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Exercise Plus Duloxetine for Knee Osteoarthritis
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University of Maryland, Baltimore
Knee Osteoarthritis
Depression
This study evaluates the addition of duloxetine to aerobic exercise in the treatment of
symptomatic knee osteoarthritis and depressive symptoms in adults. All participants will
receive the receive the treatment protocol, which will first be evaluated in terms of
feasibility... expand
This study evaluates the addition of duloxetine to aerobic exercise in the treatment of symptomatic knee osteoarthritis and depressive symptoms in adults. All participants will receive the receive the treatment protocol, which will first be evaluated in terms of feasibility and then pilot tested. Type: Interventional Start Date: Oct 2021 |
Hip Muscle Power, Lateral Balance Function, and Falls in Aging
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University of Maryland, Baltimore
Accidental Falls
Falls and their consequences are among the major problems in the medical care of older
individuals. The long-term goal of this research is to develop a mechanistically based
therapeutic intervention to enhance muscle power, weight-shifting capability, and lateral
balance function... expand
Falls and their consequences are among the major problems in the medical care of older individuals. The long-term goal of this research is to develop a mechanistically based therapeutic intervention to enhance muscle power, weight-shifting capability, and lateral balance function through protective stepping to prevent falls. When human balance is challenged, protective stepping is a vital strategy for preventing a fall during activities of daily life. Many older people at risk for falls have particular difficulties with successfully stepping sideways as a protective response to loss of balance in the lateral direction. Age-related declines in lateral balance function result from neuromuscular and biomechanical limitations in hip abductor-adductor muscle power generation. This study will test whether these impairments can be improved with high-velocity hip muscle resistance power training that will be more effective than conventional resistance strength training. Type: Interventional Start Date: Sep 2019 |
Robot Aided Rehabilitation - Multi-joint Evaluations
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University of Maryland, Baltimore
Stroke
Sensory and motor impairments following stroke can lead to substantial disability involving
the arm and hand. The investigator hypothesized that excessive local and cross-coupled
stiffness, diminished individuation and proprioceptive acuity will be present among multiple
degree... expand
Sensory and motor impairments following stroke can lead to substantial disability involving the arm and hand. The investigator hypothesized that excessive local and cross-coupled stiffness, diminished individuation and proprioceptive acuity will be present among multiple degree of freedom in the upper limb. The stiffness and spasticity will increase with time post-stroke. The objective of this study is to quantify the progression throughout the arm and hand during recovery from stroke. The investigator will measure the clinical assessment scores, and neuromechanical properties including range of motion, active and passive cross coupling, and spasticity by the IntelliArm robot. Type: Observational Start Date: May 2018 |
Blood-brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Standard of Care Treatment...
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InSightec
Brain Tumor
The purpose of this study is to evaluate the safety and efficacy of targeted blood brain
barrier disruption with Exablate Model 4000 Type 2.0/2.1 for the treatment of NSCLC brain
metastases in patients who are undergoing planned pembrolizumab monotherapy.
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The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier disruption with Exablate Model 4000 Type 2.0/2.1 for the treatment of NSCLC brain metastases in patients who are undergoing planned pembrolizumab monotherapy. Type: Interventional Start Date: Aug 2022 |
Hyperbaric Oxygen Brain Injury Treatment Trial
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Hennepin Healthcare Research Institute
Traumatic Brain Injury
The purpose of this innovative adaptive phase II trial design is to determine the optimal
combination of hyperbaric oxygen treatment parameters that is most likely to demonstrate
improvement in the outcome of severe TBI patients in a subsequent phase III trial.
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The purpose of this innovative adaptive phase II trial design is to determine the optimal combination of hyperbaric oxygen treatment parameters that is most likely to demonstrate improvement in the outcome of severe TBI patients in a subsequent phase III trial. Type: Interventional Start Date: Jun 2018 |
MR Guided Focused Ultrasound (FUS) for the Treatment of Trigeminal Neuralgia
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University of Maryland, Baltimore
Trigeminal Neuralgia
The purpose of this study is to assess the safety and effectiveness of MRI-guided focused
ultrasound (MRgFUS) for treating Trigeminal Neuralgia. Trigeminal Neuralgia (pain) is a type
of pain involving the face that can be disabling to those it affects.
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The purpose of this study is to assess the safety and effectiveness of MRI-guided focused ultrasound (MRgFUS) for treating Trigeminal Neuralgia. Trigeminal Neuralgia (pain) is a type of pain involving the face that can be disabling to those it affects. Type: Interventional Start Date: Feb 2021 |
DMID 21-0041; Influenza CVD 59000
University of Maryland, Baltimore
Influenza
The primary objective of EMIT-2 is to use a randomized controlled trial (RCT) design to
implement interventions which are known to reduce inhalation (airborne) transmission, so that
the contribution of transmission by route of aerosols for influenza may be identified.
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The primary objective of EMIT-2 is to use a randomized controlled trial (RCT) design to implement interventions which are known to reduce inhalation (airborne) transmission, so that the contribution of transmission by route of aerosols for influenza may be identified. Type: Interventional Start Date: Feb 2023 |
7-Day Trial of Sucraid for Alleviating CSID Symptoms in Subjects With Low, Moderate, and Normal Sucrase...
QOL Medical, LLC
Congenital Sucrase-Isomaltase Deficiency
CSID
Sucrase Isomaltase Deficiency
This is a Phase 4, U.S. only, multi-center study using a 7-day therapeutic response dose
(TRD) of commercial Sucraid® to assess the response of treatment in 1100 symptomatic
pediatric (6 months to 17 years old) subjects with low, moderate, and normal sucrase activity
determined... expand
This is a Phase 4, U.S. only, multi-center study using a 7-day therapeutic response dose (TRD) of commercial Sucraid® to assess the response of treatment in 1100 symptomatic pediatric (6 months to 17 years old) subjects with low, moderate, and normal sucrase activity determined by a disaccharidase assay via EGD within 1 year of the Screening Visit. This study will also explore the relationship between known genetic CSID mutations and sucrase activities via (EGD) disaccharidase assay (low, moderate, and normal). Type: Interventional Start Date: Aug 2022 |
Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine
Amgen
Migraine
This study will evaluate the efficacy and safety of erenumab in migraine prevention in
children (6 to <12 years) and adolescents (12 to <18 years) with chronic migraine. The study
hypothesis is that in pediatric subjects with chronic migraine, the combined erenumab dose
group... expand
This study will evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to <12 years) and adolescents (12 to <18 years) with chronic migraine. The study hypothesis is that in pediatric subjects with chronic migraine, the combined erenumab dose group has a greater reduction from baseline to week 9 through week 12 (month 3) in monthly migraine days (MMDs) when compared with placebo in the double-blind treatment phase (DBTP). Type: Interventional Start Date: Sep 2019 |
Sleep for Stroke Management and Recovery Trial
University of Michigan
Ischemic Stroke
Sleep Apnea
Sleep Apnea, Obstructive
TIA
Stroke
The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA)
with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA
(1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after... expand
The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke. Type: Interventional Start Date: May 2019 |
Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve...
Abbott Medical Devices
Mitral Regurgitation
Mitral Insufficiency
Mitral Valve Insufficiency
Cardiovascular Diseases
Valve Disease, Heart
Prospective, controlled, multicenter clinical investigation with four trial cohorts:
Randomized, Non-repairable, Severe Mitral Annular Calcification (MAC) and Severe Mitral
Annular Calcification Continued Access Protocol (MAC CAP). Subjects in the Randomized cohort
will be... expand
Prospective, controlled, multicenter clinical investigation with four trial cohorts: Randomized, Non-repairable, Severe Mitral Annular Calcification (MAC) and Severe Mitral Annular Calcification Continued Access Protocol (MAC CAP). Subjects in the Randomized cohort will be randomized in a 1:1 ratio to the trial device or to the MitraClip system. Subjects in the Non-repairable, Severe MAC, and Severe MAC CAP cohorts will receive the trial device. The objective of the Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT) is to evaluate the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System for the treatment of patients with symptomatic, moderate-to-severe or severe mitral regurgitation or for patients with symptomatic mitral valve disease due to severe mitral annular calcification. This randomized controlled trial will provide the opportunity to evaluate the safety and clinical benefits of the Tendyne Transcatheter Mitral Valve System compared to the MitraClip System in patients with symptomatic, moderate-to-severe or severe mitral regurgitation, within approved MitraClip indications. In addition, the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System will be evaluated in patients with severe mitral annular calcification who are at prohibitive risk for mitral valve surgery. Patients who are not suitable for mitral valve surgery for reasons other than severe mitral annular calcification and are also not suitable for transcatheter repair with MitraClip, will be enrolled in the Non-repairable cohort. Subjects will be seen at screening, pre- and post-procedure, discharge, 30 days, 3 months, 6 months, and annually through 5 years. Type: Interventional Start Date: Jun 2018 |
Gastroschisis Outcomes of Delivery (GOOD) Study
Medical College of Wisconsin
Gastroschisis
The objective of this study is to investigate the hypothesis that delivery at 35 0/7- 35 6/7
weeks in stable patients with gastroschisis is superior to observation and expectant
management with a goal of delivery at 38 0/7 - 38 6/7 weeks. To test this hypothesis, we will
complete... expand
The objective of this study is to investigate the hypothesis that delivery at 35 0/7- 35 6/7 weeks in stable patients with gastroschisis is superior to observation and expectant management with a goal of delivery at 38 0/7 - 38 6/7 weeks. To test this hypothesis, we will complete a randomized, prospective, multi-institutional trial across NAFTNet-affiliated institutions. Patients may be enrolled in the study any time prior to 33 weeks, but will be randomized at 33 weeks to delivery at 35 weeks or observation with a goal of 38 weeks. The primary composite outcome will include stillbirth, neonatal death prior to discharge, respiratory morbidity, and need for parenteral nutrition at 30 days. Type: Interventional Start Date: Feb 2018 |
Robot Aided Rehabilitation - Intervention
University of Maryland, Baltimore
Stroke
Sensorimotor impairments following stroke often involve complex pathological changes across
multiple joints and multiple degrees of freedom of the arm and hand, thereby rendering them
difficult to diagnose and treat. The objective of this study is to evaluate multi-joint
neuromechanical... expand
Sensorimotor impairments following stroke often involve complex pathological changes across multiple joints and multiple degrees of freedom of the arm and hand, thereby rendering them difficult to diagnose and treat. The objective of this study is to evaluate multi-joint neuromechanical impairments in the arm and hand, then conduct impairment-specific treatment, and determine the effects of arm versus hand training and the effects of passive stretching before active movement training. Type: Interventional Start Date: Oct 2018 |
Time-Restricted Eating to Address Persistent Cancer-Related Fatigue
University of Maryland, Baltimore
Neoplasms
Therapy
Fatigue
Diet Therapy
Time
This study will assess the feasibility of delivering a 12-week time-restricted eating
intervention as well as the intervention's preliminary efficacy on persistent cancer-related
fatigue among cancer survivors compared to a general health education control. Participants
will... expand
This study will assess the feasibility of delivering a 12-week time-restricted eating intervention as well as the intervention's preliminary efficacy on persistent cancer-related fatigue among cancer survivors compared to a general health education control. Participants will be randomized 1:1 to one of two arms: time-restricted eating or control. Those in the intervention arm will self-select a 10-hour eating window in which to consume all food and beverages (water is allowed any time, black coffee and unsweetened tea are allowed in the morning). Both groups will receive weekly educational tips on healthy lifestyle behaviors in cancer survivorship. This study will also explore relationships between fatigue, circadian rhythm, and glucose metabolism. The hypothesis is that recruitment will be feasible, and participants will adhere to time-restricted eating and complete study activities over the course of the 12 weeks. The second hypothesis is that time-restricted eating will lead to less fatigue at 12 weeks compared to the control, accounting for baseline fatigue levels. Type: Interventional Start Date: Jan 2023 |
Safety and Efficacy of the Bacteriophage Preparation, ShigActive™, in a Human Experimental Model of Shigellosis
Intralytix, Inc.
Shigellosis
The study is a first-in-human Phase 1/2a randomized, double-blind, placebo-controlled trial
to assess the clinical safety and efficacy of ShigActive in healthy adults with experimental
Shigella challenge.
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The study is a first-in-human Phase 1/2a randomized, double-blind, placebo-controlled trial to assess the clinical safety and efficacy of ShigActive in healthy adults with experimental Shigella challenge. Type: Interventional Start Date: Feb 2023 |
ICG Fluorescence Imaging in Post-traumatic Infection
Dartmouth-Hitchcock Medical Center
Trauma Injury
The focus of this prospective observational study is to (1) establish the range and variation
associated with bone/soft tissue perfusion in fracture patients, using ICG fluorescence
imaging; (2) examine the relationship between perfusion and complications such as surgical... expand
The focus of this prospective observational study is to (1) establish the range and variation associated with bone/soft tissue perfusion in fracture patients, using ICG fluorescence imaging; (2) examine the relationship between perfusion and complications such as surgical site infection (SSI), persistent SSI, and fracture nonunion; (3) to determine whether the quantitative ICG fluorescence can be used to guide bony debridement in the setting of infected fracture to minimize complications. Type: Observational [Patient Registry] Start Date: Sep 2020 |
Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia
Janssen Research & Development, LLC
Warm Autoimmune Hemolytic Anemia
The main purpose of this study is to evaluate the efficacy and safety of M281 in participants
with warm autoimmune hemolytic anemia (wAIHA).
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The main purpose of this study is to evaluate the efficacy and safety of M281 in participants with warm autoimmune hemolytic anemia (wAIHA). Type: Interventional Start Date: Oct 2019 |
RejuvenAir® System Trial for COPD With Chronic Bronchitis
CSA Medical, Inc.
Chronic Bronchitis
Chronic Obstructive Pulmonary Disease (COPD) is defined as an impaired ability to move air
within the lungs and is a major public health problem that is projected to rank fifth
worldwide in terms of disease burden and third in terms of mortality. Chronic bronchitis (CB)
is... expand
Chronic Obstructive Pulmonary Disease (COPD) is defined as an impaired ability to move air within the lungs and is a major public health problem that is projected to rank fifth worldwide in terms of disease burden and third in terms of mortality. Chronic bronchitis (CB) is a common clinical phenotype within the umbrella of a COPD diagnosis and is classically defined as chronic cough and sputum production for 3 months a year for 2 consecutive years2, but many studies have used different definitions to define it- chronic cough and sputum production for one year or cough and sputum production on most days of the week. CB is associated with multiple clinical consequences, including; the worsening of lung function decline, increasing risk of acute exacerbations of COPD, increased risk of developing pneumonia, reduced health related quality of life, and an increase in all-cause mortality. Type: Interventional Start Date: Jul 2020 |
The Effects of Fluoxetine and/or DHEA
University of Maryland, Baltimore
Type 1 Diabetes Mellitus
(1) To determine how the Selective Serotonin Reuptake Inhibitor (SSRI), fluoxetine (Prozac),
an antidepressant often used to treat depression, stimulates the participant's body's ability
to defend against low blood sugar (hypoglycemia). (2) To learn how a hormone,
dehydroepiandrosterone... expand
(1) To determine how the Selective Serotonin Reuptake Inhibitor (SSRI), fluoxetine (Prozac), an antidepressant often used to treat depression, stimulates the participant's body's ability to defend against low blood sugar (hypoglycemia). (2) To learn how a hormone, dehydroepiandrosterone (DHEA), stimulates the participant's body's ability to defend itself from low blood sugar (hypoglycemia). DHEA is a hormone produced naturally in the human body. However, it can be manufactured and is sold as an over-the-counter dietary supplement. The dose the investigators are giving in this study is higher than the usual recommended dosage taken as a supplement for certain medical conditions. (3) To study combined effects of fluoxetine and DHEA during low blood glucose. In the present study, the investigators will measure the participant's body's responses to hypoglycemia when given fluoxetine or DHEA or fluoxetine and DHEA or a placebo (a pill with no fluoxetine or DHEA). Approximately 64 individuals with type 1 diabetes will take part in this study. Type: Interventional Start Date: Dec 2017 |
CAN-2409 Plus Prodrug With Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC
Candel Therapeutics, Inc.
Non Small Cell Lung Cancer
The purpose of this clinical trial is to evaluate the effects of adding CAN-2409 + prodrug
for stage III/IV NSCLC patients who are on standard of care first line immune checkpoint
inhibitors (ICI) treatment with evidence that the clinical response is inadequate. CAN-2409
is... expand
The purpose of this clinical trial is to evaluate the effects of adding CAN-2409 + prodrug for stage III/IV NSCLC patients who are on standard of care first line immune checkpoint inhibitors (ICI) treatment with evidence that the clinical response is inadequate. CAN-2409 is an oncolytic viral immunotherapy that induces tumor-infiltrating T-cells and a consequent PD-L1 up-regulation. A combination of CAN-2409 added to standard of care (SOC) checkpoint inhibitors may lead to improved long-term outcomes for patients with NSCLC who have suboptimal response to ICI therapy. Type: Interventional Start Date: Oct 2020 |
Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial
Thomas G. Brott, M.D.
Carotid Stenosis
Carotid revascularization for primary prevention of stroke (CREST-2) is two independent
multicenter, randomized controlled trials of carotid revascularization and intensive medical
management versus medical management alone in patients with asymptomatic high-grade carotid... expand
Carotid revascularization for primary prevention of stroke (CREST-2) is two independent multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management will be uniform for all randomized treatment groups and will be centrally directed. Type: Interventional Start Date: Dec 2014 |
Evaluation and Follow-up of People With Tick-borne Diseases
National Institute of Allergy and Infectious Diseases (NIAID)
Lyme Disease
Tick-Borne Disease
Background:
Lyme disease is the most common tick-borne disease in the United States, but other diseases
transmitted by ticks have also been on the rise in recent years. Early symptoms of a
tickborne disease include fever, headache, fatigue and possible rash. Researchers... expand
Background: Lyme disease is the most common tick-borne disease in the United States, but other diseases transmitted by ticks have also been on the rise in recent years. Early symptoms of a tickborne disease include fever, headache, fatigue and possible rash. Researchers want to collect information and samples from people with Lyme disease and other tick-borne illnesses to better understand and diagnose these diseases. Objective: To evaluate and follow people with tick-borne diseases to help researchers learn more about these infections. Eligibility: People ages 18 and older who have or are suspected of having a tick-borne infection. Design: Participants will have an initial visit, and visits about 1, 6, and 12 months later. The visits can include a physical exam, blood tests, collection of blood, urine and saliva samples for research, and filling out health-related questionnaires. Participants who have the rash of Lyme disease may be invited to have up to 3 skin punch biopsies of the rash for research. Type: Observational Start Date: Mar 2023 |
TruGraf® Long-term Clinical Outcomes Study
Transplant Genomics, Inc.
Kidney Transplant Rejection
This is a prospective, multi-center, observational study. Subjects will have OmniGraf™
(TruGraf® and TRAC™) testing at study enrollment and thereafter every 3 months. In addition
subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at any time there is a clinical
suspicion... expand
This is a prospective, multi-center, observational study. Subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at study enrollment and thereafter every 3 months. In addition subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at any time there is a clinical suspicion of acute rejection. Data collection for the primary objective extends over a 2-year period. Type: Observational Start Date: Sep 2020 |
A Balanced Reach Training Platform to Address Balance Disorders in Older and Neurologically Disabled...
VA Office of Research and Development
Older Men and Women With High Fall Risk
Falls are by far the leading cause of accidental injury and death in older adults. The
Veteran population is more severely affected by falls since it is significantly older than
the overall population (45% over 65 years of age vs. 13%); and Veterans would benefit
substantially... expand
Falls are by far the leading cause of accidental injury and death in older adults. The Veteran population is more severely affected by falls since it is significantly older than the overall population (45% over 65 years of age vs. 13%); and Veterans would benefit substantially more from an accurate diagnosis and treatment of fall propensity. Despite its importance, much is still unknown about the manner in which balance control is compromised by age and disease. Therapeutic interventions for people who are at risk of falling have proven to be of limited utility. Engineering methods are well suited to study and evaluate balance; but have to date been applied to overly simplified scenarios that lack the complexity to probe the musculoskeletal and neurophysiological bases for balance and falls. The long term objective of this research, which began with a VA Rehabilitation Research & Development (RR&D) Career Development Award (CDA-2), is to develop improved directives and protocols for the diagnosis and treatment of balance-related posture and movement coordination problems. This proposal significantly advances engineering methods to address existing gaps in the diagnosis and treatment of balance impairments through the development of a Balanced Reach Training Protocol (BRTP). The BRTP continuously challenges subjects to perform reaching tasks at the limits of their balance for an extended period of time, and increases these limits as subjects demonstrate improved performance. The goal of this tool is to quantitatively assess and improve at-risk individuals' ability to maintain balance when disturbed by volitional movements of the body and its parts-an important class of balance disturbances integral to many activities of daily living that can precipitate falls. The BRTP focuses on performance at and just beyond the limits of balance, unlike most such tests and training protocols that do not challenge subjects in this way. The BRTP's most immediate and salient metric is the limiting boundary of standing reach; and we hypothesize that expanding this boundary, as the BRTP is designed to do, will improve balance and make individuals more resistant to falls (in the context of expected balance disturbances). Confirmation of this hypothesis could provide a new perspective on existing training protocols' modest success rates, and direction for the design of new protocols with the potential to significantly improve these rates. [Though the BRTP is a training platform, we also believe that the performance metrics and analytical results produced by it can form the basis for new diagnostic measures that more reliably and precisely quantify and explain balance performance problems; and track changes in them over time.] Such diagnostic and treatment protocols would be particularly beneficial to the VA Health Care System, as it would lead to improvements in: patient throughput, quality of care, and treatment costs. Though this proposal targets the aging Veteran population, the BRTP is a general tool that can aid in the diagnosis and treatment of balance disorders arising from conditions other than aging. These include obesity, diabetes (which often leads to lower extremity muscle degeneration and peripheral neuropathy), sarcopenia, vestibular disorders, and neurological disorders such as stroke. Veterans whose balance has been compromised by Traumatic Brain Injury (TBI) (whether combat-related or not) may also benefit from the BRTP. Type: Observational Start Date: Nov 2021 |
Recovery After Cerebral Hemorrhage
University of Maryland, Baltimore
Intra Cerebral Hemorrhage
Subarachnoid Hemorrhage
Intraventricular Hemorrhage
Nontraumatic Haemorrhage
Background:
While the intensive care of patients with life-threatening brain illnesses has advanced
tremendously, a large number of therapies are still without proper scientific support.
This can be partly explained by the fact that mechanisms of initial brain injury are... expand
Background: While the intensive care of patients with life-threatening brain illnesses has advanced tremendously, a large number of therapies are still without proper scientific support. This can be partly explained by the fact that mechanisms of initial brain injury are still not well understood. Why additional neurological injury occurs during a patient's stay in the NeuroCritical Care Unit (NCCU) despite current best, evidence-based clinical practices, is also not well understood. However, over the past decade, better tools have become available to measure and monitor the impact of our clinical care on the rapidly changing physiology and chemistry of the injured brain. Some of these tools are CT, MRI, ultrasound, and catheter-based technology measuring blood flow and metabolism. These tools have enabled earlier detection of injury and complications and newer therapeutic strategies. Purpose: Examine disease pathways common to all brain injuries seen in the University of Maryland's 22-bed NCCU. Life-threatening neurological illnesses cared for in the NCCU include massive stroke, bleeding in and around the brain (subarachnoid hemorrhage, intracerebral hemorrhage, subdural hemorrhage, intraventricular hemorrhage), brain tumors, difficult to control seizures, neurologic infections, nerve and muscle diseases (such as myasthenia gravis or Guillain-Barre Syndrome), and spinal cord disorders among others. Many NCCU patients are comatose or paralyzed and may suffer injuries in other parts of the body as well. This effort will require the creation of a robust clinical database for the capture of data including patient characteristics (age, sex), clinical characteristics, medical treatments, surgical interventions, physiological data (such as vital signs, cerebral blood flow, intracranial pressure, cerebral oximetry, etc), laboratory data, and standard-of-care diagnostic studies such as electroencephalography (EEG), ultrasound, CT, MRI, and angiograms. Similar databases exist at other major centers for neurocritical care and have been instrumental to the identification of characteristics both predictive of and associated with outcomes of patients long after their stay in the NCCU. In addition, the samples collected will be included in the University of Maryland Medicine (UMM) Biorepository which is a shared resource to enable biomedical research by University of Maryland faculty. Type: Observational [Patient Registry] Start Date: Sep 2014 |