprotein, triglycerides and low density lipo-protein. The percentage error of calculated values in reference to measured values was ascertained. Pearson correlation between measured and calculated results was determined among all persons and classified by HIV status. The total error of calculated analytes was 7% (low density lipo-protein), 17% (high density lipo-protein), 39% (triglycerides) and 4% (total cholesterol). Pearson correlations were 0.98 (all persons), 0.98 (HIV-negative) and 0.98 (HIV-positive) for low density lipo-protein, 0.89 (all persons), 0.90 (HIV-positive) and 0.88 (HIV-negative) for high density lipo-protein, 0.75 (all persons), 0.76 (HIV-negative) and 0.77 (HIV-positive) for triglycerides, 0.99 (all persons), 0.98 (HIV-negative) and 0.99 (HIV-positive) for total cholesterol. In conclusion, Friedewald equation reliably calculated low density lipo-protein, total cholesterol (most accurate) and high density lipo-protein while triglycerides calculation was erroneous among persons aged ≥ 50 years.
Experienced hearing aid users’ perspectives of assessment and communication within audiology: A qualitative study using digital methods
Authors: Parmar Bhavisha , Mehta Kinjal , Vickers Deborah , Bizley Jennifer K. 
Published: September 2021

AbstractObjectiveTo explore experienced hearing aid users’ perspectives of audiological assessments and the patient-audiologist communication dynamic during clinical interactions.DesignA qualitative study was implemented incorporating both an online focus group and online semi-structured interviews. Sessions were audio-recorded and transcribed verbatim. Iterative-inductive thematic analysis was carried out to identify themes related to assessment and communication within audiology practice.Study samplesSeven experienced hearing aid users took part in an online focus group and 14 adults participated in semi-structured interviews (age range: 22 - 86 years; 9 males, 11 females).ResultsThemes related to assessment included the unaided and aided testing procedure and relating tests to real world hearing difficulties. Themes related to communication included the importance of communication strategies, explanation of test results and patient centred care in audiology.ConclusionTo ensure that hearing aid services meet the needs of the service users, we should explore user perspectives and proactively adapt service delivery. This approach should be ongoing, in response to advances in hearing aid technology. Within audiology, experienced hearing aid users’ value 1) comprehensive, relatable hearing assessment, 2) clear, concise, deaf aware patient-audiologist communication, 3) accessible services and 4) a personalised approach to recommend suitable technology and address patient specific aspects of hearing loss.
Genome-wide pleiotropy analysis identifies novel blood pressure variants and improves its polygenic risk scores
Authors: Zhu Xiaofeng , Zhu Luke , Wang Heming , Cooper Richard S , Chakravarti Aravinda 
Published: September 2021

AbstractSystolic and diastolic blood pressure (S/DBP) are highly correlated modifiable risk factors for cardiovascular disease (CVD). We report here a bidirectional Mendelian Randomization (MR) and pleiotropy analysis of systolic and diastolic blood pressure (BP) summary statistics from the UKB-ICBP BP genome-wide association study (GWAS) and construct a composite genetic risk score (GRS) by including pleiotropic variants. The composite GRS captures greater (1.11-3.26 fold) heritability for BP traits and increases (1.09- and 2.01-fold) Nagelkerke’s R2 for hypertension (HTN) and cardiovascular disease (CVD). We replicated 118 novel BP pleiotropic variants including 18 novel BP loci using summary statistics from the Million Veteran Program (MVP) study. An additional 219 novel BP signals and 40 novel loci were identified after meta-analysis of the UKB-ICBP and MVP summary statistics but without further independent replication. Our study provides further insight into BP regulation and provides a novel way to construct a GRS by including pleiotropic variants for other complex diseases.
University of Texas at Arlington (UTA) in-house COVID-19 testing program
Authors: Rudewick Roy , Gunby Taylor , Smith Anajane G. , Guo Zibiao , Middleton Angela J. , Cox Necole , Haseltine Florence P. 
Published: September 2021

AbstractThe pandemic caused by the spread of the virus SARS-CoV-2 threatened to severely disrupt the activities of student-athletes. (REF) In order to provide a safe environment for athletic competition, the National Collegiate Athletic Association (NCAA) mandated testing of student-athletes. The goal was to rapidly identify student-athletes and the athletic staff member who either tested positive for SARS-CoV-2 or were in contact with individuals who tested positive. Rapid identification of infected individuals and their contacts allowed the University to implement quarantine standards and quarantine facilities quickly as needed. The University of Texas at Arlington (UTA) developed an in-house testing program and was quickly able to meet the NCAA requirements, allowing UTA to continue its athletic participation with minimal forfeiture of scheduled games. The purpose of this paper is to report the implementation UTA’s COVID prevention program for the university’s athletic program. This program will provide valuable information to other universities’ planning for the management of COVID prevention in their athletic programs. Challenges and solutions are identified.
Combined Impact of Prior SARS-CoV-2 Infection and Vaccination on Antibody Presence
Authors: Shuford Jennifer A , Swartz Michael D , Lakey David L , Aguillard Kimberly A , Pont Stephen J , Valerio-Shewmaker Melissa A , Boerwinkle Eric 
Published: September 2021

AbstractAs COVID-19 continues to spread rapidly and vaccine uptake stagnates, questions remain about the amount of SARS-CoV-2 antibodies present in the population induced by either SARS-CoV-2 infection, by a COVID-19 vaccine, or both.The TEXAS Coronavirus Antibody REsponse Survey (CARES) is a statewide seroprevalence program which utilizes the Roche S-test to detect antibodies to the SARS-CoV-2 spike protein and the Roche N-test to detect antibodies to the SARS-CoV-2 nucleocapsid protein, to monitor the combined impact of prior infection and the COVID-19 vaccine. The current sample size having both S- and N-test data and reported vaccination status is 8,846.Participants with prior infection (i.e. N+) and with either partial or full vaccination have the highest proportion of those showing the maximum value of the S-test (80.95% and 83.07%, respectively). Using a permutation test, there is no statistically significant difference between the median S-test value for those that have had prior infection and are partially vaccinated versus those that have had prior infection and are fully vaccinated. These groups both show significantly higher median amount compared to the other three groups: N+/not vaccinated, N-/partially vaccinated, and N-/fully vaccinated (all p-values < 0.0001).Unvaccinated individuals with prior infection have one of the lowest median S-test values. For participants with previous SARS-CoV-2 infection and a COVID-19 vaccine, the median S-test value is high and is not statistically different between those who are partially vaccinated and those who are fully vaccinated.
QuaID: Enabling Earlier Detection of Recently Emerged SARS-CoV-2 Variants of Concern in Wastewater
Authors: Sapoval Nicolae , Liu Yunxi , Lou Esther G. , Hopkins Loren , Ensor Katherine B , Schneider Rebecca , Stadler Lauren B , Treangen Todd J 
Published: September 2021

AbstractAs clinical testing declines, wastewater monitoring can provide crucial surveillance on the emergence of SARS-CoV-2 variants of concern (VoC) in communities. Multiple recent studies support that wastewater-based SARS-CoV-2 detection of circulating VoC can precede clinical cases by up to two weeks. Furthermore, wastewater based epidemiology enables wide population-based screening and study of viral evolutionary dynamics. However, highly sensitive detection of emerging variants remains a complex task due to the pooled nature of environmental samples and genetic material degradation. In this paper we propose quasi-unique mutations for VoC identification, implemented in a novel bioinformatics tool (QuaID) for VoC detection based on quasi-unique mutations. The benefits of QuaID are three-fold: (i) provides up to 3 week earlier VoC detection compared to existing approaches, (ii) enables more sensitive VoC detection, which is shown to be tolerant of >50% mutation drop-out, and (iii) leverages all mutational signatures, including insertions & deletions.
Anticarcinogenic effects from plasma elderly trained: the role of mitochondrial function
Authors: Peres Alessandra , Dorneles Gilson Pires , Branchini Gisele , Bordignon Fernanda , Romão Pedro R T , Minuzzi Luciele , Lira Fabio S , Cavalcante Mateus , Elsner Viviane 
Published: September 2021

AbstractThis study aimed to evaluate the effects of a multimodal exercise training on systemic cytokine levels of the elderly, and the impact of post-exercise training plasma on prostate cancer cell viability and proliferationin vitro. Fasting blood samples were collected from eight institutionalized elderly before and after eight weeks of multimodal exercise training (twice a week). The levels of interleukin(IL)-1ra, IL-1β, IL-2, IL-6, IL-10, IL-17, interferon (IFN)-α, tumor necrosis factor (TNF)-α, fibroblast growth factor (FGF)-1, platelet-derived growth factor (PDGF) and transforming growth factor (TGF)-α were evaluated in the peripheral blood. PC3 prostate cancer cell lines were incubated with 10% plasma acquired before and after exercise training from each participant. Multimodal exercise training increased the plasma levels of IL-2, IL-10, IFN-α, and FGF-1, and decreased TNF-α concentrations. PC3 cells presented decreased cell viability evaluated by MTT and lactate dehydrogenase activity as well as lower rates of cell proliferation after the incubation with post-training plasma samples. Furthermore, the incubation of PC-3 cells with post-training plasma decreased the mitochondrial membrane polarization and increased mitochondrial reactive oxygen species (ROS) production without changes in cytosolic ROS. Post-training plasma did not change apoptosis or necrosis rates in the PC-3 cell line. In conclusion, we showed that systemic adaptations in plasma mediators of institutionalized elderly might alter cell viability and proliferation by targeting mitochondrial ROS in a prostate cancer cell line.