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  • Clinical Study Reports (CSR) Used in the Systematic Review of Neuraminidase Inhibitors for Preventing and Treating Influenza in Healthy Adults and Children with Confirmed or Suspected Exposure to Natural Influenza
    UMB Dataset

    Alternate Title(s)
    CSRs used in Cochrane review of neuroaminidase inhibitors for influenza
    Authors
    Peter Doshi
    Description

    Dataset consists of 107 full clinical study reports (CSRs) of published and unpublished randomized, placebo-controlled clinical trials of two neuraminidase inhibitors. A systematic review of the CSRs and other regulatory documents was conducted to determine the potential benefits and harms of oseltamivir (Tamiflu) and zanamivir (Relenza). Outcome measures included time to first alleviation of symptoms, influenza outcomes, complications, admissions to hospital, and adverse events in the intention to treat population. Completeness of relevant parts of the CSRs was determined via an extraction form based on the CONSORT statement checklist. Authors have provided the full set of clinical study reports for both medications provided to the Cochrane collaboration by Roche, GlaxoSmithKline, and the European Medicines Agency (EMA) for use in the systematic review of these neuraminidase inhibitors for treating/preventing influenza in healthy adults and children. A guest post on the "Dryad News and Views" site regarding the dataset of clinical study reports and the resulting Cochrane systematic review is available at: https://blog.datadryad.org/2014/04/17/tamiflu-data/

    Subject
    Influenza, Human
    Access Rights
    Free to All
  • Comparison of In Vivo Expression Levels of IL-4 and IL-4d2 in Mouse Lung Tissue
    UMB Dataset

    Alternate Title(s)
    Comparison of In Vivo Expression Levels of IL-4 and IL-4 delta2 in Mouse Lung Tissue
    Authors
    Sergei P. Atamas
    Description

    The primary goal of this project was to compare in vivo gene expression levels of the cytokine, IL-4, and its natural splice variant, IL-4δ2, in the lungs of mice. Intratracheal replication-deficient adenovirus-mediated gene delivery of mouse IL-4 or IL-4δ2 was utilized to create three mice overexpressing IL-4 and three overexpressing IL-4δ2 in their lungs. An additional three mice were similarly infected with control AdV-NULL virus not encoding a cytokine. 14 days postinfection, lung tissue was homogenized, total RNA extracted, and results analyzed. The data demonstrate that IL-4 and its splice variant differentially affect global gene expression which has implications for the use of targeted therapy for various diseases. The dataset consists of 9 microarray data tables corresponding to each of the samples. Additionally, a supplementary TAR file of the raw data is also available to download.

    Subject
    Gene Expression Profiling
    Microarray Analysis
    Timeframe
    2010 - 2010
    Access Rights
    Free to All
  • Dataset (data extraction spreadsheet) of an Exploratory Review of Clinical Study Reports of Randomised Controlled Trials
    UMB Dataset

    Authors
    Peter Doshi
    Tom Jefferson
    Description

    This dataset (data extraction spreadsheet) is associated with an exploratory evaluation of pharmaceutical industry clinical study reports (CSR) for possible use in evidence synthesis and systematic reviews. 78 CSRs from public sources were selected for data extraction. The report dates range from 1991 through 2011, inclusive, and represent 90 randomized controlled trials of 14 pharmaceuticals. The primary outcome measures include presence and length of essential elements of trial design and reporting and compression factor (ratio of page length for CSRs compared to its published counterpart in a scientific journal). The dataset is comprised of an audited table of extracted and derived variables the details for which are described in an accompanying readme file. The uncorrected (original) and corrected extraction sheets as well as audit records are available upon request from Peter Doshi, corresponding author (pdoshi@rx.umaryland.edu).

    Subject
    Drug Industry
    Access Rights
    Free to All
  • Foster Parent Focus Groups for Improving Engagement in the Court Process
    UMB Dataset

    Authors
    Corey S. Shdaimah
    Description

    This dataset is the result of 6 focus groups of Maryland foster parents and their experiences with the court process. The groups were recruited from Baltimore City (2), Baltimore County (1), Montgomery County (1), Queen Anne’s County (1), and Allegany County (1) with a total of 45 participants. The guided discussions concentrated on the factors that either hindered or promoted foster parent involvement in the court process as well as suggestions for improvement. The dataset consists of verbatim transcripts of the group dialogs incorporating issues such as communication, accurate information, and the court environment/setting.

    Subject
    Foster Home Care
    Geographic Coverage
    Maryland
    Timeframe
    2015 - 2015
    Access Rights
    Author approval required
  • Heroin in Transition Study (HIT)
    UMB Dataset

    Authors
    Daniel Ciccarone
    George J. Unick
    Jenny K. Cohen
    Sarah G. Mars
    1 more author(s)...
    Description

    Dataset comprises hospitalization rates for opioid injection-related skin and soft-tissue infections (O-SSTI) correlated with changes in the price and purity of heroin for the years 1993 through 2010, inclusive. Data is derived from the Healthcare Cost and Utilization Project (HCUP) Nationwide Inpatient Sample (NIS) and the Drug Enforcement Administration (DEA) System to Retrieve Information from Drug Evidence (STRIDE) databases for 27 Metropolitan Statistical Areas (MSAs).

    Subject
    Substance-Related Disorders
    Geographic Coverage
    US
    Timeframe
    1993 - 2010
  • Participant Experiences in Baltimore City's Specialized Prostitution Diversion Program
    UMB Dataset

    Authors
    Corey S. Shdaimah
    Marie Bailey-Kloch
    Philip Osteen
    Description

    This dataset was generated from a qualitative, exploratory study to understand how the Baltimore Specialized Prostitution Diversion Program (SPD) operated and was experienced by those working and participating in it. Qualitative data included observations of participants during their interactions with the court and SPD staff as well as interviews with twenty-one SPD clients. Administrative program data was collected in 2010 on 616 arrestees and included demographic information, self-assessment for areas of need, and participants’ goals. Administrative court data collected by SPD staff was also examined for 221 eligible participants and included court dates, weekly attendance, and program completion. The semi-structured interview guide allowed participant input with questions centered on their understanding and experience of the program, what impeded or facilitated their participation and engagement with the program, and general recommendations.

    Subject
    Sex Workers
    Geographic Coverage
    Baltimore
    Timeframe
    2010 - 2011
    Access Rights
    Author approval required
  • Patient Consent to Publication and Data Sharing in Industry and NIH-Funded Clinical Trials
    UMB Dataset

    Authors
    O'Mareen Spence
    Richie Onwuchekwa Uba
    Seongbin Shin
    Peter Doshi
    Description

    Clinical trial participants are often motivated by the altruistic assumption that study results will contribute to medical knowledge. Additionally, the sharing of research data is rapidly developing into an ethical standard. An evaluation of 144 blank (sample) informed consent forms (ICF) was undertaken to determine the extent to which clinical trial participants were apprised of researchers’ intent to publish results, share de-identified data, and the overall benefit to medical knowledge. This dataset consists of 98 ICFs from industry-funded trials from the European Medicines Agency (EMA) and 46 ICFs from publicly-funded trials listed in the National Heart, Lung and Blood Institute (NHLBI) Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC). The documents were reviewed for identification and extraction of stated or implied language for the following 5 aspects of each study: publication of results, sharing de-identified data, data ownership, confidentiality of identifiable data and, whether the trial will produce knowledge that offers public benefit. Results indicate that investigators rarely disclose intent to share de-identifiable data or commitment to publish. All ICFs are available via 2 zip files, one for the industry-funded trials and the other for the trials in BioLINCC. Also included is the study extraction sheet.

    Subject
    Informed Consent
    Timeframe
    1983 - 2013
    Access Rights
    Free to All
  • Transcriptomic comparisons of macroscopically normal-appearing and scarred lung tissues in idiopathic pulmonary fibrosis
    UMB Dataset

    Authors
    Sergei P. Atamas
    Description

    Idiopathic pulmonary fibrosis (IPF) produces scarring in the peripheral and basilar regions of the lung with macroscopically normal-appearing tissue in the central and apical areas. This study involved comparing transcriptomic profiles of the latter with transcriptomes of scarred IPF and healthy control lung tissues. The primary goal of the research was to elucidate the pathobiology of the disease in its earliest stages. Tissue samples were taken from lung explants of 3 IPF patients and healthy lung tissue from 3 transplant donors. Dataset includes 10 sequence reads from macroscopically normal-appearing areas and 8 from scarred regions from IPF lungs, and an additional 8 from the normal control tissue for a total of 26 samples. 1 supplementary PDF and 7 supplementary datasets in Excel are available at: http://dx.doi.org/10.1016/j.cellimm.2018.01.002

    Subject
    Gene Expression Profiling
    Sequence Analysis
    Timeframe
    2016 - 2017
    Access Rights
    Free to All
  • US Regional and Demographic Differences in Prescription Opioid and Heroin-Related Overdose Hospitalizations
    UMB Dataset

    Authors
    George J. Unick
    Daniel Ciccarone
    Description

    Dataset is comprised of heroin overdose-related and prescription opioid overdose-related hospitalization rates for the years 2000 through 2014. Data is derived from the Healthcare Cost and Utilization Project (HCUP) Nationwide Inpatient Sample (NIS). Included are rates by census region and division with separate rates for age and race.

    Subject
    Substance-Related Disorders
    Geographic Coverage
    US
    Timeframe
    2000 - 2014
  • Voices of Child Care Providers: An Exploratory Study on the Impact of Policy Changes
    UMB Dataset

    Authors
    Corey S. Shdaimah
    Elizabeth Palley
    Amanda Miller
    Description

    This dataset is the result of a qualitative study exploring the impact on child care providers of recent changes in government policies such as the 2014 reauthorization of the Child Care Development Block Grant and the increasing number of state-funded pre-kindergarten programs. Although there is much research on the benefits of quality care for children, and some research on the struggles of parents seeking high quality care, few elicit the perspective of this crucial work force. Six focus groups were conducted with a total of 49 providers. Two groups each, one with center-based providers and one with home-based providers, were held in an urban, suburban, and rural location. Focus group data were supplemented with data from interviews with six rural providers, for a total study sample of 55. All interviews and focus groups were transcribed verbatim and analyzed using a constant comparative method and coding for emergent and sensitizing concepts

    Subject
    Child Care
    Geographic Coverage
    New York (State)
    Timeframe
    2016 - 2017
    Access Rights
    Permission subject to IRB approval