2,900 research outputs found

    Kepler-210: An active star with at least two planets

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    We report the detection and characterization of two short-period, Neptune-sized planets around the active host star Kepler-210. The host star's parameters derived from those planets are (a) mutually inconsistent and (b) do not conform to the expected host star parameters. We furthermore report the detection of transit timing variations (TTVs) in the O-C diagrams for both planets. We explore various scenarios that explain and resolve those discrepancies. A simple scenario consistent with all data appears to be one that attributes substantial eccentricities to the inner short-period planets and that interprets the TTVs as due to the action of another, somewhat longer period planet. To substantiate our suggestions, we present the results of N-body simulations that modeled the TTVs and that checked the stability of the Kepler-210 system.Comment: 8 pages, 8 Encapsulated Postscript figure

    Timing and characteristics of cumulative evidence available on novel therapeutic agents receiving Food and Drug Administration accelerated approval

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    Context: Therapeutic agents treating serious conditions are eligible for Food and Drug Administration (FDA) accelerated approval. The clinical evidence accrued on agents receiving accelerated approval has not been systematically evaluated. Our objective was to assess the timing and characteristics of available studies. Methods: We first identified clinical studies of novel therapeutic agents receiving accelerated approval. We then (1) categorized those studies as randomized or non-randomized; (2) explored whether or not they evaluated the FDA-approved indications; and (3) documented the available treatment comparisons. We also meta-analyzed the difference in start times between randomized studies that (1) did or did not evaluate approved indications and (2) were or were not designed to evaluate the agentā€™s effectiveness. Findings: In total, 37 novel therapeutic agents received accelerated approval between 2000 and 2013. Our search identified 7,757 studies including 1,258,315 participants. Only one third of identified studies were randomized controlled trials. Of 1,631 randomized trials with advanced recruitment status, 906 were conducted in therapeutic areas for which agents received initial accelerated approval, 202 were in supplemental indications, and 523 were outside approved indications. Only 411/906 (45.4%) trials were designed to test the effectiveness of agents that received accelerated approval (ā€œevaluationā€ trials); others used these agents as common background treatment in both arms (ā€œbackgroundā€ trials). There was no detectable lag between average start times of trials conducted within and outside initially approved indications. ā€œEvaluationā€ trials started on average 1.52 years, (95% CI: 0.87 to 2.17) earlier than ā€œbackgroundā€ trials. Conclusions: Cumulative evidence on agents with accelerated approvals has major limitations. Most clinical studies including these agents are small and non-randomized, and about a third are conducted in unapproved areas, typically concurrently with those conducted in approved areas. Most randomized trials including these therapeutic agents are not designed to evaluate directly their clinical benefits but incorporate them as standard treatment

    An umbrella review of systematic reviews on the impact of the COVID-19 pandemic on cancer prevention and management, and patient needs.

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    The COVID-19 pandemic led to relocation and reconstruction of health care resources and systems, and to a decrease in healthcare utilization, and this may have affected the treatment, diagnosis, prognosis, and psychosocial well-being of patients with cancer. We aimed to summarize and quantify the evidence on the impact of the COVID-19 pandemic on the full spectrum of cancer care. An umbrella review was undertaken to summarize and quantify the findings from systematic reviews on impact of the COVID-19 pandemic on cancer treatment modification, delays, and cancellations; delays or cancellations in screening and diagnosis; psychosocial well-being, financial distress, and use of telemedicine as well as on other aspects of cancer care. PubMed and WHO COVID-19 Database was searched for relevant systematic reviews with or without meta-analysis published before November 29th, 2022. Abstract, full text screening and data extraction were performed by two independent reviewers. AMSTAR-2 was used for critical appraisal of included systematic reviews. 51 systematic reviews evaluating different aspects of cancer care were included in our analysis. Most reviews were based on observational studies judged to be at medium and high risk of bias. Only 2 of the included reviews had high or moderate scores based on AMSTAR-2. Findings suggest treatment modifications in cancer care during the pandemic versus the pre-pandemic period were based on low level of evidence. Different degrees of delays and cancellations in cancer treatment, screening and diagnosis were observed, with low-and-middle income countries and countries that implemented lockdowns being disproportionally affected. A shift from in-person appointments to telemedicine use was observed, but utility of telemedicine, challenges in implementation and cost-effectiveness in different areas of cancer care were little explored. Evidence was consistent in suggesting psychosocial well-being (e.g., depression, anxiety, and social activities) of patients with cancer deteriorated, and cancer patients experienced financial distress, albeit results were in general not compared to pre-pandemic levels. Impact of cancer care disruption during the pandemic on cancer prognosis was little explored. In conclusion, Substantial but heterogenous impact of COVID-19 pandemic on cancer care has been observed. Evidence gaps exist on this topic, with mid- and long-term impact on cancer care being most uncertain
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