Treatment Trials

8 Clinical Trials for Various Conditions

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COMPLETED
Assessment of InfraScanner 2000™ in Detecting Subdural and Epidural Hematomas
Description

The goal of this study is to determine the sensitivity, specificity, and positive and negative predictive values of the a portable near-infrared-based device (portable NIR-based device), the InfraScanner 2000™, to detect intracranial hematomas (epidural hematomas (EDH) and/or subdural hematomas (SDH)) in patients hospitalized at Mbarara Regional Referral Hospital (MRRH) who have sustained or who are suspected to have sustained head trauma.

COMPLETED
Assessment of InfraScanner 2000™ in Detecting Subdural and Epidural Hematomas
Description

The goal of this study is to determine the sensitivity, specificity, and positive and negative predictive values of the a portable near-infrared-based device (portable NIR-based device), the InfraScanner 2000™, to detect intracranial hematomas (epidural hematomas (EDH) and/or subdural hematomas (SDH)) in patients hospitalized at Duke University Hospital (DUH) who have sustained or who are suspected to have sustained head trauma and have consequently received a brain computed tomography (CT) scan(s).

UNKNOWN
Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury
Description

This is a randomized, controlled clinical trial at three sites to determine the safety and preliminary efficacy of the study drug to treat severe head trauma (GCS 4-8). It is hypothesized that the drug may lower pressure in the brain, reduce mortality and the patient may have improved neurological function following treatment.

COMPLETED
Observational Endothelin and Markers of Cellular Apoptosis In CSF Head Injury
Description

The goal of this study is to answer the following questions: * What is the time course of the expected changes in endothelin levels during the first two weeks after injury and how does this relate to outcome? * What is the relation between endothelin levels (big ET-1 and ET-1) in plasma and cerebrospinal fluid and type of injury, from CT scans and GCS? * What is the relation between endothelin levels (big ET-1 and ET-1) in plasma and cerebrospinal fluid and outcome measurements like GOSE, ICP and CT scans? * What is the relation between neurohormones related to the neutral endopeptidase (NEP) (ANP, BNP and cGMP) in plasma and cerebrospinal fluid and type of injury, from CT scans and GCS? * What is the relation between endothelin levels (big ET-1 and ET-1) in plasma and cerebrospinal fluid and markers for apoptosis?

COMPLETED
Study of Oxycyte in Severe Closed Head Injury
Description

Brain damage as a result of decreased oxygen to the brain is found in 80% of patients that die with severe head injuries. Laboratory studies in animals and clinical trials have shown that increasing oxygen in the brain results in better brain oxygen consumption, less cell death, and better functional outcome. This study will test the hypothesis that Oxycyte is an effective way to increase brain oxygen levels in severe head injury.

COMPLETED
Hypertonic Saline With Dextran for Treating Hypovolemic Shock and Severe Brain Injury
Description

The purpose of this study is to evaluate the clinical outcome of patients following blunt traumatic injury with hypovolemic shock, who receive either lactated ringer's solution or hypertonic saline with dextran (HSD) resuscitation; also, to focus specifically on neurologic outcome in patients with brain injury and on the effect of HSD resuscitation on inflammatory cell responsiveness.

COMPLETED
Life Improvement Following Traumatic Brain Injury
Description

The purpose of this study is to test the effectiveness of a telephone-based and in-person Cognitive Behavioral Therapy (CBT) intervention for treating Major Depressive Disorder (MDD) following Traumatic Brain Injury. Participants are randomly assigned to receive one of the following: 1) Telephone-based CBT, 2) In-person CBT, or 3) Usual care (control).

TERMINATED
Cerebral Hemodynamic Effects of Hypertonic Solutions in Severely Head-Injured Patients
Description

This is a clinical study comparing the physiologic effects of two hypertonic solutions (mannitol, hypertonic saline) with a particular emphasis on changes in cerebral blood flow in patients with intracranial hypertension following serious traumatic brain injury (TBI).