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Historically, participation in clinical trials has been skewed towards certain groups. However, research on the factors that influence participation, both positive and negative, is limited.
Brain injury clinical trial patients help us identify these factors by sharing trial experiences during the course of the interventional medical study.
This study will include a diverse group of participants to gather a wide range of information on clinical trial experiences. The collected data will then be used to benefit future brain injury patients who are considering participating in a medical study.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who decide to enroll in a brain injury clinical trial. | 3 months | |
| Rate of patients who remain in brain injury clinical trial to trial completion. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Brain injury patients who are actively considering enrolling in an intensive clinical trial, but have not yet completed enrollment and randomization.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael B Gill | Contact | 4159004227 | bask@withpower.com |
| Name | Affiliation | Role |
|---|---|---|
| Michael B Gill | Power Life Sciences Inc. | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20129503 | Background | Maas AI, Roozenbeek B, Manley GT. Clinical trials in traumatic brain injury: past experience and current developments. Neurotherapeutics. 2010 Jan;7(1):115-26. doi: 10.1016/j.nurt.2009.10.022. | |
| 30465951 | Background | Wat R, Mammi M, Paredes J, Haines J, Alasmari M, Liew A, Lu VM, Arnaout O, Smith TR, Gormley WB, Aglio LS, Mekary RA, Zaidi H. The Effectiveness of Antiepileptic Medications as Prophylaxis of Early Seizure in Patients with Traumatic Brain Injury Compared with Placebo or No Treatment: A Systematic Review and Meta-Analysis. World Neurosurg. 2019 Feb;122:433-440. doi: 10.1016/j.wneu.2018.11.076. Epub 2018 Nov 20. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 10, 2023 | Jan 10, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| 33161752 | Background | Kjeldsen SS, Brodal L, Brunner I. Activity and rest in patients with severe acquired brain injury: an observational study. Disabil Rehabil. 2022 Jun;44(12):2744-2751. doi: 10.1080/09638288.2020.1844317. Epub 2020 Nov 8. |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |