Dataset consists of 107 full clinical study reports (CSRs) of published and unpublished randomized, placebo-controlled clinical trials of two neuraminidase inhibitors.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/
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.
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 (email@example.com).
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.
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).
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.
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.
This dataset is the result of a phase 3, randomized, double-blind, placebo-controlled efficacy trial of a single dose live oral cholera vaccine. PXVX0200 was developed to rapidly confer protection to humanitarian relief workers and other travelers visiting cholera-endemic areas as well as residents in regions experiencing outbreaks. Existing licensed vaccines require 2 or 3 (children) doses weeks apart. The trial consisted of 3 groups of volunteers each of which were randomly split into receiving either the PXVX0200 vaccine or a placebo. One group was challenged with virulent V. cholera O1 El Tor Inaba strain N16961 inoculum 10 days post-vaccination. A second group was challenged 3 months post-vaccination, while individuals in the third group remained unchallenged. A total of 197 volunteers participated in the trial. This dataset includes demographics and clinical and immunology measures from the 3 study sites: University of Maryland, Baltimore School of Medicine, Cincinnati Children’s Hospital Medical Center, Ohio, and the Vaccine Testing Center, University of Vermont College of Medicine. (National clinical trial registry number: NCT01895855; Research funded by: PaxVax, Inc.)
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
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.