Project HALO: A Post-Market, Observational Registry of Data Derived from Serenity LiquidTM, Serenity GenomeTM, and Clinical Parameters (Preprint)

2021 ◽  
Author(s):  
Monika Hagen ◽  
Danette Newton ◽  
Jonathan Richina ◽  
Petra Gambon Stow ◽  
Jonathan Douissard
Keyword(s):  
Clinical Data ◽  
Clinical Course ◽  
Genetic Data ◽  
Data Repository ◽  
Research Database ◽  
Clinical Parameters ◽  
Real World Setting ◽  
Post Market ◽  
Initial Dataset ◽  
The Impact

BACKGROUND Registries are a valuable tool for data collection and observation of medical innovations in a real-world setting. Serenity LiquidTM and Serenity GenomeTM are newly launched diagnostic platforms analyzing large genetic datasets in combination with clinical data to deliver precision preventative medicine. To this point, no systematic data is available to observe the use and clinical implementations of these platforms. OBJECTIVE To create a data repository collecting data from Serenity LiquidTM, Serenity GenomeTM, and clinical parameters for analyses. METHODS Individuals receiving Serenity LiquidTM or Serenity GenomeTM are solicited to participate in this registry. In addition to the initial dataset, a clinical update is secured every six months. Data from the registry participants are pseudo-anonymized and archived in a HIPPA-compliant research database for regular analyses. RESULTS Includes but is not limited to correlations between genetic and clinical data, the impact of genetic data on the clinical course of patients, comparisons between specific cohorts (within this database and against historical cohorts) on an ongoing basis. CONCLUSIONS This is a prospective registry collecting genetic and clinical data to gather important information, provide novel insights by continuously analyzing the data in this registry.

High Resolution Array-CGH Provides New Insights Into the Prognosis of Chronic Lymphocytic Leukemia (CLL): Is 8p Loss Worse Than 17p Loss?.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 2339-2339
Author(s):  
Andrea Rinaldi ◽  
Michael Mian ◽  
Davide Rossi ◽  
Francesco Forconi ◽  
Clara Deambrogi ◽  
...  
Keyword(s):  
Cox Regression ◽  
Clinical Course ◽  
Conflicts Of Interest ◽  
Univariate Analysis ◽  
Lymphocytic Leukemia ◽  
Rank Test ◽  
Western World ◽  
Clinical Parameters ◽  
Log Rank Test ◽  
The Impact

Abstract Abstract 2339 Poster Board II-316 BACKGROUND: CLL, the most common adult-onset leukemia in the Western world, has a heterogeneous clinical course. Many advances have led to a better understanding of its pathogenesis and to improvements in treatment strategies, but striking solutions are still missing. We conducted a study to evaluate the impact of genomic aberrations on the clinical course. METHODS: From January 1980 to May 2008, 395 frozen samples of CLL patients, were prospectively collected in four centers. Extracted DNA was analyzed with Affymetrix Human Mapping 6.0 arrays. Normal matched DNA was analyzed for one fourth of the cases. Correlations between minimal common regions (MCR) and clinical parameters were evaluated with the Fisherôs-exact test and their impact on OS with the log-rank test. A p-value after Bonferroni multiple test correction (MTC) (p-adj.) <0.05 was considered as statistically significant. Up to now 266 samples have been analyzed. RESULTS: Analysis of the clinical parameters (CPs) and known risk factors (Rai/Binet, age, doubling time, LDH, beta2, IGVH status, p53 mutations, telomere length, CD38, 11q, 17p) was consistent to previous published series. ZAP70 did not affect the clinical course, likely due inter-laboratories variability. After a median follow up of 53 months, 143/239 (60%) of the patients have started therapy and 63/261 (24%) died. 5-yr OS was 82%. Fisher test between the MCRs and CPs revealed an inverse relation between the presence of trisomy 12 by FISH and del13q14.3, an association between del17p and losses of 8p regions and between CD38 and 12q gain. Before MTC, 46 MCRs had a significant impact on OS and 67. After MTC, 3 regions maintained their role: 8p22 loss (38/248, 15%, p-adj.=0.002, median OS: 26 months vs. 48), 17p13.3-11.2 loss (20/248, 8%, p-adj.=0.001; median OS: 10 months vs. 48). In univariate analysis, the log-rank test among pts with 8p-/17p- (8/248, 3%), 8p- (30/248, 12%), 17p- (12/248, 5%), wild type (198/248, 80%) was statistically significant (p<0.001; see figure). Importantly, none of the analyzed clinical and biological parameters was associated with this aberration. CONCLUSIONS: Loss of 8p22 designated a CLL subgroup with a worse outcome among all patients and in the subset with 17p loss. Our data suggested that this aberration might constitute an independent prognostic factor to be evaluated in independent studies. Results, including a Cox regression model, will be presented on all 395 cases. Disclosures: No relevant conflicts of interest to declare.

Variations in inpatient stays for non-metastatic HER2- breast cancer (BC), non-small cell lung cancer (NSCLC), and colorectal cancer (CRC) in a real world setting.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18099-e18099
Author(s):  
Jennifer Malin ◽  
Stacey DaCosta Byfield ◽  
Benjamin Chastek ◽  
Stephanie Korrer ◽  
Thomas Horstman ◽  
...  
Keyword(s):  
Clinical Data ◽  
Claims Data ◽  
Administrative Claims ◽  
Cancer Type ◽  
Prior Authorization ◽  
Inpatient Stay ◽  
Her2 Breast Cancer ◽  
Real World Setting ◽  
End Of Treatment ◽  
The Impact

e18099 Background: We aim to compareprevalence and duration of inpatient stays during the most commonly used chemotherapy regimens for BC, NSCLC, and CRC in a commercially insured population. Methods: This analysis used clinical data obtained from a prior authorization program for chemotherapy linked with administrative claims data from 6/1/2015 to 5/31/2016. Clinical data included cancer type, stage at diagnosis, relevant biomarkers, and evidence of progression/relapse. Eligible patients included commercially insured members with a prior authorization request for one of the most commonly used NCCN recommended regimens for BC, NSCLC and CRC. Outcomes, including percent of patients experiencing an inpatient stay and number of inpatient days were tracked from the first claim for chemotherapy until end of treatment due to discontinuation, death or change in treatment, with remaining patients censored at 5/31/2016 or end of enrollment. Results: There were 1612 HER2- BC, 237 NSCLC, and 386 CRC patients who completed therapy during the study period. Incidence and inpatient stay days per 100 patient months for the most common regimens for each cancer are summarized in the table. Conclusions: The rates and duration of inpatient stays varied substantially across the most commonly used therapies for BC, NSCLC and CRC. These data show the importance of systematically incorporating the impact of hospitalizations alongside other clinical outcomes in treatment choice in routine clinical practice. As the database grows over time, these data will help clinicians and patients better evaluate regimen choices for various cancers. [Table: see text]

The Impact of Angiotensin-II Receptor Blockers on Cardiovascular Events in Hypertensive Patients – Evidence from Real-life Databases

2010 ◽  
Vol 6 (3) ◽  
pp. 33
Author(s):  
Robert J Petrella ◽  
Keyword(s):  
Angiotensin Ii ◽  
Antihypertensive Drugs ◽  
Real Life ◽  
Angiotensin Ii Receptor Blockers ◽  
Angiotensin Ii Receptor ◽  
Real World Setting ◽  
Actual Experience ◽  
Receptor Blockers ◽  
Randomised Controlled ◽  
The Impact

It is widely recognised that hypertension is a major risk factor for the development of future cardiovascular (CV) events, which in turn are a major cause of morbidity and mortality. Blood pressure (BP) control with antihypertensive drugs has been shown to reduce the risk of CV events. Angiotensin-II receptor blockers (ARBs) are one such class of antihypertensive drugs and randomised controlled trials (RCTs) have shown ARB-based therapies to have effective BP-lowering properties. However, data obtained under these tightly controlled settings do not necessarily reflect actual experience in clinical practice. Real-life databases may offer alternative information that reflects an uncontrolled real-world setting and complements and expands on the findings of clinical trials. Recent analyses of practice-based real-life databases have shown ARB-based therapies to be associated with better persistence and adherence rates and with superior BP control than non-ARB-based therapies. Analyses of real-life databases also suggest that ARB-based therapies may be associated with a lower risk of CV events than other antihypertensive-drug-based therapies.

scholarly journals Prognostic implications of troponin T variations in inherited cardiomyopathies using systems biology

2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Rameen Shakur ◽  
Juan Pablo Ochoa ◽  
Alan J. Robinson ◽  
Abhishek Niroula ◽  
Aneesh Chandran ◽  
...  
Keyword(s):  
Heart Failure ◽  
Systems Biology ◽  
Sudden Cardiac Death ◽  
Risk Stratification ◽  
Clinical Data ◽  
Cardiac Death ◽  
Troponin T ◽  
Management Options ◽  
Familial Cardiomyopathy ◽  
The Impact

AbstractThe cardiac troponin T variations have often been used as an example of the application of clinical genotyping for prognostication and risk stratification measures for the management of patients with a family history of sudden cardiac death or familial cardiomyopathy. Given the disparity in patient outcomes and therapy options, we investigated the impact of variations on the intermolecular interactions across the thin filament complex as an example of an unbiased systems biology method to better define clinical prognosis to aid future management options. We present a novel unbiased dynamic model to define and analyse the functional, structural and physico-chemical consequences of genetic variations among the troponins. This was subsequently integrated with clinical data from accessible global multi-centre systematic reviews of familial cardiomyopathy cases from 106 articles of the literature: 136 disease-causing variations pertaining to 981 global clinical cases. Troponin T variations showed distinct pathogenic hotspots for dilated and hypertrophic cardiomyopathies; considering the causes of cardiovascular death separately, there was a worse survival in terms of sudden cardiac death for patients with a variation at regions 90–129 and 130–179 when compared to amino acids 1–89 and 200–288. Our data support variations among 90–130 as being a hotspot for sudden cardiac death and the region 131–179 for heart failure death/transplantation outcomes wherein the most common phenotype was dilated cardiomyopathy. Survival analysis into regions of high risk (regions 90–129 and 130–180) and low risk (regions 1–89 and 200–288) was significant for sudden cardiac death (p = 0.011) and for heart failure death/transplant (p = 0.028). Our integrative genomic, structural, model from genotype to clinical data integration has implications for enhancing clinical genomics methodologies to improve risk stratification.

scholarly journals Is the use of contraceptives associated with periodontal diseases? A systematic review and meta-analyses

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Micaele Maria Lopes Castro ◽  
Maria Karolina Martins Ferreira ◽  
Iasmin Encaua Essashika Prazeres ◽  
Paula Beatriz de Oliveira Nunes ◽  
Marcela Baraúna Magno ◽  
...  
Keyword(s):  
Systematic Review ◽  
Quantitative Analysis ◽  
Periodontal Diseases ◽  
Hormonal Contraceptive ◽  
Cochrane Library ◽  
Hormonal Contraceptives ◽  
Clinical Parameters ◽  
Significant Difference ◽  
Meta Analyses ◽  
The Impact

Abstract Background Previous studies indicated an impact of hormonal contraceptive use on oral health. This systematic review aimed to investigate the evidence supporting the impact of the use of hormonal contraceptives and periodontal diseases. Methods This study is based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and based on the PECO acrostic. Inclusion criteria comprised observational studies including women (P), which evaluated hormonal contraceptive users (E) and hormonal contraceptive non-users (C), to verify the association between this hormonal therapy and the periodontal diseases (O). Searches were performed on 5 databases: PubMed, Scopus, Web of Science, Cochrane Library, LILACS and grey literature (OpenGrey and Google Scholar). After the selection process, the included studies were evaluated qualitatively. Moreover, quantitative data were analyzed in two meta-analyses for clinical attachment loss (CAL) and probing depth (PD). Finally, the level of certainty was measured with the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) tool between periodontal clinical parameters. Results 18 articles were eligible for the qualitative synthesis and 7 of them were selected for quantitative analysis. Hence, 15 of the eligible articles reported an association between the use of hormonal contraceptives and severity of periodontal disease. However, 6 articles demonstrated high risk of bias and were excluded from quantitative synthesis. The meta-analysis showed a statistically significant difference for CAL (MD 0.24 [0.09, 0.40]; p = 0.002), but in PD (MD 0.05 [− 0.05, 0.15]; p = 0.33) such difference was not identified. A very low level of evidence was found between the clinical parameters. Conclusions The use of hormonal contraceptives may be associated to severity of periodontal diseases. However, the quantitative analysis points to an inconclusive outcome due to the high level of heterogeneity. The association is biologically plausible, however additional studies are warranted to better elucidate the clinical significance of this possible association.

scholarly journals SARS-CoV-2 and Cytomegalovirus Co-Infections—A Case Series of Critically Ill Patients

2021 ◽  
Vol 10 (13) ◽  
pp. 2792
Author(s):  
Patrícia Moniz ◽  
Sérgio Brito ◽  
Pedro Póvoa
Keyword(s):  
Intensive Care Unit ◽  
Critically Ill ◽  
Immune Suppression ◽  
Clinical Course ◽  
Health Care Systems ◽  
Case Series ◽  
Confounding Factors ◽  
Care Systems ◽  
The Impact ◽  
Cmv Reactivation

The SARS-CoV-2 pandemic has placed great strain on the most developed of health care systems, especially in the context of critical care. Although co-infections with cytomegalovirus (CMV) are frequent in the critically ill due to underlying immune suppression of multiple causes, the impact on COVID-19 patients remains unclear. Furthermore, severe COVID-19 has recently been associated with significant immune suppression, and this may in turn impact CMV reactivation, possibly contributing to clinical course. Nevertheless, multiple confounding factors in these patients will certainly challenge upcoming research. The authors present a case series of five patients admitted to the intensive care unit (ICU) in the context of respiratory failure due to severe COVID-19. All patients evolved with CMV reactivation during ICU stay.

The Impact of Laryngopharyngeal Reflux on Occurrence and Clinical Course of Recurrent Respiratory Papillomatosis

2021 ◽  
Author(s):  
Daša Gluvajić ◽  
Maja Šereg‐Bahar ◽  
Aleš Jerin ◽  
Rado Janša ◽  
Irena Hočevar‐Boltežar
Keyword(s):  
Clinical Course ◽  
Laryngopharyngeal Reflux ◽  
Recurrent Respiratory Papillomatosis ◽  
The Impact

Are neutrophil extracellular traps the link for the cross-talk between periodontitis and rheumatoid arthritis physiopathology?

Rheumatology ◽  
2021 ◽  
Author(s):  
Sicília Rezende Oliveira ◽  
José Alcides A de Arruda ◽  
Ayda Henriques Schneider ◽  
Valessa Florindo Carvalho ◽  
Caio Machado ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Cross Talk ◽  
Neutrophil Extracellular Traps ◽  
Periodontal Therapy ◽  
Clinical Parameters ◽  
Extracellular Traps ◽  
Early Ra ◽  
The Cross ◽  
High Concentrations ◽  
The Impact

Abstract Objectives Neutrophil extracellular traps (NETs) play a role in the pathogenesis of periodontitis and rheumatoid arthritis (RA). However, it remains poorly understood whether NETs participate in the cross-talk between periodontitis and RA. Herein, we investigated the production of NETs in individuals with periodontitis and RA and its association with clinical parameters. The impact of periodontal therapy on RA and NET release was also assessed. Methods The concentration of NETs and cytokines was determined in the saliva and plasma of individuals with early RA (n = 24), established RA (n = 64), and individuals without RA (n = 76). The influence of periodontitis on the production of NETs and cytokines was also evaluated. Results Individuals with early RA had a higher concentration of NETs in saliva and plasma than individuals with established RA or without RA. Periodontitis resulted in an increase in the concentration of NETs of groups of individuals without RA and with early RA. The proportion of individuals with high concentrations of IL-6, IL-10 and GM-CSF was higher among individuals with periodontitis than among individuals without periodontitis. The concentrations of TNF-α, IL-6, IL-17/IL-25, and IL-28A were particularly high in individuals with early RA. Worse periodontal clinical parameters, RA onset and RA activity were significantly associated with circulating NETs. Periodontal therapy was associated with a reduction in the concentration of NETs and inflammatory cytokines and amelioration in periodontitis and RA. Conclusion This study reveals that NETs are a possible link between periodontitis and RA, with periodontal therapy resulting in a dramatic switch in circulating NET levels.

scholarly journals Childlessness, Individual Socioeconomic Resources, and Health: Exploring Variation in 20 Countries

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 515-516
Author(s):  
Nekehia Quashie ◽  
Christine Mair ◽  
Radoslaw Antczak ◽  
Bruno Arpino
Keyword(s):  
Older Adults ◽  
Health Outcomes ◽  
Health Indicators ◽  
Data Repository ◽  
Middle Income ◽  
Individual Level ◽  
Socioeconomic Resources ◽  
Middle Income Countries ◽  
Using Data ◽  
The Impact

Abstract Childless older adults may be at risk for poorer health cross-nationally, yet most studies on this topic analyze only a small number of countries and only 1 or 2 health outcomes. To our knowledge, two papers exist that explore associations between childlessness and multiple indicators of health using data from a large number of regionally diverse countries (e.g., 20 countries from North America, Asia, and Europe), but neither study includes an examination of socioeconomic resources. The level of health risk faced by childless older adults is likely to be distinctly shaped by older adults’ socioeconomic resources (e.g., education, income, wealth). Associations between childlessness, socioeconomic resources, and health may also differ by country context. Using harmonized, cross-national data for adults aged 50 and older across 20 high- and middle-income countries (United States (HRS), European Union (SHARE), Mexico (MHAS), and China (CHARLS) from the Gateway to Global Aging data repository), we explore if and how individual-level socioeconomic resources (income, education, wealth) moderate associations between childlessness and five health indicators (self-rated health, ADL limitations, IADL limitations, chronic conditions, and depression). Results suggest that associations between childlessness and health outcomes vary by individual socioeconomic resources in some country contexts, but not in others. We discuss these findings in light of the impact of individual-level socioeconomic resources on older adults’ support options and health outcomes cross-nationally.

scholarly journals Stiffness and Strength of Stabilized Organic Soils—Part I/II: Experimental Database and Statistical Description for Machine Learning Modelling

Geosciences ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. 243
Author(s):  
Hernandez-Martinez Francisco G. ◽  
Al-Tabbaa Abir ◽  
Medina-Cetina Zenon ◽  
Yousefpour Negin
Keyword(s):  
Machine Learning ◽  
Statistical Analysis ◽  
Portland Cement ◽  
Soil Stabilization ◽  
Data Availability ◽  
Data Repository ◽  
Organic Soils ◽  
Experimental Database ◽  
Soil Mixing ◽  
The Impact

This paper presents the experimental database and corresponding statistical analysis (Part I), which serves as a basis to perform the corresponding parametric analysis and machine learning modelling (Part II) of a comprehensive study on organic soil strength and stiffness, stabilized via the wet soil mixing method. The experimental database includes unconfined compression tests performed under laboratory-controlled conditions to investigate the impact of soil type, the soil’s organic content, the soil’s initial natural water content, binder type, binder quantity, grout to soil ratio, water to binder ratio, curing time, temperature, curing relative humidity and carbon dioxide content on the stabilized organic specimens’ stiffness and strength. A descriptive statistical analysis complements the description of the experimental database, along with a qualitative study on the stabilization hydration process via scanning electron microscopy images. Results confirmed findings on the use of Portland cement alone and a mix of Portland cement with ground granulated blast furnace slag as suitable binders for soil stabilization. Findings on mixes including lime and magnesium oxide cements demonstrated minimal stabilization. Specimen size affected stiffness, but not the strength for mixes of peat and Portland cement. The experimental database, along with all produced data analyses, are available at the Texas Data Repository as indicated in the Data Availability Statement below, to allow for data reproducibility and promote the use of artificial intelligence and machine learning competing modelling techniques as the ones presented in Part II of this paper.

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