|drug783||Chloroquine or hydroxychloroquine Wiki||0.26|
|drug82||ADAM Sensor Wiki||0.19|
|drug338||Attention Control Group Wiki||0.19|
|drug1854||Lopinavir / Ritonavir Pill Wiki||0.19|
|drug103||ARCT-021 Dose Regimen 1 Wiki||0.19|
|drug78||ACT-541478 30 mg Wiki||0.19|
|drug62||AAZ Covid-19 rapid test Wiki||0.19|
|drug1632||Immunofluorescence Imaging Wiki||0.19|
|drug60||A short video intervention Wiki||0.19|
|drug100||ARCT-021 Dose 2 Wiki||0.19|
|drug2049||Mindful Self-Compassion Wiki||0.19|
|drug2547||Placebo injection Wiki||0.19|
|drug153||Acacia Senegal Wiki||0.19|
|drug81||ACT-541478 high or low dose (or placebo) Wiki||0.19|
|drug2395||PHQ-9 Depression Scale Wiki||0.19|
|drug1421||Group Lifestyle Balance™ Wiki||0.19|
|drug2234||Non-Heated Vest Wiki||0.19|
|drug75||ACT-541478 10 mg Wiki||0.19|
|drug638||COVID-19 PCR Wiki||0.19|
|drug2230||Non interventional study Wiki||0.19|
|drug76||ACT-541478 100 mg Wiki||0.19|
|drug726||Cannabis, Medical Wiki||0.19|
|drug102||ARCT-021 Dose 4 Wiki||0.19|
|drug1361||GAD-7 General anxiety disorder scale Wiki||0.19|
|drug1799||LSALT peptide Wiki||0.19|
|drug3162||Sodium bicarbonate Wiki||0.19|
|drug104||ARCT-021 Dose Regimen 2 Wiki||0.19|
|drug3953||mRNA in urine test Wiki||0.19|
|drug77||ACT-541478 1000 mg Wiki||0.19|
|drug101||ARCT-021 Dose 3 Wiki||0.19|
|drug1458||Heated Vest Wiki||0.19|
|drug3573||Ultrasound lung imaging as part of FAST+ evaluation Wiki||0.19|
|drug79||ACT-541478 300 mg Wiki||0.19|
|drug269||Antibody testing Wiki||0.19|
|drug80||ACT-541478 dose E1 Wiki||0.19|
|drug99||ARCT-021 Dose 1 Wiki||0.19|
|drug44||38-questions questionnaire Wiki||0.19|
|drug2166||Nebulised heparin Wiki||0.19|
|drug8||0.9% Sodium-chloride Wiki||0.19|
|drug61||A vignette intervention Wiki||0.19|
|drug937||Covid-19 Standard of Care Wiki||0.19|
|drug1848||Liver injury Wiki||0.19|
|drug290||Apramycin injection Wiki||0.19|
|drug1787||L-ascorbic acid Wiki||0.13|
|drug1549||Hydroxychloroquine Sulfate Regular dose Wiki||0.13|
|drug557||Brief cognitive intervention Wiki||0.13|
|drug1548||Hydroxychloroquine Sulfate Loading Dose Wiki||0.13|
|drug1978||Matching placebo Wiki||0.11|
|drug3257||Standard treatment Wiki||0.08|
|drug895||Convalescent Plasma Wiki||0.04|
|drug3221||Standard of Care Wiki||0.03|
|D058186||Acute Kidney Injury NIH||0.32|
|D013119||Spinal Cord Injuries NIH||0.23|
|D001930||Brain Injuries, NIH||0.22|
|D055370||Lung Injury NIH||0.21|
|D000070642||Brain Injuries, Traumatic NIH||0.20|
|D000070627||Chronic Traumatic Encephalopathy NIH||0.19|
|D013226||Status Epilepticus NIH||0.19|
|D002543||Cerebral Hemorrhage NIH||0.19|
|D013345||Subarachnoid Hemorrhage NIH||0.19|
|D005879||Tourette Syndrome NIH||0.19|
|D015428||Myocardial Reperfusion Injury NIH||0.19|
|D015427||Reperfusion Injury NIH||0.19|
|D000690||Amyotrophic Lateral Sclerosis NIH||0.13|
|D000755||Anemia, Sickle Cell NIH||0.13|
|D000068099||Trauma and Stressor Related Disorders NIH||0.13|
|D016472||Motor Neuron Disease NIH||0.13|
|D001714||Bipolar Disorder NIH||0.13|
|D000067073||Psychological Trauma NIH||0.11|
|D040921||Stress Disorders, Traumatic NIH||0.10|
|D013313||Stress Disorders, Post-Traumatic NIH||0.10|
|D001927||Brain Diseases NIH||0.09|
|D055371||Acute Lung Injury NIH||0.08|
|D012128||Respiratory Distress Syndrome, Adult NIH||0.07|
|D015212||Inflammatory Bowel Diseases NIH||0.07|
|D003424||Crohn Disease NIH||0.06|
|D019966||Substance-Related Disorders NIH||0.06|
|D059350||Chronic Pain NIH||0.06|
|D009103||Multiple Sclerosis NIH||0.05|
|D001523||Mental Disorders NIH||0.04|
|D002318||Cardiovascular Diseases NIH||0.03|
|D045169||Severe Acute Respiratory Syndrome NIH||0.03|
|D016638||Critical Illness NIH||0.02|
|D018352||Coronavirus Infections NIH||0.02|
|D003141||Communicable Diseases NIH||0.01|
|HP:0001919||Acute kidney injury HPO||0.30|
|HP:0006802||Abnormal anterior horn cell morphology HPO||0.19|
|HP:0002133||Status epilepticus HPO||0.19|
|HP:0002138||Subarachnoid hemorrhage HPO||0.19|
|HP:0001342||Cerebral hemorrhage HPO||0.19|
|HP:0007354||Amyotrophic lateral sclerosis HPO||0.19|
|HP:0002037||Inflammation of the large intestine HPO||0.07|
|HP:0012532||Chronic pain HPO||0.06|
|HP:0100280||Crohn's disease HPO||0.06|
|HP:0001626||Abnormality of the cardiovascular system HPO||0.03|
There are 29 clinical trials
The purpose of this RCT is to examine the efficacy of a Group Lifestyle Balance™ (GLB) program adapted for people with traumatic brain injury (TBI) on primary (weight) and secondary outcomes at 3, 6, 12, and 18 months from enrollment into the program.
Description: Weight will be obtained using the same scale over the study period that is accessible to people with and without a mobility device (e.g. walker; wheelchair)Measure: Change in weight Time: Baseline, 3 months, 6, months, 12 months, and 18 months
Description: The Garmin Vivofit will be worn for the study duration to measure physical activity data.Measure: Step Count Time: 3 months, 6 months, 12 months, and 18 months
Description: Waist circumference will be measured at the umbilicus and mild-upper arm circumference following American College of Sports Medicine guidelines.Measure: Waist and Arm Circumference Time: Baseline, 3 months, 6 months, 12 months, and 18 months
Description: Using an automatic cuff (average of three readings, patient seated) diastolic and systolic scores will be recorded.Measure: Blood Pressure Time: Baseline, 3 months, 6 months, 12 months, and 18 months
Description: Fasting venous sample will be obtained for blood glucose, HDL/LDL, cholesterol, and triglyceride level.Measure: HbA1c and Lipid Panel Time: Baseline, 3 months, 6 months, 12 months, and 18 months
Description: The Framingham Heart Study diabetes risk score will be calculated using predictors including age, gender, fasting glucose, body mass index, HDL cholesterol and triglyceride levels, blood pressure, and parental history. Risk score calculator and regression model are free and used in GLB weight-loss trials. Each risk predictor is assigned points ranging from. Risk factors are combined and a total score is calculated, with higher scores designating greater 8-year risk.. The age range for this score is 45 years or older, and therefore only individuals over this age will have calculated scores. Furthermore, the minimum cut-off score is 3.Measure: Risk of Diabetes Time: Baseline, 3 months, 6 months, 12 months, and 18 months
Description: Satisfaction with life will be measured using the Satisfaction with Life Scale (SWLS). The SWLS is a 5-item scale designed to measure global cognitive judgements of one's life satisfaction. Participants indicate how much they agree or disagree with each of the 5 items using a 7-point scale that ranges from 7-strongly agree to 1-strongly disagree. Scores are added together and a total score is calculated, with higher scores signifying higher satisfaction with life and lower scores signifying lower satisfaction with life.Measure: Satisfaction with Life Time: Baseline, 3 months, 6 months, 12 months, and 18 months
Description: TSH, Cortisol, IL-6, THNF, BDNF, IGF, and VEGF will be collected.Measure: Biomarkers Time: Baseline, 3 months, 6 months, 12 months, and 18 months
Description: Assesses walking speed in (m/s) which is correlated to mobility in the community, capacity to perform ADLs, risk of falls, re-hospitalization, and risk of cognitive decline.Measure: 10 Meter Walk Test (10MWT) Time: Baseline, 3 months, 6 months, and 12 months
Description: Assesses distance walked (rolled for wheelchair users) over 6 minutes as a sub-maximal test of aerobic capacity.Measure: 6 Minute Walk Test (6MWT) Time: Baseline, 3 months, 6 months, and 12 months
Description: Social Support for Diet and Exercise Behaviors Scale is a 23-item survey including four subscales: support for healthy eating (5 items); support for physical activity (11 items); social undermining for healthy eating (5 items) and physical activity (2 items). Each item is rated on a scale of 1 to 5 (1 none; 5 very often), with respondents asked to rate support from family, friends, and coworkers. Higher scores represent greater support and internal consistency ranged from Cronbach's α 0.72-0.76.Measure: Social Support assessed by the Social Support for Diet and Exercise Behaviors Scale Time: Baseline, 3 months, 6 months, 12 months, and 18 months
Description: The Feasibility and Usability survey includes 14 items that assesses the participant's subjective experience with the App, level of difficulty, prompting sequence, length, and understanding. Scores above 3 on the scale (1 [totally disagree] - 5 [totally agree]) indicate that the App was easy to use.Measure: App Feasibility and Usability using the Feasibility and Usability Survey Time: 6 months, 12 months, and 18 months
Description: NEWS assesses residents' perception of neighborhood design features, categorized into subscales related to physical activity, including residential density, land use mix (including both indices of proximity and accessibility), street connectivity, infrastructure for walking/cycling, neighborhood aesthetics, traffic and crime safety, and neighborhood satisfaction. Subscales are scored as a mean of items. Higher scores denote higher walkability.Measure: Neighborhood Walkability assessed by the Neighborhood Environment Walkability Scale (NEWS) Time: Baseline and 12 months
Description: Measure includes 28 items that assess health practices among people with disabilities and yields a total Health Practices score plus 4 subscales scores regarding Exercise, Nutrition, Health Practices, and Psychological Well Being. Items are rated on a 5-point scale from 0 'not at all' to 4 'completely.' Scores range from 0-28 with higher scores indicating higher exercise self-efficacy.Measure: Self-Reported Activities of Health using the Self-Reported Activities of Health for Health Promotion Scale Time: Baseline, 12 months, and 18 months
Description: This inventory consists of 40 life events and asks the participant to recall if any of the events happened within the previous year (e.g., death of spouse; personal illness; change in sleep). Endorsement of these events are totaled and higher scores indicate a greater amount of stressful life events. Point values for the Holmes and Rahe Stress Inventory were weighted and summed for each individual based on scoring instructions. Individuals who scored 150 points or less were categorized as low susceptibility to a health breakdown in the next two years, 151-300 points were 50% chance of health breakdown, and 301 points or more were 80% chance of health breakdown.Measure: Stressful Life Events assessed by the Holmes and Rahe Stress Inventory Time: Baseline, 3 months, 6 months, 12 months, and 18 months
Description: The GLB TBI/Attention Control groups will both use this app. Usage and engagement will be collected.Measure: App Data Time: 6 months, 12 months, and 18 months
Description: The MOCA is a brief, 8-section assessment of various cognitive domains including executive function, memory, language, attention, concentration, orientation, and working memory in neurologic populations. Each item on the MOCA is allocated a set of points adding up to 30.Measure: Executive Function assessed by the Montreal Cognitive Assessment Time: Baseline, 3 months, and 12 months
Description: Self-Report Habit Index measures self-reported perceptions of habit strength for an identified behavior. The measure has high internal reliability across four studies. The measure consists of 12 items using a 7-point Likert scale ranging from "completely disagree" to "completely agree", with higher scores representing greater perception of habit strength.Measure: Self-reported perceptions of habit strength assessed by the Self-Report Habit Index (SRHI) Time: Baseline, 3 months, and 12 months
Description: The PHQ-8 is a brief self-report measure of major depressive disorder, derived from the PHQ-9 by removing the last question regarding suicide assessment.It is considered to be a valid measure of depression for population-based studies and clinical populations, and has been used in studies of patients with physical injury. Frequency of symptoms during the last 2 weeks is assessed on a 0 (not at all) to 3 (nearly every day) scale. A cut-off score of 10 or greater is considered diagnostic for current depressionMeasure: Depression assessed using the Patient Health Questionnaire-8 item Time: Baseline, 12 months, and 18 months
Description: Walk Score is publically available and measures walkability of any address using a patented system. Fore each address, Walk Score analyzes hundreds of walking routes to nearby amenities and awards points based on distance to each amenities. Scores are given on a scale of 0 to 100.Measure: Walk Score Time: Baseline and 12 months
Description: The BAST is a 47 item, theoretically grounded, validated survey of behavioral and emotional symptoms for community-based adults with TBI. This assessment is a shortened version of the validated 77-item survey, with questions related to environmental stressors and mood removed due to repetitiveness to other questions in survey packet. Responses are asked over the past two weeks using an ordinal scale from 0 "rarely" to 5 "very often." There are 6 subscales: Negative Affect, Substance Use, Executive Function, Fatigue, Impulsivity, and Maladaptive Coping. Higher scores indicate more symptoms in those domains. This measure will be used to characterize behavioral/emotional symptoms and to explore whether these are factors that influenceMeasure: Behavioral Assessment Time: Baseline and 6 months
Description: The ten items from the General Self-Efficacy Scale (GSE) are deigned to examine goal-setting, effort investment, persistence in face of barriers and recovery from setbacks as constructs of perceived self-efficacy. The total score is the sum ranging from 10-40 and the instrument has been normed against the U.S. Adult population with a mean score of 29.48.Measure: General Self Efficacy Time: Baseline, 12 months, and 18 months
Description: The BRFSS is a state-based system of health surveys that collects information on health risk behaviors, preventative health practices, and health care access primarily related to chronic disease and injury. The GLB-TBI uses the two subscales of Healthy Eating and Physical Activity from the 2017 version of the BRFSS. It consists of 14 items.Measure: Behavioral Risk Factor Surveillance Time: Baseline, 3, 6, 12, and 18 months.
Description: This is an FDA cleared and validated indirect calorimetry device. It is handheld and measures oxygen consumption (V02) to determine resting metabolic rate (RMR)Measure: MedGem Time: Baseline
Description: The metabolic score calculator will be used at all time points to determine the risk for metabolic syndrome. The following variables will be used to determine metabolic risk using the free metabolic risk calculator: gender, race and ethnicity, systolic blood pressure, fasting glucose, triglycerides, high-density lipoprotein (HDL), weight, height, and waist circumference. Scores are calculated are standardized to the general population.Measure: Metabolic Score Calculator (MetS) Time: Baseline, 3, 6, 12, and 18 months
Description: Information on substance use will be collected using the AUDIT-C (for alcohol use) and three questions regarding tobacco and non-prescriptive drug use.Measure: Substance Use Time: Baseline, 12 months
Description: This self-report survey was developed by the National Institute of Mental Health. The full survey consists of 64 questions with an open-ended section at the end to elicit concerns and feedback related to the effects of COVID-19. For this current study, however, only sections on Exposure Status (10 items), Life Changes (15 items), and Emotions/Worries (7 items), and the open-ended question will be asked. Questions are asked "over the past two weeks."Measure: CRISIS (CoRonavIruS Health Impact Survey) V0.3 Adult Baseline Form Time: Up to 12 months
Description: The Social Isolation Short-Form 4a is taken from the Patient-Reported Outcomes Measurement Information System (PROMIS). This form assesses the perceptions of being "avoided, excluded, detached, disconnected from, or unknown by, others. There is no timeframe for the form. The measure is normed to the US population.Measure: PROMIS Social Isolation Short Form 4a Time: Up to 12 months
Description: To assess media exposure and fear of media exposure during COVID-19 we have added 6 questions. These are asked "over the past two weeks." These questions address time spent watching the television, listening to radio, reading the newspaper, and searching the internet and social media. In addition, a 6th question related to fear is asked using a 5-point Likert scale.Measure: Media Questionnaire Time: Up to 12 months
Persons with higher levels of spinal cord injury (above the 2nd thoracic vertebrae; tetraplegia) are unable to maintain normal core body temperature (Tcore) when exposed to cool environments. In persons with tetraplegia, even limited exposure to cool temperatures may cause Tcore to approach hypothermic values and impair cognitive performance. Conversely, an increase in Tcore from subnormal to normal range may improve cognitive performance. Prior work has shown that cool seasonal temperatures have an adverse effect on personal comfort and the ability to perform vital daily activities of self-care in persons with tetraplegia. Interventions that address the vulnerability to hypothermia are limited. A self-regulating heated vest designed specifically for persons with tetraplegia is a novel and promising strategy to address this problem. By more effectively maintaining Tcore, the vest can decrease the adverse impact of cool temperatures on comfort, quality of life, and performance of vital daily tasks for Veterans with tetraplegia during the cooler seasons.
Description: Tcore will be continuously monitored throughout baseline and thermal challenge periods (with heated & non-heated vests) by a TX-2 Rectal probe and Iso-Thermex Multichannel Thermometer (Columbus Instruments, Columbus, OH). The probe will be placed 10 cm beyond the anal sphincter.Measure: Change in Core Body Temperature (Tcore) Time: Visits 2 & 3 (subjects with tetraplegia only): Continuously throughout baseline & Thermal Challenge (2 hrs) periods. The change in Tcore from baseline to the end of Thermal Challenge will be determined.
Description: The cognitive battery will be administered once at BL and once after Thermal Challenge in persons with tetraplegia only (Visits 2 & 3). Testing conditions will be identical, quiet, and distraction-free. Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV): Subjects will be asked to repeat 2-9 numbers forward, backward and in ascending order to assess attention, processing speed, and working memory. Each assessment requires 10 min.Measure: Change in Cognitive Performance: WAIS-IV Time: Visits 2 & 3 (subjects with tetraplegia only): At the end baseline (at 15 min) & end of Thermal Challenge (at 120 min) periods. The change in cognitive performance from baseline to the end of Thermal Challenge will be determined.
Description: Delayed Recall section of the Montreal Cognitive Assessment (MoCA): Subjects will be asked to repeat 5 simple words immediately and then recall them after a 5-minute delay to assess working memory. Each assessment requires 6 min.Measure: Change in Cognitive Performance: Delayed Recall Time: Visits 2 & 3 (subjects with tetraplegia only): At the end baseline (at 15 min) & end of Thermal Challenge (at 120 min) periods. The change in cognitive performance from baseline to the end of Thermal Challenge will be determined.
Description: Stroop Color and Word: Subjects will be asked to read words of colors, colors of fonts to assess attention and processing speed; color of fonts of words which describe conflicting colors to assess response inhibition (executive functioning). Subjects will practice each of the assessments for approximately 10 seconds prior to the actual test to ensure understanding of the instructions. Each assessment requires 4 min.Measure: Change in Cognitive Performance: Stroop Time: Visits 2 & 3 (subjects with tetraplegia only): At the end baseline (at 15 min) & end of Thermal Challenge (at 120 min) periods. The change in cognitive performance from baseline to the end of Thermal Challenge will be determined.
Description: Thermal Comfort will be measured every 10 minutes throughout BL and thermal challenge periods by the Zhang 6-point thermal comfort scale: +3 (very comfortable), +2 (comfortable), +1 (just comfortable), -1 (just uncomfortable), -2 (uncomfortable), and -3 (very uncomfortable). A greater frequency of +1, +2, and +3 scores are considered more desirable than -1, -2, and -3 scores during the Thermal Challenge. Each assessment requires only the time needed for the subject to respond (typically less than 10 seconds).Measure: Change in Thermal Comfort (TC) Time: Visits 1, 2, & 3 (all subjects): During baseline & every 10 minutes throughout Thermal Challenge (2 hrs). The change in TC from baseline to the end of Thermal Challenge will be determined.
Description: Skin thermocouples (TX-4 Skin Surface probes, Columbus Instruments, Columbus, OH) will be taped to 12 sites on the anterior trunk. Tsk data will be collected continuously throughout the baseline (BL) and Thermal Challenge periods. All areas under the vest will have skin temperatures less than or equal to 39 degrees C.Measure: Change in Skin Temperature (Tsk) under the heated vest Time: Visits 2 & 3 (all subjects): Continuously throughout baseline (15 min) & Thermal Challenge (2 hrs) periods. The change in Tsk from baseline to the end of Thermal Challenge will be determined.
Description: Thermal sensation will be measured on the Zhang 9-point Thermal Sensation scale: +4 (very hot), +3 (hot), +2 (warm), +1 (slightly warm), 0 (neutral), -1 (slightly cool), -2 (cool), -3 (cold), and -4 (very cold). TS should be no greater than "warm" this would include identification of "hot spots". Each assessment requires only the time needed for the subject to respond (typically less than 10 seconds).Measure: Change in Thermal Sensation (TS) Time: Visit 1 (able-bodied subjects only): During baseline & every 10 minutes throughout Thermal Challenge (2 hrs). The change in TS from baseline to the end of Thermal Challenge will be determined.
Veterans with co-occurring Posttraumatic Stress Disorder and Substance Use Disorder (PTSD-SUD) experience more severe symptomatology and poorer response to existing treatments than Veterans with either disorder alone. Guilt is a common posttraumatic reaction and has been implicated as a risk factor for the development and maintenance of PTSD and substance use. Combat Veterans often report experiencing moral injury defined as perpetrating, failing to prevent, or witnessing acts that violate the values they live by in their civilian lives, which can lead to feelings of guilt and shame. Accordingly, reduction in guilt and increase in self-compassion may lead to improved quality of life for Veterans. This project will conduct a pilot study to evaluate changes in self-compassion, guilt, and PTSD-SUD symptom severity in a sample of Veterans after receiving 8 sessions of Mindful Self Compassion treatment (via a telehealth modality during COVID-19 pandemic). Findings will have significant impact on effective treatment options and lead to improvements in Veterans' quality of life and posttraumatic symptoms.
Description: The SCS is a 26-item self-report questionnaire in which respondents describe how they relate to themselves during times of distress. The SCS includes the 5 item Self-Kindness subscale (ranging from 5-25; higher scores reflect more self-kindness), the 5-item Self-Judgment subscale (ranging from 5-25; higher scores reflect more self-judgment), the 4-item Common Humanity subscale (ranging from 4-20; higher scores reflect higher levels of common humanity), the 4-item Isolation subscale (ranging from 4-20; higher scores indicate higher levels of isolation), the 4-item Mindfulness subscale (ranging from 4-20; higher scores reflect higher levels of mindfulness) and the 4-item Over-Identification subscale (ranging from 4-20). Responses are given on a 5-point scale from "1-Almost Never" to "5-Almost Always." Mean scores on the six subscales are then averaged to create an overall self-compassion score ranging from 26 to 130. Higher scores correspond to higher levels of self-compassion.Measure: Self-Compassion Scale (SCS); Change from baseline in Self-Compassion at post-treatment (2 mo) and follow up (3mo) Time: Baseline, 8-10 weeks, 12-14 weeks
Description: The TRGI is a 32-item validated self-report measure assessing traumatic guilt. The TRGI has three scales - Guilt Severity, Distress, and Guilt Cognitions. In all 32 items the answers are recorded on 5-point scale (ranging from 0 - not at all true to 4 - extremely true). Eight items are reverse-scored. We will use the TRGI as one of our eligibility criteria and to monitor changes in guilt and related cognitions over time.Measure: Trauma-Related Guilt Inventory (TRGI); Change from baseline in trauma-related guilt at post-treatment (2 mo) and follow up (3mo) Time: Baseline, 8-10 weeks, 12-14 weeks
Description: The ISS is a 30-item self-report measure assessing shame proneness scored on a 5-point Likert scale ranging from 0 = "never" to 4 = "almost always". The ISS yields sum scores for two subscales, self-esteem (6 items; range = 0-24 with higher scores reflecting higher levels of self-esteem) and internalized shame (24 items; range = 0-96 with higher scores reflecting higher levels of shame) and has been well-validated with research and clinical populations. The self-esteem items are interspersed to counteract a negative response set.Measure: Internalized Shame Scale (ISS); Change from baseline in shame at post-treatment (2 mo) and follow up (3mo) Time: Baseline, 8-10 weeks, 12-14 weeks
Description: The CAPS is a semi-structured interview used to assess PTSD diagnostic criteria and severity. Respondents select up to three of the most traumatic events they have experienced, and those events are used as the basis for assessing PTSD symptoms. The CAPS assesses each of the 20 items from the DSM-5 criteria B, C, D, and E. The assessor combines information about frequency and intensity of an item into a single severity rating (0=Absent; 1=Mild/subthreshold; 2=Moderate/threshold; 3=Severe/markedly elevated; 4=Extreme/incapacitating). CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms (range = 0-40). Similarly, CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms corresponding to a given DSM-5 cluster: Criterion B (items 1-5); Criterion C (items 6-7); Criterion D (items 8-14); and, Criterion E (items 15-20).Measure: Clinician Administered PTSD Scale for DSM-5; Change from baseline in PTSD symptoms at post-treatment (2 mo) and follow up (3mo) Time: Baseline, 8-10 weeks, 12-14 weeks
Description: The WHO-QOL BREF is a 26-item validated self-report measure that that assesses quality of life across four domains: physical (7 items, range 1-5), psychological (6 items, range 1-5), social relationships (3 items, range 1-5), and environment (8 items, range 1-5). The four domain scores denote an individual's perception of quality of life in each particular domain. The mean score of items within each domain is used to calculate the domain score. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). There are also two items that are examined separately: question 1 asks about an individual's overall perception of quality of life on a scale of 1 - "very poor" to 5 - "very good". Question 2 asks about an individual's overall perception of their health on a scale of 1 - "very dissatisfied" to 5 - "very satisfied". The WHO-QOL-BREF has excellent internal validity and test-retest reliability.Measure: Quality Of Life Enjoyment & Satisfaction Questionnaire (WHO-QOL-BREF); Change from baseline in quality of life at post-treatment (2 mo) and follow up (3mo) Time: Baseline, 8-10 weeks, 12-14 weeks
Description: The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking. The TLFB will be employed at all three assessment points to evaluate alcohol and other substance use during the 90 days preceding each interview. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period. The TLFB will be used at each follow-up to establish: percentage days heavy drinking, percent days abstinent, length of initial abstinence, length of use episodes, severity of relapse and current alcohol/drug use pattern. The Alcohol TLFB has been shown to have good psychometric characteristics with a variety of groups, and can generate variables that provide a wide range of information about an individual's use (e.g., pattern, variability, and magnitude of use).Measure: Timeline Follow-back; Change from baseline in frequency of substance use at post-treatment (2 mo) and follow up (3mo) Time: Baseline, 8-10 weeks, 12-14 weeks
Description: Beck Scale for Suicidal Ideation (BSSI): This scale is a 19-items instrument that evaluates the presence and intensity of suicidal thoughts in a week before evaluation (19). Each item is scored based on an ordinal scale from 0 to 2 and the total score is 0 to 38 with higher score indicating more risk for suicide.Measure: Beck Scale for Suicidal Ideation; Change from baseline in suicidal risk at post-treatment (2 mo) and follow up (3mo) Time: Baseline, 8-10 weeks, 12-14 weeks
This will be a multistate, multicenter clinical study to determine the efficacy and safety of medical cannabis for a wide variety of chronic medical conditions.
Description: Covid-19 infection rates in cannabis users will be compared to rates in the general population. Our online questionnaire responses will compare infection rates of cannabis users in this study against the Johns Hopkins University Coronavirus Research Center data (https://coronavirus.jhu.edu).Measure: Prevention of COVID-19 Time: Five years
Description: Severity of persistent symptoms in cannabis users testing positive for active infection and/or antibodies will also be compared to the general population. Patients will answer the widely used FLU-PRO questionnaire, which asks about flu symptoms and severity, to capture diagnoses, symptoms, and medical interventions related to COVID-19. The data from cannabis user patients will be compared with national and international data surveys, such as the Covid Symptom Study (https://covid.joinzoe.com/us-2).Measure: Treatment of COVID-19 Time: Five years
Description: The primary objective is to assess the efficacy and safety of medical cannabis as medicine for treatment of chronic pain and other chronic debilitating diseases. Pain will be measured by Brief Pain Inventory (BPI) numeric scale. Change from baseline in BPI will be assessed at 3-month intervals. For prospective associations between cannabis use and outcomes, use of a lagged mixed-effects models will examine temporal associations between cannabis use and pain severity, opioid sparing, and patient satisfaction. Data will be analyzed from baseline and the annual follow-up waves.Measure: Treatment of Symptoms Time: Five years
Description: Secondary objectives include evaluating increases or decreases in quality of life, and increases or decreases in concomitant opioid use. Satisfaction with treatment will be measured by a Visual Analog Score (VAS). Change From baseline in Satisfaction with treatment measured by (VAS) be assessed at 3-month intervals.Measure: Cannabis Impact on Quality of Life Time: Five years
Description: Tertiary objectives will examine preferences for routes of administration, and preferences for THC / CBD ratios. Categorical factors will be summarized using frequencies and percentages, while continuous measure distributions will be described using means, standard deviations, and quartiles of interest.Measure: Cannabis Route and Dosing Time: Five years
Description: Incidence of Treatment-Related Adverse Events will be measured by Physician Global Assessment (PGA) numeric scale. Number of participants with Treatment-Related Adverse Events will be assessed by CTCAE v4.0.Measure: Monitoring Adverse Events Time: Five years
This will be a prospective observational trial to better understand the range and variation associated with bone/soft tissue perfusion in fracture patients and examine the relationship between perfusion, measured using quantitative Indocyanine green (ICG) fluorescence and complications such as surgical site infection (SSI), persistent SSI, and fracture nonunion.
Description: Post-procedure surgical site infection using CDC criteria will be documented at each follow-up appointment up to six monthsMeasure: Post procedure surgical site infection Time: six months
Description: All unplanned reoperations will be documentedMeasure: Unplanned fracture-related reoperation Time: six months
The kidney may be affected in coronavirus-2019 disease (COVID-19). This study assessed the predictors and outcomes of acute kidney injury (AKI) among individuals with COVID-19.
Description: the incidence of Acute Kidney InjuryMeasure: Rate of Acute Kidney Injury Time: From date of admission until the date of discharge or death from any cause, up to 60 days
Description: death from any cause in the hospitalMeasure: Rate of Death Time: From date of admission until the date of death from any cause, up to 60 days
Description: days from admission to discharge or deathMeasure: the length of hospital stay Time: From date of admission until the date of discharge or death from any cause, up to 60 days
The current COVID-19 pandemic is providing healthcare organizations with considerable challenges and opportunities for rapid cycle improvement efforts, in diagnostic and patient management arenas. Healthcare providers are tasked with limiting the use of personal protective equipment while minimizing unnecessary exposures to the virus. Results from real-time PCR tests to detect active COVID-19 infections may not be available in a timely fashion during emergent trauma assessments. Since the start of the COVID-19 pandemic, a rapidly expanding body of literature has identified a pattern of imaged lung abnormalities with CT and ultrasound (US) characteristic of an active viral infection. US evaluation provides a reliable, portable, and reproducible way of evaluating acute patients in a real time setting. During initial trauma evaluations, patients may also receive adjunct imaging modalities like the Focused Assessment with Sonography in Trauma (FAST) exam designed to discover life threatening findings that may require urgent interventions. We therefore propose a study expanding on the current FAST adjunct evaluation in the trauma bay that may include lung parenchyma imaging at the initial assessment to help stratify patients into low or high-risk groups for active COVID-19 infections. We believe the use of point of care US in the initial assessment of the trauma patient may help identify potentially infected individuals and aid ED providers to best directing subsequent laboratory and imaging evaluations for these patients, while further directing the necessary protective measures for additional team members involved in the care of the injured patient.
Description: Will correlate FAST+ pulmonary findings and published CT findings noted in active COVID infection to determine if FAST+ is a suitable diagnostic tool in detecting active COVID infection. Plan to use FAST+ imaging findings to stratify patients into low or high-risk COVID-19 infection groups.Measure: Correlation of FAST+ pulmonary findings with active COVID infection Time: 12 months
Description: Exploratory outcomes will focus on description of additional ancillary findings of the FAST+ examination in those patients who later are determined to be COVID-19 positive compared to those determined to be COVID-19 negative (e.g., patterns of pleural space disease).Measure: Description of additional ancillary findings of the FAST+ examination among infected and non-infected patients Time: 12 months
The primary objective of the study is to evaluate the days until reaching clinical stability after starting randomization in hospitalized patients with elevated inflammatory parameters and severe COVID-19 lung injury.
Description: Assess the days until clinical stability is achieved after initiating randomization in hospitalized patients with elevated inflammatory parameters and severe COVID-19 lung injury. Clinical stability is defined if all the following criteria are met for 48 consecutive hours: Body temperature ≤ 37.0ºC; PaO2 / FiO2> 400 and / or SatO2 / FiO2> 300; Respiratory rate ≤ 24 rpmMeasure: Time to reach clinical stability Time: 28 days
Description: daysMeasure: Time to reach an afebrile state for 48 hours. Time: 56 days
Description: daysMeasure: Time to reach PaO2 / FiO2> 400 and / or SatO2 / FiO2> 300 Time: 56 days
Description: daysMeasure: Time to reach FR ≤ 24 rpm for 48 hours Time: 56 days
Description: daysMeasure: Time to normalization of D-dimer (<250 ug / L) Time: 56 days
Description: daysMeasure: Time until PCR normalization (<5mg / L). Time: 56 days
Description: daysMeasure: Time until normalization of ferritin (<400ug / L) Time: 56 days
Description: viral loadMeasure: Study the impact of immunosuppressive treatment on viral load using quantitative PCR Time: 56 days
Description: daysMeasure: Time until hospital discharge Time: 56 days
Description: daysMeasure: Need for ventilatory support devices Time: 56 days
Description: daysMeasure: Duration that it is necessary to maintain ventilatory support. Time: 56 days
Description: daysMeasure: COVID-19 mortality Time: 56 days
Description: daysMeasure: all-cause mortality Time: 56 days
Description: cytokines quantification technique by LuminexMeasure: Analyze the expanded cytokine profile before the start of treatment and their evolution every 7 days after admission Time: 56 days
Description: IDIBELL Clinical Research and Clinical Trials Unit will oversee the monitoring and pharmacovigilanceMeasure: Describe the side effects and their severity attributed to tacrolimus and / or methylprednisolone. Time: 56 days
This study will test to see if a 72-hour intravenous vitamin C infusion protocol (100 mg/kg every 8 hours) in patients with hypoxemia and suspected COVID-19 will reduce the lung injury caused by the SARS-Cov-2.
Description: Documented days free off mechanical ventilation the first 28 days post enrollmentMeasure: Number of ventilator-free days Time: Up to 28 days
Description: Mortality at 28-days by all causesMeasure: All-cause-mortality Time: Up to 28 days
Description: Number of days free of acute inflammation (defined as CRP >= 10 mg/L)Measure: Acute-inflammation-free days Time: Up to 28 days
Description: Number of days that the participant is free of organ failure in ALL of the following organ systems: Cardiovascular, Respiratory, Neurological, Liver, Bone marrow organ, RenalMeasure: Organ-failure-free days Time: Up to 1 year
Coronavirus disease was first diagnosed in December 2019, in the city of Wuhan, China. The World Health Organization recently declared coronavirus disease 2019 (COVID-19) as a pandemic. The infection is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is a single-stranded RNA virus, which in humans causes mild respiratory symptoms and generally has a good prognosis. However, in a certain group of patients it manifests as severe pneumonia, respiratory distress syndrome, multiple organ dysfunction and death. The factors associated with a worse prognosis are older than 60 years, the presence of diabetes, cardiovascular disease and obesity. According to studies carried out in the Eastern world, the prevalence of liver injury in patients with COVID-19 disease varies between 14% and 53%, being more prevalent in patients with severe symptoms of COVID-19 disease. It is not really known whether the liver involvement of patients with SARS-CoV-2 infection is secondary to the direct effect of the virus on the liver. One of the mechanisms of action of SARS-CoV-2 is through the binding to the angiotensin-converting enzyme receptor, which is present in cholangiocytes, this could explain its excretion in faeces. However, liver injury could be due to the immune response generated in the body by the virus with systemic inflammatory response syndrome and the release of inflammatory cytokines such as IL6, generating direct cytopathic damage to the liver. On the other hand, it could be the product of hepatotoxic drugs administered during hospitalization, such as antibiotics, antivirals or non-steroidal anti-inflammatory drugs. Liver biopsy described microvacuolar steatosis, and a mild portal and lobular inflammatory infiltrate . Therefore, the aim this study is to assess the prevalence of liver complications (liver injury, decompensation of cirrhosis) in patients diagnosed with COVID-19 in Latin America. As secondary objectives, the investigators will describe the clinical characteristics of COVID-19 disease and identify risk factors associated with poor prognosis,
Description: Hospitalized patients with COVD-19 who developed liver injuryMeasure: Liver injury in patients with COVID-19 Time: through study completion, an average of 6 months
Description: Factors associated with worse outcomeMeasure: Prognostic factors associated with death Time: through study completion, an average of 6 months
Description: Description of patients hospitalized with COVID-19Measure: Clinical characteristics of patients who developed liver injury Time: through study completion, an average of 6 months
The authors hypothesize that the SARS-CoV-2 virus can affect the kidneys, causing them to be damaged. The present study aims to explain the mechanisms of kidney injury in patients diagnosed with COVID-19.
Description: estimated glomerular filtration rate (eGFR), ml/min, in groups with mild, moderate and severe COVID-19Measure: The effect of COVID-19 severity on the severity of renal failure Time: 2 months
Description: viral RNA concentration in urine, ME/mlMeasure: The expression of viral RNA in the urine with the severity of renal failure Time: 2 months
Description: albumine excretion with urine, g/mlMeasure: The severity of microalbuminuria in patients with COVID-19 of different conditions and renal failure Time: 2 months
Description: estimated glomerular filtration rate (eGFR), ml/minMeasure: Assessment of the severity of renal impairment in patients who died from COVID-19 Time: 2 months
Description: Duration of viral RNA detection in urine by PCR, weeksMeasure: Estimation of the duration of urinary viral RNA isolation in patients undergoing COVID-19 Time: 2 months
Description: expression of ACE-2 by imminohistochemistry at autopsy specimenMeasure: Expression of ACE-2 receptors in the kidneys of patients with renal failure who died from COVID-19 Time: 2 months
This research study is designed to investigate the use of a simple cognitive task for decreasing the number of intrusive memories of traumatic events experienced by refugees and asylum seekers with a diagnosis of Post-traumatic Stress Disorder (PTSD) currently living in the UK. The intervention includes a memory reminder cue, a 10-minute time gap and then around 20 minutes playing the mobile phone game Tetris, using mental rotation instructions. The study will have a multiple baseline case-series design (AB), with a randomised duration of baseline length up to three weeks. Thus, participants will complete a no-intervention phase of up to three weeks, followed by an intervention phase. Please see the intervention section for more details about the intervention sessions. Follow ups are conducted after each week to monitor the frequency of intrusive memories of trauma in a pen-and-paper diary. It is predicted that participants will report fewer intrusive memories after receiving the intervention than in the preceding baseline phase.
Description: Number of intrusive memories of traumatic events recorded by participants in a daily pen and and paper diary.Measure: Frequency of intrusive memories Time: Baseline weeks 1-3, throughout the duration of the intervention phase (approximately 5 weeks), post-intervention weeks 1-2 and for 1 week 2 months post-intervention. Change is assessed from baseline to post-intervention.
Description: A brief bespoke measure of concentration adapted from that used previously with refugees (Holmes et al., 2017). It has three questions about disruption to concentration from intrusive memories. A higher score on each question means a worse outcome.Measure: Concentration Time: Baseline, 2-weeks post-intervention and 2-months post-intervention
Description: Developed by Woodfield Trauma Service. The measure asks how many hours the person has spent doing various activities in the past two weeks (for example, domestic chores, exercise, cultural activities). A higher score means a better outcome.Measure: Social and Occupational Activity Tally (SOAT) Time: Baseline, 2-weeks post-intervention and 2-months post-intervention
Description: Four items from the Dissociative Experiences Scale II - items two, three, 14 and 20 (DES II; Carlson, & Putnam, 1993). Each item asks how often (from 0% to 100% of the time) the dissociative experience described happens to the individual. A higher score on each question means a worse outcome.Measure: Dissociation Time: Baseline, 2-weeks post-intervention and 2-months post-intervention
Description: The PCL-5 (Weathers, Litz, Keane, Palmieri, Marx, & Schnurr, 2013) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Total scores can range from 0 to 80, with higher scores meaning a worse outcome.Measure: Post-Traumatic Stress Disorder (PTSD) Checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5) Time: Baseline and 2-weeks post-intervention
Description: The PHQ-9 (Kroenke, Spitzer & Williams, 2001) is a nine-item self-report measure that assesses the nine DSM-IV symptoms of depression. Total scores can range from 0 to 27, with higher scores meaning a worse outcome.Measure: Patient Health Questionnaire (PHQ-9) Time: Baseline and 2-weeks post-intervention
Description: The WHO DAS 2.0 (World Health Organisation, 2010) is a measure of health and disability. Total scores can range from 0 to 48, with higher scores meaning a worse outcome.Measure: World Health Organisation Disability Assessment Schedule 2.0 (WHO DAS 2.0) 12 item version Time: Baseline and 2-weeks post-intervention
Description: A bespoke measure to assess adherence to self-guided practice of the intervention. It includes four questions to assess how often, and for how long, the person played Tetris after experiencing intrusive memories during the previous week.Measure: Self-Guided Intervention Adherence Questionnaire Time: Time Frame: Intervention sessions 2-5, 1 week post-intervention, 2 weeks post-intervention and 2 months post-intervention.
Description: A bespoke questionnaire to gain feedback on the intervention. It includes 16 questions to assess acceptability and usefulness of the intervention with a variety of response options including yes/no, visual analogue scales and open responses.Measure: Feedback Questionnaire Time: 1-week post-intervention.
Randomized, placebo controlled study to determine if nebulized heparin may reduce the severity of lung injury caused by the novel coronavirus, also known as COVID-19
The study will analyze the incidence, clinical outcomes and predictors of myocardial injury in a large patient population with COVID-19 treated in Mount Sinai Hospital (MSH) system. In addition, the study team will explore the association between high-sensitivity troponin I (TnI) levels and clinical characteristics, biomarkers, cardiac tests data and treatment approaches to uncover the potential mechanisms responsible for COVID-19 induced myocardial injury.
Description: Number of death during hospitalizationMeasure: Number of In-Hospital Death Time: During hospitalization, average 2-3 weeks
Description: Length of stay in the hospitalMeasure: Length of Stay Time: During hospitalization, average 2-3 weeks
Description: Successful treatment will be defined by two consecutive negative tests for COVID-19Measure: Number of Successful Treatment Time: During hospitalization, average 2-3 weeks
To evaluate the proportion of subjects alive and free of respiratory failure (e.g. need for non-invasive or invasive mechanical ventilation, high flow oxygen, or ECMO) and free of the need for continued renal replacement therapy (RRT) on Day 28. The need for continued RRT at Day 28 will be defined as either dialysis in the past 3 days (Day 26, 27, or 28) or an eGFR on Day 28 <10 mL/min/1.73 m2.
Description: To evaluate the efficacy of intravenous LSALT peptide plus standard of care to prevent the progression of COVID-19 to mild, moderate or severe ARDS, acute kidney injury, cardiomyopathy, acute liver injury, coagulopathy, or death in patients infected with SARS-CoV-2 compared with placebo plus standard of care.Measure: Development of Acute Respiratory Distress Syndrome (ARDS) and Other Organ Injuries Time: 28 days
Description: High-frequency oscillatory ventilation, with its rapid delivery of low tidal volumes and a respiratory rate in the range of 60 to 900 breaths/minute, has also been utilized in ARDS patients.Measure: Ventilation-free days Time: 28 days
Description: Oxygen therapy provided as non-invasive therapy for ARDS patients.Measure: Time on nasal cannula or oxygen masks Time: 28 days
Description: 28 day mortality - all cause and attributableMeasure: 28 day mortality - all cause and attributable Time: 28 days
Description: ICU and hospitalization length of stay (days)Measure: ICU and hospitalization length of stay (days) Time: 28 days
Description: Swab (nasopharyngeal, nasal, throat, sputum, or lower respiratory tract) at baseline (Day 1) and every 3 days thereafter until eradication → virologic clearance rateMeasure: SARS-CoV2 testing Time: 28 days
Description: Extracorporeal membrane oxygenation (ECMO) is often used for severe ARDS to allow lung healing/repair and reverse respiratory failure.Measure: Need and duration for extracorporeal membrane oxygenation (ECMO) Time: 28 days
Description: Vasopressor free daysMeasure: Vasopressor free days Time: 28 days
Description: Chest X-rays performed at Baseline, Day 3, at clinical improvement, and end-of-treatment (EOT) and study (EOS) to determine presence of bilateral opacities.Measure: Radiographic pulmonary assessments Time: 28 days
Description: Change in daily mMRC dyspnea and SOFA scores (0 to 4) with 4 being the most severe outcomeMeasure: Change in modified Medical Research Council (mMRC) dyspnea and Sequential Organ Failure Assessment (SOFA) scores Time: 28 days
Description: Incidence of other organ (non-lung) disordersMeasure: Incidence of non-lung disorders Time: 28 days
Description: Change in liver function tests (ALT, AST, and total bilirubin levels) from baselineMeasure: Measures of liver dysfunction Time: 28 days
Description: Change in SCr and eGFR from baselineMeasure: Measures of kidney dysfunction Time: 28 days
Description: Change in highly-sensitive troponin (hs-troponin) from baselineMeasure: Measures of cardiac dysfunction Time: 28 days
Description: Change from baseline ACT, aPTT, and/or PT/INR levelsMeasure: Measures of coagulopathies Time: 28 days
Description: Change in baseline antiviral immunoglobulins (IgG, IgM) at EOS.Measure: Changes in immunogenic responses Time: 28 days
Description: Changes in total healthcare costs from admission to discharge between treatment groups.Measure: Healthcare outcomes Time: 28 days
Description: Change in serum cytokines including IL-1α, IL-1ß, IL-1ra, IL-5, IL-6, IL-8, IL-12, TNFα, CXCL10/IP10, MCP-3, and ferritin drawn at the same time as LSALT peptide levelsMeasure: Molecular changes in pro-inflammatory pathways Time: 28 days
Description: Pharmacokinetics of LSALT peptide over the study period.Measure: Pharmacokinetics of LSALT peptide Time: 28 days
The two biomarkers determined in urine, "Tissue Inhibitor of Metalloproteinases 2 (TIMP-2)" and "Insulin-like Growth Factor-Binding Protein 7 (IGFBP7)", can indicate the occurrence of Acute kidney injury (AKI) in cardiac surgery and critically ill patients at an early stage. However, no data are available whether these parameters can also predict the occurrence of AKI in the context of COVID-19 infection. An early prediction of AKI can be helpful for the optimisation of therapeutic management to improve patient outcome and for the triage of patients. The aim of this observational study is to evaluate whether the biomarker [TIMP- 2]*[IGFBP7] can predict the occurrence of AKI in critically ill patients suffering from SARS-CoV2 associated acute respiratory distress syndrome.
Description: Occurence of moderate or severe AKIMeasure: Occurence of acute kidney injury (AKI) Time: within 7 days after beginning of moderate or severe ARDS
Description: e.g., Analysis of interleukin (IL) 6, IL8Measure: Add-on analysis: pro- and antiinflammatory mediators Time: within 7 days after beginning of moderate or severe ARDS
The study is a prospective, randomized, placebo-controlled, single-blind phase 2 clinical study of the efficacy and safety of CERC-002, a potent inhibitor of LIGHT, for the treatment of patients with COVID-19 pneumonia who have mild to moderate ARDS. LIGHT is a cytokine in the TNF super family (TNFSF14) which drives inflammation and induces many other cytokines including IL-1, IL-6 and GM-CSF. LIGHT levels have been shown to be elevated in COVID-19 infected patients and inhibiting LIGHT is hypothesized to ameliorate the cytokine storm which has shown to be a major factor in progression of ARDS. The study will assess the efficacy and safety of CERC-002 in patients with severe COVID-19 over a 28 day period as single dose on top of standard of care.
Description: Respiratory failure defined based on resource utilization requiring at least one of the following: Endotracheal intubation and mechanical ventilation Oxygen delivered by high-flow nasal cannula (heated, humidified oxygen delivered via reinforced nasal cannula at flow rates >20L/min with fraction of delivered oxygen ≥0.5) Noninvasive positive pressure ventilation, Extracorporeal membrane oxygenationMeasure: Proportion of patient alive and free of respiratory failure Time: Baseline to Day 28
Description: 1-month mortalityMeasure: Proportion of subjects who are alive Time: Baseline to Day 28
Persons with spinal cord injury (PwSCI) are at a greater risk for major health conditions and poorer health outcomes than persons without spinal cord injury (SCI). They often experience a great deal of health needs both on a physiological level as well as a psychosocial level. PwSCI frequently require supports and services to be able to live independently within the community. These services and supports are sometimes difficult to access within the community when the country is operating under regular capacity, in current times with the global COVID-19 pandemic, the challenges for obtaining and accessing supports and services will become much greater. The proposed project aims to identify the specific needs during this time of crisis and to provide referrals and resources to ameliorate those needs by surveying PwSCI in the St. Louis region. The project also hopes to determine if these persons experience isolation during shelter at home orders. PwSCI, who the investigators serve or have served in the past, will be contacted via phone or e-mail once a month for six months and asked to complete a questionnaire that will allow the investigators to track the participant's needs during the COVID-19 pandemic.
Description: Instrumental Support refers to the perception that people in one's social network are available to provide material or functional aid in completing daily tasks (such as making meals or providing transportation) if needed. This self-report measure for adults (ages 18 and above) is an 8-item calibrated scale.This study will use the measure to determine if people's instrumental support changes during a pandemic.Measure: NIH Toolbox Instrumental Support Survey - change in instrumental support Time: Baseline, 3 month and 6 month
Description: A scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each of the 3 items as hardly ever (score of "1"), some of the time (score of "2"), or often (score of "3"). The scores for each individual question can be added together to give you a possible range of scores from 3 to 9. The higher the score the more lonely the person will be. This study will use the measure to determine if people feel socially isolated during a pandemic.Measure: UCLA (University of California - Los Angeles) 3-item Loneliness Scale - change in social isolation Time: Baseline, 3 month and 6 month
Document and evaluate the impact of societal restrictions due to the pandemic on SCI- and ABI-related disability and functional impairments, and the resultant effects on psychological wellbeing, physical wellbeing and quality of life for those with SCI/ABI.
Description: Fear of COVID-19 QuestionnaireMeasure: Change in Fear of COVID-19 Time: baseline, 3 months, 6 months
Description: NeuroQol SF v1.0 - Ability to Part. in SRAMeasure: Change in ability to participate in social roles and activities Time: baseline, 3 months, 6 months
Description: NeuroQol SF v1.0 - DepressionMeasure: Change in depressive symptoms Time: baseline, 3 months, 6 months
Description: NeuroQol SF v1.0 - Pos. Affect & Well-BeingMeasure: Change in positive affect and well-being Time: baseline, 3 months, 6 months
Description: NeuroQol SF v1.0 - AnxietyMeasure: Change in anxiety Time: baseline, 3 months, 6 months
Description: NeuroQol SF v1.0 - FatigueMeasure: Change in fatigue Time: baseline, 3 months, 6 months
Description: NeuroQol SF v1.0 - Emotional & Beh. DyscontrolMeasure: Change in emotional and behavioural dyscontrol Time: baseline, 3 months, 6 months
Description: NeuroQol SF v1.0 - Satisfaction w SRAMeasure: Change in satisfaction with social roles and activities Time: baseline, 3 months, 6 months
Description: NeuroQol SF v1.0 - Sleep DisturbanceMeasure: Change in sleep disturbance Time: baseline, 3 months, 6 months
Description: NeuroQol SF v1.0 - StigmaMeasure: Change in stigma Time: baseline, 3 months, 6 months
Description: NeuroQol SF v1.0 - Cognitive FunctionMeasure: Change in cognitive function Time: baseline, 3 months, 6 months
Description: 23 questions about strategies to social distanceMeasure: Change in social distancing strategies used Time: baseline, 3 months, 6 months
Description: 22 questions about social distancingMeasure: Change in thoughts and feelings about social distancing Time: baseline, 3 months, 6 months
The purpose of this study is to assess the safety and tolerability of the investigational product, SBI-101, in COVID-19 subjects with Acute Kidney Injury (AKI). SBI-101 is a biologic/device combination product designed to regulate inflammation and promote repair of injured tissue using allogeneic human mesenchymal stromal cells. SBI-101 will be integrated into the renal replacement circuit and patients will be treated for up to 24 hours.
The aim is to describe the epidemiology and determine the independent risk factors for mortality and acute organ injury in AKI and to assess the impact of different treatment strategies on survival. This will allow the development of prevention strategies and design of appropriately powered intervention studies.
Description: As defined by Kidney Diseases: Improving Global Outcomes (KDIGO) criteriaMeasure: Incidence of any stage of acute kidney injury Time: 14 days
Description: MortalityMeasure: Mortality Time: 14-day, hospital, and intensive care unit (ICU) mortality
Description: Defined by return of creatinine to < 1.5 times of baselineMeasure: Renal recovery Time: 14 days
Description: PercentageMeasure: Percentage of patients who receive renal replacement therapy Time: 14 days
Description: Percentage of participants who are dialysis dependentMeasure: Percentage of participants who are dialysis dependent Time: Through study completion, an average of 90 days
Description: Days without vasoactive medications and mechanical ventilationMeasure: Free-days of vasoactive medications and mechanical ventilation Time: Day 30
Description: Length of intensive care unit and hospital stayMeasure: Length of intensive care unit and hospital stay Time: Through study completion, an average of 90 days
Description: Congestive heart failure, Arrhythmia, Acute respiratory distress syndrome, Septic shock, Acute cardiac injury, pneumoniaMeasure: Number of participants with consequences following AKI Time: Through study completion, an average of 90 days
Description: Time from illness onset to need for mechanical ventilator supportMeasure: Time from illness onset to need for mechanical ventilator support Time: Through study completion, an average of 30 days
The actual COVID-19 epidemy is an unprecedented healthcare problem. Although acute respiratory distress syndrome is the main organ failure, acute kidney injury (AKI) has appeared to be more frequent and more severe than expected. Some data suggested a potential direct renal tropism of the virus, or undirect injury by "cytokine storm". The aims of this study are: 1. To describe incidence, severity and mortality associated with AKI during covid-19 infection in ICU 2. To identify specific risk factors for AKI 3. To explore pathophysiologic mechanism of AKI during COVID-19 infection
Description: AKI will be defined according with KDIGO guidelines: increase in creatinine of more than 1,5 fold compared to baseline Severe CVOID-19 infection is defined as 1/ confirm COVID-19 infection (by TDM and/or qRT-PCR) 2/ Requirement of ICU support during more than 72hMeasure: Primary endpoint is the incidence, the severity and the mortality associated with AKI during COVID-19 severe infection Time: 7 months
This study is an observational registry of children with or suspected to have SARS CoV2 (COVID-19) admitted to pediatric intensive care units (PICU). This registry will help describe the prevalence, rate and severity of acute kidney injury (AKI) in children with Severe Acute Respiratory Syndrome Coronavirus-2(SARS CoV2) across the world. The registry will be developed using a point prevalence methodology and then full retrospective review. Once a week, from April through June 2020, data collection will occur in "real-time" to estimate a weekly point prevalence of AKI and renal replacement therapy (RRT). The operational definition of "patients under investigation" (PUIs) will be used to identify the denominator of patients to be studied. The PUIs will be cohorted into SARS CoV2 test positive, test negative, test pending, or test unavailable. The primary aim of this study is to deliver a global, objective data driven analysis of the burden of AKI in virus positive patients or patients under investigation (PUI) who are admitted to the pediatric intensive care unit.
Description: Kidney Disease Improving Global Outcomes (KDIGO) Staged AKI by serum creatinine or urine outputMeasure: Acute Kidney Injury (AKI) Time: 14 days
Description: Survival to ICU discharge or Day 14Measure: Survival Time: 14 days
Description: The use of extracorporeal membrane oxygenation (ECMO) and/or renal replacement therapyMeasure: Rate of Extracorporeal Therapy Requirement Time: 14 days
Description: >20% fluid overload as defined as the net fluid balance since ICU admission (in liters) divided by ICU admission weightMeasure: Fluid overload Time: Day of Enrollment
Description: The exposure of enrolled patients to known nephrotoxic medications, including diureticsMeasure: Rate of nephrotoxic medication exposure Time: Day of Enrollment
COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to many countries of the world. The aim of this multi-centered study is to guide for the approach, organization, diagnosis and treatment of the patients admitted due to trauma to emergency department during the pandemic period.
Description: within the study period, trauma patients who admitted to any of the seven study centers will be recorded.Measure: trauma admissions Time: 3 months
A prospective cohort minimal risk study to determine the impact of the COVID-19 crisis on outcomes of neurologically injured ICU patients.
Description: Care treatment such as ventilator use, intubation, and/or tracheostomyMeasure: Limitations of patient care- Frequency of care not being provided Time: During In-hospital course, up to 1 month
Open-label randomized study comparing the current standard of care treatment of Covid-19 in hospitalized patients with evidence of cardiac injury vs. a group of the same type of patients treated with colchicine plus current standard of care.
Description: Composite of all-cause mortalityMeasure: All Cause Mortality Time: 90 days
Description: Need for Mechanical VentilationMeasure: Mechanical Ventilation Time: 90 days
Description: Need for Mechanical Circulatory SupportMeasure: Mechanical Circulatory Support Time: 90 days
Description: Time to Primary EndpointMeasure: Time to Deterioration Time: 90 days
Description: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0".Measure: Adverse Events Time: 90 days
Description: Peak Troponin LevelsMeasure: Troponin Time: 90 days
Description: Troponin Levels Change from BaselineMeasure: Delta Time: 90 days
Description: Change from Baseline on BNP levelsMeasure: BNP Time: 90 days
Description: Changes from Baseline on C Reactive ProteinMeasure: Changes in C Reactive Protein Time: 90 days
Description: Hospital Length of StayMeasure: LOS Time: 90 days
Description: Re-Hospitalization RatesMeasure: Re-Hospitalization Time: 90 days
Description: Changes in D Dimer from BaselineMeasure: Changes in D Dimer Time: 90 days
Existing information suggests that a drug called heparin, given through a device called a nebuliser, will decrease severity of lung damage caused by COVID-19 who require the assistance of a ventilator to breathe. It is thought that heparin could do this through multiple mechanisms. The investigators will measure the effect with a marker called d-dimer, which is related to blood clotting, and monitor the safety of this treatment as one of the major outcomes for the study. The investigators will also assess clinical outcomes such as markers of oxygen levels, time to liberation from a ventilator in patients with COVID-19 lung disease, and functional outcomes at day 28 and 60 as secondary outcomes.
Description: Effect of nebulised heparin on d-dimer profile, assessed via d-dimer AUC and via a mixed effects model, with data collected on days 1, 3, 5 and 10.Measure: D-dimer profile Time: Up to day 10.
Description: Safety of nebulised heparin delivered by aerogen solo nebuliser in patients with COVID-19 induced severe respiratory failure, as measured by the incidence of severe adverse events.Measure: Frequenccy of Severe Adverse Outcomes Time: Up to day 60
Description: Determine the impact of nebulised heparin on oxygenation indexMeasure: Oxygenation Index Time: Up to day 10
Description: Effect of nebulised heparin on indices of inflammation (Interleukin (IL)-1β, IL-6, IL-8, IL-10 and soluble TNF receptor 1 (sTNFR1), C-reactive protein, procalcitonin, Ferritin,) will be assessed (AUC on days 1, 3, 5 and 10)Measure: Indices of Inflammation Time: Up to day 10
Description: Effect of nebulised heparin on the ratios of IL-1β/IL-10 and IL-6/IL-10 will also be assessed.Measure: Ratios of Indices of Inflammation Time: Up to day 10
Description: Effect of nebulised heparin on other indices of coagulation (Fibrinogen; lactate dehydrogenase) will be assessed (AUC on days 1, 3, 5 and 10).Measure: Indices of Coagulation Time: Up to day 10
Description: Determine the effect of nebulised heparin on Quasi-Static Lung Compliance (i.e. tidal volume/(Plateau pressure-PEEP) measured on days 1,3,5,10.Measure: Quasi-Static Lung Compliance Time: Up to day 10
Description: Time to separation from invasive ventilation, where non survivors are treated as though not separated from invasive ventilation.Measure: Time to separation from invasive ventilation Time: Up to day 28
Description: Number treated with neuromuscular blockers instituted after enrolmentMeasure: Number treated with neuromuscular blockers Time: Up to day 10
Description: Number treated with prone positioning instituted after enrolmentMeasure: Number treated with Prone positioning Time: Up to day 10
Description: Number treated with extra-corporeal membrane oxygenation instituted after enrolmentMeasure: Number treated with extra-corporeal membrane oxygenation Time: Up to day 10
Description: Number tracheotomisedMeasure: Number requiring Tracheostomy Time: Up to day 28
Description: Time to separation from invasive ventilation among survivorsMeasure: Time to separation from invasive ventilation among survivors Time: Up to day 28
Description: Time to separation from the ICU to day 28, where non-survivors to day 28 are treated as though not separated from invasive careMeasure: Discharge to ward Time: Up to day 28
Description: Time to discharge from the ICU to day 28, among survivorsMeasure: Discharge to ward in survivors Time: Up to day 28
Description: Survival to day 28; Survival to day 60; and Survival to hospital discharge, censored at day 60Measure: Patient Survival Time: Up to day 60
Description: Number residing at home or in a community setting at day 60Measure: Number of patients residing at home or in a community setting at day 60 Time: Up to day 60
Description: Number residing at home or in a community setting at day 60, among survivorsMeasure: Number of surviving patients residing at home or in a community Time: Up to day 60
The study aims to assess the potential benefit and evaluate the safety and tolerability of a single subcutaneous (SC) dose of VIB7734 in hospitalized patients with documented infection of severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) with pulmonary involvement. Subjects will be administered a single dose of VIB7734 injected under the skin, assessed for efficacy for 28 days and followed for an additional 42 days.
Description: Critical illness is defined by respiratory failure (requiring any of the following: endotracheal intubation, oxygen delivered by high flow nasal cannula, non-invasive positive pressure ventilation, extracorporeal membrane oxygenation or clinical diagnosis of respiratory failure) or shock (systolic blood pressure < 90 mm Hg, or diastolic blood pressure < 60 mm Hg, or requiring vasopressors)Measure: The proportion of patients who achieve treatment success through Day 28, defined as avoidance of death and critical illness Time: Day 1 (Baseline) through Day 28
Description: Defined as measure of safetyMeasure: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent fatal and life-threatening SAEs, Treatment-emergent Serious Adverse Events Time: Day 1 (Baseline) through Day 70
Description: Safety evaluation via review of labs (white blood cell (WBC) with differential counts, hemoglobin, platelet count, liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], and total bilirubin levels), serum chemistry, cardiac troponin coagulation markers (prothrombin time [PT], partial thromboplastin time [PTT], D dimer, fibrinogen), and urinalysis)Measure: Change in safety laboratory parameters Time: Day 1 (Baseline) through Day 70
Our overarching goal is to improve the outcomes of critically ill COVID-19 patients with or at risk for development of acute kidney injury (AKI). The objective of this study is to determine the role of a protocol to manage urine alkalization using a simple medication that has been used for a very long time, is safe, and without significant side-effects. We aim to determine the feasibility and safety of a urine alkalinization protocol for the prevention of AKI in patients testing positive for COVID-19.
Description: Primary feasibility outcome will be the proportion of patients treated who achieve >50% of urine measurements pH ≥= 7.2 over the duration of treatment.Measure: pH Time: 10 days
Description: Primary efficacy outcome will be the number of days alive and free of stage 2-3 AKI (up to 28) in each group.Measure: Number of Days Alive Free of Stage 2-3 AKI Time: 28 days post-treatment
Description: proportion of patients developing stage 2-3 AKI (or stage 3 if already at stage 2 at enrollment).Measure: Stage 2-3 AKI Time: 28 days
Description: Ventilator-free days to 28 daysMeasure: Vent-Free Time: 28 days
Description: Hospital-free days to 60 daysMeasure: Hospital-Free Time: 60 days post-index hospitalization
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