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Strategies for Anticoagulation During Venovenous ECMO
Acute Hypoxemic Respiratory Failure
Anticoagulant-induced Bleeding
Thromboembolism
Moderate intensity titrated dose anticoagulation has been used in patients receiving
extracorporeal membrane oxygenation (ECMO) to prevent thromboembolism and thrombotic
mechanical complications. As technology has improved, however, the incidence of
thromboembolic events has... expand
Moderate intensity titrated dose anticoagulation has been used in patients receiving extracorporeal membrane oxygenation (ECMO) to prevent thromboembolism and thrombotic mechanical complications. As technology has improved, however, the incidence of thromboembolic events has decreased, leading to re-evaluation of the risks of anticoagulation, particularly during venovenous (V-V) ECMO. Recent data suggest that bleeding complications during V-V ECMO may be more strongly associated with mortality than thromboembolic complications, and case series have suggested that V-V ECMO can be safely performed without moderate or high intensity anticoagulation. At present, there is significant variability between institutions in the approach to anticoagulation during V-V ECMO. A definitive randomized controlled trial is needed to compare the effects of a low intensity fixed dose anticoagulation (low intensity) versus moderate intensity titrated dose anticoagulation (moderate intensity) on clinical outcomes during V-V ECMO. Before such a trial can be conducted, however, additional data are needed to inform the feasibility of the future trial. Type: Interventional Start Date: May 2022 |
Conditioning SCID Infants Diagnosed Early
SCID
The investigators want to study if lower doses of chemotherapy will help babies with SCID to
achieve good immunity with less short and long-term risks of complications after
transplantation. This trial identifies babies with types of immune deficiencies that are most
likely... expand
The investigators want to study if lower doses of chemotherapy will help babies with SCID to achieve good immunity with less short and long-term risks of complications after transplantation. This trial identifies babies with types of immune deficiencies that are most likely to succeed with this approach and offers them transplant early in life before they get severe infections or later if their infections are under control. It includes only patients receiving unrelated or mismatched related donor transplants. The study will test if patients receiving transplant using either a low dose busulfan or a medium dose busulfan will have immune recovery of both T and B cells, measured by the ability to respond to immunizations after transplant. The exact regimen depends on the subtype of SCID the patient has. Donors used for transplant must be unrelated or half-matched related (haploidentical) donors, and peripheral blood stem cells must be used. To minimize the chance of graft-versus-host disease (GVHD), the stem cells will have most, but not all, of the T cells removed, using a newer, experimental approach of a well-established technology. Once the stem cell transplant is completed, patients will be followed for 3 years. Approximately 9-18 months after the transplant, vaccinations will be administered, and a blood test measuring whether your child's body has responded to the vaccine will be collected. Type: Interventional Start Date: Oct 2018 |
Natural History Study of Synucleinopathies
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 |
Noninvasive Brain Stimulation to Enhance Reading Comprehension Ability in Adults
Reading Disability
The goal of this project is to address the urgent need for effective, scalable adult literacy
interventions by integrating breakthroughs in two separate fields: 1.) the brain network
science of resilience to reading disorders and 2.) high-definition non-invasive brain network... expand
The goal of this project is to address the urgent need for effective, scalable adult literacy interventions by integrating breakthroughs in two separate fields: 1.) the brain network science of resilience to reading disorders and 2.) high-definition non-invasive brain network stimulation. This study will first establish the efficacy of a novel, noninvasive stimulation protocol on reading behavior and brain metrics; then will determine how stimulation-induced effects interact with baseline reading comprehension ability; and lastly, will identify whether stimulation-induced effects are more clinically-beneficial than canonical behavioral interventions. Results may foundationally change how we treat low adult literacy, and have the potential for wider reaching impacts on non-invasive stimulation protocols for other clinical disorders. Type: Interventional Start Date: Nov 2022 |
Hemodialysis.-Induced Hypotension Therapy for End Stage Kidney Disease
Hemodialysis Complication
Hypotension of Hemodialysis
Bradykinin is a potent vasodilator that is formed by the activation of the kallikrein-kinin
system. We and others have shown that bradykinin increased during hemodialysis; however, the
role of bradykinin in dialysis-induced hypotension (DIH) has not been evaluated. Preliminary... expand
Bradykinin is a potent vasodilator that is formed by the activation of the kallikrein-kinin system. We and others have shown that bradykinin increased during hemodialysis; however, the role of bradykinin in dialysis-induced hypotension (DIH) has not been evaluated. Preliminary results from a pilot clinical trial showed that bradykinin B2 receptor blockade with icatibant prevents excessive blood pressure during hemodialysis. Thus, in this study, we will test the overarching hypothesis that blockade plasma kallikrein with lanadelumab would ameliorate the reduction of blood pressure during hemodialysis in patients who are prone to DIH. For this purpose, we will conduct a parallel arm, double-blind placebo-controlled trial, using lanadelumab to evaluate the occurrence of Type: Interventional Start Date: Jul 2022 |
Epidemiology of Silent and Overt Strokes in Sickle Cell Disease
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 individuals,
often poor and underserved, in the US. Silent and overt strokes contribute significantly to
morbidity in adults with SCD, resulting in functional impairment, challenges with school and... expand
Sickle Cell Disease (SCD) is a rare disease occurring in an estimated 100,000 individuals, often poor and underserved, in the US. Silent 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 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. Type: Observational Start Date: Jun 2017 |
Hormonal, Metabolic, and Signaling Interactions in PAH
Idiopathic Pulmonary Arterial Hypertension
Heritable Pulmonary Arterial Hypertension
Scleroderma Associated Pulmonary Arterial Hypertension
Appetite Suppressant Associate PAH
Our hypothesis is that optimal treatment of the dysfunctional metabolic pathways which
underlie PAH will improve pulmonary vascular function and consequences of the disease.
expand
Our hypothesis is that optimal treatment of the dysfunctional metabolic pathways which underlie PAH will improve pulmonary vascular function and consequences of the disease. Type: Observational Start Date: Sep 2012 |
Neurophysiology Biomarkers of Cognitive Impairment Associated With Deep Brain Stimulation
Parkinson Disease
The study aims to investigate cognitive impairment associated with Deep Brain Stimulation
(DBS) in Parkinson's Disease patients, with a focus on identifying neurophysiology biomarkers
of DBS associated cognitive changes. Using neurophysiology data recorded during DBS surgeries... expand
The study aims to investigate cognitive impairment associated with Deep Brain Stimulation (DBS) in Parkinson's Disease patients, with a focus on identifying neurophysiology biomarkers of DBS associated cognitive changes. Using neurophysiology data recorded during DBS surgeries and post-implantation, the research intends to identify biomarkers in order to optimize electrode placement, enhance programming, and ultimately minimize DBS-related cognitive side effects. Type: Interventional Start Date: Jul 2023 |
(89Zr Panitumumab) With PET/CT for Diagnosing Metastases in Patients With Head and Neck Squamous Cell...
Head and Neck Squamous Cell Carcinoma
Metastatic Head and Neck Squamous Cell Carcinoma
Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck
The goal of this phase I clinical trial is to evaluate the usefulness of an imaging test
(zirconium Zr 89 panitumumab [89Zr panitumumab]) with positron emission tomography
(PET)/computed tomography (CT) for diagnosing the spread of disease from where it first
started (primary... expand
The goal of this phase I clinical trial is to evaluate the usefulness of an imaging test (zirconium Zr 89 panitumumab [89Zr panitumumab]) with positron emission tomography (PET)/computed tomography (CT) for diagnosing the spread of disease from where it first started (primary site) to other places in the body (metastasis) in patients with head and neck squamous cell carcinoma. Traditional PET/CT has a low positive predictive value for diagnosing metastatic disease in head and neck cancer. 89Zr panitumumab is an investigational imaging agent that contains radiolabeled anti-EGFR antibody which is overexpressed in head and neck cancer. The main question this study aims to answer is the sensitivity and specificity of 89Zr panitumumab for the detection of indeterminate metastatic lesions in head and neck cancer. Participants will receive 89Zr panitumumab infusion and undergo 89Zr panitumumab PET/CT 1 to 5 days after infusion. Participants will otherwise receive standard of care evaluation and treatment for their indeterminate lesions. Researchers will compare the 89Zr panitumumab to standard of care imaging modalities (magnetic resonance imaging (MRI), CT, and/or PET/CT). Type: Interventional Start Date: May 2023 |
BRAVE Strategy - Breast Cancer Risk Assessment -achieVing Equity
Breast Cancer
The central goal of this study is to test strategies to implement evidence-based breast
cancer risk assessment in healthcare clinics in Tennessee. The BRAVE Strategy (Breast cancer
Risk Assessment - achieVing Equity) study aims to assess the feasibility, reach,
acceptability,... expand
The central goal of this study is to test strategies to implement evidence-based breast cancer risk assessment in healthcare clinics in Tennessee. The BRAVE Strategy (Breast cancer Risk Assessment - achieVing Equity) study aims to assess the feasibility, reach, acceptability, and appropriateness of select customized strategies to increase uptake of breast cancer risk assessment. The investigators will achieve these aims through a conducting a stepped-wedge trial conducted in 10 healthcare clinics in the state of Tennessee. The primary outcome is the proportion of women age 25-49 having risk assessment. Secondary outcomes include the numbers of 1) women identified as high-risk; 2) pursuing risk-adherent screening; and 3) diagnosed with breast cancer. Type: Interventional Start Date: Mar 2022 |
Asymptomatic Renal Calculi in Recurrent Urinary Tract Infections
Urinary Tract Infections
Kidney Stone
This study will assess patients who have recurrent urinary tract infections and kidney stones
which are not blocking the kidney or causing other problems. Currently, we don't know if
taking out these stones will improve recurrent urinary tract infections or not. Patients will... expand
This study will assess patients who have recurrent urinary tract infections and kidney stones which are not blocking the kidney or causing other problems. Currently, we don't know if taking out these stones will improve recurrent urinary tract infections or not. Patients will make a decision with their surgeon about removing or monitoring their stone(s). Whether or not their infections continue with surgery or monitoring will be noted, and this information may help to inform future treatment decisions. The purpose of this study is to assess if treatment of these asymptomatic stones affects the rate of recurrent urinary tract infections. Type: Observational [Patient Registry] Start Date: Sep 2020 |
Investigating N-3 Fatty Acids to Prevent Neonatal Tobacco-related outcomeS
Preterm Labor
Tobacco Use Disorder
Smoking is the most important modifiable risk factor for adverse pregnancy outcomes including
preterm birth, neonatal death, and maternal complications. Rates of smoking cessation during
pregnancy are low, particularly in underserved populations, and currently approved
pharmacotherapies... expand
Smoking is the most important modifiable risk factor for adverse pregnancy outcomes including preterm birth, neonatal death, and maternal complications. Rates of smoking cessation during pregnancy are low, particularly in underserved populations, and currently approved pharmacotherapies for smoking cessation either are considered unsafe in pregnancy or have uncertain effectiveness. Identifying safe and effective interventions, which might mitigate the adverse effects of smoking on maternal-fetal outcomes, is a major public health priority. We hypothesize that smoking-induced n-3 LCPUFA relative deficiencies may be an important mechanism contributing to tobacco-related adverse pregnancy outcomes and that n-3 LCPUFA supplementation specifically targeted to pregnant smokers may reduce these complications. Support for this hypothesis comes from a recent secondary analysis of the Omega-3 Fatty Acids Supplementation to Prevent Preterm Birth trial that found that only smokers taking n-3 LCPUFAs had a reduction in preterm labor risk as compared to non-smokers. While compelling, this study was a post hoc analysis that included only a small sample of smokers and did not collect data on smoking behaviors during follow up. Yet the ascertainment of longitudinal smoking behavior is critical, as some clinical studies have found that supplemental n-3 LCPUFAs might also reduce nicotine cravings, and lower daily cigarette use. Thus, smokers may doubly benefit from replenishing n-3 LCPUFAs via lower risk of preterm labor and/or increased smoking cessation. To address these knowledge gaps, we are proposing a multi-center, randomized, placebo-controlled, double-blinded study of n-3 LCPUFA supplementation in 400 pregnant smokers. We will collect detailed information on smoking behavior, validated biological markers of cigarette exposure (urinary cotinine, end-expiratory carbon monoxide) and biomarkers of n-3 LCPUFA status (red blood cell phospholipid membrane fatty acids). Our specific aims of this proposal are to 1) determine the effect of supplemental n-3 LCPUFAs on gestational age at delivery and preterm labor in pregnant smokers and 2) determine the effect of n-3 LCPUFA supplementation on tobacco use in pregnant smokers. We will recruit potential participants from eight obstetrics clinics across the Middle-Tennessee area. Our study could have a major translational impact on both adverse tobacco-related birth outcomes and smoking cessation efforts. Type: Interventional Start Date: Nov 2020 |
The ExTINGUISH Trial of Inebilizumab in NMDAR Encephalitis
Autoimmune Encephalitis
Encephalitis
Determine the difference in the modified Rankin score at 16 weeks in participants with
anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis treated with "first-line"
immunomodulatory therapies provided as standard-of-care, and either inebilizumab
(investigational agent)... expand
Determine the difference in the modified Rankin score at 16 weeks in participants with anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis treated with "first-line" immunomodulatory therapies provided as standard-of-care, and either inebilizumab (investigational agent) or placebo. Type: Interventional Start Date: Mar 2022 |
Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2
Neurotrophic Keratopathy
The objective of this study is to compare the safety and efficacy of RGN-259 to placebo for
the treatment of Neurotrophic Keratopathy (NK)
expand
The objective of this study is to compare the safety and efficacy of RGN-259 to placebo for the treatment of Neurotrophic Keratopathy (NK) Type: Interventional Start Date: Apr 2023 |
Clinical Utility of Residual Hearing in the Cochlear Implant Ear
Hearing Loss, Sensorineural
Hearing Loss
Hearing Loss, Bilateral
The current study is a randomized multi-center clinical trial that investigates the role an
intraoperative hearing monitoring system (electrocochleography) has on helping to save
residual hearing in patients undergoing cochlear implantation (CI).
expand
The current study is a randomized multi-center clinical trial that investigates the role an intraoperative hearing monitoring system (electrocochleography) has on helping to save residual hearing in patients undergoing cochlear implantation (CI). Type: Interventional Start Date: Nov 2021 |
Safety of Sildenafil in Premature Infants With Severe Bronchopulmonary Dysplasia
Bronchopulmonary Dysplasia of Newborn
This is a multicenter, randomized, placebo-controlled, sequential dose-escalating,
double-masked, safety study of sildenafil in premature infants (inpatient in Neonatal
Intensive Care Units (NICUs)) with severe bronchopulmonary dysplasia (BPD).
expand
This is a multicenter, randomized, placebo-controlled, sequential dose-escalating, double-masked, safety study of sildenafil in premature infants (inpatient in Neonatal Intensive Care Units (NICUs)) with severe bronchopulmonary dysplasia (BPD). Type: Interventional Start Date: May 2021 |
Comparing Two Methods to Follow Patients With Pancreatic Cysts
Pancreatic Carcinoma
The purpose of this study is to compare the two approaches for monitoring pancreatic cysts.
The study doctors want to compare more frequent monitoring vs less frequent monitoring in
order to learn which monitoring method leads to better outcome for patients with pancreatic... expand
The purpose of this study is to compare the two approaches for monitoring pancreatic cysts. The study doctors want to compare more frequent monitoring vs less frequent monitoring in order to learn which monitoring method leads to better outcome for patients with pancreatic cysts. Type: Interventional Start Date: Jun 2020 |
Study of Individuals Affected With Hypoplasminogenemia
Plasminogen Deficiency
This is an Investigator initiated retrospective and prospective single cohort study. The
study will utilize an international registry and develop a specimen biobank to provide an
improved understanding of the natural history of hyposplasminogenemia, to elucidate the
heterogeneity... expand
This is an Investigator initiated retrospective and prospective single cohort study. The study will utilize an international registry and develop a specimen biobank to provide an improved understanding of the natural history of hyposplasminogenemia, to elucidate the heterogeneity of phenotypic expression, identify markers to predict disease course, and inform improved therapeutic modalities Type: Observational Start Date: Dec 2018 |
Crizotinib in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Removed by...
ALK Gene Rearrangement
ALK Gene Translocation
ALK Positive
Stage IB Non-Small Cell Lung Carcinoma AJCC v7
Stage II Non-Small Cell Lung Cancer AJCC v7
This randomized phase III trial studies how well crizotinib works in treating patients with
stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation
in a protein called anaplastic lymphoma kinase (ALK). Mutations, or changes, in ALK can make... expand
This randomized phase III trial studies how well crizotinib works in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called anaplastic lymphoma kinase (ALK). Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. Crizotinib may be an effective treatment for patients with non-small cell lung cancer and an ALK fusion mutation. Type: Interventional Start Date: Mar 2015 |
Comprehensive Postpartum Management for Women With Hypertensive Disorders of Pregnancy
Hypertension, Pregnancy-Induced
Postpartum Preeclampsia
Hypertension; Maternal
Investigators propose a comprehensive management program for postpartum patients with HDP who
are at risk for severe maternal morbidity and mortality. Our program will emphasize three key
components: 1) self-monitoring of blood pressures with app-based reporting connected to our... expand
Investigators propose a comprehensive management program for postpartum patients with HDP who are at risk for severe maternal morbidity and mortality. Our program will emphasize three key components: 1) self-monitoring of blood pressures with app-based reporting connected to our electronic health record, 2) blood pressure management directed by a program navigator with guideline and physician support and 3) facilitated transitions of care to primary care clinicians for hypertension management. Investigators will randomize 300 patents with HDP on postpartum day one with follow up through 3 months postpartum. Primary outcome will be blood pressure reporting at 7-10 postpartum. Secondary outcomes include blood pressure control at 7-10 days postpartum, identification and treatment of severe blood pressures, severe maternal morbidity, hospital readmission, triage visits for hypertension, postpartum and primary care visit attendance, and multiple patient-reported outcome measures. All outcomes will be stratified by race (Black and non-Black) to evaluate disparities and by tight versus usual blood pressure control to evaluate the impact of strict postpartum blood pressure control on outcomes. Investigators hypothesize that a comprehensive postpartum HDP management program will improve hypertension control for all patients and reduce disparities that affect Black patients, and that stricter blood pressure control will be associated with fewer adverse outcomes. Type: Interventional Start Date: May 2023 |
Validation of Cutaneous Nerve Demyelination in Diagnosis and Treatment of CIDP
CIDP
The goal of this observational study is to learn about chronic inflammatory demyelinating
polyneuropathy. The main question the investigators would like to answer is 1) can skin
biopsy identify demyelination better than nerve conduction studies (electrical tests of the
nerves)?... expand
The goal of this observational study is to learn about chronic inflammatory demyelinating polyneuropathy. The main question the investigators would like to answer is 1) can skin biopsy identify demyelination better than nerve conduction studies (electrical tests of the nerves)? and 2) how do nerves improve after treatment in CIDP? Participants will be asked to undergo skin biopsy of the finger at baseline and at 3 months and 6 months after treatment with IVIG (which is the FDA approved treatment for CIDP). Type: Observational Start Date: Feb 2023 |
Practical Approaches to Care in Emergency Syncope
Syncope
Presyncope
Syncope, or transient loss of consciousness, is a common reason for visit to the Emergency
Department and often leads to extensive testing and hospitalization. Using objective risk
scores to determine which patients with syncope will actually benefit from these
interventions,... expand
Syncope, or transient loss of consciousness, is a common reason for visit to the Emergency Department and often leads to extensive testing and hospitalization. Using objective risk scores to determine which patients with syncope will actually benefit from these interventions, and which can be safely discharged home with minimal testing, is critical to providing sensible medical care. This study will evaluate the validity of two syncope risk-stratification tools and investigate their impact on healthcare utilization and patient safety, thus improving the quality of care for the 1-2 million patients who experience syncope every year in the United States Type: Observational Start Date: Sep 2020 |
Chemoradiation vs Immunotherapy and Radiation for Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma
Cancer
Cancer of Head and Neck
Cancer, Advanced
Cancer, Metastatic
The purpose of this study is to compare any good or bad effects of using pembrolizumab (an
experimental drug) and radiation therapy (RT), compared to using cisplatin chemotherapy and
radiation therapy (RT) in the treatment of patients with head and neck squamous cell
carcinoma... expand
The purpose of this study is to compare any good or bad effects of using pembrolizumab (an experimental drug) and radiation therapy (RT), compared to using cisplatin chemotherapy and radiation therapy (RT) in the treatment of patients with head and neck squamous cell carcinoma (HNSCC). Type: Interventional Start Date: Mar 2018 |
Virtual Reality Training for Social Skills in Schizophrenia - Comparison With Cognitive Training
Schizophrenia
Schizo Affective Disorder
Social Skills
Social impairments are core features of schizophrenia that lead to poor outcome. Social
skills and competence improve quality of life and protect against stress-related exacerbation
of symptoms, while supporting resilience, interpersonal interactions, and social affiliation.... expand
Social impairments are core features of schizophrenia that lead to poor outcome. Social skills and competence improve quality of life and protect against stress-related exacerbation of symptoms, while supporting resilience, interpersonal interactions, and social affiliation. To improve outcome, it is necessary to remediate social deficits. Existing psychosocial interventions are moderately effective but the effort-intensive nature (high burden), low adherence, and weak transfer of skills to everyday life present significant hurdles toward recovery. Thus, there is a dire need to develop effective, engaging and low-burden social interventions for people with schizophrenia that will result in better compliance rates and functional outcome. In a previous pilot study, the investigators tested the effectiveness of a novel adaptive virtual reality (VR) intervention in improving targeted social cognitive function (social attention, as indexed by eye scanning patterns) in individuals with schizophrenia. 10 sessions of 1-hour VR intervention were sufficient to engage the target mechanism of social attention and improve negative symptoms. Acceptability and compliance were very high among the participants. ' The next phase, supported by a R33 grant will compare the VR social skills training with a control condition. This new protocol includes a control condition for the exposure to computerized training across the 10 sessions and incidental exposure to social interactions (i.e. interactions with experimenters twice a week for 5 weeks) by including a control condition, which involves computerized brain fitness training for 10 sessions. Type: Interventional Start Date: Oct 2021 |
Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Participants With Epstein-Barr...
Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD)
Solid Organ Transplant Complications
Lymphoproliferative Disorders
Allogeneic Hematopoietic Cell Transplant
Stem Cell Transplant Complications
The purpose of this study is to determine the clinical benefit and characterize the safety
profile of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant
lymphoproliferative disease (EBV+ PTLD) in the setting of (1) solid organ transplant (SOT)... expand
The purpose of this study is to determine the clinical benefit and characterize the safety profile of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the setting of (1) solid organ transplant (SOT) after failure of rituximab and rituximab plus chemotherapy or (2) allogeneic hematopoietic cell transplant (HCT) after failure of rituximab. Type: Interventional Start Date: Dec 2017 |
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