Faculty Opinions recommendation of Safety and immunogenicity of two novel type 2 oral poliovirus vaccine candidates compared with a monovalent type 2 oral poliovirus vaccine in children and infants: two clinical trials.

2021 ◽  
Author(s):  
Brian Eley
Keyword(s):  
Clinical Trials ◽  
Oral Poliovirus Vaccine ◽  
Vaccine Candidates

scholarly journals Safety and immunogenicity of two novel type 2 oral poliovirus vaccine candidates compared with a monovalent type 2 oral poliovirus vaccine in healthy adults: two clinical trials

The Lancet ◽  
2021 ◽  
Vol 397 (10268) ◽  
pp. 39-50 ◽  
Author(s):  
Ilse De Coster ◽  
Isabel Leroux-Roels ◽  
Ananda S Bandyopadhyay ◽  
Christopher Gast ◽  
Kanchanamala Withanage ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Oral Poliovirus Vaccine ◽  
Healthy Adults ◽  
Vaccine Candidates

scholarly journals Safety and immunogenicity of two novel type 2 oral poliovirus vaccine candidates compared with a monovalent type 2 oral poliovirus vaccine in children and infants: two clinical trials

The Lancet ◽  
2021 ◽  
Vol 397 (10268) ◽  
pp. 27-38 ◽  
Author(s):  
Xavier Sáez-Llorens ◽  
Ananda S Bandyopadhyay ◽  
Christopher Gast ◽  
Tirza De Leon ◽  
Rodrigo DeAntonio ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Oral Poliovirus Vaccine ◽  
Vaccine Candidates

scholarly journals Poliopolis: pushing boundaries of scientific innovations for disease eradication

2019 ◽  
Vol 14 (15) ◽  
pp. 1321-1330 ◽  
Author(s):  
Pierre Van Damme ◽  
Ilse De Coster ◽  
Ananda S Bandyopadhyay ◽  
Leen Suykens ◽  
Patrick Rudelsheim ◽  
...  
Keyword(s):  
Healthy Adult ◽  
Vaccine Development ◽  
Polio Eradication ◽  
Oral Poliovirus Vaccine ◽  
Paralytic Poliomyelitis ◽  
Outbreak Response ◽  
Routine Immunisation ◽  
Vaccine Candidates ◽  
Adult Volunteers

Although global polio eradication is within reach, sustained eradication of all polioviruses requires cessation of oral poliovirus vaccine use to mitigate against vaccine-derived poliovirus circulation and vaccine-associated paralytic poliomyelitis. The first step in this direction was the WHO-recommended global withdrawal of live attenuated type 2 Sabin poliovirus from routine immunisation in May 2016, with future use restricted to outbreak response, and handling controlled by strict containment provisions (GAPIII). This creates unique challenges for development and testing of novel type 2 poliovirus vaccines. We describe the creation of a novel purpose-built containment facility, Poliopolis, to study new monovalent OPV2 vaccine candidates in healthy adult volunteers, which may be a model for future endeavors in vaccine development for emergency use.

Effects of diacerein intake on cardiometabolic profiles in type 2 diabetics: a systematic review and meta-analysis of clinical trials.

2020 ◽  
Vol 27 ◽  
Author(s):  
Peyman Nowrouzi-Sohrabi ◽  
Reza Tabrizi ◽  
Mohammad Jalali ◽  
Navid Jamali ◽  
Shahla Rezaei ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Body Weight ◽  
Total Cholesterol ◽  
Ldl Cholesterol ◽  
Meta Analysis ◽  
Hdl Cholesterol ◽  
Cochrane Central Register ◽  
Statistical Heterogeneity

Introduction: A systematic review and meta-analysis of clinical trials was undertaken to evaluate the effect of diacerein intake on cardiometabolic profiles in patients with type 2 diabetes mellitus (T2DM). Methods: Electronic databases such as PubMed, EMBASE, Scopus, Web of Science, Google Scholar, and Cochrane Central Register of Controlled Trials were searched from inception to 31 July 2019. Statistical heterogeneity was evaluated using Cochran’s Q test and I-square (I2 ) statistic. Data were pooled using random-effect models and weighted mean difference (WMD). Results: From 1,733 citations, seven clinical trials were eligible for inclusion and meta-analysis. A significant reduction in hemoglobin A1c (HbA1c) (WMD -0.73; 95%CI -1.25 to -0.21; P= 0.006; I2 = 72.2%) and body mass index (BMI) (WMD -0.55; 95%CI -1.03 to -0.07; P= 0.026; I2 = 9.5%) were identified. However, no significant effect of diacerein intake was identified on fasting blood sugar (FBS) (WMD - 9.00; 95%CI -22.57 to 4.57; P= 0.194; I2 = 60.5%), homeostatic model assessment for insulin resistance (HOMA-IR) (WMD 0.39; 95%CI 0.95 to 1.73; P= 0.569; I2 = 2.2%), body weight (WMD -0.54; 95%CI -1.10 to 0.02; P= 0.059), triglycerides (WMD -0.56; 95%CI -24.16 to 23.03; P= 0.963; I2 = 0.0%), total-cholesterol (WMD -0.21; 95%CI -12.19 to 11.78; P= 0.973; I2 = 0.0%), HDL-cholesterol (WMD -0.96; 95%CI -2.85 to 0.93; P= 0.321; I2 = 0.0%), and LDL-cholesterol levels (WMD -0.09; 95%CI -8.43 to 8.25; P= 0.983; I2 = 37.8%). Conclusion: Diacerein intake may reduce HbA1c and BMI; however, no evidence of effect was observed for FBS, HOMA-IR, body weight, triglycerides, total-cholesterol, HDL-cholesterol or LDL-cholesterol.

Personalized Behavioral Nutrition Intervention in Older Asian Americans with Type 2 Diabetes during COVID-19 Pandemic: Study Protocol for a Pilot, Hybrid, Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Jisook Ko ◽  
Yan Du ◽  
Rozmin Jiwani ◽  
Chengdong Li ◽  
Jing Wang
Keyword(s):  
Type 2 Diabetes ◽  
Clinical Trials ◽  
Pilot Study ◽  
Glycemic Control ◽  
Asian Americans ◽  
Control Group ◽  
Management Approach ◽  
Self Monitoring ◽  
Behavioral Nutrition

BACKGROUND The COVID-19 pandemic has challenged the in-person-based self-management approach (i.e., face-to-face or group approach) of type 2 diabetes (T2D). Older adults with T2D, including Asian Americans (AAs), have experienced worsening of diabetes control due to various reasons, including uncertainty of continuous access to essential diabetes medications, devices, education, limited health literacy, as well as constant anxiety and stress. Hybrid clinical trials that incorporate virtual elements into the in-person-based study could provide these vulnerable populations with accessible and timely interventions OBJECTIVE The primary aims of this pilot study are to determine (1) the effect of personalized behavioral nutrition (PBN) intervention on glycemic control, weight control, and metabolites profiles; and (2) the acceptability of PBN. to enhance glycemic control using personalized behavioral nutrition. METHODS Participants will be recruited with a web-based registry, advertisements in ethnic newspapers, and social network services popular among AAs. A total of 60 AAs, aged 65 years or older, who are descendants of Chinese, Korean, or South Asian, and have a diagnosis of T2D will be randomized into two groups: a PBN group (n=30) and a control group (n=30). A 4-week PBN intervention comprises three components: 1) digital self-monitoring; 2) personal nutrition change goals and recommendations; and 3) diabetes nutrition educations. All participants will complete digital self-monitoring on diet, physical activity, and blood glucose. In addition, all participants will access an interactive digital platform to track their self-monitoring data and communicate with the research team. The effectiveness and acceptability of implementing the intervention will be assessed. RESULTS Funding support and institutional review board approval for this study have been secured. Data collection started in August 2020 and is ongoing. CONCLUSIONS To our knowledge, this is the first study to determine the effectiveness and acceptability of PBN utilizing a metabolomics approach and digital-assisted intervention with hybrid RCT among older AAs. The findings of this pilot study will inform the development of a full-scale PBN protocol and hybrid clinical trials that can be adapted for people with T2D in the ongoing pandemic.

scholarly journals Imaging endpoints for clinical trials in MacTel type 2

Eye ◽  
2021 ◽  
Author(s):  
Daniel Pauleikhoff ◽  
Laurenz Pauleikhoff ◽  
Emily Y. Chew
Keyword(s):  
Clinical Trials

scholarly journals Impact of timing of randomization after an acute coronary syndrome and subsequent events in patients with type 2 diabetes mellitus: an analysis of the EXAMINE trial

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Elharram ◽  
A Sharma ◽  
W White ◽  
G Bakris ◽  
P Rossignol ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Clinical Trials ◽  
Type 2 Diabetes Mellitus ◽  
Acute Coronary Syndrome ◽  
Primary Outcome ◽  
Funding Source ◽  
Coronary Syndrome ◽  
The Impact

Abstract Background The timing of enrolment following an acute coronary syndrome (ACS) may influence cardiovascular (CV) outcomes and potentially treatment effect in clinical trials. Using a large contemporary trial in patients with type 2 diabetes mellitus (T2DM) post-ACS, we examined the impact of timing of enrolment on subsequent CV outcomes. Methods EXAMINE was a randomized trial of alogliptin versus placebo in 5380 patients with T2DM and a recent ACS. The primary outcome was a composite of CV death, non-fatal myocardial infarction [MI], or non-fatal stroke. The median follow-up was 18 months. In this post hoc analysis, we examined the occurrence of subsequent CV events by timing of enrollment divided by tertiles of time from ACS to randomization: 8–34, 35–56, and 57–141 days. Results Patients randomized early (compared to the latest times) had less comorbidities at baseline including a history of heart failure (HF; 24.7% vs. 33.0%), prior coronary artery bypass graft (9.6% vs. 15.9%), or atrial fibrillation (5.9% vs. 9.4%). Despite the reduced comorbidity burden, the risk of the primary outcome was highest in patients randomized early compared to the latest time (adjusted hazard ratio [aHR] 1.47; 95% CI 1.21–1.74) (Figure 1). Similarly, patients randomized early had an increased risk of recurrent MI (aHR 1.51; 95% CI 1.17–1.96) and HF hospitalization (1.49; 95% CI 1.05–2.10). Conclusion In a contemporary cohort of T2DM with a recent ACS, early randomization following the ACS increases the risk of CV events including recurrent MI and HF hospitalization. This should be taken into account when designing future clinical trials. Figure 1 Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): Takeda Pharmaceutical

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