scholarly journals Retraction notice to "Impact of the COVID-19 Pandemic on Stroke Epidemiology and Clinical Stroke Practice in the US" [Journal of Stroke and Cerebrovascular Diseases, Vol. 30, No. 4 (April), 2021: 105639]

2021 ◽  
Vol 30 (8) ◽  
pp. 105982
Author(s):  
Daniel Friedlich ◽  
Tali Newman ◽  
Stephanie Bricker
Keyword(s):  
Cerebrovascular Diseases ◽  
The Us ◽  
Retraction Notice ◽  
Stroke Epidemiology

scholarly journals The role of lumateperone in the treatment of schizophrenia

2021 ◽  
Vol 11 ◽  
pp. 204512532110340
Author(s):  
Alveena Batool Syed ◽  
James Robert Brašić
Keyword(s):  
Conflicts Of Interest ◽  
Treatment Plan ◽  
Critical Evaluation ◽  
Antipsychotic Agents ◽  
Cerebrovascular Diseases ◽  
Metabolic Dysfunction ◽  
Limited Information ◽  
The Us ◽  
Comprehensive Evaluations

Schizophrenia is a devastating mental disorder resulting in marked morbidity and mortality despite the optimal use of all currently available interventions. For this reason, the release of lumateperone (CaptylaR), also known as ITI-007, an orally administered, atypical antipsychotic provided a welcome novel tool for clinicians to utilize precision medicine to tailor an optimal treatment plan to the specific needs of each person with schizophrenia. To generate a foundation for clinicians to assess the risks and benefits of lumateperone in relation to other interventions for schizophrenia, we conducted a search of items for ‘ITI-007’ and ‘lumateperone’ on PubMed, ScienceDirect, Web of Science, Google Scholar, and www.clinicaltrials.gov . We present a critical evaluation of the limited information about lumateperone for schizophrenia, its use approved by the US Food and Drug Administration. Lumateperone merits consideration for patients with treatment-resistant schizophrenia and for patients with schizophrenia who are vulnerable to developing metabolic dysfunction and movement disorders. On the other hand, lumateperone should not be used for (a) women who are pregnant or breastfeeding, children, adolescents, and elderly patients with dementia-related psychosis, (b) patients who are at risk for cerebrovascular diseases, (c) patients who use inducers and moderate or strong inhibitors of the cytochrome P450-3A4 (CYP3A4) isozyme, and (d) patients who use alcohol and other sedating agents. Clinical trials from multiple centers without financial conflicts of interest to market lumateperone are needed to directly compare and contrast lumateperone and other antipsychotic agents to generate trustworthy evidence to be assessed objectively by clinicians treating patients with schizophrenia. Future investigations will provide the foundations to identify the evidence for comprehensive evaluations of the role of lumateperone in the treatment of people with schizophrenia and other conditions.

Abstract TP292: Patient Reported Outcomes in Stroke Clinical Trials

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Christopher Carr ◽  
Laya Reddy ◽  
Azad Hussain ◽  
Sean Murray ◽  
Neha Vazirani ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Patient Reported Outcomes ◽  
Randomized Clinical Trials ◽  
Depression Scale ◽  
Large Degree ◽  
Cerebrovascular Diseases ◽  
Neurological Deficits ◽  
Health Profile ◽  
Patient Reported ◽  
The Us

Stroke is the 5 th -leading cause of death in the US and the major cause of disability. Many patients who have suffered from strokes are left with permanent neurological deficits, new occupational and social difficulties, and reductions in quality of life that may be idiosyncratic or vary considerably from patient to patient. Solicitation of patient reported outcomes (PROs) in the treatment and recovery from strokes is therefore imperative. We examined a list compiled in 2013 for Stroke by Magin et al. of representative stroke-related, randomized clinical trials published in 10 high-impact journals between 2002 and 2012 to assess whether PROs were collected and which constructs were reported. We categorized PRO measures as stroke-specific (e.g. Stroke Impact Scale), health profile and utility scales (e.g. Beck Depression Scale), or general (e.g. pain visual analog scale). Two reviewers independently abstracted PRO measures from each article and disagreements were resolved by consensus. Fisher’s exact test was used for statistical analyses. Of the 99 articles that met study inclusion criteria, 20% concerned prevention, 22% acute treatment, and 58% rehabilitation. A plurality of trials were European (43%) followed by studies based in the US (25%), Asian countries (10%), and Australia (10%). Altogether, 37% of studies used a PRO of any kind. Stroke-specific PROs were collected in 17% of studies, health profile and utility scales were used in 17%, and general PROs were used in 23%. There were no significant differences in PRO use with regards to year of publication or study location. Health profile and utility scales (p=0.01) and unclassified PROs (p<0.001) were most-commonly reported in rehabilitation trials. Stroke-specific PROs were most commonly published in the journals Brain and Journal of Stroke and Cerebrovascular Diseases (p=0.001). Overall, our review and analysis detected a low prevalence and a large degree of heterogeneity of PRO measures reported in stroke-related clinical trials. Future stroke research must routinely incorporate PROs into the study design to help patients, caregivers, and providers make informed decisions about stroke prevention, treatment, and rehabilitation options that yield outcomes of greatest importance to them.

scholarly journals Different strokes for different folks: epidemiology of cerebrovascular diseases amongst Chinese-Canadians residing in Toronto

2015 ◽  
Vol 42 (S1) ◽  
pp. S36-S36
Author(s):  
JY Chu ◽  
JK Chu ◽  
DK Chu ◽  
S Lam
Keyword(s):  
Diabetes Mellitus ◽  
Retrospective Study ◽  
Population Based ◽  
Cerebrovascular Diseases ◽  
Retrospective Case ◽  
Chinese Canadians ◽  
Vascular Stenosis ◽  
Stroke Epidemiology ◽  
The Relationship

Introduction: It has been recognized in the past few decades that different ethnic groups living in Canada may have different stroke epidemiology. This presentation is focused on the stroke patterns of Chinese-Canadians living in the Toronto area. Methods: Two retrospective case-controlled studies were carried out between 1990- 2000 to study the stroke characteristics of Chinese-Canadians living in Toronto. Statistical analysis was carried out by the Institute of Clinical Evaluative Sciences. A further retrospective study was also carried out in 2011 to look at the relationship between stroke and diabetes mellitus amongst this population. Results: Chinese-Canadians were found to have 1/6 the prevalence of extracranial vascular stenosis. They have a higher frequency of intracranial vascular disease which may be due to the higher frequency of hypertension and diabetes mellitus. Higher incidence of intracranial hemorrhage was found compared to Caucasian controls which may be due to the lack of awareness and optimal treatment of their hypertension. Details of the results of these three studies will be presented. Conclusions: This is the first long term retrospective study of the stroke patterns and epidemiology for Chinese-Canadians residing in Toronto. Further prospective population-based study will be vital to study the important interactions between genetics and environment in the pathogenesis of different strokes for different folks.

The Eleventh Circuit Holds that Agreements in which Pharmaceutical Companies Pay Generic Companies Not to Compete May be Valid

2004 ◽  
Vol 32 (1) ◽  
pp. 181-184
Author(s):  
Amy Garrigues
Keyword(s):  
Pharmaceutical Companies ◽  
Court Decisions ◽  
Patent Holder ◽  
Trial Court ◽  
Court Of Appeals ◽  
The Us ◽  
Antitrust Laws ◽  
Per Se ◽  
Appeals Court ◽  
Two Sides

On September 15, 2003, the US. Court of Appeals for the Eleventh Circuit held that agreements between pharmaceutical and generic companies not to compete are not per se unlawful if these agreements do not expand the existing exclusionary right of a patent. The Valley DrugCo.v.Geneva Pharmaceuticals decision emphasizes that the nature of a patent gives the patent holder exclusive rights, and if an agreement merely confirms that exclusivity, then it is not per se unlawful. With this holding, the appeals court reversed the decision of the trial court, which held that agreements under which competitors are paid to stay out of the market are per se violations of the antitrust laws. An examination of the Valley Drugtrial and appeals court decisions sheds light on the two sides of an emerging legal debate concerning the validity of pay-not-to-compete agreements, and more broadly, on the appropriate balance between the seemingly competing interests of patent and antitrust laws.

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