Identify disease categories in which single-item global impression (GI) scales were included in product labeling of new drugs approved by the US Food and Drug Administration (FDA) in January ...2009-December 2019 and review the characteristics of GIs included in product labeling of new FDA-approved drugs (January 2017-December 2019).
FDA Clinical Outcome Assessment (COA) Compendium was reviewed for drug labels that included GIs for drugs approved in 2009-2016. The indication, year of approval, ICD-10 code, and GI respondent were noted. A manual review of labels of FDA-approved drugs (2017-2019) was undertaken to identify GIs included in the labels. Corresponding drug approval packages were reviewed to identify details of any regulatory reviewer comments related to GIs. GI characteristics were noted from the drug label or the review documents, including the respondent, type of measure (static or dynamic), item wording, concept assessed, and response options.
Product labeling containing GIs was most common in diseases related to the skin, nervous system, behavioral disorders, and the musculoskeletal system. GIs were included in 30/77 (39.0%) drug labels in the four disease categories.
In the past 10 years, GIs have been included as endpoint measures in confirmatory clinical trials and have generated evidence of treatment benefit in diseases related to the skin, nervous system, behavioral disorders, and the musculoskeletal system. GIs frequently provide important insights into the patient experience. Before GIs are included in clinical trials to assess treatment benefit, it is important to ensure that they are valid, reliable, and responsive.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
In this paper, we present the results of a detailed geomorphological and sedimentological study of a coastal sector of southern Italy, the Pineta della foce del Garigliano SCI (i.e. Site of Community ...Importance), which is largely affected by shoreline retreat and the degradation of dune habitat. The analysis of shoreline evolution demonstrates that severe erosion processes have occurred over the last 50 years. They caused the complete dismantling of the foredune, whereas the anomalous and advanced position of the secondary dune promoted a progressive loss of vegetation habitat of high environmental value such as juniper (Juniperus oxycedrus ssp. macrocarpa). Morpho-sedimentary data and hydrodynamic models suggest that the main climate events promoted a net longshore transport toward the South. Our analyses confirm that erosion processes are linked to natural factors but several negative human practices have contributed to the acceleration of shoreline retreat and degradation of the dune habitat. In addition to its scientific value, the map and data here presented represent an important tool for beach management purposes.
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
Clinical details
A 52-year-old man presented with neck pain, nausea and vomiting (Hunt-Hess grade 1). CT scan showed subarachnoid hemorrhage. Cerebral angiography showed multiple arterial aneurysms ...(right communicating posterior, right anterior choroid, left pericallosal, intraorbital ophthalmic bilaterally). All aneurysms but intraorbital ophthalmic ones were treated with endovascular embolisations. As the intraorbital aneurysms were asymptomatic no treatment was performed. The patient was dismissed without any neurological deficits.
Discussion
Intraorbital ophthalmic aneurysms are very uncommon, with extremely rare rupture. No treatment is indicated when the aneurysm is unruptured and asymptomatic. Surgical treatment is advised only after rupture or symptomatic mass effect.
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
We report a case of 61-year-old man with an intriguing differential diagnosis between two often interchangeably ambiguous coronary conditions, successfully resolved through the application of OCT and ...physiological assessments. This clinical scenario highlights the importance of a multidisciplinary approach for achieving a thorough understanding of complex coronary pathologies.
•It is crucial to diagnose and treat the “patient” rather than focusing solely on addressing the “stenosis.”•Intravascular Imaging plays a pivotal role in achieving accurate diagnosis and providing precise procedural guidance.•Physiology continues to be the essential tool for determining whether a lesion should undergo mechanical treatment or not.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Aim of this study was to evaluate left ventricular function during exercise in 10 male elite runners and in 10 sedentary males. End-diastolic (EDV) and end-systolic volume (ESV), left ventricular ...ejection fraction (EF), early peak transmitral flow velocity (peak E), time-velocity integral of mitral inflow (m-TVI); mitral cross sectional area (m-CSA); mitral stroke volume (SV), and cardiac output (CO) were measured by echo-Doppler. We simultaneously analyzed: VO2max by spirometric method, mean arterial blood pressure (MAP) by sphygmomanometer, and heart rate (HR) by ECG. The parameters were measured under basal conditions (level 1), at 50% of maximal aerobic capacity (level 2), at peak of exercise (level 3) and during recovery. Ejection fraction in athletes increased significantly at peak of exercise through Frank-Starling mechanism. Stroke volume and cardiac output increased significantly in athletes at peak of exercise. Left ventricular diastolic function was superior in athletes versus controls: in fact, higher peak E in athletes enhanced early diastolic ventricular filling. Therefore, the athletes showed complex cardiovascular adjustments induced by training, which allowed an higher peak working power, a greater cardiac output, and VO2max when compared with an untrained control population.
…Vous verrez, de poème en poème tout ce que l’on jette en chemin ! On se déleste en avançant. Pourtant, tout est à recommencer, toujours : l’atteinte du sommet est un leurre… René Char, Dans ...l’atelier du poète, Quarto Gallimard, Paris, 2003, p. 835
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