25 children ranging in age from 6 to 10 years participated in this bilateral split-mouth study evaluating two dental sealants for retention and secondary caries development. Data were collected comparing resin based and glass ionomer based sealants with and without tooth preparation at 6-month intervals over a 2 year period. Dataset includes demographic and clinical measures and sealant performance evaluation and comparison at 6, 12, 18 and 24 months.
Randomised, placebo-controlled clinical trials are considered the gold standard for evaluating new vaccines. To assess its efficacy and safety, the manufacturer of quadrivalent human papillomavirus (qHPV) vaccine conducted multiple clinical trials involving approximately 30,000 volunteers. The trials of the qHPV vaccine are reported as ‘placebo-controlled.’ However, participants in the ‘placebo’ arms received an injection-containing amorphous aluminium hydroxyphosphate sulfate (AAHS), a proprietary adjuvant. AAHS is used in the qHPV vaccine to boost immune response, but the rationale for adding it to the ‘placebo’ is not reported in publications of these trials and is contrary to the advice of the public health bodies and regulators. Standard recommendations for control recipients in trials testing an unlicensed, experimental vaccine include using either an inert substance or an approved efficacious vaccine. However, several pivotal trial publications incompletely reported important methodological details and inaccurately described the formulation that the control arms received. Under the Restoring Invisible and Abandoned Trials Initiative (RIAT), the primary objective of this study was to characterize the reporting of the methodology with respect to the rationale for the choice of standalone aluminum-containing adjuvanted controls. Clinical study reports (CSRs) from five randomized controlled trials described as placebo-controlled were obtained from the European Medicines Agency (EMA). Content and rationale for the choice of control used in each trial was extracted across six data sources: trial publications, register records, CSR synopses, CSR main bodies, protocols and informed consent forms. For each source within each trial, the following was recorded: (1) the phrases used to describe the comparator to qHPV vaccine; (2) the rationale for using aluminum-containing adjuvant as a control, if present and (3) all listed contents (ingredients) of formulation received by intervention and control arms. This dataset includes data extraction sheets and RIAT protocol documentation publicly accessible via the Open Science Framework with the CSRs available upon request.
The Amish Research Group of the University of Maryland School of Medicine has been studying the Old Order Amish population in Lancaster County, PA, since 1993. This database currently consists of health-related data on over 7,000 adults resulting from studies ranging from population and basic science to clinical and translational research. Areas of investigation include: Cardiovascular Risk, Diabetes, Bone Health, Blood Pressure, Vascular Imaging, Aging, Breast Tissue Density, Platelet Aggregation, Microbiome, Wellness, and Brain Imaging. Extensive genetic data (genotyping and sequencing) is also available.
Murine typhus is a febrile disease caused by the bacterium, Rickettsia typhi (R. typhi), and transmitted via infected fleas. This study investigated midgut responses of infected versus uninfected cat fleas (Ctenocephalides felis) by constructing cDNA libraries and examining transcript levels. Select C. felis serine proteases, GTPases and defense response genes were compared to identify differences in gene expression between the two states of infection. A total of 1152 transcripts from both libraries were sequenced, generating 906 high quality sequences, 472 from the uninfected and 434 from the infected midgut library.
Data and figures are provided on the effects of fluoxetine, a selective serotin reuptake inhibitor (SSRI) antidepressant, on the gut microbiome and metabolome in a rat model to better understand the effect of this drug on women during gestation and lactation. Throughout pregnancy and lactation, female rats received the SSRI fluoxetine or vehicle. High resolution 16S ribosomal RNA marker gene sequencing and targeted metabolic analysis were used to assess the fecal microbiome and metabolic availability, respectively.
Data from Medicaid fee-for-service and managed care claims from one Mid-Atlantic state were analyzed for this cross-sectional study. The dataset consists of a total of 16,969 youths under the age of 20 with a mental health diagnosis and a pharmacy claim for antipsychotic medication in 2003. Data for each individual includes demographic, Medicaid program category (ie, foster care, disabled), psychiatric diagnostic codes, and psychotropic medications by major therapeutic class.
This study evaluated the Accountability and Incentives Management (AIM) system, a graduated response approach implemented by the Maryland Department of Juvenile Services (DJS) in July 2015. AIM was designed to promote youth accountability and to reduce rates of supervision violations and recidivism for all youth under community supervision. The primary intent of the program was to address the high rates of DJS detention and committed placements resulting from violations of probation (VOPs), and to address racial disproportionality in the deep end of the juvenile justice system. The study entailed a process evaluation of AIM’s implementation; a two-group, quasi-experimental design to assess youth outcomes; and a cost savings analysis. The treatment group (AIM cohort) included 1,590 adjudicated youths who started/completed probation or aftercare supervision with Maryland DJS between November 1, 2015 and October 31, 2017. Propensity score matching was used to create a statistically equivalent comparison group, comprised of 1,590 youth who were supervised prior to AIM implementation (July 1, 2013-June 30, 2015). The primary data sources were administrative data collected through DJS’s management information systems and included each youth’s demographic characteristics (e.g., gender, race/ethnicity, age, and county of jurisdiction), delinquency history (e.g., referrals to DJS, VOPs, adjudications, and commitment dispositions), placement history (e.g., detention and committed placements), and supervision history (e.g., aftercare and probation). Specific AIM-related data such as risk/needs assessment (risk level and treatment needs) and treatment planning information were also maintained by DJS case managers. This dataset is comprised of both publicly available and restricted data. (Need to add a sentence or two about what type of data is publicly available versus restricted.)
For two decades the standard drug therapy for patients with Crohn’s disease (CD) and ulcerative colitis (UC) has been anti-tumor necrosis factor agents (anti-TNFs) such as adalimumab (Humira), certolizumab pegol (Cimzia), infliximab (Remicade) and several others. More recently, vedolizumab (Entyvio) has entered the market as the first gut-selective integrin blocker that offers an alternative treatment for inflammatory bowel disease (IBD). Using the FDA Adverse Event Reporting System (FAERS) database, this study compared adverse event reports (AE) for the two types of therapies. The search retrieved 499 reports for vedolizumab and 119,620 for anti-TNFs for the years 1998 through 2015. Using the proportional reporting ratio (PPR) and the empirical Bayesian geometric mean (EBGM) algorithms, AE data were reviewed for signals of disproportionate reporting for the two types of drugs. This dataset includes statistical summary tables of characteristics (demographic) and a variety of adverse event comparisons of vedolizumab, anti-TNFs, and all other medications. Cleaned FAERS data was provided with permission by DrugLogic, Inc. Interested researchers may contact DrugLogic Inc. (Reston, VA) by calling 800-393-1313 or emailing firstname.lastname@example.org
The AFFIRM clinical trial was instituted to compare the impact on total mortality between two treatment strategies for managing atrial fibrillation (AF): maintenance of sinus rhythm (includes control of heart rate) and control of heart rate alone. Anticoagulation was used with both treatments. 4060 patients from over 200 sites in the U.S. and Canada participated in the study. All enrollees had AF and at least one additional risk factor for stroke or death. Dataset includes patient baseline characteristics, clinical measures, medications, hospitalizations, major adverse events and mortality, and cognitive ability assessments as well as selected quality of life measures.
This dataset consists of survey responses from 57 African American parents/caregivers whose child was receiving care for ADHD in a university-affiliated pediatric primary care unit. The 47 item questionnaire entitled Attitudes, Satisfaction, Knowledge, and Medication Experiences (ASK-ME) was developed by the primary author to assess views of stimulant medication for ADHD. In addition to demographic information, the dataset includes treatment characteristics, whether or not the child received counseling, and responses to 7 items specifically related to attitude toward medication. A copy of the survey is available from Dr. Susan dosReis upon request.