scholarly journals Bronchoscopic Targeted Lung Denervation in Patients with Severe Asthma: Preliminary Findings

Respiration ◽  
2021 ◽  
pp. 1-6
Author(s):  
Jorine E. Hartman ◽  
Karthi Srikanthan ◽  
Cielito Caneja ◽  
Nick H.T. ten Hacken ◽  
Huib A.M. Kerstjens ◽  
...  
Keyword(s):  
Health Status ◽  
Severe Asthma ◽  
Treatment Options ◽  
Event Data ◽  
Day Case ◽  
Serious Adverse Events ◽  
Adverse Event Data ◽  
Submucosal Glands ◽  
Asthma Patients ◽  
Stimulation Of

Treatment options for severe asthma are limited, particularly in those patients who do not meet criteria for biologicals. Targeted lung denervation (TLD) is the bronchoscopic ablation of the peribronchial vagal nerve trunks to reduce cholinergic stimulation of airway smooth muscle and submucosal glands. This report describes the experience of the first 2 asthma patients treated with TLD worldwide. The participants were 54 and 51 years of age, and both had severe asthma (GINA 5) (FEV<sub>1</sub>: 53% and 113% of predicted; AQLQ scores: 5.3 and 4.4). Both participants were treated with TLD in a single day-case procedure under general anaesthesia. Lung function, health status, and adverse event data were collected at baseline and 12 months after TLD. No treatment-related serious adverse events were reported up to 12 months. Cough symptoms improved in both participants, and 1 participant reported a marked reduction in rescue medication use at 6 months. There were no significant changes in spirometry, lung volumes, or health status. In conclusion, TLD was performed safely in both participants, but more evidence is needed to clarify safety and efficacy of TLD in severe asthma. Therefore, further investigation of the treatment in severe asthma patients would be useful.

scholarly journals Systematic drug repositioning through mining adverse event data in ClinicalTrials.gov

PeerJ ◽  
2017 ◽  
Vol 5 ◽  
pp. e3154 ◽  
Author(s):  
Eric Wen Su ◽  
Todd M. Sanger
Keyword(s):  
Adverse Event ◽  
Text Mining ◽  
Randomized Trials ◽  
Drug Repositioning ◽  
Drug Repurposing ◽  
Event Data ◽  
Serious Adverse Events ◽  
Adverse Event Data ◽  
Novel Method ◽  
Mining Tools

Drug repositioning (i.e., drug repurposing) is the process of discovering new uses for marketed drugs. Historically, such discoveries were serendipitous. However, the rapid growth in electronic clinical data and text mining tools makes it feasible to systematically identify drugs with the potential to be repurposed. Described here is a novel method of drug repositioning by mining ClinicalTrials.gov. The text mining tools I2E (Linguamatics) and PolyAnalyst (Megaputer) were utilized. An I2E query extracts “Serious Adverse Events” (SAE) data from randomized trials in ClinicalTrials.gov. Through a statistical algorithm, a PolyAnalyst workflow ranks the drugs where the treatment arm has fewer predefined SAEs than the control arm, indicating that potentially the drug is reducing the level of SAE. Hypotheses could then be generated for the new use of these drugs based on the predefined SAE that is indicative of disease (for example, cancer).

scholarly journals An algorithmic approach for the treatment of severe uncontrolled asthma

2018 ◽  
Vol 4 (1) ◽  
pp. 00125-2017 ◽  
Author(s):  
Eleftherios Zervas ◽  
Konstantinos Samitas ◽  
Andriana I. Papaioannou ◽  
Petros Bakakos ◽  
Stelios Loukides ◽  
...  
Keyword(s):  
Severe Asthma ◽  
Severe Disease ◽  
Treatment Options ◽  
Management Planning ◽  
Algorithmic Approach ◽  
Small Subgroup ◽  
Asthma Patients ◽  
New Treatment ◽  
Impaired Quality

A small subgroup of patients with asthma suffers from severe disease that is either partially controlled or uncontrolled despite intensive, guideline-based treatment. These patients have significantly impaired quality of life and although they constitute <5% of all asthma patients, they are responsible for more than half of asthma-related healthcare costs. Here, we review a definition for severe asthma and present all therapeutic options currently available for these severe asthma patients. Moreover, we suggest a specific algorithmic treatment approach for the management of severe, difficult-to-treat asthma based on specific phenotype characteristics and biomarkers. The diagnosis and management of severe asthma requires specialised experience, time and effort to comprehend the needs and expectations of each individual patient and incorporate those as well as his/her specific phenotype characteristics into the management planning. Although some new treatment options are currently available for these patients, there is still a need for further research into severe asthma and yet more treatment options.

scholarly journals Overlap between adverse events (AEs) and serious adverse events (SAEs): a case study of a phase III cancer clinical trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Elizabeth C. James ◽  
David Dunn ◽  
Adrian D. Cook ◽  
Andrew R. Clamp ◽  
Matthew R. Sydes
Keyword(s):  
Clinical Trial ◽  
Adverse Event ◽  
Adverse Events ◽  
Safety Data ◽  
Event Data ◽  
Serious Adverse Events ◽  
Serious Adverse Event ◽  
Adverse Event Data ◽  
Grade 3 ◽  
Mapping Exercise

Abstract Background Safety data is required to be collected in all clinical trials and can be separated into two types of data, adverse events and serious adverse events. Often, these types of safety data are collected as two discrete data sets, where adverse events that also meet the criteria for seriousness should be reported in both datasets. Safety analyses are often conducted using only the adverse event dataset, which should feature all safety events reported. We investigated whether the reporting of safety in both datasets was systematically followed and explored the impact of this on safety analyses in ICON8, an ovarian cancer clinical trial. Methods Text searches of serious adverse event data identified events that could potentially match the data reported in the adverse event dataset (looking at pre-specified AE terms only). These serious adverse events were then mapped to adverse event data according to predefined criteria: (a) event term matches, (b) date of onset and date of assessment within 30 days of each other, (c) date of assessment lies between date of onset and date of resolution and (d) events confirmed to occur in the same chemotherapy cycle. A combined dataset of all unique safety events (whether originally reported in the adverse event or serious adverse event dataset) was created and safety analyses re-performed. Results 51,019 adverse events were reported in ICON8, of which 42,410 were included in the mapping exercise. One thousand five hundred six serious adverse event elements were reported, of which 668 were included in the mapping exercise. Sixty-one percent of serious adverse event elements was matched to an already-reported adverse event. Supplementing these additional safety events and re-performing safety analyses increased the proportion of patients with at least one grade 3 or worse safety events in all arms from 42 to 47% in the control arm and 61 to 65% and 52 to 59% in the research arms. The difference in proportions of grade 3 or worse event in the research arms compared to the control arm changed by 18% (95% confidence interval [CI] 12 to 24%) and 12% (95% CI 6 to 18%), respectively. Conclusions There was low agreement in mapping serious adverse events to already reported adverse events, with nearly 40% of serious adverse events included in the mapping exercise not mapped to an already reported adverse event. Any analyses of safety data that use only adverse event datasets or do not clearly account for serious adverse event data will likely be missing important safety information. Reporting standards should make clear which datasets were used for analyses.

Phosphene perceptions and safety of chronic visual cortex stimulation in a blind subject

2020 ◽  
Vol 132 (6) ◽  
pp. 2000-2007 ◽  
Author(s):  
Soroush Niketeghad ◽  
Abirami Muralidharan ◽  
Uday Patel ◽  
Jessy D. Dorn ◽  
Laura Bonelli ◽  
...  
Keyword(s):  
Visual Cortex ◽  
Adverse Events ◽  
Clinical Intervention ◽  
Occipital Cortex ◽  
Neuronal Population ◽  
Serious Adverse Events ◽  
Stimulation Parameters ◽  
The Right ◽  
Visual Cortical ◽  
Stimulation Of

Stimulation of primary visual cortices has the potential to restore some degree of vision to blind individuals. Developing safe and reliable visual cortical prostheses requires assessment of the long-term stability, feasibility, and safety of generating stimulation-evoked perceptions.A NeuroPace responsive neurostimulation system was implanted in a blind individual with an 8-year history of bare light perception, and stimulation-evoked phosphenes were evaluated over 19 months (41 test sessions). Electrical stimulation was delivered via two four-contact subdural electrode strips implanted over the right medial occipital cortex. Current and charge thresholds for eliciting visual perception (phosphenes) were measured, as were the shape, size, location, and intensity of the phosphenes. Adverse events were also assessed.Stimulation of all contacts resulted in phosphene perception. Phosphenes appeared completely or partially in the left hemifield. Stimulation of the electrodes below the calcarine sulcus elicited phosphenes in the superior hemifield and vice versa. Changing the stimulation parameters of frequency, pulse width, and burst duration affected current thresholds for eliciting phosphenes, and increasing the amplitude or frequency of stimulation resulted in brighter perceptions. While stimulation thresholds decreased between an average of 5% and 12% after 19 months, spatial mapping of phosphenes remained consistent over time. Although no serious adverse events were observed, the subject experienced mild headaches and dizziness in three instances, symptoms that did not persist for more than a few hours and for which no clinical intervention was required.Using an off-the-shelf neurostimulator, the authors were able to reliably generate phosphenes in different areas of the visual field over 19 months with no serious adverse events, providing preliminary proof of feasibility and safety to proceed with visual epicortical prosthetic clinical trials. Moreover, they systematically explored the relationship between stimulation parameters and phosphene thresholds and discovered the direct relation of perception thresholds based on primary visual cortex (V1) neuronal population excitation thresholds.

INFLUENCE OF RIGHT VENTRICULAR LEAD IMPLANTATION SITE CHOICE ON PACING EFFICIENCY

2020 ◽  
pp. 13-17
Author(s):  
Dmitrii Aleksandrovich Lopyn ◽  
Stanislav Valerevich Rybchynskyi ◽  
Dmitrii Evgenevich Volkov
Keyword(s):  
Heart Failure ◽  
Right Ventricular ◽  
Longitudinal Strain ◽  
Treatment Options ◽  
Global Longitudinal Strain ◽  
Optimal Method ◽  
Cardiac Stimulation ◽  
Ventricular Lead ◽  
The Right ◽  
Stimulation Of

Currently the electrophysiological treatment options have been considered to be the most effective for many patients with arrhythmogenic cardiomyopathies, as well as in those with arrhythmias on the background of heart failure. Currently, the dependence of efficiency of the pacemakers on the location of the electrodes has been proven. In order to study the effect of a myocardial dysynchrony on the effectiveness of pacing depending on the location of the right ventricular electrode, an investigation has been performed. This study comprised the patients with a complete atrioventricular block, preserved ejection fraction of the left ventricle (more than 50 %), with no history of myocardial infarction, who were implanted with the two−chamber pacemaker. It has been established that the best results were achieved with a stimulation of the middle and lower septal zone of the right ventricle, the worst ones were obtained with a stimulation of its apex. It has been found that the dynamics of the magnitude of segmental strains and a global longitudinal strain coincided with the dynamics of other parameters of the pacemaker effectiveness, which indicated the pathogenetic value of myocardial dysynchrony in the progression of heart failure after implantation of the pacemaker. Therefore it could be concluded that the studying of myocardial mobility by determining a longitudinal strain for assessing the functional state of the myocardium and the effectiveness of pacing is highly advisable. It is emphasized that the use of the latest strains−dependent techniques for cardiac performance evaluation in the patients with bradyarrhythmia have a great potential to predict the development of chronic heart failure and to choose the optimal method of physiological stimulation of the heart. Key words: right ventricular lead, cardiac stimulation, myocardial dyssynchrony.

scholarly journals Comparing Patient Characteristics, Clinical Outcomes, and Biomarkers of Severe Asthma Patients in Taiwan

Biomedicines ◽  
2021 ◽  
Vol 9 (7) ◽  
pp. 764
Author(s):  
Shih-Lung Cheng ◽  
Kuo-Chin Chiu ◽  
Hsin-Kuo Ko ◽  
Diahn-Warng Perng ◽  
Hao-Chien Wang ◽  
...  
Keyword(s):  
Severe Asthma ◽  
Clinical Characteristics ◽  
Linear Models ◽  
Patient Characteristics ◽  
Emergency Department Visits ◽  
Receiver Operating Characteristic Curves ◽  
Increased Risk ◽  
Significant Difference ◽  
Asthma Patients ◽  
Patients At Risk

Purpose: To understand the association between biomarkers and exacerbations of severe asthma in adult patients in Taiwan. Materials and Methods: Demographic, clinical characteristics and biomarkers were retrospectively collected from the medical charts of severe asthma patients in six hospitals in Taiwan. Exacerbations were defined as those requiring asthma-specific emergency department visits/hospitalizations, or systemic steroids. Enrolled patients were divided into: (1) those with no exacerbations (non-exacerbators) and (2) those with one or more exacerbations (exacerbators). Receiver operating characteristic curves were used to determine the optimal cut-off value for biomarkers. Generalized linear models evaluated the association between exacerbation and biomarkers. Results: 132 patients were enrolled in the study with 80 non-exacerbators and 52 exacerbators. There was no significant difference in demographic and clinical characteristics between the two groups. Exacerbators had significantly higher eosinophils (EOS) counts (367.8 ± 357.18 vs. 210.05 ± 175.24, p = 0.0043) compared to non-exacerbators. The optimal cut-off values were 292 for EOS counts and 19 for the Fractional exhaled Nitric Oxide (FeNO) measure. Patients with an EOS count ≥ 300 (RR = 1.88; 95% CI, 1.26–2.81; p = 0.002) or FeNO measure ≥ 20 (RR = 2.10; 95% CI, 1.05–4.18; p = 0.0356) had a significantly higher risk of exacerbation. Moreover, patients with both an EOS count ≥ 300 and FeNO measure ≥ 20 had a significantly higher risk of exacerbation than those with lower EOS count or lower FeNO measure (RR = 2.16; 95% CI, 1.47–3.18; p = < 0.0001). Conclusions: Higher EOS counts and FeNO measures were associated with increased risk of exacerbation. These biomarkers may help physicians identify patients at risk of exacerbations and personalize treatment for asthma patients.

Adverse Event Data for Years 2018 to 2020 for Diabetes Devices

2021 ◽  
pp. 193229682110116
Author(s):  
Jan S. Krouwer
Keyword(s):  
Adverse Event ◽  
Blood Glucose ◽  
Adverse Events ◽  
Performance Evaluations ◽  
Routine Analysis ◽  
Event Data ◽  
Adverse Event Data ◽  
Continuous Glucose Monitors ◽  
Device Use ◽  
Test Result

Unlike performance evaluations, which are often conducted under ideal conditions, adverse events occur during actual device use for people with diabetes. This report summarizes the number of adverse events for the years 2018 to 2020 for the 3 diabetes devices: blood glucose meters (BG), continuous glucose monitors (CGM), and insulin pumps. A text example of a CGM injury is provided. Possible reasons are suggested for trends. Whereas the rate per test result (events/usage) is exceedingly small, the rate per patient (events/people with diabetes that use insulin) is of concern. Hence, it is important to determine event causes and provide corrective actions. The first step is to put in place routine analysis of adverse event data for diabetes devices.

scholarly journals Trends in oral corticosteroids use in severe asthma: a 14-year population-based study

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Mohsen Sadatsafavi ◽  
Amir Khakban ◽  
Hamid Tavakoli ◽  
Solmaz Ehteshami-Afshar ◽  
Larry D. Lynd ◽  
...  
Keyword(s):  
Severe Asthma ◽  
Poisson Regression ◽  
Population Based ◽  
Population Based Study ◽  
Factors Associated ◽  
Asthma Patients ◽  
Oral Corticosteroids ◽  
Administrative Health Databases ◽  
Time Since Diagnosis

Abstract Background Oral corticosteroids are important components of pharmacotherapy in severe asthma. Our objective was to describe the extent, trends, and factors associated with exposure to oral corticosteroids (OCS) in a severe asthma cohort. Methods We used administrative health databases of British Columbia, Canada (2000–2014) and validated algorithms to retrospectively create a cohort of severe asthma patients. Exposure to OCS within each year of follow-up was measured in two ways: maintenance use as receiving on average ≥ 2.5 mg/day (prednisone-equivalent) OCS, and episodic use as the number of distinct episodes of OCS exposure for up to 14 days. Trends and factors associated with exposure on three time axes (calendar year, age, and time since diagnosis) were evaluated using Poisson regression. Results 21,144 patients (55.4% female; mean entry age 28.7) contributed 40,803 follow-up years, in 8.2% of which OCS was used as maintenance therapy. Maintenance OCS use declined by 3.8%/calendar year (p < 0.001). The average number of episodes of OCS use was 0.89/year, which increased by 1.1%/calendar year (p < 0.001). Trends remained significant for both exposure types in adjusted analyses. Both maintenance and episodic use increased by age and time since diagnosis. Conclusions This population-based study documented a secular downward trend in maintenance OCS use in a period before widespread use of biologics. This might have been responsible for a higher rate of exacerbations that required episodic OCS therapy. Such trends in OCS use might be due to changes in the epidemiology of severe asthma, or changes in patient and provider preferences over time.

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