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Brain Injuries clinical trials

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NCT ID: NCT03342612 Terminated - Clinical trials for Mild Traumatic Brain Injury

Multimodal Neuroimaging Analysis After Mild Traumatic Brain Injury

CHANGE-TBI
Start date: July 18, 2016
Phase: N/A
Study type: Interventional

Mild Traumatic Brain Injury (mTBI), including concussion, is a real public health problem. Indeed mTBI might induce long-term brain disorders with increased risk of neurodegenerative diseases and the healthcare costs can be significant for both the individual and the society. However mTBI is called the "silent epidemic", because of the lack of research in this field in France as well as in the rest of the world. Most of the time, mTBI is associated with sports injuries, road traffic accidents and falls. The risk of neurodegenerative diseases is significantly increased with the repetition of mTBI, which may have a cumulative effect. In this context, playing football (or 'soccer') is associated with a high risk of concussion and with frequent head-ball contacts which are repeated during the training and matches. Moreover, football is the most popular team sport in the world, with more than 265 million players. The long-term impact of "heading" in football is still debated in the literature. Nevertheless, several studies suggest the possible emergence of early neurocognitive disorders. Otherwise, while mTBI is usually characterized by normal brain images using traditional neuroimaging techniques, microscopic anatomical changes might be detectable by new neuroimaging techniques. According to recent studies, cognitive dysfunctions could be based on these microstructural changes in the gray matter and white matter, secondary to the primary mechanical injury. Studies that have examined the structural changes in the brain white matter in football players are rare and lack of evidence regarding the consequences of accumulated brain impacts explains the lack of preventive measures in this sport. In addition, post-traumatic secondary lesions cause functional alterations of the neurovascular unit and its effect on cerebral perfusion may play a crucial role, which has never been yet explored in humans over the long term. In this research, the investigators will develop a unique multi-modal neuroimaging protocols to assess brain changes after minor head trauma and over the time. Investigators want to perform magnetic resonance imaging (MRI) to assess cerebral blood flow using Arteria Spin Labelling (ASL), structural changes using Diffusion Tensor Imaging (DTI), susceptibility weighted imaging (SWI), and functional changes using BOLD resting-functional MRI.

NCT ID: NCT03342495 Completed - Stroke Clinical Trials

Evaluating Innovations in Transition From Pediatric to Adult Care - The Transition Navigator Trial

TNT
Start date: February 6, 2018
Phase: N/A
Study type: Interventional

The Transition Navigator Trial (TNT) is a pragmatic randomized controlled trial evaluating the effectiveness of usual care plus a patient navigator service versus usual care plus newsletters and other educational materials, to improve transition outcomes among adolescents aged 16-21 who have chronic health conditions requiring transfer to adult specialty care. The study will provide urgently needed data to guide health care providers and policy makers regarding the provision of coordinated transition care. These results have the potential to: 1. Change care delivery 2. Improve health outcomes 3. Improve the experiences of young adult transition to adult care

NCT ID: NCT03342183 Completed - Clinical trials for Chronic Kidney Disease

Reducing Hemodialysis Induced Recurrent Brain Injury to Improve Patients' Lives

Start date: January 8, 2018
Phase: N/A
Study type: Interventional

Patients who receive dialysis for kidney failure suffer severe cognitive impairment. Hemodialysis causes circulatory stress and ischemia, which causes severe brain injury. It has been demonstrated that a procedure known as Remote Ischemic Preconditioning(RIPC), which involves wrapping a blood pressure cuff around a patient's leg and inflating has the potential of protecting many organs, such as the heart from the effects of dialysis. Our study aims to investigate this phenomenon to determine the extent to which it provides protection to a dialysis patient's brain.

NCT ID: NCT03341572 Recruiting - Sepsis Clinical Trials

The Effect of Positive End Expiratory Pressure on Central Venous Pressure Among Patients With Different Lung Compliance

Start date: November 13, 2017
Phase: N/A
Study type: Interventional

To observe the effect of PEEP on CVP among patients with different respiratory compliance

NCT ID: NCT03341325 Completed - Brain Injuries Clinical Trials

Neurovascular Reactions to AAT in Patients With DOC

AAT NIRS
Start date: February 1, 2017
Phase: N/A
Study type: Interventional

There is practical evidence but no scientific investigations that persons with severe disorders of consciousness can profit from animal-assisted therapy regarding their level of awareness. The aim of this study is to investigate the effect of animal-assisted therapy on brain activity of inpatients at REHAB Basel with severe disorders of consciousness. To do so, the frontal brain activity of 20 the inpatients at REHAB Basel in a minimally conscious state is investigated via near-infrared spectroscopy (NIRS). Moreover, 20 healthy participants are included as control subjects.

NCT ID: NCT03339505 Completed - Brain Trauma Clinical Trials

Effect of Antisecretory Factor, Given as a Food Supplement to Adult Patients With Severe Traumatic Brain Injury

SASAT
Start date: September 17, 2017
Phase: Phase 3
Study type: Interventional

The present trial intends to assess whether Salovum®, an egg powder enriched for antisecretory factor given to patients with severe traumatic brain injury will improve outcome compared to a control group given placebo egg powder. 100 patients with GCS<9 will be enrolled and randomised to active or placebo treatment during maximum 5 days. Salovum® or placebo will be administered orally by nasogastric feeding tubes. Primary endpoint will be overall 30 data mortality. Secondary endpoints will be intracranial pressure and treatment intensity level.

NCT ID: NCT03339037 Terminated - Clinical trials for Traumatic Brain Injury

Hyperbaric Oxygen Therapy Effect on Post Concussion Syndrome in Children

TBIPED
Start date: November 1, 2017
Phase: N/A
Study type: Interventional

Due its high incidence, mTBI and its consequences of PPCS are a major public health issue. There is no consensus regarding the treatment of PPCS in pediatrics. Relying on its results in adults, HBOT offers a promising new direction of treatment, which targets the basic pathological processes responsible for post-concussion symptoms. The effect of hyperbaric oxygen therapy in pediatric TBI has never been evaluated. The aim of the current study is to evaluate in a prospective cross-over, randomized study, the effect of HBOT on children with PPCS due to mild TBI.

NCT ID: NCT03330379 Completed - Brain Injuries Clinical Trials

Comparison of Two Strategies for Endotracheal Tube Cuff Underinflation Prevention During Invasive Mechanical Ventilation

CONTIPRESS
Start date: March 1, 2018
Phase: N/A
Study type: Interventional

During invasive mechanical ventilation, maintaining endotracheal tube cuff pressure (Pcuff) around 25 cmH2O is recommended for sealing the upper airways. The continuous control of Pcuff with a simple mechanical device, the Tracoe Smart CuffmanagerTM, has never been assessed. The investigators hypothesize that the Tracoe Smart CuffmanagerTM would allow a reduction of the incidence of underinflation episodes, as compared with the intermittent strategy of Pcuff control.

NCT ID: NCT03328221 Completed - Clinical trials for Acquired Brain Injury

Physical Activity on Heart Rate Variability in Patients With Severe Acquired Brain Injury

Start date: September 1, 2017
Phase:
Study type: Observational

This study aims to explore autonomic cardiovascular regulation, through measures of heart rate variability (HRV), during different passive and active activities in patients with severe acquired brain injury and a low conscious state. Data from active rehabilitation will be compared with passive periods of rest as well as nightly variance during a continuous 5-day period.

NCT ID: NCT03327467 Available - Cerebral Palsy Clinical Trials

Expanded Access Protocol: Umbilical Cord Blood Infusions for Children With Brain Injuries

Start date: n/a
Phase:
Study type: Expanded Access

This protocol is designed to enable access to intravenous infusions of banked umbilical cord blood (CB), that is thawed and not more than minimally manipulated, for children with various brain disorders. Children with cerebral palsy, congenital hydrocephalus, apraxia, stroke, hypoxic brain injury and related conditions will be eligible if they have normal immune function and do not qualify for, have previously participated in, or are unable to participate in an active cell therapy clinical trial at Duke Medicine. For the purpose of this protocol the term children refers to patients less than 26 years of age. Cord blood is administered as a cellular infusion without prior treatment with chemotherapy or immunosuppression. The mechanism of action is through paracrine signaling of cord blood monocytes inducing endogenous cells to repair existing damage.