StudyFinder
Search Results
36 Study Matches
In-Home Adjustment of New Spinal Cord Injury Caregivers
Perrin, Paul, B - pperrin@vcu.edu
Perrin, Paul, B
NCT03244098
HM20009566
Inclusion Criteria:
SCI Patient Inclusion Criteria:
• have a telephone in the home or cellular phone and are able to talk on the phone in English
• are able to provide informed consent
• demonstrate a clinician-rated loss in motor/sensory function on the ASIA scale (i.e., have a spinal cord injury) Caregiver
Inclusion Criteria:
• have a telephone in the home or cellular phone and are able to talk on the phone in English
• are able to provide informed consent
• are a primary caregiver of the individual with SCI
• Caregivers with scores below 10 on the literacy screen will identify a family member or friend to review the guidebook with the caregiver. If no one is identified, the TAP clinician will review the materials with the caregiver and function in that additional capacity
Exclusion Criteria:
• individual with SCI receives his/her primary care from a professional caregiver or other individual outside of the household besides the primary caregiver
• individuals with SCI or caregivers with known current uncontrolled substance dependence, aphasia, anosognosia (deficit in self-awareness), or treatment due to known self-inflicted injury
• individuals living alone
• prisoners
• SCI patient without decision making capacity to consent
Behavioral: Transition Assistance Program
Spinal Cord Injuries, External Causes of Injury and Poisoning (800-999)
Multi-Center African-American Inflammatory Bowel Disease Study (MAAIS) (MAAIS)
Lisa Datta, MS - ibd@jhu.edu
Kuemmerle, John, F
NCT01169194
HM12998
Inclusion Criteria:
• African Americans with a confirmed diagnosis of Inflammatory Bowel Disease (IBD)
• African Americans without a diagnosis of IBD and without a family history of IBD for comparison purposes
Exclusion Criteria:
Patients whose IBD cannot be confirmed
Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis, Indeterminate Colitis, IBD, CD, UC, IC, African American IBD, African American CD, African American UC, African American IC, Black IBD, Black CD, Black UC, Black IC, African American Inflammatory Bowel Disease, African American Crohn's Disease, African American Ulcerative Colitis, African American Indeterminate Colitis, Black Inflammatory Bowel Disease, Black Crohn's Disease, Black Ulcerative Colitis, Black Indeterminate Colitis
OKRA STUDY (OKRA)
Ruddley, Joyce, R - joyce.ruddley@vcuhealth.org
Kumar, Dhiren
NCT03326076
HM20012716
KOAR
• Patient's health care provider adopts and intends to apply the center's AlloSure Routine Testing Schedule as part of the information used to manage the patient.
• Subjects willing to provide written informed consent to participate. KOAR
• Recipients of transplanted organs other than kidney
• Recipients of a transplant from a monozygotic (identical)
• Recipients of a bone marrow transplant
• Recipients who are pregnant
• Recipients who are under the age of 18
• Recipient who are less than 14 days post-transplant
Inclusion Criteria:
• Patient's health care provider adopts and intends to apply the center's AlloSure Routine Testing Schedule as part of the information used to manage the patient.
• Subjects willing to provide written informed consent to participate. KOAR
Exclusion Criteria:
___________________________________________________________
Exclusions for AlloSure? Intended Use
Specimens from patients for whom any of the following are true will not be tested:
• Recipients of transplanted organs other than kidney
• Recipients of a transplant from a monozygotic (identical)
• Recipients of a bone marrow transplant
• Recipients who are pregnant
• Recipients who are under the age of 18
• Recipient who are less than 14 days post-transplant
Diagnostic Test: Donor-derived cell-free DNA (AlloSure?), Other: Standard care, Diagnostic Test: Peripheral blood gene expression profiling (AlloMap Kidney), Diagnostic Test: Analytic platform (IBox)
Kidney Transplant Rejection
Effects of a Mindfulness Intervention in Caregivers of People With Dementia (CARING) (CARING)
Dzierzewski, Jospeh - dzierzewski@vcu.edu
Dzierzewski, Jospeh
NCT03857308
HM20011802
Inclusion Criteria:
• English speaking
• Self-reporting informal caregivers of persons with dementia
Exclusion Criteria:
• Self-reported major depressive disorder with psychotic features
• History of schizophrenia
• Bipolar disorder
• Uncorrected severe sensory impairments or chronic debilitating health problems that could hinder participating in the interventions
• Previous MBSR training or regular meditative practice within previous 6 months
Behavioral: Mindfulness Training, Behavioral: Reappraisal Training
Caregivers, Burnout, Sleep
well-being, sleep, caregiver
Postprandial Monocyte Maturation and Vascular Dysfunction Following High-Fat Meals - Study 1
Franco, Robert, "Lee" - francorl@vcu.edu
Franco, Robert, "Lee"
NCT03958734
HM20015510
Inclusion Criteria:
• college-age: 18-30 years old
• normal fasting triglyceride (<150 mg/dL) (American College of Sports Medicine Guidelines for Exercise Testing and Prescription, 10th Edition).
• normal body composition: % body fat, males <25%, females <32% (American College of Sports Medicine Guidelines for Exercise Testing and Prescription, 10th Edition)
• self-reported engagement in moderate-vigorous intensity physical activity and/or an exercise training regimen OR self-reported low physical activity and no engagement in an exercise training regimen (International Physical Activity Questionnaire)
• low cardiorespiratory fitness (VO2peak; male: =<45 mL/kg/min; female: =<35 mL/kg/min; categorized as =40th percentile by ACSM Guidelines for Exercise Testing and Prescription, 10th Edition; 44, 45, 46, 47) OR high cardiorespiratory fitness (VO2peak; male: =55 mL/kg/min; female: 45 mL/kg/min; categorized as =70th percentile by ACSM Guidelines for Exercise Testing and Prescription, 10th Edition; 44, 45, 46, 47) f.) for female participants, presence of a normal, monthly menstrual cycle with or without prescribed contraceptive methods. .
Exclusion Criteria:
• presence of diagnosed cardiovascular, metabolic, or renal disease or dysfunction
• presence of signs and symptoms suggestive of cardiovascular, metabolic, or renal disease
• presence of musculoskeletal injury
• pregnancy
• history of smoking
• engagement in an abnormal eating behavior
• unable to communicate effectively in English
• moderate cardiorespiratory fitness (VO2peak; male: 46-54 mL/kg/min; female: 36-44 mL/kg/min)
• elevated or high fasting triglycerides (>150 mg/dL)
• absence of a normal, monthly menstrual cycle with or without prescribed contraceptive methods
Other: High-fat meal
Cardiovascular Risk Factor, Lipemia, Diseases of Circulatory System (390-459)
Vascular Dysfunction
Enroll -HD: A Prospective Registry Study in a Global Huntington's Disease Cohort
Noopur Modi - Info@Enroll-HD.org
Barrett, Matthew, James
NCT01574053
HM14477
Inclusion Criteria:
• Carriers: This group comprises the primary study population and consists of individuals who carry the HD gene expansion mutation.
• Controls: This group comprises the comparator study population and consists of individuals who do not carry the HD expansion mutation. These two major categories can be further subdivided into six different subgroups of eligible individuals:
• Manifest/Motor-manifest HD: Carriers with clinical features that are regarded in the opinion of the investigator as diagnostic of HD.
• Pre-Manifest/-Motor-manifest HD: Carriers without clinical features regarded as diagnostic of HD.
• Genotype Unknown: This group includes a first or second degree relative (i.e., related by blood to a carrier) who has not undergone predictive testing for HD and therefore has an undetermined carrier status.
• Genotype Negative: This group includes a first or second degree relative (i.e., related by blood to a carrier) who has undergone predictive testing for HD and is known not to carry the HD expansion mutation.
• Family Control: Family members or individuals not related by blood to carriers (e.g., spouses, partners, caregivers).
• Community Controls: Individuals unrelated to HD carriers who did not grow up in a family affected by HD. Data collected from community controls will be used for generation of normative data for sub-studies. Participant status will be captured in the study database using 2 variables: 1) Investigator Determined Status: this will be based on clinical signs and symptoms and genotyping performed as part of medical care, and will be updated at every visit; and 2) Research Genotyping Status: this will be based on genotyping conducted as part of Enroll-HD study procedures. Based on research genotyping, participants will be reclassified under this variable from Genotype Unknown to 'Carriers' or 'Controls'. Investigators and participants will be blinded to this reclassification.
Exclusion Criteria:
• Individuals who do not meet inclusion criteria,
• Individuals with choreic movement disorders in the context of a negative test for the HD gene mutation.
• For Community Controls: those individuals with a major central nervous system disorder will be excluded (e.g. stroke, Parkinson's disease, multiple sclerosis, etc.). Participants under 18 may be eligible to participate (if they have juvenile-onset HD).
Huntington's Disease
Huntington's Disease, Huntington Disease, Juvenile Huntington's Disease, Registry, Cohort, CHDI
Virginia Commonwealth University Stress Reduction Study
Hadley Rahrig, M.S. - rahrighm@mymail.vcu.edu
NCT04190030
Inclusion Criteria:
• Stable medication regiment for 8 weeks prior to enrollment if taking antidepressant or anxiolytic medications. (will not be advertised but screened)
• Free of major, uncorrected sensory impairments and cognitive deficits
• Free of a certain psychiatric disorders or history thereof; specifically, a new diagnosis of a (non-acute) medical or psychiatric condition within the last 3 months, report a hospitalization over the last 3 months, report current drug abuse (e.g., recreational drug use, alcohol intake in excess of 2 drinks per day).
• Adults aged 18 - 55 years of age
• Right hand dominant (will not be advertised but screened)
• Personal SmartPhone (Android or iOS operating systems).
• Naive to meditation practice (will not be advertised but screened)
• At least a moderate level of perceived stress (scale score > 5 on the 4-item Perceived Stress Scale (PSS; reflects above-average perceived stress)
Exclusion Criteria:
• left-handed
• are unwilling or unable to complete study assessments or treatments
• report a new diagnosis of a (non-acute) medical or psychiatric condition within the last 3 months
• report a hospitalization over the last 3 months
• report current drug abuse (e.g., recreational drug use, smoke more than ? pack per day, alcohol intake in excess of 2 drinks per day)
• are prisoners
• no personal SmartPhone (Android or iOS operating systems)
Behavioral: mindfulness training, Behavioral: cognitive reappraisal training
Stress
Mindfulness
Reducing Error in ER Settings Through Attention Restoration Theory (RESTART)
Stephen Miller, DO - stephen.miller@vcuhealth.org
NCT04528862
Inclusion Criteria:
? Emergency Medicine Resident of any PGY level. (1-5)
Exclusion Criteria:
• Anybody under the age of 18
• Pregnancy
Behavioral: Nature slides, Behavioral: Urban slides
Attention Fatigue, Attention Restoration
Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients (SOLVE-CRT)
Nicholas Vesom - clinical@ebrsystemsinc.com
Ellenbogen, Kenneth, A
NCT02922036
HM20014794
Inclusion/Exclusion:
Inclusion Criteria
• Patient with a class I or IIa (1) or (2) indication for implantation of a CRT-D device according to current available guidelines (with additional QRS criteria on Class IIa (1)):
• Class I: NYHA II, III, IV, EF ≤ 35%, LBBB, QRS ≥ 150ms
• Class IIa (1): NYHA II, III, IV, EF≤ 35%, LBBB, QRS ≥ 130 to < 150ms
• Class IIa (2): NYHA II, III, IV, EF≤ 35%, non-LBBB, QRS ≥ 150ms
• Patient is a:
• 'Non-responder' [Not Enrolling]: Patients who have a CRT system that is functional and despite an adequate trial of Guideline Directed Medical Therapy (GDMT) and attempts at optimal device programming the patient has not responded to therapy for a minimum of 6 months. Non-response is defined as:
• EF has remained unchanged or worsened (defined as < 5% increase since implant), and
• The patient's clinical status based in the totality of available clinical evidence (such as NYHA Class, exercise tolerance, QOL, or global assessment) has remained unchanged or worsened, as determined by the local Site Enrollment Committee OR
• 'Previously Untreatable': Patients who have a full or partial CRT system, who meet general inclusion criteria and are deemed as 'previously untreatable' for one of the following reasons: i. Patients in whom CS lead implantation for CRT has failed
• CS lead implant was attempted but abandoned due any of the following: difficult CS access or anatomy, inadequate lead location, inadequate pacing thresholds, persistent phrenic nerve pacing, or other procedural challenges ii. CS lead implanted but has been programmed OFF
• LV lead that was implanted but not operational includes patients in whom the LV lead is inoperative or programmed off due to improper function such as high threshold, non-capture, phrenic nerve pacing, lead failure, lead dislodgement, or sub-optimal LV lead location OR c. 'High Risk Upgrade: Patients who have a relative contraindication to CS lead implant, due to:
• venous occlusion or lesion precluding implant
• pocket infection risk (at co-implanted device site)
• considered high risk for CS implant due to co-morbidities
• Patients on a stable Guideline Directed Medical Therapy (GDMT)
• Patient must be 18 years old or over
• Patient has signed and dated informed consent
• Patient has suitable anatomy for implant of the WiSE CRT System (e.g. adequate acoustic window, LV wall thickness in target implant area ≥ 5 mm, absence of LV wall structural abnormalities which may preclude implant) Exclusion Criteria Patients who meet any one of these criteria will be excluded from the investigation:
• Pure RBBB
• LVEDD ≥ 8cm
• Non-ambulatory or unstable NYHA class IV
• Contraindication to heparin, chronic anticoagulants or antiplatelet agents
• Triple anticoagulant patients who cannot tolerate peri-procedural stopping of anticoagulation therapy
• Attempted device implant (pacemaker, ICD, CRT, LV lead) or successful co-implant within prior 30 days.
• Patients with planned or expected lithotripsy treatment post implant
• Life expectancy of < 12 months
• Chronic hemodialysis
• Stage 4 or 5 renal dysfunction defined as eGFR < 30
• Grade 4 mitral valve regurgitation
• Noncardiac implanted electrical stimulation therapy devices
• Patients with a prosthetic aortic valve in which the electrode cannot be implanted via a transseptal approach
• Patients with a prosthetic mitral valve in which the electrode cannot be implanted via a retrograde aortic approach
• Unstable angina, acute MI, CABG, or PTCA within the past 1 month
• Correctable valvular disease that is the primary cause of heart failure
• Recent CVA or TIA (within the previous 3 months)
• Patients with a history of paroxysmal or persistent atrial fibrillation/flutter are excluded if they have had a documented AF episode > 30 min or a cardioversion in the past 1 month.
• Patients with permanent AF are excluded if they have intact AV node conduction (RV pacing <95%)
• Already included in another clinical study that could confound the results of this study
• Pregnancy
• Known drug or alcohol addiction or abuse
• Moderate or severe aortic stenosis
• Subject unable to attend follow-up at the investigative center or unable, for physical or mental reasons, or to comply with the trial's procedures
• For Part II Randomized patients only, those who will not tolerate being randomized to the Control Group for 6 months
• Patient with a class I or IIa (1) or (2) indication for implantation of a CRT-D device according to current available guidelines (with additional QRS criteria on Class IIa (1)):
• Class I: NYHA II, III, IV, EF ≤ 35%, LBBB, QRS ≥ 150ms
• Class IIa (1): NYHA II, III, IV, EF≤ 35%, LBBB, QRS ≥ 130 to < 150ms
• Class IIa (2): NYHA II, III, IV, EF≤ 35%, non-LBBB, QRS ≥ 150ms
• Patient is a:
• 'Non-responder' [Not Enrolling]: Patients who have a CRT system that is functional and despite an adequate trial of Guideline Directed Medical Therapy (GDMT) and attempts at optimal device programming the patient has not responded to therapy for a minimum of 6 months. Non-response is defined as:
• EF has remained unchanged or worsened (defined as < 5% increase since implant), and
• The patient's clinical status based in the totality of available clinical evidence (such as NYHA Class, exercise tolerance, QOL, or global assessment) has remained unchanged or worsened, as determined by the local Site Enrollment Committee OR
• 'Previously Untreatable': Patients who have a full or partial CRT system, who meet general inclusion criteria and are deemed as 'previously untreatable' for one of the following reasons: i. Patients in whom CS lead implantation for CRT has failed
• CS lead implant was attempted but abandoned due any of the following: difficult CS access or anatomy, inadequate lead location, inadequate pacing thresholds, persistent phrenic nerve pacing, or other procedural challenges ii. CS lead implanted but has been programmed OFF
• LV lead that was implanted but not operational includes patients in whom the LV lead is inoperative or programmed off due to improper function such as high threshold, non-capture, phrenic nerve pacing, lead failure, lead dislodgement, or sub-optimal LV lead location OR c. 'High Risk Upgrade: Patients who have a relative contraindication to CS lead implant, due to:
• venous occlusion or lesion precluding implant
• pocket infection risk (at co-implanted device site)
• considered high risk for CS implant due to co-morbidities
• Patients on a stable Guideline Directed Medical Therapy (GDMT)
• Patient must be 18 years old or over
• Patient has signed and dated informed consent
• Patient has suitable anatomy for implant of the WiSE CRT System (e.g. adequate acoustic window, LV wall thickness in target implant area ≥ 5 mm, absence of LV wall structural abnormalities which may preclude implant) Exclusion Criteria Patients who meet any one of these criteria will be excluded from the investigation:
• Pure RBBB
• LVEDD ≥ 8cm
• Non-ambulatory or unstable NYHA class IV
• Contraindication to heparin, chronic anticoagulants or antiplatelet agents
• Triple anticoagulant patients who cannot tolerate peri-procedural stopping of anticoagulation therapy
• Attempted device implant (pacemaker, ICD, CRT, LV lead) or successful co-implant within prior 30 days.
• Patients with planned or expected lithotripsy treatment post implant
• Life expectancy of < 12 months
• Chronic hemodialysis
• Stage 4 or 5 renal dysfunction defined as eGFR < 30
• Grade 4 mitral valve regurgitation
• Noncardiac implanted electrical stimulation therapy devices
• Patients with a prosthetic aortic valve in which the electrode cannot be implanted via a transseptal approach
• Patients with a prosthetic mitral valve in which the electrode cannot be implanted via a retrograde aortic approach
• Unstable angina, acute MI, CABG, or PTCA within the past 1 month
• Correctable valvular disease that is the primary cause of heart failure
• Recent CVA or TIA (within the previous 3 months)
• Patients with a history of paroxysmal or persistent atrial fibrillation/flutter are excluded if they have had a documented AF episode > 30 min or a cardioversion in the past 1 month.
• Patients with permanent AF are excluded if they have intact AV node conduction (RV pacing <95%)
• Already included in another clinical study that could confound the results of this study
• Pregnancy
• Known drug or alcohol addiction or abuse
• Moderate or severe aortic stenosis
• Subject unable to attend follow-up at the investigative center or unable, for physical or mental reasons, or to comply with the trial's procedures
• For Part II Randomized patients only, those who will not tolerate being randomized to the Control Group for 6 months
Device: WiSE System
Heart Failure
Colorectal Health Research Champions
Hunley, Rachel - rachel.hunley@vcuhealth.org
Sheppard, Vanessa, B.
NCT04812743
HM20017398
Inclusion Criteria:
the individual is > 30 years of age
• They are literate
• They are/were directly or indirectly impacted by colorectal cancer and interested in becoming a champion for colorectal cancer research. To participate in a chat hosted by the CHRC the inclusion criteria is:
• adult of any gender
• over 30 years of age. Exclusion Criteria for chat hosted by the CHRC: -Those < 30 years of age
Behavioral: Colorectal Health Research Champions
Cancer of Colon, Cancer of Rectum, Rectum, Colon
Prevention
Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 3
Ryan Garten, PhD - rsgarten@vcu.edu
NCT04916340
Inclusion Criteria:
* apparently healthy and free of overt cardiovascular, pulmonary, or metabolic disease
* for PTSD group, a score of ≥ 33 on PCL-5 checklist
* for GAD group, a score of ≥ 10 on the GAD-7 self-report scale and \< 33 on the PCL-5 checklist
* for Healthy Control group, a score of ≤ 10 on the GAD-7 self-report scale and \< 33 on the PCL-5 checklist
Exclusion Criteria:
* taking medications that could influence cardiovascular function
* current smokers who have recently quit smoking
* illicit drug use or excessive alcohol consumption
* pregnant women
* significant calorie restriction or vitamin/mineral deficiencies
* limited English proficiency BEHAVIORAL: Muscular Strength Training Group, BEHAVIORAL: Muscular Fitness Training Group
Peripheral Vascular Diseases
cardiovascular disease, vascular function, PTSD, GAD, Oxidant
Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 1
Ryan Garten, PhD - rsgarten@vcu.edu
NCT04916327
Inclusion Criteria:
* apparently healthy and free of overt cardiovascular, pulmonary, or metabolic disease
* for PTSD group, a score of ≥ 33 on PCL-5 checklist
* for GAD group, a score of ≥ 10 on the GAD-7 self-report scale and \< 33 on the PCL-5 checklist
* for Healthy Control group, a score of ≤ 10 on the GAD-7 self-report scale and \< 33 on the PCL-5 checklist
Exclusion Criteria:
* taking medications that could influence cardiovascular function
* current smokers who have recently quit smoking
* illicit drug use or excessive alcohol consumption
* pregnant women
* significant calorie restriction or vitamin/mineral deficiencies
* limited English proficiency DIETARY_SUPPLEMENT: Antioxidant, DIETARY_SUPPLEMENT: Placebo
Peripheral Vascular Diseases
cardiovascular disease, vascular function, PTSD, GAD, Oxidant
Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 2
Ryan Garten, PhD - rsgarten@vcu.edu
NCT04922762
Inclusion Criteria:
* apparently healthy and free of overt cardiovascular, pulmonary, or metabolic disease
* for PTSD group, a score of ≥ 33 on PCL-5 checklist
* for GAD group, a score of ≥ 10 on the GAD-7 self-report scale and \< 33 on the PCL-5 checklist
* for Healthy Control group, a score of ≤ 10 on the GAD-7 self-report scale and \< 33 on the PCL-5 checklist
Exclusion Criteria:
* taking medications that could influence cardiovascular function
* current smokers who have recently quit smoking
* illicit drug use or excessive alcohol consumption
* pregnant women
* significant calorie restriction or vitamin/mineral deficiencies
* limited English proficiency BEHAVIORAL: Moderate Intensity, Normal Volume Exercise Training, BEHAVIORAL: High Intensity, Normal Volume Exercise Training, BEHAVIORAL: Moderate Intensity, High Volume Exercise Training
Peripheral Vascular Diseases
cardiovascular disease, vascular function, PTSD, GAD, Oxidant
CONTIGO - A Narrative Intervention to Enhance Genetic Counseling and Testing
Alejandra Hurtado de Mendoza, Ph.D - ahd28@georgetown.edu
NCT05130606
Inclusion Criteria:
Aim 1 and 2.
* Self-identify as a Latina woman
* Be 18 years old or older
* Be able to provide informed consent
* Be fluent in Spanish
* Meet NCCN criteria to be considered for genetic cancer risk assessment for HBOC, whether by a personal history of cancer or family history of cancer
* No previous participation in genetic counseling or testing for hereditary breast and ovarian cancer risk
* No other family members are participating in this study
* Have not participated in any previous studies involving interventions about HBOC or GCT
Aim 3.
* Be 18 years old or older
* Be fluent in English or Spanish
* Have a role in the partner community clinic as either a) full-time or part-time employee b) intern c) volunteer
Exclusion Criteria:
\- BEHAVIORAL: Culturally Targeted Narrative Video: "Is My Cancer Hereditary? Rosa Visits a Genetic Counselor.", BEHAVIORAL: FORCE Fact Sheet
Hereditary Breast and Ovarian Cancer
Breast cancer, Ovarian cancer, Hereditary cancer, Latinas
Microeconomic Intervention to Reduce HIV Transmission in Economically Disadvantaged Transgender Women
Eric Benotsch, PhD - ebenotsch@vcu.edu
Benotsch, Eric, G
NCT04275310
HM20011245
Inclusion Criteria:
• Transgender woman
• 18-45 years of age At least one of the following economic vulnerability factors: unemployment or underemployment [less than 20 hours/week], low income [less than the Medicaid poverty threshold], housing insecurity in the past year or food insecurity in the past year • Behavioral vulnerability to HIV transmission (reported at least one episode of unprotected sex in prior 6 months or at least one other behavioral HIV transmission risk factor in the past 6 months: [transactional sex, multiple sexual partners, 1-time sexual partner, sex under the influence of drugs or alcohol, sex with partner of unknown HIV status).
Exclusion Criteria:
• obvious signs of intoxication or cognitive impairment
• cannot speak English.
Behavioral: Microeconomic Intervention
Hiv, Transgenderism
CIMR Neuromuscular Research Biobank (NRB-0001)
Nicholas Johnson - nicholas.johnson@vcuhealth.org
NCT05434572
Inclusion Criteria:
* Willing and able to give informed consent
* Positive diagnosis or suspected diagnosis of neuromuscular disease, or
* Family history of neuromuscular disease, or
* Healthy volunteer
* Age Neonates-75
Exclusion Criteria:
* Unwilling to sign consent Neuromuscular Diseases, Neuromuscular Disorder, Neuromuscular Diseases in Children
Neuromuscular, Research Repository, Biobank, Neuromuscular Disorder
FearLess in Cognitively Intact Patients With Glioma (FearLess)
Ashlee Loughan, PhD - ashlee.loughan@vcuhealth.org
NCT05604365
Inclusion Criteria:
Patient inclusion:
• Confirmed glioma diagnosis (grade II-IV) via histopathology
• Be a minimum of 2 weeks post surgical repair or biopsy (if applicable)
• Elevated FCR [> 13 on Fear of Cancer Recurrence Inventory]
• Primarily English speaking Caregiver Inclusion:
• Loved one, or non-paid care partner to a patient with a confirmed glioma diagnosis (grade II-IV) via histopathology
• Elevated FCR [> 13 on Fear of Cancer Recurrence Inventory]
• Primarily English speaking
• Age 18+
Exclusion Criteria:
Patient:
• Cognitive impairment [< or equal to 31 on the Telephone Interview for Cognitive Status (TICS)]
• Inability to attend virtual sessions (e.g. due to lack of stable internet connection, difficulty using technology)
• Inability to understand and provide informed consent. Caregiver:
• Inability to attend virtual sessions (e.g. due to lack of stable internet connection, difficulty using technology)
• Inability to understand and provide informed consent.
Behavioral: FearLess Intervention
Glioma, Fear of Cancer
Salad Bars in the National School Lunch Program: Impact on Dietary Consumption Patterns in Elementary School Students
Sarah M Farthing, MS - sarah.malone@vcuhealth.org
NCT05605483
Inclusion Criteria:
Students
• All K-6th grade students at target schools who participate in the school lunch program on
rating day
Cafeteria staff
• All cafeteria personnel at the randomly selected target schools will be eligible to
complete surveys
Exclusion Criteria:
Students
• Unsure sex of child
Cafeteria staff
• None
Other: Salad bar, Other: Waitlisted control
Diet, Food, and Nutrition
Periaqueductal Gray-vagus Nerve Interface Malfunction Explain the Natural History With Its Numerous Co-morbidities?
Gisela Chelimsky, M.D. - gisela.chelimsky@vcuhealth.org
NCT05618054
Inclusion Criteria:
* Females 12-21 years old
* Able to communicate and provide consent/assent
* English speaking
* Diagnosed with POTS (POTS will be defined standardly as a symptomatic ≥ 40 bpm rise in heart rate without a drop in blood pressure and with symptoms of orthostatic intolerance clinically)
* Age-matched healthy control subjects: no POTS or other neurological disorders
Exclusion Criteria:
* Inflammatory arthritis, connective tissue or auto-immune disorder
* Any chronic neurological disorder besides POTS
* Evidence of unstable medical disorder, such as kidney (rising creatinine, or end-stage renal failure) or liver impairment (rising AST or ALT, or end-stage with coagulopathy), poorly controlled significant cardiovascular (CHF), respiratory, endocrine (diabetes - A1c \> 9 - or untreated thyroid dysfunction) or uncontrolled psychiatric illness (such as untreated depression, psychosis, etc.)
* Neuropathy, central nervous system disorder (e.g., Cerebral palsy, developmental delay, seizure disorder, MS, stroke, etc.)
* Treatment with a drug or medical device within the previous 30 days that has not received regulatory approval
* Use of hormones (except insulin, thyroid replacement or oral contraceptives, which will be carefully documented)
* Current substance or alcohol abuse
* Any major surgical intervention with general anesthesia in the last 60 days and minor procedure, such as tooth extraction, endoscopy, etc., with local or conscious sedation within 7 days
* Any on-going or pending medical, health or disability related litigation, or current pursuit of disability
* Any condition that in the judgment of the investigator would interfere with the patient's ability to provide informed consent, comply with study instructions, place the patient at increased risk, or which would clearly confound the interpretation of the study results (specific reason will be documented)
* Chronic use of narcotics for pain
* Claustrophobia or any metal hardware that may interfere with MRI
* Investigators and study staff BEHAVIORAL: Looming task
Postural Tachycardia Syndrome
Enhancing Oral Cancer Awareness Among Minorities
Tamas Gal, Ph.D - Tamas.Gal@vcuhealth.org
NCT06682494
Inclusion Criteria:
* Identify as African American as defined by the US Census
* Participants must be able to read, speak, and write in English
Exclusion Criteria:
* Individuals who cannot physically or mentally participate in the research project will be excluded
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Prisoners BEHAVIORAL: Traditional Education, BEHAVIORAL: AI-powered Chatbox
Oral Cancer, Chatbot, Patient Education, Prevention, Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer, Oropharyngeal Cancers
AI-powered Chatbox, Oral cancer prevention, Socio-economic barriers
Pancreatic Cancer Early Detection Consortium (PRECEDE)
Naveen Fawas, BS - naveen.fawaz@arborresearch.org
NCT04970056
Inclusion Criteria:
Individuals from the following groups who present for clinical evaluation and assessment of PDAC risk at any of the participating sites can be offered participation in the PRECEDE database:
Cohort 1
Individuals without history of PDAC meeting any of the following criteria:
• 2+ relatives with PDAC on same side of family where 2 affected are first degree related to each other and at least 1 affected is first degree related to subject; age 50+ or ≤10 years younger than earliest PDAC in family at time of diagnosis.
• 2 affected first degree relatives with PDAC; age 50+ or 10 years younger than earliest PDAC in family
• BRCA1, BRCA2, PALB2, ATM, MLH1, MSH2, MSH6, PMS2, EPCAM pathogenic or likely pathogenic variant AND 1 first or second degree relative with PDAC; age 50+ or 10 years younger than earliest PDAC in family
• Familial Atypical Moles and Malignant Melanoma (FAMMM) with pathogenic or likely pathogenic CDKN2A variant; age 40+
• Peutz-Jegher syndrome with STK11 pathogenic or likely pathogenic variant; age 35+
• Hereditary pancreatitis with PRSS1 pathogenic or likely pathogenic variant and history of pancreatitis; age 40+ Cohort 2 Individuals without history of PDAC meeting any of the following criteria:
• ATM, BRCA1, BRCA2, or PALB2 pathogenic or likely pathogenic variant regardless of family history, age 50+
• 2+ relatives with PDAC on the same side of family, any degree of relation, not meeting other criteria above; age 50+ or 10 years younger than earliest PDAC in family
• 1 first degree relative with PDAC ≤ age 45; age up to 10 years younger than PDAC diagnosis in family member Cohort 3 Individual meeting criteria for Cohorts 1 or 2 EXCEPT age (i.e. too young to qualify for Cohorts 1 or 2) Cohort 4 Individuals without history of PDAC presenting for evaluation who do not meet any criteria for 1-3, 6, or the Cyst Cohort. Cohort 5 Individuals without history of PDAC who are not otherwise engaged in pancreas surveillance at a participating site may be invited to participate in the PRECEDE database and to donate a biosample (e.g. blood, saliva, and/or buccal swab) for discovery studies. This may include relatives of individuals in Cohorts 1-4,6, and the Cyst Cohort. Cohort 6a Individuals diagnosed with PDAC after enrollment in PRECEDE meeting any of the following criteria:
• Family history includes at least one first degree relative with PDAC, or 2 relatives with PDAC who are first degree related to each other
• Personal or family history of a pathogenic or likely pathogenic germline variant in ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2,PMS2, PRSS1, STK11 Cohort 6b Individuals with a personal history of PDAC meeting any of the following criteria:
• Family history includes at least one first degree relative with PDAC, or 2 relatives with PDAC who are first degree related to each other
• Personal or family history of a pathogenic or likely pathogenic germline variant in ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2,PMS2, PRSS1, STK11
• Diagnosed ≤ age 45 Cyst Cohort Individuals with a personal history of a pancreatic cystic neoplasm not meeting any criteria for Cohorts 1-3 or 6 (no known family history of PDAC, no known pathogenic germline variants linked to PDAC risk)
Exclusion Criteria:
* Individuals not meeting the criteria above. Pancreas Cancer, Pancreas Cyst, Pancreatic Ductal Adenocarcinoma, Genetic Predisposition
Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S03)
ctrrecruit@vcu.edu
NCT06611540
Inclusion Criteria:
* Willingness and ability to provide a documented informed consent.
* Is 25 years or older.
* Has an intact cervix.
* Has had a referral for colposcopy and/or cervical excisional procedure in which routine cervical cancer screening has included HPV testing (HPV primary screening, co-testing, or atypical squamous cells of undetermined significance \[ASC-US\] cytology triage) or abnormal cytology performed within the past 12 months preceding the referral visit.
* Willing and able to undergo colposcopy, and if clinically indicated for SOC purposes, a biopsy, endocervical curettage, and/or a cervical excisional procedure, as applicable.
Exclusion Criteria:
* Is pregnant when presenting for the referral visit or gave birth within the past 3 months.
* Has a known history of excisional or ablative therapy to the cervix (e.g., loop electrosurgical excision procedure \[LEEP\], cone biopsy, cervical laser surgery, cryotherapy, thermal ablation) in the last 12 months prior to the referral visit.
* Has had a complete or partial hysterectomy, either supracervical or involving removal of the cervix, via self-report or confirmation via medical records.
* Known medical conditions that, in the opinion of the investigator, preclude study participation.
* Previous participation in the SHIP Trial. Participation is defined as completing the self-collection.
* Is experiencing unusual bleeding or pelvic pain. PROCEDURE: Biospecimen Collection, PROCEDURE: Cervical Biopsy, PROCEDURE: Colposcopy, OTHER: Electronic Health Record Review, PROCEDURE: Endocervical Curettage, PROCEDURE: Excision, PROCEDURE: HPV Self-Collection, PROCEDURE: Human Papillomavirus Test, OTHER: Questionnaire Administration
Cervical Carcinoma, Human Papillomavirus Infection
A Study of Emapalumab for Pediatric Aplastic Anemia
Andromachi Scaradavou, MD - ScaradaA@mskcc.org
NCT06430788
Inclusion Criteria:
* Patients undergoing workup for suspected newly diagnosed sAA:
* Patients with severe cytopenias and a hypocellular marrow concerning for sAA
* Patients that meet the definition for suspected sAA (Camitta Criteria) as follows:
Marrow Cellularity: \<25%, or 25-50% with \<30% residual hematopoietic cells Peripheral cytopenias (at least 2 of 3) Absolute neutrophil count (ANC): \<500 x 10\^9/L Platelets: \<20 x 10\^9/L Absolute Reticulocyte Count: \<60 x 10\^9/L
* Patients that do not have evidence of leukemia or MDS
* Patients \< 25 years of age at time of diagnosis
* Able to tolerate emapalumab and IST (with standard institutional organ function criteria)
Exclusion Criteria:
* Uncontrolled infection at presentation.
* Patients who have undergone previous treatment for sAA.
* Patients with known inherited bone marrow failure
* Patient who has completed a full workup for sAA including having results back from telomere testing, DEB and genetics (when applicable), as well as having an appropriate willing and available donor and would otherwise be admitted for HSCT within 2 weeks of enrolling on the trial
* Patients with leukemia or MDS
* Patient or parent or guardian unable to give informed consent or unable to comply with the treatment protocol including research tests. BIOLOGICAL: Emapalumab
Aplastic Anemia, Cytopenia, Hypocellular Marrow
pediatric aplastic anemia, aplastic anemia, cytopenia, hypocellular marrow, Emapalumab, Memorial Sloan Kettering Cancer Center, 23-278
Advancing Water Security: A Community Participatory School-Based Hydration Intervention
Sarah Farthing, MS - sarah.malone@vcuhealth.org
Melanie Bean
NCT06714929
Inclusion Criteria:
* Lunchroom observations: All students (K-5th \[Pre-Kindergarten if applicable\]) who eat lunch in the cafeteria on assessment days are eligible
* BMI and dental caries assessments: 1) student enrolls in study while in 3rd grade (followed through 5th g)
* Student surveys: Students in 4th-5th grade are eligible to complete surveys assessing beverage intake and perceptions of hydration practices within their school district.
* Staff surveys: All staff in the target schools will be eligible to complete the Personnel Survey.
Exclusion Criteria:
* Lunchroom observations: None.
* BMI and dental caries assessments: Students are ineligible if they are unable to complete assessments due to developmental or physical reasons, 2) planning to move in the study duration
* Student surveys: None.
* Staff surveys: None. BEHAVIORAL: Hydration
Dental Caries, Obesity Prevention
hydration, water, sugar-sweetened beverages, dental caries, overweight and obesity
Psychobiological Responses Following Exercise and Brain Stimulation
Edmund Acevedo - eoacevedo@vcu.edu
NCT06874595
Inclusion Criteria:
* Healthy adults
* aged 18 to 50
* consent and complete a Physical Activity Readiness Questionnaire (PAR-Q)
* be free from any neurological or psychiatric disorder
* not be taking any medication that could affect the central nervous system
* not have any contraindication for HD-tDCS (i.e. not having metal implanted in the head, pacemaker, medical bumps, seizures, lesions on the scalp or head ) or for bioelectrical impedance (i.e., electronic medical implant, such as a pacemaker or implantable cardioverter defibrillator, and limb amputation)
* not be regular users of tobacco products (cigarettes, cigars, chewing tobacco)
* not consume an average of more than ten alcoholic beverages per week
Exclusion Criteria:
* Individuals who do not meet the PAR-Q screening criteria for participation in moderate physical activity will be excluded from participating in this study
* women who are pregnant will be exclude from this study OTHER: Cycling exercise at 65% of HRR for 20 minutes followed by HD-tDCS (exercise + HD-tDCS), OTHER: Cycling exercise at 65% of HRR exercise followed by sham HD-tDCS (exercise + sham tDCS), OTHER: No exercise followed by HD-tDCS (no exercise + HD-tDCS)., OTHER: State Anxiety Inventory, OTHER: Visual Analog Scale for Anxiety
Psychological
Exercise and Brain Stimulation
ASSESS ALL ALS Study
ALL ALS Patient Navigator - info@all-als.org
NCT06578195
Inclusion Criteria for ALS participants:
• Age 18 years or older
• Capable of providing informed consent
• Willing to follow study procedures
• Diagnosis of ALS by a physician
• Access to a smartphone, computer or tablet, and internet (need not be in the home - access to a public library or other available computer with internet connection is sufficient) Inclusion Criteria for control participants:
• Age 18 years or older
• Capable of providing informed consent
• Willing to follow study procedures
• No diagnosis of ALS , Progressive Muscular Atrophy (PMA) or Primary Lateral Sclerosis (PLS)
• No history of familial ALS/Frontotemporal Dementia (FTD) in a close family member\*\* unless the participant has previously tested negative for the known causative ALS genes. Participants with a family history of singleton ALS are permitted to enroll. * \*\* Defined by the presence of a known ALS causative gene such as C9orf72 in a family member or a family history suggestive of an inherited ALS/FTD syndrome defined by two family members with a history of ALS and/or FTD.
• Access to a smartphone, computer or tablet, and internet (need not be in the home - access to a public library or other available computer with internet connection is sufficient) Exclusion Criteria for all participants:
• Significant cognitive impairment, clinical dementia, or unstable psychiatric illness, including psychosis, active suicidal ideation, suicide attempt, or untreated major depression \<= 90 days of screening, that would interfere with the study procedure, according to Investigator's judgement.
• Clinically significant unstable medical condition (other than ALS) (e.g., cardiovascular instability, systemic infection, untreated thyroid dysfunction, malignant and potentially progressive cancer) that would render the participant unlikely to be able to complete 12 months of follow-up, according to Investigator's judgment. Exclusion Criteria for participants undergoing optional Lumbar Puncture
• Medically unable to undergo lumbar puncture (LP) as determined by the site investigator (i.e., bleeding disorder, a skin infection at or near the LP site, known or suspected intracranial or intraspinal tumor or other cause of increased intracranial pressure).
• Allergy to Lidocaine or other local anesthetic agents.
• Use of anticoagulant medication or antiplatelet medications (aside from aspirin 81 mg) that cannot be safely withheld prior to lumbar puncture.
• Blood dyscrasia, abnormal bleeding diathesis, or the use of dialysis for renal failure.
• Current pregnancy based on participant self-report
• Clinical judgement of the site investigator that the participant would be unable to undergo multiple lumbar punctures.
• Age 18 years or older
• Capable of providing informed consent
• Willing to follow study procedures
• Diagnosis of ALS by a physician
• Access to a smartphone, computer or tablet, and internet (need not be in the home - access to a public library or other available computer with internet connection is sufficient) Inclusion Criteria for control participants:
• Age 18 years or older
• Capable of providing informed consent
• Willing to follow study procedures
• No diagnosis of ALS , Progressive Muscular Atrophy (PMA) or Primary Lateral Sclerosis (PLS)
• No history of familial ALS/Frontotemporal Dementia (FTD) in a close family member\*\* unless the participant has previously tested negative for the known causative ALS genes. Participants with a family history of singleton ALS are permitted to enroll. * \*\* Defined by the presence of a known ALS causative gene such as C9orf72 in a family member or a family history suggestive of an inherited ALS/FTD syndrome defined by two family members with a history of ALS and/or FTD.
• Access to a smartphone, computer or tablet, and internet (need not be in the home - access to a public library or other available computer with internet connection is sufficient) Exclusion Criteria for all participants:
• Significant cognitive impairment, clinical dementia, or unstable psychiatric illness, including psychosis, active suicidal ideation, suicide attempt, or untreated major depression \<= 90 days of screening, that would interfere with the study procedure, according to Investigator's judgement.
• Clinically significant unstable medical condition (other than ALS) (e.g., cardiovascular instability, systemic infection, untreated thyroid dysfunction, malignant and potentially progressive cancer) that would render the participant unlikely to be able to complete 12 months of follow-up, according to Investigator's judgment. Exclusion Criteria for participants undergoing optional Lumbar Puncture
• Medically unable to undergo lumbar puncture (LP) as determined by the site investigator (i.e., bleeding disorder, a skin infection at or near the LP site, known or suspected intracranial or intraspinal tumor or other cause of increased intracranial pressure).
• Allergy to Lidocaine or other local anesthetic agents.
• Use of anticoagulant medication or antiplatelet medications (aside from aspirin 81 mg) that cannot be safely withheld prior to lumbar puncture.
• Blood dyscrasia, abnormal bleeding diathesis, or the use of dialysis for renal failure.
• Current pregnancy based on participant self-report
• Clinical judgement of the site investigator that the participant would be unable to undergo multiple lumbar punctures.
Amyotrophic Lateral Sclerosis
ALS, Amyotrophic Lateral Sclerosis, biomarker, observational
Examining Lateralized Aspects of Motor Control Using Non-invasive Neural Stimulation
Brooke Dexheimer, PhD, OTD, OTR/L - dexheimerb@vcu.edu
NCT05947279
Inclusion Criteria:
* Right-handed as determined by the short-form Edinburgh Handedness Inventory
* Between the ages of 18 and 40
Exclusion Criteria:
* Mixed- or left-handed as determined by the short-form Edinburgh Handedness Inventory
* Self-reported history of any of the following:
Seizure and/or diagnosis of epilepsy Fainting spells Concussion with loss of consciousness Ringing in the ears (tinnitus) Cochlear implants Migraines Diagnosed psychological or neurological condition Metal in the scalp
* Any previous adverse reaction to a brain stimulation technique
* Any previous adverse reaction to 3D virtual reality environments (i.e. 'cybersickness')
* Possibility of being currently pregnant (for females only)
* Current open head wound or skin condition of the scalp
* Current implanted device(s) (i.e. cardiac pacemaker) BEHAVIORAL: Comparing motor adaptation reaching performance
Motor Adaptation and Generalization, Posterior Parietal Cortex, Cerebellum
Health Education Approach to Lung Screening (HEALS)
Massey IIT Research Operations - masseyepd@vcu.edu
NCT06070870
Inclusion Criteria:
* Meets current USPSTF guidelines for lung cancer screening (LCS)
* 20 pack-year smoking history Note: A pack-year is a way of calculating how much a person has smoked in their lifetime.
One pack-year is the equivalent of smoking an average of 20 cigarettes-1 pack-per day for a year.
* Currently smokes or has quit smoking within the past 15 years
* Identifies as Black or African-American Note: Both Hispanic/Latino and Non-Hispanic/Latino patients are eligible as long as they also identify as Black or African-American (eg, Afro-Latino).
* Willing to complete all navigation-related study activities
* Able to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
A patient who meets any of the following exclusion criteria is ineligible to participate in the study:
* Known history of cancer (except squamous cell skin cancer), or coughing up blood in the past 5 years, as reported by the individual
* Has undergone a previous lung cancer screening
* Inability to speak English
* Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements BEHAVIORAL: Patient Navigation
Lung Cancer
Lung cancer, Screening
The Impact of Chronic E-Cigarette Usage on Microvascular Health
Paula Rodriguez Miguelez - prodriguezmig@vcu.edu
NCT06860698
e-Cig users arm
• Between 18 and 29 years of age Exclusion * 17 years old and younger or 30 years old and older * Use of cigarettes or other tobacco products more than 50 times in their lifetime. * Evidence of cardiovascular, pulmonary, renal, hepatic, metabolic, cerebral diseases or sleep disorders * Disorder or use of medication that affects cardiopulmonary health * Evidence of pregnancy or current nursing
Inclusion Criteria:
* Between 18 and 29 years of age
* Used e-cigarettes with nicotine (≥3 times/week for ≥6 months)
Exclusion Criteria:
* 17 years old and younger or 30 years old or older.
* Former combustible tobacco user/ former smoker
* Use of cigarettes for 15 days or more in the past 60 days
* Use of other tobacco products (cigars, hookah, smokeless), marijuana and/or illicit or prescription drugs weekly or more frequently in the past 60 days
* Evidence of cardiovascular, pulmonary, renal, hepatic, metabolic, cerebral diseases or sleep disorders
* Disorder or use of medication that affects cardiopulmonary health
* Evidence of pregnancy or current nursing
Non e-Cig using arm
Inclusion
• Between 18 and 29 years of age Exclusion * 17 years old and younger or 30 years old and older * Use of cigarettes or other tobacco products more than 50 times in their lifetime. * Evidence of cardiovascular, pulmonary, renal, hepatic, metabolic, cerebral diseases or sleep disorders * Disorder or use of medication that affects cardiopulmonary health * Evidence of pregnancy or current nursing
OTHER: E-cig use
E-Cig Use
Microvascular Health
Feasibility and Acceptability of Using Weighted Blankets to Prevent and /or Mitigate Delirium
Heather Fudala, PhD - heather.fudala@vcuhealth.org
NCT06161480
Inclusion Criteria:
* 18 years of age or older.
* Requiring ICU level of care.
* Have a primary medical diagnosis.
* Proficient in English.
Exclusion Criteria:
* BMI less than 18.5.
* Significant deficit in cognitive functioning that is not expected to improve due to an end---stage disease stage or permanent injury (e.g., end-stage encephalopathy, traumatic or anoxic brain injury, dementia).
* Known pregnancy.
* Prisoners.
* Presence of skin injury (e.g., surgical wound, pressure injury, moisture injury) in an anatomical location where additional weight/pressure of blanket could prevent healing and /or lead to an expansion of the injury.
* Patients with skin injuries to areas easily left uncovered by the blanket (e.g., hands, feet) can be enrolled with additional communication to clinical team to leave areas uncovered to prevent additional injury.
* Paralysis effecting an area the weighted blanket will cover.
* Current neuromuscular blocking agent.
* Presence of recent/unhealed fractures on an area the blanket will cover (e.g., lower limb long bone, rib, pelvis, spine).
* History of claustrophobia reported by patient and/or their legally authorized representative (LAR).
* Fever of 37.5°C (99.5°F).
* Limited English proficiency. DEVICE: Weighted Blanket
Delirium