Biocompatibility Considerations for Orally Inhaled and Nasal Drug Products and Other Drug--Device Combination Products.

Biocompatibility considerations have historically been important for orally inhaled and nasal drug products (OINDPs) and other drug-device combination products, because finished device components and packaging in these products are often in direct contact with formulation and the patient. The International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) discusses, in this article, the current regulatory landscape associated with biocompatibility and how biocompatibility is typically assessed for OINDPs, including risk management considerations and navigation of regulatory requirements. The article also describes current challenges related to alignment of regulatory expectations, particularly for drug-device combination products, and proposes some questions and topics for further discussion with regulatory agencies and other stakeholders to help advance alignment.

Acute telestroke evaluations during the COVID-19 pandemic.

We sought to analyze the effect of COVID-19 on telestroke requests and to characterize patients remotely evaluated for acute ischemic stroke (AIS) during this time. This study is a retrospective database review of all telestroke requests at one academic vascular neurology center telestroke network with seven remote sites in the USA between March 15 and April 30, 2020. Data were compared with historical cohort spanning same time frame in 2019 using parametric or nonparametric methods as appropriate.

Acute Large Vessel Ischemic Stroke in Patients With COVID-19-Related Multisystem Inflammatory Syndrome.

Background: Acute ischemic stroke (AIS) is rare in children, and diagnosis is often delayed. Neurological involvement may occur in multisystem inflammatory syndrome in children (MIS-C), but very few cases of AIS in patients with MIS-C have been reported.

Patient Descriptions: We two patients with AIS presenting with large vessel occlusive disease in previously healthy adolescents recently exposed to SARS-CoV-2 infection.

Immune-mediated diseases and thromboembolic events: a modified Delphi panel.

Introduction: A multidisciplinary panel of physicians was convened to gain understanding of the relationship between thromboembolic events (TEs) and immune-mediated diseases (IMDs). The primary objective of the panel was to assess areas of consensus on the IMD most prone to TE as well as modifiable and unmodifiable factors that might exacerbate or mitigate the risk of TEs.

Methods: Thirteen nationally recognized physicians were selected based on their contributions to guidelines, publications and patient care.

Acute Ischemic Stroke and COVID-19: Experience From a Comprehensive Stroke Center in Midwest US.

COVID-19 has been associated with increased risk of venous and arterial thromboembolism including ischemic stroke. We report on patients with acute ischemic stroke and concomitant COVID-19 in a diverse patient population. This is a retrospective analysis of patients hospitalized with acute ischemic stroke (AIS) and COVID-19 to our comprehensive stroke center in Chicago, IL, between March 1, 2020, and April 30, 2020.

Neurological manifestations and COVID-19: Experiences from a tertiary care center at the Frontline.

Objective: To report neurological manifestations seen in patients hospitalized with Coronavirus disease 2019 (COVID-19) from a large academic medical center in Chicago, Illinois.

Methods: We retrospectively reviewed data records of 50 patients with COVID-19 who were evaluated by the neurology services from March 1, 2020 - April 30, 2020. Patients were categorized into 2 groups based on timing of developing neurological manifestations: the "Neuro first" group had neurological manifestations upon initial assessment, and the "COVID first" group developed neurological symptoms greater than 24 h after hospitalization.

The Influence of Diffusion Weighted Imaging Lesions on Outcomes in Patients with Acute Spontaneous Intracerebral Hemorrhage.

Background/objective: Diffusion weighted imaging (DWI) lesions have been well described in patients with acute spontaneous intracerebral hemorrhage (sICH). However, there are limited data on the influence of these lesions on sICH functional outcomes. We conducted a prospective observational cohort study with blinded imaging and outcomes assessment to determine the influence of DWI lesions on long-term outcomes in patients with acute sICH.

The Spectrum of Nontraumatic Convexity Subarachnoid Hemorrhage.

Background: Nontraumatic convexity subarachnoid hemorrhage (cSAH) is a nonaneurysmal variant that is associated with diverse etiologies.

Methods: With IRB approval, we retrospectively reviewed consecutive nontraumatic cSAH from July 1, 2006 to July 1, 2016. Data were abstracted on demographics, medical history, neuroimaging, etiology, and clinical presentation.

Fractal fluctuations in muscular activity contribute to judgments of length but not heaviness via dynamic touch.

The applied muscular effort to wield, hold, or balance an object shapes the medium by which action-relevant perceptual judgments (e.g., heaviness, length, width, and shape) are derived.

Muscular effort differentially mediates perception of heaviness and length via dynamic touch.

Our ability to perceive properties of handheld objects (e.g., heaviness, orientation, length, width, and shape) by wielding via dynamic touch is crucial for tooling and other forms of object manipulation-activities that are the basis of much human experience.

Location of a grasped object's effector influences perception of the length of that object via dynamic touch.

Perception of properties of a grasped object via dynamic touch (wielding) contributes to dexterity in tool use (e.g., using a hammer, screwdriver) and sports (e.

Mobile Real-time Tracking of Acute Stroke Patients and Instant, Secure Inter-team Communication - the Join App.

Purpose: The primary correlate to survival and preservation of neurologic function in patients suffering from an acute ischemic stroke is time from symptom onset to initiation of therapy and reperfusion. Communication and coordination among members of the stroke team are essential to maximizing efficiency and subsequently early reperfusion. In this work, we aim to describe our preliminary experience using the Join mobile application as a means to improve interdisciplinary team communication and efficiency.

Predictors of false-positive stroke thrombectomy transfers.

Background: Most patients with large vessel occlusion (LVO) stroke need to be transferred to receive thrombectomy. To save time, the decision to transfer often relies on clinical scales as a surrogate for LVO rather than imaging. However, clinical scales have been associated with high levels of diagnostic error.

Three-Month Outcomes Are Poor in Stroke Patients with Cancer Despite Acute Stroke Treatment.

Introduction: Stroke risk is increased in cancer patients. Prognosis in these patients is poor, with higher in-hospital mortality and increased subsequent mortality. However, data on stroke in cancer patients are limited, specifically regarding acute stroke treatment and functional outcomes.

Participation in a Tele-Stroke Program Improves Timeliness of Intravenous Thrombolysis Delivery.

Background: We sought to assess the effects of participation in a tele-stroke program on timeliness of intravenous tissue plasminogen activator (IVtPA) administration.

Methods: Among 259 consecutive acute ischemic stroke patients treated with IVtPA through the Rush tele-stroke program, we compared two cohorts: Period 1 (July 2011 to June 2013) and Period 2 (July 2013 to July 2014). We collected data on demographics, National Institutes of Health Stroke Scale (NIHSS), and times of last known normal (LKN), initiation of tele-stroke consult, and IVtPA administration.

MRI Detection of Cerebral Infarction in Subarachnoid Hemorrhage.

Objective: To investigate magnetic resonance imaging (MRI) detection of cerebral infarction (CI) in patients presenting with subarachnoid hemorrhage (SAH).

Background: CI is a well-known complication of SAH that is typically detected on computed tomography (CT). MRI has improved sensitivity for acute CI over CT, particularly with multiple, small, or asymptomatic lesions.

Elevated international normalized ratio as a manifestation of post-thrombolytic coagulopathy in acute ischemic stroke.

Background: A serious complication of intravenous tissue plasminogen activator (tPA) in acute ischemic stroke is hemorrhage. Coagulation factors that may potentially increase the risk of bleeding after tPA are not well understood.

Methods: We retrospectively reviewed 284 acute ischemic stroke patients who received tPA.

Telestroke in an urban setting.

Background: Telestroke is a viable alternative in rural areas where neurologists or stroke expertise is unavailable. Urban applications of telestroke have not been previously described.

Materials And Methods: All patients evaluated using remote telestroke technology at four urban spoke hospitals between March 2011 and March 2013 were included in this analysis.

Risk stratification for the in-hospital mortality in subarachnoid hemorrhage: the HAIR score.

Background: The intracerebral hemorrhage (ICH) score is a simple grading scale that can be used to stratify risk of 30 day mortality in ICH patients. A similar risk stratification scale for subarachnoid hemorrhage (SAH) is lacking. We sought to develop a risk stratification mortality score for SAH.

Posterior reversible leukoencephalopathy syndrome presenting with global cerebral edema and herniation.

Background: We report a case of global cerebral edema and herniation due to Posterior Reversible Leukoencephalopathy Syndrome (PRES).

Methods: Case report.

Results: A 37-year-old healthy female developed persistent severe occipital headache, and after 1 month of persistent headache, developed an episode of loss of consciousness.

Relative changes in transcranial Doppler velocities are inferior to absolute thresholds in prediction of symptomatic vasospasm after subarachnoid hemorrhage.

The absolute transcranial Doppler (TCD) velocity threshold has been validated as a screening tool for vasospasm after subarchnoid hemorrhage (SAH). We assessed whether relative changes in velocity were superior to absolute TCD thresholds in the detection of symptomatic vasospasm. We reviewed consecutive patients with aneurysmal SAH who underwent serial TCD monitoring and survived at least 7 days.