|drug4516||hyperbaric oxygen therapy (HBOT) Wiki||0.45|
|drug4517||hyperimmune plasma Wiki||0.45|
|drug1199||Dexmedetomidine Injectable Product Wiki||0.45|
|drug2650||OT Guided Cognitive Interventions Wiki||0.45|
|drug735||COVID visitation restrictions Wiki||0.45|
|drug1806||Hydroxychloroquine Sulfate Regular dose Wiki||0.32|
|drug1805||Hydroxychloroquine Sulfate Loading Dose Wiki||0.32|
|drug1060||Convalescent plasma Wiki||0.10|
|drug3728||Standard of Care Wiki||0.07|
|D020196||Trauma, Nervous System NIH||0.45|
|D000071257||Emergence Delirium NIH||0.45|
|D013896||Thoracic Diseases NIH||0.32|
|D001927||Brain Diseases NIH||0.20|
|D006333||Heart Failure NIH||0.13|
|D006331||Heart Diseases NIH||0.12|
|D016638||Critical Illness NIH||0.11|
|D002318||Cardiovascular Diseases NIH||0.08|
|D011024||Pneumonia, Viral NIH||0.05|
|D012127||Respiratory Distress Syndrome, Newborn NIH||0.04|
|D055371||Acute Lung Injury NIH||0.04|
|D012128||Respiratory Distress Syndrome, Adult NIH||0.03|
There are 5 clinical trials
Title: Guided Occupational Therapist (OT) Cognitive Interventions for Critically Ill Patients Short Title: GOTCI Methodology: Randomized Control Trial Study Duration: 12-15 months Study Centre: Single Center - South Health Campus, ICU, Calgary, Alberta, Canada Objectives: The aim for this study is to evaluate the effect of specific OT guided cognitive interventions on delirium in adult critically ill patients. Number of Subjects: 112 Primary Outcome: Delirium Prevalence and Duration Secondary Outcomes: Cognitive function, physical function, quality of life, ICU length of stay, hospital length of stay and days of mechanical ventilation. Inclusion Criteria: Adult Critically Ill Patients admitted to South Health Campus ICU, Calgary, Alberta Type of Intervention: OT guided cognitive intervention based on RASS score Dose: One on one therapeutic sessions with an OT. Five days a week, Monday to Friday, between 0800-1600. There will be twice daily sessions for 20 minutes each. Duration of administration: Cognitive Therapy to be initiated Monday to Friday, for the duration of participant ICU admission. Reference therapy: Standard of care within the Department of Critical Care Medicine in Calgary is delirium prevention strategies using the ABCDEF bundled approach. Statistical Methodology: Descriptive statistics (mean, median, proportion) will be employed to describe the study population. The primary outcome of delirium prevalence will be explored using multivariable logistic regression, which will provide an estimate of the odds ratio and accompanying 95% confidence intervals. Both per protocol and intent to treat analyses will be performed.
Description: Ever Delirium: Measured using the Intensive Care Delirium Screening Checklist (ICDSC). If the patient has a positive score in the ICDSC at any point during the patient's ICU stay then the patient is considered to have delirium and qualifies for Ever Delirium. Delirium Duration: Number of days the patient has a positive score on the ICDSC. This does not have to be consecutive days.Measure: Delirium Prevalence and Duration Time: From date of patient enrolment to ICU discharge, an average of 6.7 days.
Description: Johns Hopkins Adapted Cognitive Exam (ACE) o The Adapted Cognitive Exam is the first valid and reliable examination for the assessment and quantification of cognition in critically ill patients. It provides a useful, objective tool that can be used by any member of the interdisciplinary critical care team to support clinical assessment and research efforts.Measure: Cognitive Function Time: Measured within 24 hours of patient ICU admission and again after the treatment period is completed which is an average of 6.7 days.
Description: Dates will be obtained from electronic medical charts. I.e. Sunrise Clinical Manager.Measure: ICU length of stay Time: ICU admission date to ICU discharge date is the time the patient will be given the treatment which is an average of 6.7 days.
Description: The Functional Status Score for the ICU (FSS-ICU). The Functional Status Score for the ICU (FSS-ICU) is an assessment of physical function specifically designed for ICU patients. It is scored based on 5 mobility domains (rolling in bed, lying to sitting, sitting balance, sitting to standing and walking) and the level of assistance the patient requires to complete the task. Each item is out of 7, with total scores ranging from 0-35 and a high score correlating to high function. The FSS-ICU has good validity when compared to other functional measures in the ICU, it has been demonstrated to have good interrater reliability and has minimal floor and ceiling effect.Measure: Physical Function Time: Measured within 48 hours of ICU admission and again after the treatment period is completed which is an average of 6.7 days.
Description: The 5 Level EQ 5D version is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal (Van Reenan & Janssen, 2015). It covers five dimensions; mobility, self-care, usual activities, pain/discomfort and anxiety/depression which are measured with one of five response options (no problems, slight problems, moderate problems, severe problems, and extreme problems). A total of 3125 possible health states is defined in this way. Each state is referred to in terms of a 5 digit code. For example, state 11111 indicates no problems on any of the 5 dimensions, while state 12345 indicates no problems with mobility, slight problems with washing or dressing, moderate problems with doing usual activities, severe pain or discomfort and extreme anxiety or depression (Reenan & Janssen, 2015, p. 9). The EQ5D-5L also includes a visual analog scale to measure health state (0-100).Measure: Quality of Life using the EQ5D-5L (EuroQual 5 Dimensions-5 Levels). This is a health quality of life measure assessing five domains; mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Time: Measured after the treatment period is completed (within 24 hours of discharge) which is an average of 6.7 days.
Description: Dates will be obtained from electronic medical charts. i.e. MetavisionMeasure: Days of Mechanical Ventilation Time: Measured on day 1 of mechanical ventilation through to day of extubation (cessation of mechanical ventilation), an average of 4 days.
Description: Date of hospital admission and discharge will be obtained from electronic medical chart. i.e. Sunrise Clinical Manager.Measure: Length of Hospital Stay Time: Up to 6 months
A continuous infusion of Dexmedetomidine (DEX) will be administered to 80 patients admitted to Critical Care because of signs of Respiratory Insufficiency requiring non-invasive ventilation. Measurements of respiratory performance and quantification of cellular and molecular inflammatory mediators. The primary outcome will be the avoidance of mechanical ventilation with secondary outcomes duration of mechanical ventilation, avoidance of delirium after sedation and association of mediators of inflammation to outcomes. Outcomes will be compared to a matched historical control (no DEX) series
Description: (Presence/Absence) requirement of mechanical ventilationMeasure: Mechanical ventilation Time: expected within first three days (non conclusive due to lack of evidence yet)
Description: Duration of mechanical ventilation if it is required (hours from the start)Measure: Duration of mechanical ventilation Time: expected within first seven days (non conclusive due to lack of evidence yet)
Description: Delirium criteria as defined in DSM-4Measure: Delirium on recovery from sedation Time: First 24 hours after retiring dexmedetomidine sedation
Delirium and acute neurocognitive impairment are increasingly observed in adult and pediatric patients with COVID-19. Prospective clinical studies combining clinical and laboratory examinations including specific biomarkers of neuroaxonal injury were not performed for COVID-19. The value of biomarkers of neuroaxonal injury was proven in preliminary studies. These biomarkers could thus contribute to the systematic detection of neurocognitive impairment in patients with COVID-19. Due to worldwide increasing numbers of hospitalized patients with COVID-19, biomarkers of neuroaxonal injury are highly valuable to detect and monitor cognitive impairment, especially with regard to limited resources available to perform time-consuming brain imaging. Biomarkers of neuroaxonal injury are therefore not only of great interest to detect neurocognitive impairment but also to quantify the severity of brain injury in patients with COVID-19.
Description: Assessment of neurocognitive impairment using validated toolsMeasure: Incidence of delirium/neurocognitive impairment in adult and pediatric patients with COVID-19 compared to patients without COVID-19 Time: Day 90
Description: Measurement of biomarker levels (e.g. NSE, S100B, neurofilament proteins) derived from blood samplesMeasure: Change in neuroaxonal injury biomarker levels in patients with COVID-19 compared to patients without COVID-19 Time: Change from baseline biomarker levels at day 28
Description: Assessment of the neurocognitive performance of patients using validated tests (e.g. Short Blessed Test)Measure: Neurocognitive 3-months outcome in patients with COVID-19 compared to patients without COVID-19 Time: Day 90
Description: Assessment of the change in the neurocognitive performance of patients using validated tests (e.g. IQCODE)Measure: Neurocognitive 3-months outcome in patients with COVID-19 compared to patients without COVID-19 Time: Change from baseline IQCODE results at day 90
Description: Assessment of the overall quality of life using validated tests [e.g. Modified Rankin Scale with a range from 0 (no symptoms) to 6 (dead)]Measure: Quality of life in patients with COVID-19 compared to patients without COVID-19 after hospital discharge Time: Day 90
Description: Cumulative days in hospitalMeasure: Length of hospital stay in patients with COVID-19 compared to patients without COVID-19 Time: 1 year
Description: Survival after 90 daysMeasure: 90-day survival in patients with COVID-19 compared to patients without COVID-19 Time: Day 90
The primary purpose of this research is to determine whether Valproate alone, and in combination with Quetiapine, lowers confusion and agitation in persons with severe Corona Virus Disease (COVID)19 pneumonia during weaning from the breathing machine (ventilator). Though Valproate and Quetiapine are often given to persons with severe confusion with agitation, the purpose of this small research study is specifically for: a) persons infected with COVID 2019 on a ventilator whose agitation is not responding to the usual medications (like dexmedetomidine), and b) to reduce the time persons are treated with dexmedetomidine, which requires continuous close monitoring in an ICU.
Description: Richmond Agitation Sedation Scale (RASS) score ranges from +4 (combative) to 0 (alert & calm) to -5 (unarousable).Measure: Change from baseline RASS score of +3 or greater Time: Baseline, Day 7
Description: Total dose of dexmedetomidine administered will be reported from baseline RASS score of +3 or greater.Measure: Total dose of dexmedetomidine administered Time: Day 7
Description: Incidence of Treatment Emergent Adverse Events will include: QTc duration > 470 msecs. Increase in Liver Function Tests to a Grade 3 or higher using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. Suicidality reported as having a score of moderate or high risk using the Columbia-Suicide Severity Rating Scale Screening (C-SSRS). C-SSRS is a calculated risk assessment tool that scores suicidality from no risk to high risk.Measure: Incidence of Treatment Emergent Adverse Events Time: Day 7
Patients are part of a family network. When any person in a family becomes critically unwell and requires the assistance of an Intensive Care Unit (ICU), this has an impact on all members of that family. COVID-19 changed visiting for all patients in hospitals across Scotland. It is not known what effect these restrictions will have on patients' recovery, nor do we understand the impact it may have on their relatives or staff caring for them. This study will look at the implications of the visiting restrictions as a consequence of the COVID-19 pandemic upon patients without COVID-19 who are in the cardiothoracic ICU. It will also explore the impact of these restrictions on them, their relatives and staff. This study will be carried out within a single specialised intensive care unit in Scotland using mixed methods. The first arm of this study will use retrospective data that is routinely collected in normal clinical practice. The investigators will compare patient outcomes prior to COVID-19 with outcomes following the implementation of COVID-19 visiting restrictions. The aim is to establish if the restrictions on visiting has an impact on the duration of delirium. Delirium is an acute mental confusion and is associated with longer hospital stays and worse outcomes in this patient group. The second arm of this study involves semi-structured interviews with patients, relatives and staff that will allow deeper exploration of the issues around current visiting policy. The interviews will last approximately 1 hour and will address these issues. They will then be transcribed word for word and analysed using grounded theory, meaning the theories will develop from the data as it is analysed.
Description: Number of days patient found to have delirium using the Confusion Assessment Method for the ICU (CAM-ICU)Measure: Duration of delirium Time: From the date of admission to the Intensive Care Unit (ICU) until discharge from the ICU or death, whichever came first, up to 12 months.
Description: CAM-ICUMeasure: Incidence of delirium Time: From the date of admission to the Intensive Care Unit (ICU) until discharge from the ICU or death, whichever came first, up to 12 months.
Description: DaysMeasure: Length of critical care stay Time: From the date of admission to the ICU until discharge from the ICU or death, whichever came first, up to 12 months.
Description: DaysMeasure: Length of hospital stay Time: From the date of admission to the hospital until discharge from the hospital or death, whichever came first, up to 12 months.
Description: DaysMeasure: Length of time ventilated Time: From the date of admission to the ICU until discharge from the ICU or death, whichever came first, up to 12 months.
Description: Semi structured interviewsMeasure: Exploring the experiences of patients, relatives and staff of the visitation restrictions during the COVID-19 pandemic Time: 18 months
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports