scholarly journals Predictive Monitoring: IMPact in Acute Care Cardiology Trial (PM-IMPACCT) - A Randomized Clinical Trial Protocol (Preprint)

2021 ◽  
Author(s):  
Jess Keim-Malpass ◽  
Sarah J Ratcliffe ◽  
Liza P Moorman ◽  
Matthew T Clark ◽  
Katy N Krahn ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Acute Care ◽  
Predictive Analytics ◽  
Healthcare Providers ◽  
Standard Of Care ◽  
Clinical Deterioration ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Icu Transfer ◽  
The Impact

BACKGROUND Patients on acute care wards who deteriorate and are emergently transferred to intensive care units have poor outcomes. Early identification of decompensating patients might allow for earlier clinical intervention and reduced morbidity and mortality. Advances in bedside continuous predictive analytics monitoring (i.e., artificial intelligence (AI)-based risk prediction) make complex data easily available to healthcare providers, and can provide early warning of potentially catastrophic clinical events. We present a dynamic, visual predictive analytics monitoring tool that integrates real-time bedside telemetric physiologic data into robust clinical models to estimate and communicate risk of imminent events. This tool, CoMET (Continuous Monitoring of Event Trajectories), has been shown in retrospective observational studies to predict clinical decompensation on the acute care ward. There is a need to more definitively study this advanced predictive analytics or AI monitoring system in a prospective, randomized controlled clinical trial. OBJECTIVE The goal of this trial is to determine the impact of an AI-based visual risk analytic, CoMET, on: (1) improving patient outcomes related to clinical deterioration, (2) response time to proactive clinical action, and (3) costs to the healthcare system. METHODS We propose a cluster randomized controlled trial (NCT04359641) to test the impact of displaying CoMET on an acute care cardiology and cardiothoracic surgery hospital floor. The number of admissions to a room undergoing cluster-randomization is estimated to be 10,424 over the 20-month study period. Cluster randomization based on bed number occurs every 2 months. The intervention cluster will have the CoMET score displayed (along with standard of care), while the usual care group receives standard of care only. RESULTS The primary outcome will be hours free from events of clinical deterioration. Hours of acute clinical events are defined as time when one or more of the following occur: emergent ICU transfer, emergent surgery prior to ICU transfer, cardiac arrest prior to ICU transfer, emergent intubation, or death. The clinical trial began randomization in January 2021. CONCLUSIONS Very few AI-based health analytics are translated from algorithm to real-world use. This study will use robust prospective, randomized controlled clinical trial methodology to assess the effectiveness of an advanced AI predictive analytics monitoring system incorporating real-time telemetric data for identifying clinical deterioration on acute care wards. This analysis will strengthen the ability of healthcare organizations to evolve as learning health systems, which apply bioinformatics data to improve patient outcomes by incorporating AI into knowledge tools that are successfully integrated into clinical practice by healthcare providers. CLINICALTRIAL Clinical trials identifier: NCT04359641

scholarly journals The impact of minimally invasive restorative techniques on perception of dental pain among pregnant women: a randomized controlled clinical trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
May M. Adham ◽  
Mona K. El Kashlan ◽  
Wafaa E. Abdelaziz ◽  
Ahmed S. Rashad
Keyword(s):  
Clinical Trial ◽  
Dental Caries ◽  
Pregnant Women ◽  
Dental Pain ◽  
Controlled Clinical Trial ◽  
Atraumatic Restorative Treatment ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Caries Removal ◽  
The Impact

Abstract Background The public dental care sector is striving to fulfill the preventive and restorative needs of Egyptians, including pregnant women, who may not receive timely care due to misconceptions about dental treatment during pregnancy. Because of this, they are likely to suffer dental pain, with higher risk of infection affecting their offsprings. Aim of the study To compare the effectiveness of chemo-mechanical caries removal using Papacarie-Duo and Atraumatic Restorative Treatment (ART) in reducing dental pain among pregnant women. Materials and methods A randomized controlled clinical trial was conducted, in 2019, and included 162 pregnant women visiting family health centers in Alexandria, Egypt, with dental pain due to dental caries not extending to pulp. Patients were randomly assigned to Papacarie-Duo group (n = 82) and ART group (n = 80) after stratification by number of treated surfaces. The outcome variables were reduction in pain assessed using Visual Analogue Scale (VAS), satisfaction with treatment, and time taken for dental caries removal. T test/ Mann Whitney U test were used to compare groups and Freidman test was used to compare change across time. Results Pain reduction was significantly greater in the Papacarie-Duo than the ART group (81.55% and 69.43%, P = 0.001). Patients in the Papacarie-Duo group were significantly more satisfied with treatment than those in the ART, immediately after treatment (mean = 9.60 and 8.00, P =  < 0.01) and after 6 months (mean = 9.63 and 8.16, P =  < 0.01). Significantly less excavation time was recorded in the Papacarie-Duo group than in the ART group (mean = 10.38 and 11.56 min, P =  < 0.01). Conclusion Chemo-mechanical caries removal using Papacarie-Duo is more effective in reducing dental pain, in pregnant women, and is associated with more satisfaction and less excavation time than ART. Trial registration: ID NCT04573608 (https://clinicaltrials.gov/); 5/10/2020, retrospective registration.

scholarly journals Efficacy of intravenous infusions of UC-derived MSCs for the treatment of COVID-19: A structured summary of a phase II double blinded, randomized controlled clinical trial

2020 ◽  
Author(s):  
Muhammad Ali ◽  
Azra Mehmood ◽  
Moazzam Nazeer Tarar ◽  
John D Gottsch ◽  
Zafar Nawaz ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Inflammatory Responses ◽  
Standard Of Care ◽  
Convincing Evidence ◽  
Controlled Clinical Trial ◽  
Immune Reactivity ◽  
Randomized Controlled Clinical Trial ◽  
Beneficial Effects ◽  
Randomized Controlled ◽  
Double Blinded

Abstract In this clinical research project, we will conduct a highly rigorous clinical trial where we randomize the patients between umbilical cord (UC)-derived mesenchymal stem cell (MSC) and standard of care (SOC). This study will ask the question whether the allogenic MSCs are effective in reducing death and/or progression of COVID-19 disease when administered to patients with moderate to severe symptoms. MSCs are unique group of cells with minimal immune reactivity and produce multiple beneficial effects, which include reduction of severe inflammatory reaction. There is convincing evidence from human studies that intravenous (IV) delivery of MSCs can directly impact the hyper-inflammatory responses of COVID-19 induced injury of the heart and lungs. Our study will evaluate the safety and efficacy of allogenic UC-derived MSCs administered intravenously to COVID-19 patients with moderate to severe symptom in a randomized, controlled clinical trial. In addition, we will determine whether : (i) UC-derived MSCs are effective in reducing 30-day all-cause mortality (primary endpoint) and (ii) UC-derived MSCs are effective in preventing progression to mechanical ventilation, and/or reducing an inflammatory response, and/or improving overall patient condition (secondary endpoints).

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