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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 |
Pediatric GVHD Low Risk Steroid Taper Trial
Acute Graft vs Host Disease
Allogeneic Bone Marrow Transplantation
Adverse Effects
The standard treatment for acute graft-vs-host disease (GVHD) is to suppress the activity of
the donor immune cells using steroid medications such as prednisone. Although most GVHD,
especially in children, responds well to treatment, sometimes (around 1/3 of the time) there... expand
The standard treatment for acute graft-vs-host disease (GVHD) is to suppress the activity of the donor immune cells using steroid medications such as prednisone. Although most GVHD, especially in children, responds well to treatment, sometimes (around 1/3 of the time) there is either no response to steroids or the response does not last. In those cases, the GVHD can become dangerous and even life-threatening. Unfortunately, doctors cannot predict who will have a good response to treatment based on symptom severity or initial response to steroids. As a result, nearly all children who develop GVHD are treated with long courses of high dose steroids even though that means many patients receive more treatment than they probably need. Steroid treatment can cause short-term complications like infections, high blood sugar, high blood pressure, muscle weakness, depression, anxiety, and problems sleeping and long-term complications like bone damage, cataracts in the eyes, and decreased growth. The risk of these complications increases with higher doses of steroids and longer treatment. It is important to find ways to decrease the steroid treatment in patients who do not need long courses. The doctors conducting this research have developed a blood test (GVHD biomarkers) that predicts whether a patient will respond well to steroids. The study team found that children who have low GVHD biomarkers at the start of treatment and for the first two weeks of treatment have a very high response rate to steroids. In this study, the study team will monitor GVHD symptoms and biomarkers during treatment and taper steroids quickly in patients who have GVHD that is expected to respond very well to treatment. The study team will assess how many patients respond well to lower steroid dosing and what steroid complications develop. The study team will also use surveys to obtain the patient's own assessment of their quality of life (down to age 5 years). Type: Interventional Start Date: Oct 2022 |
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 |
CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted...
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage IIA Breast Cancer AJCC v8
Anatomic Stage IIB Breast Cancer AJCC v8
Anatomic Stage IIIA Breast Cancer AJCC v8
Invasive Breast Carcinoma
This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating
further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer
who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after... expand
This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherapy and HER2-targeted therapy. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab and pertuzumab are both a form of "targeted therapy" because they work by attaching themselves to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When these drugs attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving paclitaxel, trastuzumab, and pertuzumab may enable fewer chemotherapy drugs to be given without compromising patient outcomes compared to the usual treatment. Type: Interventional Start Date: Mar 2020 |
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 |
A Safety, Pharmacokinetic and Efficacy Study of NUC-3373 in Combination With Standard Agents Used in...
Colorectal Cancer
Colorectal Neoplasms
Colorectal Carcinoma
Colorectal Tumors
Neoplasms, Colorectal
This is a three-part study of NUC-3373 administered by intravenous (IV) infusion across two
administration schedules, either as monotherapy or as part of various combinations with
agents commonly used to treat CRC (leucovorin, oxaliplatin, irinotecan, bevacizumab,
cetuximab... expand
This is a three-part study of NUC-3373 administered by intravenous (IV) infusion across two administration schedules, either as monotherapy or as part of various combinations with agents commonly used to treat CRC (leucovorin, oxaliplatin, irinotecan, bevacizumab, cetuximab and panitumumab). The primary objective is to identify a recommended dose and schedule for NUC-3373 when combined with these agents. Type: Interventional Start Date: Oct 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 |
Real World Evidence Study in Subjects With Wilson's Disease
Wilson Disease
This non-interventional Real-World Evidence (RWE) study aims to describe non-ceruloplasmin
copper values obtained using a new NCC Speciation assay by taking a small (up to 10mLs)
volume of additional blood from patients with Wilson's Disease, around the time when routine
blood... expand
This non-interventional Real-World Evidence (RWE) study aims to describe non-ceruloplasmin copper values obtained using a new NCC Speciation assay by taking a small (up to 10mLs) volume of additional blood from patients with Wilson's Disease, around the time when routine blood sampling is expected to be scheduled by the treating physician. Data will be collected over an approximate 12-month period. Type: Observational Start Date: Jun 2023 |
Study of CAbozantinib in Combination With AtezolizumaB for Muscle-Invasive BladdEr Cancer
Bladder Cancer
This is an open-label phase II study assessing the activity of cabozantinib combined with
atezolizumab in patients with resectable muscle-invasive urothelial carcinoma who are
ineligible for cisplatin-based therapy or decline cisplatin-based therapy. Each cycle equals
21 days.... expand
This is an open-label phase II study assessing the activity of cabozantinib combined with atezolizumab in patients with resectable muscle-invasive urothelial carcinoma who are ineligible for cisplatin-based therapy or decline cisplatin-based therapy. Each cycle equals 21 days. The dose of atezolizumab is 1200 mg IV flat dose every 3 weeks (Day 1) plus cabozantinib 40 mg orally daily (Day 1 through Day 21). Patients will receive three cycles of treatment prior to cystectomy unless they discontinue treatment for unacceptable toxicity or progressive disease by RECIST v1.1 or withdraw consent. Type: Interventional Start Date: May 2020 |
Effects of Early Weight Bearing on Rehabilitation Outcomes in Patients With Traumatic Ankle and Tibial...
Rehabilitation
The overall objective of this study is to compare outcomes following early versus delayed
weight bearing for adult patients operatively treated for an ankle fracture without
syndesmotic fixation. Additionally, early weight bearing will be tested in patients with
unicondylar... expand
The overall objective of this study is to compare outcomes following early versus delayed weight bearing for adult patients operatively treated for an ankle fracture without syndesmotic fixation. Additionally, early weight bearing will be tested in patients with unicondylar plateau fractures that do not involve joint impaction in the context of a pilot study. Type: Interventional Start Date: Jan 2020 |
I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
Breast Neoplasms
Breast Cancer
Breast Tumors
Angiosarcoma
TNBC - Triple-Negative Breast Cancer
The purpose of this study is to further advance the ability to practice personalized medicine
by learning which new drug agents are most effective with which types of breast cancer tumors
and by learning more about which early indicators of response (tumor analysis prior to... expand
The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success. Type: Interventional Start Date: Mar 2010 |
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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