Vanderbilt conducts research studies and clinical trials in various divisions throughout the Medical Center. We know that figuring out where to start can be one of the biggest obstacles a volunteer faces when searching for research study opportunities.


365 matching studies

Sponsor Condition of Interest
An Extension Study to Evaluate the Efficacy and Safety of HORIZANT in Adolescents With Moderate-to-Severe...
XenoPort, Inc. RLS
The objectives of the trial are to evaluate the long-term efficacy and safety of HORIZANT (Gabapentin Enacarbil) 600 mg daily, for the treatment of RLS in adolescents (13 to 17 years of age) diagnosed with moderate-to-severe primary RLS. expand

The objectives of the trial are to evaluate the long-term efficacy and safety of HORIZANT (Gabapentin Enacarbil) 600 mg daily, for the treatment of RLS in adolescents (13 to 17 years of age) diagnosed with moderate-to-severe primary RLS.

Type: Interventional

Start Date: Jan 2016

open study

Executive Function in Early Childhood
Vanderbilt University Reading Disability
Despite the fact that a substantial number of school age children struggle with both reading and math acquisition, the brain mechanisms of the overlapping aspects of reading and math skills, thought in part to be linked via executive functions (EF), have not been unpacked. This... expand

Despite the fact that a substantial number of school age children struggle with both reading and math acquisition, the brain mechanisms of the overlapping aspects of reading and math skills, thought in part to be linked via executive functions (EF), have not been unpacked. This project will use a longitudinal design, following children from Kindergarten through 1st grade, to understand how the brain networks associated with reading, math, and EF interact to predict academic outcomes and, in those who struggle academically, intervention response.

Type: Interventional

Start Date: Aug 2019

open study

Pevonedistat and Azacitidine in MDS or MDS/MPN Patients Who Fail Primary Therapy With DNA Methyl Transferase...
Vanderbilt-Ingram Cancer Center Myelodysplastic Syndromes Myeloproliferative Neoplasm
This study will evaluate the treatment combination of pevonedistat and azacitidine in the setting of DNA methyltransferase inhibitor(s) failure in patients with relapsed/refractory myelodysplastic syndrome or myelodysplastic syndrome/myeloproliferative neoplasm. expand

This study will evaluate the treatment combination of pevonedistat and azacitidine in the setting of DNA methyltransferase inhibitor(s) failure in patients with relapsed/refractory myelodysplastic syndrome or myelodysplastic syndrome/myeloproliferative neoplasm.

Type: Interventional

Start Date: Aug 2017

open study

Nivolumab Plus Relatlimab or Ipilimumab in Metastatic Melanoma Stratified by MHC-II Expression
Elizabeth Davis Metastatic Melanoma Advanced Melanoma Metastatic Melanoma Stratified by MHC-II Expression
This is an open-label, non-randomized two arm Phase 2 study of intravenous nivolumab plus intravenous ipilimumab or intravenous relatlimab in patients with metastatic melanoma stratified by MHC-II expression. expand

This is an open-label, non-randomized two arm Phase 2 study of intravenous nivolumab plus intravenous ipilimumab or intravenous relatlimab in patients with metastatic melanoma stratified by MHC-II expression.

Type: Interventional

Start Date: Jan 2019

open study

Framing Eighteen Coils in Cerebral Aneurysms Trial
Vanderbilt University Medical Center Cerebral Aneurysm
This trial is being conducted in order to compare angiographic outcomes in patients receiving 0.014-0.0155" platinum framing and filling coils (larger diameter coils) versus those treated solely with coils less than 0.014" (with a standard diameter). Hypothesis: Angiographic... expand

This trial is being conducted in order to compare angiographic outcomes in patients receiving 0.014-0.0155" platinum framing and filling coils (larger diameter coils) versus those treated solely with coils less than 0.014" (with a standard diameter). Hypothesis: Angiographic occlusion at follow-up imaging will be more frequent in patients receiving 0.014-0.0155" platinum coils during embolization compared to those receiving smaller-diameter coils.

Type: Interventional

Start Date: Aug 2012

open study

Reduction in Splanchnic Capacitance Contributes to Sympathetically Dependent Hypertension in Autonomic
Vanderbilt University Multiple System Atrophy Orthostatic Hypotension Supine Hypertension
The purpose of this study is to learn more about the regulation of the veins of the abdomen by the autonomic (involuntary) nervous system, and how this may affect high blood pressure. Normally, the autonomic nervous system controls how much blood flows in the veins. In people... expand

The purpose of this study is to learn more about the regulation of the veins of the abdomen by the autonomic (involuntary) nervous system, and how this may affect high blood pressure. Normally, the autonomic nervous system controls how much blood flows in the veins. In people with high blood pressure, however, the autonomic nervous system is changed. This change may affect the way blood flows in the veins of the abdomen which may play a role in their high blood pressure. About 32 participants will be screened for the study. The investigators estimate 16 will be eligible to participate in all of the study days.

Type: Interventional

Start Date: Apr 2016

open study

Restoration of Standing and Walking With ISMS in Humans
Vanderbilt University Spinal Cord Injury Paralysis
Spinal cord neural circuitry exists in the lumbar enlargement that makes it possible to stand and create synergistic, rhythmic stepping activity in the lower limbs. In the past 20 years, clinicians have tried to reengage such these circuits for standing and walking in the lower... expand

Spinal cord neural circuitry exists in the lumbar enlargement that makes it possible to stand and create synergistic, rhythmic stepping activity in the lower limbs. In the past 20 years, clinicians have tried to reengage such these circuits for standing and walking in the lower spinal cord of paralyzed humans through novel paradigms of physical therapy, pharmacological stimulation of the spinal cord, or recently - epidural stimulation of the spinal cord. Although standing and stepping with these maneuvers are rudimentary at best, these human studies offer promise to restore controlled, lower extremity movement to the spinal cord injured (SCI) individual. Evidence from animal data suggests that more focal activation of intraspinal circuitry (IntraSpinal Micro-Stimulation - ISMS) would produce more fatigue resistant, natural standing and stepping activity in humans. To date, there has been no direct confirmation of such circuitry in the spinal cord of bipedal humans who have been paralyzed. Furthermore, mapping of such circuitry would provide the basis of a novel intraspinal neuroprosthetic that should be able to restore control of standing or walking in a manner that is much more physiologically normal and tolerable than by stimulating each individual muscle group. Proof of the existence of these spinal circuits in man, and the ability to activate and control these circuits by first mapping the spinal cord is the basis of this proposal.

Type: Interventional

Start Date: Jan 2015

open study

Local Heat Stress in Autonomic Failure Patients With Supine Hypertension
Vanderbilt University Hypertension Pure Autonomic Failure Multiple System Atrophy Autonomic Failure
Patients with autonomic failure are characterized by disabling orthostatic hypotension (low blood pressure on standing), and at least half of them also have high blood pressure while lying down (supine hypertension). Exposure to heat, such as in hot environments, often worsens... expand

Patients with autonomic failure are characterized by disabling orthostatic hypotension (low blood pressure on standing), and at least half of them also have high blood pressure while lying down (supine hypertension). Exposure to heat, such as in hot environments, often worsens their orthostatic hypotension. The causes of this are not fully understood. The purpose of this study is to evaluate whether applying local heat over the abdomen of patients with autonomic failure and supine hypertension would decrease their high blood pressure while lying down. This will help us better understand the mechanisms underlying this phenomenon, and may be of use in the treatment of supine hypertension.

Type: Interventional

Start Date: Apr 2015

open study

Anti-Cytokine Therapy for Hemodialysis InflammatION
University of Pennsylvania End-Stage Renal Disease
Anti-Cytokine Therapy for Hemodialysis InflammatION (ACTION) is a phase II multi-center study to evaluate the safety and tolerability of anakinra, an IL-1 receptor antagonist, for patients treated with maintenance hemodialysis. expand

Anti-Cytokine Therapy for Hemodialysis InflammatION (ACTION) is a phase II multi-center study to evaluate the safety and tolerability of anakinra, an IL-1 receptor antagonist, for patients treated with maintenance hemodialysis.

Type: Interventional

Start Date: Dec 2017

open study

Gemcitabine + Carboplatin + Nivolumab Versus Gemcitabine + Oxaliplatin + Nivolumab in Cisplatin-ineligible...
Matthew Galsky Metastatic Urothelial Cancer
This is a randomized phase 2 trial of gemcitabine + carboplatin + nivolumab or gemcitabine + oxaliplatin + nivolumab for the treatment of cisplatin-ineligible patients with metastatic urothelial cancer. Randomization will be stratified on the lymph node only (and/or unresectable... expand

This is a randomized phase 2 trial of gemcitabine + carboplatin + nivolumab or gemcitabine + oxaliplatin + nivolumab for the treatment of cisplatin-ineligible patients with metastatic urothelial cancer. Randomization will be stratified on the lymph node only (and/or unresectable primary) metastatic status.

Type: Interventional

Start Date: May 2018

open study

Macular Edema Ranibizumab v. Intravitreal Anti-inflammatory Therapy Trial
JHSPH Center for Clinical Trials Uveitis Macular Edema
The Macular Edema Ranibizumab v. Intravitreal anti-inflammatory Therapy (MERIT) Trial will compare the relative efficacy and safety of intravitreal methotrexate, intravitreal ranibizumab, and the intravitreal dexamethasone implant for the treatment of uveitic macular edema persisting... expand

The Macular Edema Ranibizumab v. Intravitreal anti-inflammatory Therapy (MERIT) Trial will compare the relative efficacy and safety of intravitreal methotrexate, intravitreal ranibizumab, and the intravitreal dexamethasone implant for the treatment of uveitic macular edema persisting or reoccurring after an intravitreal corticosteroid injection. MERIT is a parallel design (1:1:1), randomized comparative trial with an anniversary close-out at the 6 month clinic visit. The primary outcome is percent change in central subfield thickness from the baseline OCT measurement to the 12 week visit.

Type: Interventional

Start Date: Mar 2017

open study

Epidemiology of Silent and Overt Strokes in Sickle Cell Disease
Vanderbilt University Medical Center Anemia, Sickle Cell Sickle Cell Disease Stroke Sickle Cell Thalassemia Sickle Cell-Beta0-Thalassemia
Sickle Cell Disease (SCD) is a rare disease occurring in an estimated 100,000 children and adults, often poor and underserved, in the United States. Silent strokes and overt strokes contribute significantly to morbidity in adults with SCD, resulting in functional impairment,... expand

Sickle Cell Disease (SCD) is a rare disease occurring in an estimated 100,000 children and adults, often poor and underserved, in the United States. Silent strokes and overt strokes contribute significantly to morbidity in adults with SCD, resulting in functional impairment, challenges with school and job performance, and premature death. Five NIH-funded randomized controlled trials (RCT) have identified therapies to prevent silent and overt strokes in children with SCD, including monthly blood transfusion therapy (for preventing initial and recurrent strokes) and hydroxyurea (for preventing initial strokes). Despite the observation that at least 99% of children with SCD in high-income countries reach adulthood, and approximately 60% of adults will experience one or more strokes (~50% with silent strokes and ~10% with overt strokes), no stroke trials have established therapeutic approaches for adults with SCD. For adults with SCD, inadequate evidence-based guidelines exist for secondary stroke prevention strategies. Applying stroke prevention strategies in children may not be effective for stroke prevention in adults with SCD, particularly given the high rate of co-morbidities. Identifying subgroups of adults with SCD and higher incidence coupled with the contribution of established stroke risk factors in the general population (smoking, diabetes, obesity, renal disease) will provide the requisite data required for the first ever phase III clinical trials focused on secondary stroke prevention in adults. In three adult sickle cell disease centers, we will conduct a prospective cohort study to test the primary hypothesis that the incidence of infarct recurrence (stroke or silent stroke) or new strokes in adults with silent strokes treated with hydroxyurea will be greater than in those without strokes treated with hydroxyurea. We will test two secondary hypotheses: 1) adults with SCD and silent strokes have cognitive morbidity when compared to adults with SCD without silent strokes; and 2) adults with SCD and strokes receiving regular blood transfusion will have a higher incidence of infarct recurrence than those with SCD without strokes. The aims include Aim 1: Compare the incidence of new overt and silent strokes in adults with SCD and silent strokes to a comparison group of adults without silent strokes or overt strokes. Aim 2: Compare the cognitive morbidity of those with silent strokes and overt strokes to those without strokes. Aim 3: Compare the incidence of new overt and silent stroke in adults with SCD and overt strokes receiving transfusion to adults with SCD without silent or overt strokes treated with hydroxyurea. All clinical information and neuroimaging will be centrally adjudicated with masked and experienced neurology and neuroradiology committees. Data generated after completion of this proposal are critical for developing the first ever phase III trials for secondary stroke prevention therapies in adults with SCD.

Type: Observational

Start Date: Jun 2017

open study

Use of Omega-3 Fat Emulsion (Omegaven) in Infants With Parenteral Nutrition Associated Liver Disease
Vanderbilt University Parenteral Nutrition Associated Liver Disease
Babies in the newborn intensive care unit who are dependent upon intravenous nutrition for a long period of time frequently develop liver damage. The fat used is called intralipid and is made from soybean oil. There is a suggestion in the literature that using fishoil based fats... expand

Babies in the newborn intensive care unit who are dependent upon intravenous nutrition for a long period of time frequently develop liver damage. The fat used is called intralipid and is made from soybean oil. There is a suggestion in the literature that using fishoil based fats called omega-3 fat emulsions can decrease or even reverse this liver damage. We will offer babies with evidence of liver damage and no ability to eat,the Omegaven and see if the liver damage reverses.

Type: Interventional

Start Date: Mar 2009

open study

Study of INCB053914 in Subjects With Advanced Malignancies
Incyte Corporation Solid Tumors
This is an open-label, dose-escalation study of the proviral integration site of Moloney murine leukemia virus (PIM) kinase inhibitor INCB053914 in subjects with advanced malignancies. The study will be conducted in 4 parts. Part 1 (monotherapy dose escalation) will evaluate... expand

This is an open-label, dose-escalation study of the proviral integration site of Moloney murine leukemia virus (PIM) kinase inhibitor INCB053914 in subjects with advanced malignancies. The study will be conducted in 4 parts. Part 1 (monotherapy dose escalation) will evaluate safety and determine the maximum tolerated dose of INCB053914 monotherapy and the recommended phase 2 dose(s) (a tolerated pharmacologically active dose that will be taken forward into the remaining parts of the study). Part 2 (monotherapy dose expansion) will further evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of the recommended Phase 2 dose(s). Part 3 (combination dose finding) will evaluate safety of INCB053914 in combination with select standard of care (SOC) agents and will identify the optimal INCB053914 dose in combination with conventional SOC regimens to take forward into Part 4. Part 4 (combination dose expansion) will further evaluate the safety, efficacy and pharmacokinetics of the recommended Phase 2 dose combination(s).

Type: Interventional

Start Date: Oct 2015

open study

Low VW Activity in Adolescent HMB
Baylor College of Medicine Von Willebrand Factor Deficiency
This is a research study for patients diagnosed with heavy menstrual bleeding (HMB) and low Von Willebrand Factor (VWF). Menstruation, also known as a period, is the regular discharge of blood and tissues from the uterus. HMB is having a heavier amount of discharge during menstrual... expand

This is a research study for patients diagnosed with heavy menstrual bleeding (HMB) and low Von Willebrand Factor (VWF). Menstruation, also known as a period, is the regular discharge of blood and tissues from the uterus. HMB is having a heavier amount of discharge during menstrual period. Low Von Willebrand Factor means that the participant has lower level of a blood protein that is important for clotting of blood and so, the participant is at a higher risk for bleeding. The purpose of this project is to study the genetic differences of adolescent females with HMB and low VWF activity and compare the genetic differences with their bleeding manifestations, response to medications and outcome.

Type: Observational

Start Date: Jan 2017

open study

Early Detection of Lung Cancer
Vanderbilt-Ingram Cancer Center Lung Cancer
This research trial studies the long term follow-up for early detection of lung cancer in current or former smokers. Following up on smokers by collecting and analyzing specimens in the laboratory, performing chest computed tomography (CT) scans, as well as reviewing medical... expand

This research trial studies the long term follow-up for early detection of lung cancer in current or former smokers. Following up on smokers by collecting and analyzing specimens in the laboratory, performing chest computed tomography (CT) scans, as well as reviewing medical records may help doctors detect lung cancer at an earlier stage.

Type: Observational

Start Date: Dec 2017

open study

Autoimmune Basis for Postural Tachycardia Syndrome
Vanderbilt University Medical Center Postural Orthostatic Tachycardia Syndrome Postural Tachycardia Syndrome Tachycardia Arrhythmias, Cardiac Autonomic Nervous System Diseases
The purpose of this study is to see if some people with postural tachycardia syndrome (POTS) have higher levels of immune proteins (autoantibodies) directed against receptors of the autonomic nervous system, and if these autoantibodies make a difference in their POTS symptoms.... expand

The purpose of this study is to see if some people with postural tachycardia syndrome (POTS) have higher levels of immune proteins (autoantibodies) directed against receptors of the autonomic nervous system, and if these autoantibodies make a difference in their POTS symptoms. The investigators also want to see if the levels of these autoantibodies stay the same over time.

Type: Interventional

Start Date: Feb 2016

open study

Mechanisms of Mindfulness-based Interventions
Vanderbilt University Medical Center Depression Anxiety Stress
Mindfulness-based Interventions (MBIs) are a family of standardized cognitive and behavioral therapies that focus on cultivating mindfulness-related skills for improving maladaptive cognitive, emotional, and behavioral processes. MBIs have been developed for a wide range of problems,... expand

Mindfulness-based Interventions (MBIs) are a family of standardized cognitive and behavioral therapies that focus on cultivating mindfulness-related skills for improving maladaptive cognitive, emotional, and behavioral processes. MBIs have been developed for a wide range of problems, disorders, and populations and are increasingly available in a variety of health settings. This mixed methods study proposes to investigate proposed neurobiological, physiological, psycho-social-behavioral, and cognitive mechanisms by which MBIs may improve health outcomes.

Type: Observational

Start Date: Jan 2019

open study

Clinical Outcomes of the ALPS Proximal Humerus Plating System
Vanderbilt University Medical Center Proximal Humeral Fracture Osteoporosis Risk
The purpose of this study is to document the performance and clinical outcomes of the A.L.P.S® Proximal Humerus Plating System. The optional, interventional arm of this study will assess bone quality in the proximal humerus of a fracture patient population. Specific Aims:... expand

The purpose of this study is to document the performance and clinical outcomes of the A.L.P.S® Proximal Humerus Plating System. The optional, interventional arm of this study will assess bone quality in the proximal humerus of a fracture patient population. Specific Aims: - Conduct physical assessments measuring shoulder strength and range of motion, physician assessment of radiographs - Obtain patient-reported outcomes regarding pain level, function capabilities, and work/leisure restrictions - Document revisions, complications, and adverse events The optional, interventional arm of this study will assess bone quality in the proximal humerus of a fracture patient population. DXA is not particularly effective at identifying individuals who are at risk of suffering a fracture. Yet, there is a growing population of diabetics and elderly individuals prone to fragility fractures. In effect, the age-related and diabetes-related increase in fracture risk is independent of a person's aBMD. These findings stress the urgency in developing diagnostic tools that can improve fracture risk prediction so that patients can be treated with the appropriate anti-fracture therapies. Shifting from the current paradigm of using X-ray based modalities to assess fracture risk, the reference point indentation (RPI) method acquires direct measurements of 'materal quality' of the bone tissue. Specifically, the OsteoProbe-RPI engages the patient's bone, and upon applying an impact force, it measures the ability of the tissue to resist micro-indentation. Despite the encouraging results from aformentioned studies applying RPI to bone, there is no evidence that a local measurement of bone material quality are predictive of fracture resistance at sites that are prone to fragility fractures (e.g. the proximal humerus). By affirming the ability of RPI to discriminate a fragility fracture from a high-energy (trauma) fracture of otherwise normal bone, the data from this optional study arm may provide justification for large prospective studies that evaluate whether intra-operative RPI is useful for surgical guidance.

Type: Interventional

Start Date: Aug 2017

open study

Trial of Olaparib in Patients With Metastatic Urothelial Cancer Harboring DNA Damage Response Gene Alterations
Matthew Galsky Metastatic Urothelial Cancer
This is a single arm open label multi-institutional phase II trial of olaparib monotherapy in subjects with metastatic urothelial cancer harboring somatic DNA damage response (DDR) alterations. The primary objective of the study is to estimate the objective response rate (per... expand

This is a single arm open label multi-institutional phase II trial of olaparib monotherapy in subjects with metastatic urothelial cancer harboring somatic DNA damage response (DDR) alterations. The primary objective of the study is to estimate the objective response rate (per RECIST 1.1) to treatment with olaparib.

Type: Interventional

Start Date: Apr 2018

open study

Mindfulness to Improve Functional Outcomes in Patients With Fibromyalgia or Central Sensitization
Vanderbilt University Medical Center Chronic Pain Fibromyalgia Central Sensitisation
The primary aim of the study will be to determine the feasibility of utilizing a web-based mindfulness program in adult patients with chronic pain with a diagnosis of fibromyalgia or central sensitization. expand

The primary aim of the study will be to determine the feasibility of utilizing a web-based mindfulness program in adult patients with chronic pain with a diagnosis of fibromyalgia or central sensitization.

Type: Interventional

Start Date: Jan 2019

open study

Natural History Study of Synucleinopathies
NYU Langone Health Patients With Synucleinopathies Neurogenic Orthostatic Hypotension Pure Autonomic Failure REM Sleep Behavior Disorder Parkinson Disease
Synucleinopathies are a group of rare diseases associated with worsening neurological deficits and the abnormal accumulation of the protein α-synuclein in the nervous system. Onset is usually in late adulthood at age 50 or older. Usually, synucleinopathies present clinically... expand

Synucleinopathies are a group of rare diseases associated with worsening neurological deficits and the abnormal accumulation of the protein α-synuclein in the nervous system. Onset is usually in late adulthood at age 50 or older. Usually, synucleinopathies present clinically with slowness of movement, coordination difficulties or mild cognitive impairment. Development of these features indicates that abnormal alpha-synuclein deposits have destroyed key areas of the brain involved in the control of movement or cognition. Patients with synucleinopathies and signs of CNS-deficits are frequently diagnosed with Parkinson disease (PD), dementia with Lewy bodies (DLB) or multiple system atrophy (MSA). However, accumulation of alpha-synuclein and death of nerve cells can also begin outside the brain in the autonomic nerves. In such cases, syncucleinopathies present first with symptoms of autonomic impairment (unexplained constipation, urinary difficulties, and sexual dysfunction). In rare cases, hypotension on standing (a disorder known as orthostatic hypotension) may be the only clinical finding. This "pre-motor" autonomic stage suggests that the disease process may not yet have spread to the brain. After a variable period of time, but usually within 5-years, most patients with abnormally low blood pressure on standing develop cognitive or motor abnormalities. This stepwise evolution indicates that the disease spreads from the body to the brain. Another indication of this spread is that acting out dreams (i.e., REM sleep behavior disorder, RBD) a problem that occurs when the lower part of the brain is affected, may also be the first noticeable sign of Parkinson disease. The purpose of this study is to document the clinical features and biological markers of patients with synucleinopathies and better understand how these disorders evolve over time. The study will involve following patients diagnosed with a synucleinopathy (PD/DLB and MSA) and those believed to be in the "pre-motor" stage (with isolated autonomic impairment and/or RBD). Through a careful series of follow-up visits to participating Centers, we will focus on finding biological clues that predict which patients will develop motor/cognitive problems and which ones have the resilience to keep the disease at bay preventing spread to the brain. We will also define the natural history of MSA - the most aggressive of the synucleinopathies.

Type: Observational

Start Date: Jun 2011

open study

Long-term Study in US Cystic Fibrosis Patients Receiving Digestive Enzyme Supplements to Assess Narrowing...
AbbVie (prior sponsor, Abbott) Fibrosing Colonopathy
This is a long-term study in cystic fibrosis patients who are participating in the Cystic Fibrosis Patient Registry to assess the occurrence and risk factors for a rare bowel disorder called fibrosing colonopathy (narrowing of the large intestine). Patients will be followed at... expand

This is a long-term study in cystic fibrosis patients who are participating in the Cystic Fibrosis Patient Registry to assess the occurrence and risk factors for a rare bowel disorder called fibrosing colonopathy (narrowing of the large intestine). Patients will be followed at their regular clinical care visits over a 10-year period and approached if they develop symptoms of fibrosing colonopathy for collection and use of further detailed information.

Type: Observational

Start Date: Jul 2012

open study

Assessing Efficacy of Neuropsychiatric Assessment and Treatment Protocols in Huntington's Disease Patients
Vanderbilt University Medical Center Huntington Disease
Phase A: Recruit 50 patients with HD, and their caregivers, to complete a neuropsychiatric and quality of life battery of scales at baseline. Have these 50 patients complete a formal psychiatric assessment with a psychiatrist within 2 weeks of this clinical battery, and the results... expand

Phase A: Recruit 50 patients with HD, and their caregivers, to complete a neuropsychiatric and quality of life battery of scales at baseline. Have these 50 patients complete a formal psychiatric assessment with a psychiatrist within 2 weeks of this clinical battery, and the results of these 2 types of assessments will be compared to establish the level of agreement between clinical rating scales and formal psychiatric assessment. Phase B: Continue to follow Phase A cohort longitudinally and administer neuropsychiatric and quality of life battery at 6 months, 12 months, and 18 months form baseline. Recruit an additional 50 patients, administer the same neuropsychiatric and quality of life battery at baseline, implement medication and counseling intervention according to a standard of care protocol, and follow up with the same neuropsychiatric and quality of life battery at 6, 12, and 18 months.

Type: Interventional

Start Date: Nov 2018

open study

Evaluation of Safety & Efficacy of BIO-11006 Inhalation Solution in Patients With ARDS
BioMarck Pharmaceuticals, Ltd. Respiratory Distress Syndrome, Adult
This Phase IIa pilot study is a placebo controlled, multicenter study to evaluate safety and efficacy of aerosolized BIO-11006 Inhalation Solution in ARDS patients. The subjects will be randomized 1:1 to either BIO-11006 125 mg twice daily plus standard of care or placebo plus... expand

This Phase IIa pilot study is a placebo controlled, multicenter study to evaluate safety and efficacy of aerosolized BIO-11006 Inhalation Solution in ARDS patients. The subjects will be randomized 1:1 to either BIO-11006 125 mg twice daily plus standard of care or placebo plus standard of care. The treatment will continue for up to 28 days. The study will enroll up to 40 adult ARDS patients in up to eight sites within USA.

Type: Interventional

Start Date: Aug 2017

open study