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CompletedNCT03629912BingocizeUpdated Mar 12, 2024Results posted

Bingocize: A Novel Mobile Application for Older Adult Health

An interventional study of Socially-Based Exercise Intervention for Older Adults in Activities of Daily Living, Accidental Fall and Sarcopenia, sponsored by Western Kentucky University. Completed at 4 sites in United States. Open to participants aged 60 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-12.

Sponsored by Western Kentucky University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
241
Allocation
Randomized
Ages
60 Years to 85 Years
Sex
All
01

Study summary

This study tests the effectiveness of using a new mobile application (Bingocize®) to improve older adults' (a) adherence to an engaging exercise program, and (b) aspects of functional performance, health knowledge, dietary habits, and cognition.

Read the detailed description

Health-promoting interventions designed to improve physical and mental fitness can help reduce health care costs; they can also help maintain, or even improve, older adults' quality of life. However, getting older adults to adhere to health-promoting exercise interventions remains difficult because such programs are often perceived as being time-consuming, painful, or unenjoyable. The present study's objective is to investigate the effectiveness of a novel technological exercise intervention program for older adults (Bingocize); in doing so, the program has the potential to improve older adults' independence and quality of life. Older adults will participate in a pre/post-intervention design with random assignment to either the experimental or one of three comparison/control groups; each group will play Bingocize in a social setting with other older adults. Participants in the experimental group will use the app to engage in twice-weekly Bingocize sessions for twelve weeks (i.e., Bingo+Exercise+Health Education); control groups will also use the app for twelve weeks but for either health education-only, exercise-only, or bingo-only.

02

Conditions studied

  • Activities of Daily Living
  • Accidental Fall
  • Sarcopenia
  • Arteriosclerosis
  • Diabetes Mellitus, Type 2
  • Hypertension
  • Cognitive Decline
  • Executive Function
  • Cognitive Aging
03

In context

Sarcopenia

1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.

This study's enrollment of 241 is above the median of 60 across 775 interventional studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

Western Kentucky University is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Normal or corrected normal vision
  • Mobility (i.e., not wheelchair bound)
  • English is native language
  • Minimum physical standards (e.g., ability to walk at least 10 meters)
  • No structured physical activity programs >150 minutes/week in last 6 months

Exclusion criteria

Exclusion Criteria:

  • Severe neurological impairments (e.g., Parkinson's)
  • Colorblindness
  • Dementia
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
241 participants (actual)

Study arms

  • Experimental
    Exercise + Health Education + Bingo

    Socially-Based Exercise Intervention for Older Adults. Participants use the Bingocize app incorporating exercises AND health information on fall risks + diet/nutrition.

    Behavioral: Socially-Based Exercise Intervention for Older Adults

  • Active comparator
    Exercise + Bingo

    Socially-Based Exercise Intervention for Older Adults. Participants use the Bingocize app incorporating exercises ONLY.

    Behavioral: Socially-Based Exercise Intervention for Older Adults

  • Active comparator
    Health Education + Bingo

    Socially-Based Exercise Intervention for Older Adults. Participants use the Bingocize app incorporating health information on fall risks + diet/nutrition ONLY.

    Behavioral: Socially-Based Exercise Intervention for Older Adults

  • No intervention
    Bingo Only

    Participants use the Bingocize app to play bingo only.

Interventions

  • BehavioralSocially-Based Exercise Intervention for Older Adults

    A socially-based app that incorporates exercise and/or health education into a format familiar and engaging to older adults, designed to improve adherence to health-promoting behaviors

    Also known as: Bingocize

06

What researchers measure

Primary outcomes

  1. Executive Function Inhibition Measure 1: Flanker Task

    Flanker Task designed to measure inhibition, part of the EXAMINER Battery (for scoring method, see References section). EXAMINER generates a score that combines reaction time and accuracy data from the incongruent trials. This scoring method generates accuracy and reaction time sub-scales that range in value between 0 and 5, and the ultimate composite score ranges in value between 0 and 10. Minimum=0, Maximum=10, higher = better.

    Time frame: Baseline and 12 Weeks

  2. Executive Function Measure: Updating Verbal Working Memory

    Dot Counting Task designed to measure verbal working memory, part of the EXAMINER Battery (for scoring method, see References). EXAMINER generates a score is the total number of items correctly recalled across all six trials. Minimum=0, Maximum=27, higher = better.

    Time frame: Baseline and 12 Weeks

  3. Executive Function Measure: Set Shifting Task

    Set Shifting Task designed to measure attention during task switching, part of the EXAMINER Battery (for scoring method, see References). EXAMINER generates a score that combines reaction time and accuracy data from the incongruent trials. This scoring method generates accuracy and reaction time sub-scales that range in value between 0 and 5, and the ultimate composite score ranges in value between 0 and 10. Minimum=0, Maximum=10, higher = better.

    Time frame: Baseline and 12 Weeks

  4. Executive Function Measure: Verbal Fluency

    Verbal Fluency Task designed to measure fluency, part of the EXAMINER Battery (for scoring method, see References). EXAMINER generates a score that represents the total number of words correctly recalled in two tasks: phonemic (letter) and semantic (category). Minimum=0, Maximum=unlimited, higher = better.

    Time frame: Baseline and 12 Weeks

  5. Chair Stands: Change in Lower-body Muscular Strength

    number of completed chair stands in 30 seconds, minimum=0, higher = better

    Time frame: Baseline and 12 Weeks

  6. Change in Dynamic Balance: 360 Degree Turns

    360 degree turns: time to complete. No minimum or maximum value set. Lower = better.

    Time frame: Baseline and 12 Weeks

  7. Executive Function Measure of Inhibition: Continuous Performance Test

    Continuance Performance Task is classic response inhibition task, part of the EXAMINER Battery (for scoring method, see References). The score here represents the number of trials out of 100 that the participant responded correctly (i.e., either successfully responded or successfully inhibited a response). Minimum=0 Maximum=100, higher = better.

    Time frame: Baseline and 12 Weeks

  8. Timed Up and Go (TUG) Test: Change in Dynamic Balance

    Timed Up and Go (TUG) Test used to assess mobility and risk for falling. Number of seconds needed to stand up from a chair, walk 10 feet, turn around, walk back 10 feet, and sit back down in chair. No minimum or maximum value is set. Lower = better.

    Time frame: Baseline and 12 Weeks

Secondary outcomes

  1. Crystallized Knowledge of Fall Risks and Proper Diet/Nutrition

    Multiple-choice questions constructed by project investigators that cover: recognition of health terms, weight management, proper diet, bone health, environmental fall risks, careful movement. Unit of measure = number correct. Minimum = 0, Maximum = 30. Higher = better.

    Time frame: Baseline and 12 Weeks

  2. Grip Strength: Changes in Upper Body Muscular Strength

    Grip strength tests using a hand-held dynamometer. No minimum or maximum set. Higher = better.

    Time frame: Baseline and 12 Weeks

  3. Fall Efficacy Scale

    Self-reported scale assessing confidence in doing activities that may be perceived as having risk for falling (see References). Minimum = 10, Maximum = 100. Lower = better.

    Time frame: Baseline and 12 Weeks

  4. Changes in Dietary Habits: Total Added Sugar Intake

    Dietary Screener Questionnaire (DSQ) assessing total added sugar intake over past 30 days

    Time frame: Baseline and 12 Weeks

  5. Changes in Quality of Life

    CDC Health related quality of life measure item 1 (general health). 1 = Excellent, 5 = Poor. Lower = Better.

    Time frame: Baseline and 12 Weeks

  6. Changes in Weight

    Weight calculated by scale measurement

    Time frame: Baseline and 12 Weeks

  7. Systolic Blood Pressure

    Systolic Blood pressure calculated by sphygmomanometer.

    Time frame: Baseline and 12 Weeks

  8. Diastolic Blood Pressure

    Diastolic Blood pressure calculated by sphygmomanometer

    Time frame: Baseline and 12 Weeks

07

Results

Posted Mar 12, 2024
Limitations and caveats
COVID-19 Pandemic began in the Middle of this Intervention, resulting in the loss of approximately 35-40% of the overall participant sample who were in the middle of the clinical trial intervention and had to withdraw from the study. Other data collection waves were started and completed before the pandemic, or started and completed after the pandemic, which introduces the possibility of history effects impacting interpretations of the data from participants who did complete the trial.

Participant flow

Participant flow — Overall Study
MilestoneExercise + Health Education + BingoExercise + BingoHealth Education + BingoBingo Only
Started73535043
Completed44404139
Not completed291394
Withdrew: Lost to follow-up19751
Withdrew: Withdrawal by subject6012
Withdrew: Illness or injury unrelated to research study3631
Withdrew: Death1000

Outcome measures

PrimaryExecutive Function Inhibition Measure 1: Flanker Task

Flanker Task designed to measure inhibition, part of the EXAMINER Battery (for scoring method, see References section). EXAMINER generates a score that combines reaction time and accuracy data from the incongruent trials. This scoring method generates accuracy and reaction time sub-scales that range in value between 0 and 5, and the ultimate composite score ranges in value between 0 and 10. Minimum=0, Maximum=10, higher = better.

Time frame:
Baseline and 12 Weeks
Reported as:
Mean · score on a scale
Executive Function Inhibition Measure 1: Flanker Task
score on a scaleExercise + Health Education + BingoExercise + BingoHealth Education + BingoBingo Only
Baseline7.30 ± 1.417.39 ± 0.957.38 ± 1.187.51 ± 1.21
Post-Intervention7.66 ± .807.54 ± .787.63 ± .797.86 ± .62
PrimaryExecutive Function Measure: Updating Verbal Working Memory

Dot Counting Task designed to measure verbal working memory, part of the EXAMINER Battery (for scoring method, see References). EXAMINER generates a score is the total number of items correctly recalled across all six trials. Minimum=0, Maximum=27, higher = better.

Time frame:
Baseline and 12 Weeks
Reported as:
Mean · units on a scale
Executive Function Measure: Updating Verbal Working Memory
units on a scaleExercise + Health Education + BingoExercise + BingoHealth Education + BingoBingo Only
Baseline21.60 ± 2.8322.42 ± 2.4322.50 ± 2.0021.69 ± 2.36
Post Intervention22.56 ± 2.2822.87 ± 2.1322.15 ± 3.1022.12 ± 2.44
PrimaryExecutive Function Measure: Set Shifting Task

Set Shifting Task designed to measure attention during task switching, part of the EXAMINER Battery (for scoring method, see References). EXAMINER generates a score that combines reaction time and accuracy data from the incongruent trials. This scoring method generates accuracy and reaction time sub-scales that range in value between 0 and 5, and the ultimate composite score ranges in value between 0 and 10. Minimum=0, Maximum=10, higher = better.

Time frame:
Baseline and 12 Weeks
Reported as:
Mean · score on a scale
Executive Function Measure: Set Shifting Task
score on a scaleExercise + Health Education + BingoExercise + BingoHealth Education + BingoBingo Only
Baseline6.70 ± .936.51 ± 1.036.67 ± .947.05 ± .94
Post-Intervention6.86 ± 1.076.82 ± .947.04 ± .987.08 ± 1.09
PrimaryExecutive Function Measure: Verbal Fluency

Verbal Fluency Task designed to measure fluency, part of the EXAMINER Battery (for scoring method, see References). EXAMINER generates a score that represents the total number of words correctly recalled in two tasks: phonemic (letter) and semantic (category). Minimum=0, Maximum=unlimited, higher = better.

Time frame:
Baseline and 12 Weeks
Reported as:
Mean · number correct
Executive Function Measure: Verbal Fluency
number correctExercise + Health Education + BingoExercise + BingoHealth Education + BingoBingo Only
Baseline Phonemic Fluency9.5 ± 4.1810.9 ± 4.399.04 ± 3.8610.51 ± 4.10
Post Intervention Phonemic Fluency10.34 ± 5.029.97 ± 3.669.04 ± 3.919.25 ± 3.71
Baseline Category Fluency10.97 ± 4.0311.32 ± 3.3510.73 ± 3.0211.28 ± 2.88
Post Intervention Category Fluency11.06 ± 3.7011.62 ± 3.749.90 ± 3.2410.97 ± 2.85
PrimaryChair Stands: Change in Lower-body Muscular Strength

number of completed chair stands in 30 seconds, minimum=0, higher = better

Time frame:
Baseline and 12 Weeks
Reported as:
Mean · chair stands completed
Chair Stands: Change in Lower-body Muscular Strength
chair stands completedExercise + Health Education + BingoExercise + BingoHealth Education + BingoBingo Only
Baseline10.07 ± 5.249.28 ± 4.029.92 ± 2.309.94 ± 2.26
Post Intervention11.18 ± 4.8911.89 ± 4.1110.87 ± 3.5510.52 ± 2.66
PrimaryChange in Dynamic Balance: 360 Degree Turns

360 degree turns: time to complete. No minimum or maximum value set. Lower = better.

Time frame:
Baseline and 12 Weeks
Reported as:
Mean · seconds
Change in Dynamic Balance: 360 Degree Turns
secondsExercise + Health Education + BingoExercise + BingoHealth Education + BingoBingo Only
Baseline4.62 ± 2.884.07 ± 1.443.43 ± 1.153.37 ± .95
Post-Intervention4.11 ± 2.043.67 ± 1.573.53 ± 1.353.52 ± 1.13
PrimaryExecutive Function Measure of Inhibition: Continuous Performance Test

Continuance Performance Task is classic response inhibition task, part of the EXAMINER Battery (for scoring method, see References). The score here represents the number of trials out of 100 that the participant responded correctly (i.e., either successfully responded or successfully inhibited a response). Minimum=0 Maximum=100, higher = better.

Time frame:
Baseline and 12 Weeks
Reported as:
Mean · number correct
Executive Function Measure of Inhibition: Continuous Performance Test
number correctExercise + Health Education + BingoExercise + BingoHealth Education + BingoBingo Only
Baseline96.76 ± 5.1496.66 ± 4.5397.26 ± 4.9498.17 ± 2.02
Post Intervention96.30 ± 6.3597.92 ± 2.6997.60 ± 4.3898.43 ± 1.65
SecondaryCrystallized Knowledge of Fall Risks and Proper Diet/Nutrition

Multiple-choice questions constructed by project investigators that cover: recognition of health terms, weight management, proper diet, bone health, environmental fall risks, careful movement. Unit of measure = number correct. Minimum = 0, Maximum = 30. Higher = better.

Time frame:
Baseline and 12 Weeks
Reported as:
Mean · number correct
Crystallized Knowledge of Fall Risks and Proper Diet/Nutrition
number correctExercise + Health Education + BingoExercise + BingoHealth Education + BingoBingo Only
Baseline19.45 ± 3.9319.60 ± 3.9620.07 ± 3.9320.12 ± 2.85
Post-Intervention23.13 ± 4.3021.67 ± 3.6723.26 ± 4.1220.41 ± 3.46
SecondaryGrip Strength: Changes in Upper Body Muscular Strength

Grip strength tests using a hand-held dynamometer. No minimum or maximum set. Higher = better.

Time frame:
Baseline and 12 Weeks
Reported as:
Mean · kilograms
Grip Strength: Changes in Upper Body Muscular Strength
kilogramsExercise + Health Education + BingoExercise + BingoHealth Education + BingoBingo Only
Baseline23.34 ± 7.3424.15 ± 8.7924.00 ± 9.6023.56 ± 6.34
Post Intervention24.45 ± 8.9824.80 ± 7.4224.73 ± 9.1524.10 ± 6.17
SecondaryFall Efficacy Scale

Self-reported scale assessing confidence in doing activities that may be perceived as having risk for falling (see References). Minimum = 10, Maximum = 100. Lower = better.

Time frame:
Baseline and 12 Weeks
Reported as:
Mean · score on a scale
Fall Efficacy Scale
score on a scaleExercise + Health Education + BingoExercise + BingoHealth Education + BingoBingo Only
Baseline16.61 ± 13.1221.00 ± 20.3919.58 ± 21.6315.13 ± 14.22
Post Intervention17.68 ± 18.4820.32 ± 23.4615.65 ± 16.4215.12 ± 15.69
SecondaryChanges in Dietary Habits: Total Added Sugar Intake

Dietary Screener Questionnaire (DSQ) assessing total added sugar intake over past 30 days

Time frame:
Baseline and 12 Weeks
Reported as:
Mean · tsp equivalents
Changes in Dietary Habits: Total Added Sugar Intake
tsp equivalentsExercise + Health Education + BingoExercise + BingoHealth Education + BingoBingo Only
Baseline13.46 ± 2.7214.07 ± 5.3014.94 ± 6.0614.09 ± 3.62
Post Intervention13.28 ± 4.5313.32 ± 3.8914.46 ± 5.1013.79 ± 3.02
SecondaryChanges in Quality of Life

CDC Health related quality of life measure item 1 (general health). 1 = Excellent, 5 = Poor. Lower = Better.

Time frame:
Baseline and 12 Weeks
Reported as:
Mean · units on a scale
Changes in Quality of Life
units on a scaleExercise + Health Education + BingoExercise + BingoHealth Education + BingoBingo Only
Baseline2.95 ± .862.83 ± .742.80 ± .923.00 ± .72
Post-Intervention2.86 ± .822.93 ± .792.83 ± .843.0 ± .76
SecondaryChanges in Weight

Weight calculated by scale measurement

Time frame:
Baseline and 12 Weeks
Reported as:
Mean · kg
Changes in Weight
kgExercise + Health Education + BingoExercise + BingoHealth Education + BingoBingo Only
Baseline84.19 ± 22.8387.91 ± 26.6078.11 ± 14.4586.79 ± 21.82
Post Intervention84.09 ± 22.1186.83 ± 22.6780.00 ± 15.9386.27 ± 21.37
SecondarySystolic Blood Pressure

Systolic Blood pressure calculated by sphygmomanometer.

Time frame:
Baseline and 12 Weeks
Reported as:
Mean · mmHg
Systolic Blood Pressure
mmHgExercise + Health Education + BingoExercise + BingoHealth Education + BingoBingo Only
Baseline135.23 ± 12.99134.03 ± 13.97136.12 ± 13.64135.18 ± 12.42
Post Intervention136.25 ± 16.63143.21 ± 10.71141.83 ± 19.02141.21 ± 22.10
SecondaryDiastolic Blood Pressure

Diastolic Blood pressure calculated by sphygmomanometer

Time frame:
Baseline and 12 Weeks
Reported as:
Mean · mmHg
Diastolic Blood Pressure
mmHgExercise + Health Education + BingoExercise + BingoHealth Education + BingoBingo Only
Baseline75.07 ± 10.0478.23 ± 8.8776.12 ± 7.6875.54 ± 7.33
Post Intervention77.14 ± 9.1779.61 ± 11.0377.83 ± 10.3979.85 ± 9.07
PrimaryTimed Up and Go (TUG) Test: Change in Dynamic Balance

Timed Up and Go (TUG) Test used to assess mobility and risk for falling. Number of seconds needed to stand up from a chair, walk 10 feet, turn around, walk back 10 feet, and sit back down in chair. No minimum or maximum value is set. Lower = better.

Time frame:
Baseline and 12 Weeks
Reported as:
Mean · seconds
Timed Up and Go (TUG) Test: Change in Dynamic Balance
secondsExercise + Health Education + BingoExercise + BingoHealth Education + BingoBingo Only
Baseline12.58 ± 6.5712.51 ± 4.4911.12 ± 2.7210.96 ± 2.98
Post-Intervention12.44 ± 6.4811.78 ± 4.7210.49 ± 3.1311.57 ± 2.96

Adverse events

Collected over Twice weekly during 1 hour program sessions, for a duration of 12 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Exercise + Health Education + Bingo1/73 (1.4%)3/73 (4.1%)0/73 (0%)
Exercise + Bingo0/53 (0%)6/53 (11.3%)0/53 (0%)
Health Education + Bingo0/50 (0%)3/50 (6%)0/50 (0%)
Bingo Only0/43 (0%)1/43 (2.3%)0/43 (0%)
Most frequent serious events
Most frequent serious events
EventExercise + Health Education + BingoExercise + BingoHealth Education + BingoBingo Only
Unspecified Health IssuesGeneral disorders2/734/532/500/43
Cancer DiagnosisGeneral disorders0/730/530/501/43
AneuryismVascular disorders0/730/531/500/43
EdemaVascular disorders0/731/530/500/43
strokeVascular disorders0/731/530/500/43
Wrist FractureMusculoskeletal and connective tissue disorders1/730/530/500/43

Baseline characteristics

All participants with baseline data.

Age, Continuous
Age, Continuous(years)Exercise + Health Education + BingoExercise + BingoHealth Education + BingoBingo OnlyTotal
Mean72.47 ± 7.2871.84 ± 7.7175.04 ± 6.6470.18 ± 7.2172.46 ± 7.37
Sex: Female, Male
Sex: Female, Male(Participants)Exercise + Health Education + BingoExercise + BingoHealth Education + BingoBingo OnlyTotal
Female63483942192
Male10511127
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Exercise + Health Education + BingoExercise + BingoHealth Education + BingoBingo OnlyTotal
Hispanic or Latino21003
Not Hispanic or Latino63493940191
Unknown or Not Reported8311325
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Exercise + Health Education + BingoExercise + BingoHealth Education + BingoBingo OnlyTotal
American Indian or Alaska Native00101
Asian12003
Native Hawaiian or Other Pacific Islander00000
Black or African American191601146
White53334932167
More than one race02002
Unknown or Not Reported00000
Region of Enrollment
Region of Enrollment(participants)Exercise + Health Education + BingoExercise + BingoHealth Education + BingoBingo OnlyTotal
United States73535043219
08

Study locations

4 sites
  • Webster County Senior Center
    Dixon, Kentucky 42409, United States
  • Chester County Senior Center
    Henderson, Tennessee 38340, United States
  • Johnson County Senior Center
    Johnson City, Tennessee 37601, United States
  • Scotts Hill Senior Center
    Scotts Hill, Tennessee 38374, United States
09

References and documents

Publications

  • Kramer JH, Mungas D, Possin KL, Rankin KP, Boxer AL, Rosen HJ, Bostrom A, Sinha L, Berhel A, Widmeyer M. NIH EXAMINER: conceptualization and development of an executive function battery. J Int Neuropsychol Soc. 2014 Jan;20(1):11-9. doi: 10.1017/S1355617713001094. Epub 2013 Oct 8. PubMed 24103232 ↗
  • Tinetti ME, Richman D, Powell L. Falls efficacy as a measure of fear of falling. J Gerontol. 1990 Nov;45(6):P239-43. doi: 10.1093/geronj/45.6.p239. PubMed 2229948 ↗

Study documents

  • Protocol and statistical analysis plan · Oct 11, 2022
  • Informed consent form · Oct 11, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — De-identified individual participant data for all primary and secondary outcome measures will be made available.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03629912
Lead sponsor
Western Kentucky University
Collaborators
National Institute on Aging (NIA)
Responsible party
Matthew Clinton Shake (Associate Professor of Psychological Sciences, Western Kentucky University) — Principal investigator
First posted
Aug 14, 2018
Start date
Aug 13, 2018
Primary completion
May 13, 2022
Completion
May 13, 2022
Results posted
Mar 12, 2024
Last update
Mar 12, 2024

Study contacts

Matthew C Shake, PhD
principal investigator · Western Kentucky University and Center for Applied Science in Health and Aging
Jason Crandall, PhD
principal investigator · Western Kentucky University and Center for Applied Science in Health and Aging

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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