Baylor College of Medicine — Biomedical Watch V2

Traitements11programmes

Essais5liés

Publications0liées

SourceDBlocale

Traitements

11

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
CD30.CAR-EBVST cellsThis study involved patients that have a cancer called diffuse large B cell lymphoma (DLBCL), NK and T cell lymphomas (NK/TL) or classical Hodgkin lymphoma (cHL) (hereafter these 3 diseases will be referred to as lymphoma). Patients lymphoma has come back or not gone away after treatment. Because there is no standard treatment for the patients cancer at this time or because the currently used treatments do not work fully in all cases, the patients are being asked to volunteer in this research study. In this study the investigators want to test a type of T cell made from a normal donor. The T cells the investigators will use are called Epstein Barr virus (EBV) specific T cells (EBVSTs) and are cells that the investigators have trained in the laboratory to recognize a EBV which is the virus that causes mono or kissing disease. Some patients with lymphoma have EBV in their cancer cells. Researchers have given T cell lines from normal donor EBVSTs to lymphoma patients who have EBV in their lymphoma cells and have seen responses in about half the patients. The cells have have been generated and are frozen in a bank. The cells are called "allogeneic" (meaning the donor is not related to the patient). CD30.CAR in EBV-specific T cells (called allogeneic CD30.CAR-EBVST) from the blood of healthy donors. The investigators are giving the cells to patients with lymphoma cells that express CD30. If the lymphoma cells also express EBV there may be some benefit from targeting both proteins. The purpose of this study is to find out the highest safe dose of allogeneic CD30.CAR-EBVST cells given following chemotherapy and used to treat lymphoma. The investigators will learn the side effects of CD30.CAR-EBVST cells in patients and see whether this therapy may help lymphoma patients	Cancer	Phase 1	Immunomodulation	United States	À vérifier
Glutathione, Brain Metabolism and Inflammation in Alzheimer's DiseaseAlzheimer's disease (AD) is associated with significant, progressive cognitive decline. Key defects in mitochondrial fuel metabolism insulin resistance, inflammation and decreased brain glucose uptake are linked to AD. This trial will investigate the effects of supplementing glycine and N-acetylcysteine vs. alanine as placebo on these defects in AD, and examine the effects on cognition.	Alzheimer	Phase 1	Remyélinisation indirecte / réparation + Immunomodulation	United States	À vérifier
ITB Titration ProtocolThe goal of this study is to better understand outcomes in children with dystonic cerebral palsy (CP) receiving intrathecal baclofen (ITB), ventral dorsal rhizotomy (VDR), or deep brain stimulation (DBS) as part of standard clinical care. The decision to proceed with ITB, VDR, or DBS is made independently of research participation. The study aims to: 1. Evaluate changes in dystonia and other clinically important outcomes; 2. Identify characteristics associated with treatment response; and 3. Develop a multidimensional outcome measure for children with dystonic CP. Participants receiving ITB will follow a study-specific standardized titration protocol designed to identify a dose that provides maximum benefit with minimal side effects. Participants in all three groups will complete research assessments and questionnaires at protocol-specified timepoints to evaluate dystonia, spasticity, function, pain, stress, and quality of life.	Myopathies	Non applicable	Traitement symptomatique	United States	À vérifier
Soterix Medical Vagus Nerve Stimulation mini-CTThis clinical trial aims to evaluate whether transcutaneous auricular vagus nerve stimulation (taVNS), a non-invasive brain stimulation method, can improve attention and memory in veterans with traumatic brain injury (TBI) and depression and/or posttraumatic stress disorder (PTSD). The study seeks to answer two main questions: 1. Can active taVNS improve attention and memory compared to sham (placebo) stimulation? 2. Does taVNS affect heart rate variability (HRV)? taVNS delivers a gentle electrical current to the vagus nerve through electrodes placed on the ear, targeting brain areas involved in attention and memory without requiring surgery. This study uses a crossover design, meaning all participants will experience two sessions: one with active taVNS and one with sham stimulation. The sham session feels similar but does not deliver actual stimulation, allowing researchers to compare the two and understand taVNS's effects on the brain. In a single visit, participants will: * Complete eligibility screening (questionnaires and vital signs). * Undergo two sessions (one active and one sham), randomly assigned. * Perform attention tasks before and after each session. * Have their heart rate monitored during the sessions. The findings will help determine whether taVNS could be an effective treatment for improving attention and memory in veterans with TBI.	SEP	Non applicable	À vérifier	United States	À vérifier
Speedboat™ UltraslimBoth Baylor St Luke's Medical Center and Mayo Scottsdale are considered endoscopic submucosal dissection (ESD) centers of excellence. The investigators at Baylor College of Medicine have previously reported our Esophageal ESD experience using the monopolar current knife. Moreover, the research team have previously reported on the clinical efficacy of the bipolar RFA knife during per-oral endoscopic myotomy (POEM) and colonic ESD. The goal of our study is to prospectively evaluate the efficacy, safety and feasibility of Esophageal ESD using a novel Bipolar-Current ESD device.	Cancer	À vérifier	À vérifier	United States	À vérifier
Ventral Dorsal RhizotomyThe goal of this study is to better understand outcomes in children with dystonic cerebral palsy (CP) receiving intrathecal baclofen (ITB), ventral dorsal rhizotomy (VDR), or deep brain stimulation (DBS) as part of standard clinical care. The decision to proceed with ITB, VDR, or DBS is made independently of research participation. The study aims to: 1. Evaluate changes in dystonia and other clinically important outcomes; 2. Identify characteristics associated with treatment response; and 3. Develop a multidimensional outcome measure for children with dystonic CP. Participants receiving ITB will follow a study-specific standardized titration protocol designed to identify a dose that provides maximum benefit with minimal side effects. Participants in all three groups will complete research assessments and questionnaires at protocol-specified timepoints to evaluate dystonia, spasticity, function, pain, stress, and quality of life.	Myopathies	Non applicable	Traitement symptomatique	United States	À vérifier
Speedboat™ UltraslimBoth Baylor St Luke's Medical Center and Mayo Scottsdale are considered endoscopic submucosal dissection (ESD) centers of excellence. The investigators at Baylor College of Medicine have previously reported our Esophageal ESD experience using the monopolar current knife. Moreover, the research team have previously reported on the clinical efficacy of the bipolar RFA knife during per-oral endoscopic myotomy (POEM) and colonic ESD. The goal of our study is to prospectively evaluate the efficacy, safety and feasibility of Esophageal ESD using a novel Bipolar-Current ESD device.	Cancer	À vérifier	À vérifier	United States	À vérifier
Glutathione, Brain Metabolism and Inflammation in Alzheimer's DiseaseAlzheimer's disease (AD) is associated with significant, progressive cognitive decline. Key defects in mitochondrial fuel metabolism insulin resistance, inflammation and decreased brain glucose uptake are linked to AD. This trial will investigate the effects of supplementing glycine and N-acetylcysteine vs. alanine as placebo on these defects in AD, and examine the effects on cognition.	Alzheimer	Phase 1	Remyélinisation indirecte / réparation + Immunomodulation	United States	À vérifier
CD30.CAR-EBVST cellsThis study involved patients that have a cancer called diffuse large B cell lymphoma (DLBCL), NK and T cell lymphomas (NK/TL) or classical Hodgkin lymphoma (cHL) (hereafter these 3 diseases will be referred to as lymphoma). Patients lymphoma has come back or not gone away after treatment. Because there is no standard treatment for the patients cancer at this time or because the currently used treatments do not work fully in all cases, the patients are being asked to volunteer in this research study. In this study the investigators want to test a type of T cell made from a normal donor. The T cells the investigators will use are called Epstein Barr virus (EBV) specific T cells (EBVSTs) and are cells that the investigators have trained in the laboratory to recognize a EBV which is the virus that causes mono or kissing disease. Some patients with lymphoma have EBV in their cancer cells. Researchers have given T cell lines from normal donor EBVSTs to lymphoma patients who have EBV in their lymphoma cells and have seen responses in about half the patients. The cells have have been generated and are frozen in a bank. The cells are called "allogeneic" (meaning the donor is not related to the patient). CD30.CAR in EBV-specific T cells (called allogeneic CD30.CAR-EBVST) from the blood of healthy donors. The investigators are giving the cells to patients with lymphoma cells that express CD30. If the lymphoma cells also express EBV there may be some benefit from targeting both proteins. The purpose of this study is to find out the highest safe dose of allogeneic CD30.CAR-EBVST cells given following chemotherapy and used to treat lymphoma. The investigators will learn the side effects of CD30.CAR-EBVST cells in patients and see whether this therapy may help lymphoma patients	Cancer	Phase 1	Immunomodulation	United States	À vérifier
Soterix Medical Vagus Nerve Stimulation mini-CTThis clinical trial aims to evaluate whether transcutaneous auricular vagus nerve stimulation (taVNS), a non-invasive brain stimulation method, can improve attention and memory in veterans with traumatic brain injury (TBI) and depression and/or posttraumatic stress disorder (PTSD). The study seeks to answer two main questions: 1. Can active taVNS improve attention and memory compared to sham (placebo) stimulation? 2. Does taVNS affect heart rate variability (HRV)? taVNS delivers a gentle electrical current to the vagus nerve through electrodes placed on the ear, targeting brain areas involved in attention and memory without requiring surgery. This study uses a crossover design, meaning all participants will experience two sessions: one with active taVNS and one with sham stimulation. The sham session feels similar but does not deliver actual stimulation, allowing researchers to compare the two and understand taVNS's effects on the brain. In a single visit, participants will: * Complete eligibility screening (questionnaires and vital signs). * Undergo two sessions (one active and one sham), randomly assigned. * Perform attention tasks before and after each session. * Have their heart rate monitored during the sessions. The findings will help determine whether taVNS could be an effective treatment for improving attention and memory in veterans with TBI.	SEP	Non applicable	À vérifier	United States	À vérifier
ITB Titration ProtocolThe goal of this study is to better understand outcomes in children with dystonic cerebral palsy (CP) receiving intrathecal baclofen (ITB), ventral dorsal rhizotomy (VDR), or deep brain stimulation (DBS) as part of standard clinical care. The decision to proceed with ITB, VDR, or DBS is made independently of research participation. The study aims to: 1. Evaluate changes in dystonia and other clinically important outcomes; 2. Identify characteristics associated with treatment response; and 3. Develop a multidimensional outcome measure for children with dystonic CP. Participants receiving ITB will follow a study-specific standardized titration protocol designed to identify a dose that provides maximum benefit with minimal side effects. Participants in all three groups will complete research assessments and questionnaires at protocol-specified timepoints to evaluate dystonia, spasticity, function, pain, stress, and quality of life.	Myopathies	Non applicable	Traitement symptomatique	United States	À vérifier

Essais cliniques

5

Molécule	Indication / population	Phase	NCT	Titre	Statut
ITB Titration Protocol	Myopathies	Non applicable	NCT06606574	PREDICT-ITB — Intrathecal Baclofen and Pediatric Dystonia	RECRUITING
Soterix Medical Vagus Nerve Stimulation mini-CT	SEP	Non applicable	NCT06723743	taVNS — Transcutaneous Vagus Nerve Stimulation for Attention and Memory	NOT_YET_RECRUITING
CD30.CAR-EBVST cells	Cancer	Phase 1	NCT04288726	Allogeneic CD30.CAR-EBVSTs in Patients With Relapsed or Refractory CD30-Positive Lymphomas	ACTIVE_NOT_RECRUITING
Glutathione, Brain Metabolism and Inflammation in Alzheimer's Disease	Alzheimer	Phase 1	NCT04740580	Glutathione, Brain Metabolism and Inflammation in Alzheimer's Disease	ACTIVE_NOT_RECRUITING
Speedboat™ Ultraslim	Cancer	À vérifier	NCT06476678	Novel Bipolar Radiofrequency Ablation Knife in Esophageal Lesions	RECRUITING

Publications

0

Molécule	Indication / population	Titre	Journal	Date
Aucune publication.