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Using a pragmatic trial design to limit exclusions, the investigators conducted a 36-month multi-center randomized effectiveness trial to compare the impact of an enhanced usual care (control) intervention, with exercise coaching (exercise), on fragility fractures and serious fall-related injuries (FF/SFRI) in patients with a previous fragility fracture. Specifically, the investigators examined the impact of the intervention on social loneliness, physical function, and bone strength. 1,139 individuals over 65 with a history of fragility fractures and/or osteoporosis were recruited over two years across three regions of Pennsylvania and randomized into either the enhanced usual care control group or exercise with coaching treatment group, where in-person exercise activities were led by trained volunteers.

Dataset (DS) 1 contains the following data used for analysis: participant characteristics at baseline by study group (referred to as Table 5 in the documentation), intervention participant characteristics at baseline based on exercise session type (referred to as Table 6), cumulative incidences of first serious fall-related injury compared by study group (referred to as Figure 3), cumulative incidence for first serious fall-related injury by age, gender, race, and osteoporosis medication (referred to as Table 8 and Figure 4), and cumulative incidence for first series fall-related injury by tertile of average intervention sessions per month (referred to as Figure 5). Other datasets used for analysis are fall injury data (DS2), monthly workout sessions data (DS3), secondary outcomes data (DS4, referred to as Table 7), and adverse events data (DS5, referred to as Table 9). DS6 includes markers designating before and after the start of the COVID-19 pandemic (March 11, 2020), allowing for analyses of participants who experienced fall-related injuries relative to COVID-19.

Datasets labeled "Miscellaneous" were not used in any analysis. These datasets contain extra measures from screening (DS7), baseline assessments (DS8), 4-month check-in visits (DS9), participant's distance to study site (DS10), coaching check-ins for weeks 1-12 (DS11), exercise sessions by month (DS12), adverse events (DS13), and end of study information (DS14).

Severe acute respiratory syndrome coronavirus 2 associated disease (COVID-19) is caused by a novel betacoronavirus, SARS-CoV-2, that was first isolated in January 2020 and has since caused a global pandemic unseen in decades in cases and mortality. At the time of initial protocol submission in April 2020, human vaccine clinical trials had just begun and experts predicted that a vaccine would not be available until April 2021 at the earliest. Therefore, new measures remained needed to prevent the spread of disease. In vitro studies suggested a potential moderate antiviral effect of hydroxychloroquine (HCQ).

This study aimed to evaluate the efficacy of HCQ to prevent COVID-19 clinical infection and to prevent viral shedding of SARS-CoV-2 among healthcare workers (HCWs), as well as to evaluate the safety and tolerability of HCQ. Participants prescreened through the Healthcare Exposure Response and Outcomes (HERO) Registry across 34 U.S. clinical centers were randomly assigned to take a placebo (n=676) or HCQ (n=683) for 30 days, with in-person clinic visits at baseline and 30 days, and an end-of-study virtual visit at 60 days. This collection contains analysis (DS1 through DS6) and tabulation (DS7 through DS44) data and accompanying documentation.

The main objective of this pragmatic randomized clinical trial (PCT) is to identify the optimal dose of aspirin for secondary prevention in atherosclerotic cardiovascular disease (ASCVD). A total of 15,076 high-risk patients with a history of a myocardial infarction (MI) or documented ASCVD were randomized in a 1:1 ratio to receive 81 mgs versus 325 mgs of aspirin every day. This trial addressed the following specific aims:

1. To compare the effectiveness of two doses of aspirin (81 mg and 325 mg) in reducing a composite of all-cause mortality and hospitalization for nonfatal MI, or nonfatal stroke, and the primary safety endpoint of major bleeding. Secondary endpoints include the components of the primary endpoint and hospitalization for transient ischemic attack, unstable angina, or coronary revascularization procedures.
2. To compare the effects of aspirin in selected subgroups of patients by sex, age, race, Internet users vs. non-users, and those with diabetes or advanced chronic kidney disease (CKD).
3. To develop and refine the infrastructure for PCORnet to conduct multiple comparative effectiveness trials in the future.
4. To explore biological mediators of heterogeneity of response to aspirin and of impact on clinical events.