scholarly journals Safety and Use of MLC601/MLC901 (NeuroAiDTM) in Primary Intracerebral Hemorrhage: A Cohort Study from the NeuroAiD Safe Treatment Registry

2020 ◽  
Vol 10 (8) ◽  
pp. 499
Author(s):  
Ramesh Kumar ◽  
Azizi Abu Bakar ◽  
Jegan Thanabalan ◽  
Sanmugarajah Paramasvaran ◽  
Charng Jeng Toh ◽  
...  
Keyword(s):  
Cohort Study ◽  
Side Effects ◽  
Intracerebral Hemorrhage ◽  
Real World ◽  
Brain Injuries ◽  
Neurological Recovery ◽  
Safe Treatment ◽  
The Real ◽  
Real World Setting ◽  
Concentration Test

Background: MLC601/MLC901 (NeuroAiD™) is a combination of natural products shown to be safe and to aid neurological recovery after brain injuries, especially ischemic stroke. Few studies have investigated NeuroAiD in primary intracerebral hemorrhage (ICH). The NeuroAiD Safe Treatment (NeST) Registry explores NeuroAiD use in the real-world setting. This cohort study aimed to assess its use and safety in ICH. Methods: The online NeST Registry of subjects with ICH given NeuroAiD prospectively collected clinical data at baseline and monthly visits (V) 1 to 3. Outcome measures included compliance, side effects, Glasgow Coma Scale (GCS), National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS), and Short Orientation-Memory-Concentration Test (SOMCT). Results: Sixty-six subjects were included. NeuroAiD was well-tolerated with fair compliance over three months. Two non-serious side effects were reported. Mean scores significantly improved on all outcome scales. The proportion of subjects with favorable outcomes significantly improved from baseline to V3: NIHSS 0–4, from 12% to 59% (p < 0.0001); GCS 13–15, from 64% to 88% (p = 0.007); mRS 0–1, from 9% to 37% (p = 0.004); and SOMCT score 0–8, from 44% to 68% (p = 0.029). Conclusions: NeuroAiD in the real-world setting was safe and showed potential for a sustained positive effect on neurological recovery after ICH.

scholarly journals Real-World Efficacy and Safety of Bevacizumab in the First-Line Treatment of Metastatic Cervical Cancer: A Cohort Study in the Total Population of Croatian Patients

2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Dora Čerina ◽  
Višnja Matković ◽  
Kristina Katić ◽  
Ingrid Belac Lovasić ◽  
Robert Šeparović ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Cohort Study ◽  
Real World ◽  
Total Population ◽  
Line Treatment ◽  
Efficacy And Safety ◽  
First Line ◽  
The Real ◽  
Real World Setting ◽  
First Line Treatment

Background. Although today it is almost preventable, cervical cancer still represents a significant cancer burden, especially in some developing parts of the world. Since the introduction of bevacizumab in the first-line treatment of metastatic disease, improvements of the outcomes were noted. However, results from randomized controlled trials are often hard to recreate in the real-world setting. Objective. To assess the real-world efficacy and safety of bevacizumab as a first-line treatment of advanced cervical cancer. Methods. We conducted a retrospective cohort study on the total population of Croatian patients diagnosed with metastatic cervical cancer from 2016 to 2019 who were treated with bevacizumab in combination with cisplatin and paclitaxel (TCB) in the first line. The comparison group was the consecutive sample of patients treated with chemotherapy alone. The primary endpoint was overall survival (OS). Secondary endpoints were progression-free survival (PFS), objective response rate, incidence of adverse events, and the proportion of treatment discontinuation. Results. We enrolled 67 patients treated with TCB and a control group of 62 patients treated with chemotherapy alone. The TCB cohort had significantly longer unadjusted OS with a median of 27.0 (95% CI 18.5; not calculable) months, compared to 15.5 (10.7; 30.1) months in the chemotherapy-alone cohort. Adjusted OS was not significantly different. PFS was significantly longer for the TCB cohort, with a median of 10.6 (95% CI 8.5; 15.4) months, than for the chemotherapy-alone cohort, with a median of 5.4 (95% CI 3.9; 9.1) months, even after adjustment for baseline covariates (HRadjusted = 0.60; 95% CI 0.39; 0.94; p = 0.027 ; false discovery rate <5%). Conclusions. In a real-world setting, TCB as a first-line treatment of metastatic cervical cancer was associated with longer PFS, better objective disease control rate, and acceptable toxicity profile in comparison to chemotherapy alone. These results may indicate its utility and potential applicability in other parts of the developing world.

Distinct effects of antihypertensives on depression in the real-world setting: A retrospective cohort study

2019 ◽  
Vol 259 ◽  
pp. 386-391 ◽  
Author(s):  
Y.Y. Cao ◽  
X. Xiang ◽  
J. Song ◽  
Y.H. Tian ◽  
M.Y. Wang ◽  
...  
Keyword(s):  
Cohort Study ◽  
Real World ◽  
Retrospective Cohort Study ◽  
Retrospective Cohort ◽  
The Real ◽  
Real World Setting

Trends in Insulin Therapy—A1C and Age at the Time of Insulin Initiation in the Real-World Setting

Diabetes ◽  
2018 ◽  
Vol 67 (Supplement 1) ◽  
pp. 2328-PUB
Author(s):  
RAJIV KOVIL ◽  
MANOJ S. CHAWLA ◽  
PURVI M. CHAWLA ◽  
MIKHIL C. KOTHARI ◽  
AMBARI F. SHAIKH
Keyword(s):  
Insulin Therapy ◽  
Real World ◽  
Insulin Initiation ◽  
The Real ◽  
Real World Setting

The Cost-Effectiveness of Pre-school Peanut Oral Immunotherapy in the Real World Setting

2021 ◽  
Author(s):  
Marcus Shaker ◽  
Edmond S. Chan ◽  
Jennifer LP. Protudjer ◽  
Lianne Soller ◽  
Elissa M. Abrams ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Real World ◽  
Oral Immunotherapy ◽  
The Real ◽  
Real World Setting ◽  
The Cost

scholarly journals Performance Characteristics of Breezhaler® and Aerolizer® in the Real-World Setting

2021 ◽  
Author(s):  
Mathieu Molimard ◽  
Ioannis Kottakis ◽  
Juergen Jauernig ◽  
Sonja Lederhilger ◽  
Ivan Nikolaev
Keyword(s):  
Real World ◽  
Performance Characteristics ◽  
The Real ◽  
Real World Setting

scholarly journals Reasoning with linguistic preferences using NPN logic

2010 ◽  
Vol 7 (3) ◽  
pp. 511-528 ◽  
Author(s):  
Goran Devedzic ◽  
Danijela Milosevic ◽  
Lozica Ivanovic ◽  
Dragan Adamovic ◽  
Miodrag Manic
Keyword(s):  
Side Effects ◽  
Decision Analysis ◽  
Decision Maker ◽  
Real World ◽  
Cognitive Maps ◽  
Fuzzy Cognitive Maps ◽  
Basic Notion ◽  
The Real ◽  
Alternative Framework ◽  
Linguistic Models

Negative-positive-neutral logic provides an alternative framework for fuzzy cognitive maps development and decision analysis. This paper reviews basic notion of NPN logic and NPN relations and proposes adaptive approach to causality weights assessment. It employs linguistic models of causality weights activated by measurement-based fuzzy cognitive maps? concepts values. These models allow for quasi-dynamical adaptation to the change of concepts values, providing deeper understanding of possible side effects. Since in the real-world environments almost every decision has its consequences, presenting very valuable portion of information upon which we also make our decisions, the knowledge about the side effects enables more reliable decision analysis and directs actions of decision maker.

Tofacitinib and risk of cardiovascular outcomes: results from the Safety of TofAcitinib in Routine care patients with Rheumatoid Arthritis (STAR-RA) study

2022 ◽  
pp. annrheumdis-2021-221915
Author(s):  
Farzin Khosrow-Khavar ◽  
Seoyoung C Kim ◽  
Hemin Lee ◽  
Su Been Lee ◽  
Rishi J Desai
Keyword(s):  
Rheumatoid Arthritis ◽  
Real World ◽  
Fixed Effects ◽  
Safety Concern ◽  
Specific Effect ◽  
Routine Care ◽  
Cardiovascular Outcomes ◽  
The Real ◽  
Real World Setting ◽  
Increased Risk

ObjectivesRecent results from ‘ORAL Surveillance’ trial have raised concerns regarding the cardiovascular safety of tofacitinib in patients with rheumatoid arthritis (RA). We further examined this safety concern in the real-world setting.MethodsWe created two cohorts of patients with RA initiating treatment with tofacitinib or tumour necrosis factor inhibitors (TNFI) using deidentified data from Optum Clinformatics (2012–2020), IBM MarketScan (2012–2018) and Medicare (parts A, B and D, 2012–2017) claims databases: (1) A ‘real-world evidence (RWE) cohort’ consisting of routine care patients and (2) A ‘randomised controlled trial (RCT)-duplicate cohort’ mimicking inclusion and exclusion criteria of the ORAL surveillance trial to calibrate results against the trial findings. Cox proportional hazards models with propensity score fine stratification weighting were used to estimate HR and 95% CIs for composite outcome of myocardial infarction and stroke and accounting for 76 potential confounders. Database-specific effect estimates were pooled using fixed effects models with inverse-variance weighting.ResultsIn the RWE cohort, 102 263 patients were identified of whom 12 852 (12.6%) initiated tofacitinib. The pooled weighted HR (95% CI) comparing tofacitinib with TNFI was 1.01 (0.83 to 1.23) in RWE cohort and 1.24 (0.90 to 1.69) in RCT-duplicate cohort which aligned closely with ORAL-surveillance results (HR: 1.33, 95% CI 0.91 to 1.94).ConclusionsWe did not find evidence for an increased risk of cardiovascular outcomes with tofacitinib in patients with RA treated in the real-world setting; however, tofacitinib was associated with an increased risk of cardiovascular outcomes, although statistically non-significant, in patients with RA with cardiovascular risk factors.Trial registration numberNCT04772248.

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