Contemporary clinical trials communications
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Contemp Clin Trials Commun · Dec 2019
Investigating the role of early low-dose aspirin in diabetes: A phase III multicentre double-blinded placebo-controlled randomised trial of aspirin therapy initiated in the first trimester of diabetes pregnancy.
Preeclampsia, preterm birth and low birth weight represent key contributing factors to perinatal morbidity and mortality. Pregnancies complicated by type 1 and type 2 diabetes are at increased risk of these complications, which are purported to be largely attributed to placental dysfunction. Studies investigating a potential role for aspirin therapy in optimizing perinatal outcome have consistently failed to demonstrate a benefit among women with pre-existing diabetes, and yet widespread aspirin administration has become common practice in many centres. This study seeks to examine the effect of aspirin therapy, administered from the first trimester until 36 weeks gestation, on perinatal outcome in women with established pre-pregnancy diabetes. Our hypothesis is that aspirin therapy will reduce complications mediated by placental dysfunction, and improve perinatal outcomes. ⋯ Aspirin therapy has been investigated for the prevention of preeclampsia owing to its reduction on thromboxane production. Previous studies have failed to demonstrate a beneficial effect of aspirin on perinatal outcome amongst women with type I or type II diabetes. It is plausible that the failure to observe benefit to date, among the limited aspirin studies that have included participants with diabetes, may be a consequence of aspirin initiation too late in pregnancy to exert any effect on placentation. We believe that if aspirin is to be used for the prevention of placental dysfunction, it must be initiated before the second active phase of trophoblast invasion, which takes place from 14 weeks' gestation onwards. No randomized trials investigating the role of aspirin in prevention of preeclampsia in pregnancies complicated by diabetes have previously initiated treatment in the first trimester, the gestational period at which it is most likely to exert an effect on placentation.
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Contemp Clin Trials Commun · Sep 2019
Design for a cohort-randomized trial of an acceptance and commitment therapy-enhanced weight management and fitness program for Navy personnel.
Overweight/obesity and inadequate fitness in active duty personnel impact the wellbeing of service members and have significant costs for military readiness and budget. ShipShape (SS), the Navy's weight management program, was designed to promote nutritional, behavioral, and exercise education to service members. Although SS is an evidence-based program, about half of those who complete the program pass the Body Composition Assessment (BCA), one part of the Navy's comprehensive Physical Fitness Assessment (PFA). ⋯ Our aims are to: 1) determine the effectiveness of ACT + SS compared to SS-only; 2) examine psychological flexibility as a mechanism underlying intervention response; and 3) explore potential moderators of intervention response. The primary outcome is weight, one of the key components of the BCA; secondary outcomes include Body Mass Index (BMI), body fat %, self-reported BCA results, physical activity, problematic eating, and quality of life. We have designed a cohort-randomized trial with interventions that are pragmatically implemented in a real-life military setting, and outcomes that are immediately relevant to service members and leadership.
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Contemp Clin Trials Commun · Sep 2019
Measurement of soft tissue drug concentrations in morbidly obese and non-obese patients - A prospective, parallel group, open-labeled, controlled, phase IV, single center clinical trial.
Pharmacokinetic (PK) and pharmacodynamic (PD) data on perioperative antibiotic prophylaxis or antibiotic therapy are rare in patients suffering from morbid obesity. Furthermore, dosing regimens should be based on PK/PD models that ensure effective antibiotic exposure not in plasma, but primarily at the site of infection, mostly in the interstitial fluid (ISF). The aim of this trial is to investigate whether current dosing regimens of various antibiotics lead to effective concentrations in the ISF of morbidly obese patients. ⋯ Inadequate dosing regimes of antibiotics may be a relevant factor for morbidity and mortality of patients, as well as for the development of bacterial antibiotic resistance. The measurement of plasma and tissue concentrations will provide information necessary for PK/PD-modelling. These data about antibiotic PK/PDcharacteristics in soft tissue and their dependence on weight should help to develop weight-dependent models for calculation of patient's individual doses of different antibiotics.
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Contemp Clin Trials Commun · Sep 2019
Reporting of master protocols towards a standardized approach: A systematic review.
In September 2018 the FDA provided a draft guidance on master protocols reflecting an increased interest in these designs by industry. Master protocols refer to a single overarching protocol developed to evaluate multiple hypotheses and may be further categorized as basket, umbrella, and platform trials. However, inconsistencies in reporting persist in the literature. We conducted a systematic review to describe master protocol reporting with the goal of facilitating the further development and spread of these innovative trial designs. ⋯ The terms 'master protocol', 'basket trial', 'umbrella trial', and 'platform trial' are inconsistently described. Careful treatment of these terms and adherence to the definitions set forth by the FDA will facilitate better understanding of these trial designs and allow them to be used broadly and to their full potential in clinical research. We encourage trial methodologists to use these trial designations when applicable.
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Contemp Clin Trials Commun · Sep 2019
Participant recruitment into a community-based diabetes prevention trial in India: Learnings from the Kerala Diabetes Prevention Program.
Data on participant recruitment into diabetes prevention trials are limited in low- and middle-income countries (LMICs). We aimed to provide a detailed analysis of participant recruitment into a community-based diabetes prevention trial in India. ⋯ This study provides valuable information for future researchers planning to implement community-based diabetes prevention trials in India or other LMICs.