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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT03974360 Completed - Clinical trials for Mild Traumatic Brain Injury

Efficacy and Tolerability of Erenumab in the Prophylactic Treatment of Persistent Post-Traumatic Headache

Start date: April 5, 2019
Phase: Phase 2
Study type: Interventional

An exploratory open-label study of PPTH patients to study the efficacy and tolerability of erenumab in the prophylactic treatment of persistent headache attributed to mild traumatic injury to the head. Approximately 100 subjects will be included to erenumab 140 mg. Patients who have participated in study with prior provocation (Ethics Committee of the Capital Region of Denmark (H-1801147 and H-18050498) and who have consented to be contacted will primarily be included. The study will begin February 2019 and is expected to last one year. Patients responding to advertisement (see add) will be contacted by phone.

NCT ID: NCT03972579 Completed - Clinical trials for Mild Traumatic Brain Injury

Behavioral Profile Matching: A Precision Medicine Approach to Concussion Rehabilitation

Start date: May 15, 2019
Phase: N/A
Study type: Interventional

At least 1 in 5 people who sustain a concussion will have persistent symptoms and difficulties with daily activities. The researchers have identified two unhelpful coping styles following a concussion - avoidance and endurance. Individuals who engage in avoidance behavior may benefit from a different type of treatment than those who engage in endurance behavior. The researchers will evaluate whether assigning individuals to a specific psychologically-informed treatment tailored to their coping style is practical, acceptable, and beneficial for their recovery.

NCT ID: NCT03968874 Recruiting - Clinical trials for Traumatic Brain Injury

Improving Sleep, Sleep-related Outcomes, and Biomarkers in Veterans

Start date: August 1, 2019
Phase: N/A
Study type: Interventional

The primary purpose of this project is to determine the effect of morning bright light therapy (MBLT) on sleep in Veterans with traumatic brain injury (TBI). Secondarily, the project aims to identify blood-based brain biomarkers (BBBM) associated with sleep in Veterans. Specific Aim 1. Determine the effect of MBLT on sleep quality in Veterans (primary outcome). Specific Aim 2. Determine the effect of MBLT on downstream effectors of improved sleep, including cognition, mood, and quality of life measures in Veterans (exploratory outcomes). Specific Aim 3. Determine the effect of MBLT on levels of specific BBBM related to sleep, and whether changes in specific BBBM predict response to MBLT (secondary outcome). This study can now be completed 100% remotely.

NCT ID: NCT03966404 Completed - Clinical trials for Mild Traumatic Brain Injury

EyeBOX Concussion Study and Registry

Start date: August 5, 2019
Phase:
Study type: Observational [Patient Registry]

The objective of this study is to further evaluate eye movements as an aid in the diagnosis of concussion / mTBI and the utility of eye movement assessment in the monitoring of symptoms over time after an initial diagnosis of concussion.

NCT ID: NCT03965611 Active, not recruiting - Clinical trials for Traumatic Brain Injury

Evolution of Oropharyngeal and Rectal Microbiota After Severe Traumatic Brain Injury

BBAX
Start date: April 21, 2019
Phase:
Study type: Observational

Modifications of the human gut microbiota have been associated with different pathological conditions such as obesity, inflammatory bowel diseases and neurodegenerative diseases. Recently the " Brain-Gut Axis ", a bidirectional communication axis between brain and gut, has been described. In recent animal studies, an acute brain injury was associated with rapid modifications of the gut microbiota. In humans, traumatic brain injury (TBI) is a leading cause of death and disability. The patterns of gut and oropharyngeal microbiota following TBI are unknown. The primary purpose of this study is to characterize gut and oropharyngeal microbiota of patients with severe TBI.

NCT ID: NCT03963804 Completed - Clinical trials for Brain Injuries, Traumatic

Objective Brain Function Assessment of mTBI/Concussion

CAS13-25
Start date: June 11, 2018
Phase:
Study type: Observational

This study (Part 3) is designed to build a database including EEG, neurocognitive performance, clinical symptoms, history and other relevant data, which will be used to derive a multimodal EEG based algorithm for the identification of concussion and tracking of recovery.

NCT ID: NCT03944447 Recruiting - Depression Clinical Trials

Outcomes Mandate National Integration With Cannabis as Medicine

OMNI-Can
Start date: December 1, 2018
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT03940443 Recruiting - Clinical trials for Traumatic Brain Injury

Differences in Mortality and Morbidity in Patients Suffering a Time-critical Condition Between GEMS and HEMS

Start date: September 3, 2019
Phase:
Study type: Observational

Introduction: Patients suffering a time-critical medical condition require rapid prehospital assessment and treatment and most often quick transportation to definitive care. This can be decisive for patient outcome. In order to minimize time from assessment to treatment, thus lowering mortality and morbidity, it is important to have a well-coordinated chain of care. The efficient use of Ground Emergency Medical Services (GEMS) and Helicopter Emergency Medical Services (HEMS) is essential in such a chain of care. Objectives: The aim is to describe differences in mortality, morbidity, assessment and treatment of two time-critical conditions, traumatic brain injury (TBI) and acute myocardial infarction (MI), in patients assessed by GEMS and HEMS respectively. Method: The project consists of a descriptive observational study and comparative cohort study. Inclusion criteria are patients considered to be suffering from TBI and acute MI, which are treated by GEMS or HEMS in the regions of Uppsala, Jämtland/Härjedalen, Dalarna and Värmland. Clinical significance: The results expect to be the basis for further studies aiming to optimize the utilization of GEMS and HEMS.

NCT ID: NCT03937947 Recruiting - Clinical trials for Traumatic Brain Injury

Traumatic Brain Injury Associated Radiological DVT Incidence and Significance Study

TARDIS
Start date: September 28, 2019
Phase:
Study type: Observational

Whilst deep vein thrombosis (DVT) is common following traumatic brain injury (TBI), optimal timing and safety of pharmacological prophylaxis is uncertain. Paradoxically the harm associated with the occurrence of is also unclear. This study is an observational pilot that aims to define the incidence of proximal DVT in patients with moderate to severe TBI. It seeks prospectively to determine if there is an association between DVT and outcome. It also seeks to explore possible associations between the occurrence of DVT and the incidence of lung injury and/or ventilator associated pneumonia.

NCT ID: NCT03932500 Recruiting - Clinical trials for Brain Injuries, Traumatic

Outcomes of Traumatic Brain Injury and External Validation of CRASH Prognostic Model

Start date: March 22, 2018
Phase:
Study type: Observational

As per World Health Organization (WHO) 2015 report, road injury is the tenth cause of mortality in the world. - 90% of these occur in Low and Middle-Income countries (LMICs) - Amongst Injuries, Traumatic Brain Injuries is the leading cause of morbidity and mortality. - Clinicians have to answer about the prognosis of the injured patient to the anxious near ones on arrival as well as throughout the course of treatment - A multicenter randomized control trial (CRASH)published a prediction model for traumatic brain injury patients - This model was based on data from High Income countries and not from Low and Middle-Income Countries - Hence to fill this gap we aim to study the outcome of patients with Traumatic Brain Injury and also validate the CRASH trial prediction model in traumatic brain injury patient - It is a Prospective Observational Study for a duration of 18 months and the sample size is 500 patients. - Acute Traumatic Brain injury patients >18 years of age admitted in Emergency surgery room. - Patients with chronic head injury and Patients who have been declared brain dead and whose organs have been retrieved are excluded. - Variable are Age, Glasgow coma score, Pupils reaction to light, Major extra cranial injuries, CT Finding. - Outcome of the study is mortality at 14th day and morbidity and mortality after 6 months of head injury.