Yale University — Biomedical Watch V2

Traitements28programmes

Essais17liés

Publications16liées

SourceDBlocale

Traitements

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
[ 18F]3F4APThe overall objective is to obtain an assessment of the pharmacokinetics of \[18F\]3F4AP in healthy volunteers and subjects with demyelinating diseases such as mild cognitive impairment (MCI), Alzheimer's Disease (AD), Multiple Sclerosis (MS), Spinal Cord Injury (SCI) and Spinal radiculopathy (SR).	Alzheimer, SEP	Phase 1	À vérifier	United States	À vérifier
[11C]PIBThe overall objective is to obtain an assessment of the pharmacokinetics of \[18F\]3F4AP in healthy volunteers and subjects with demyelinating diseases such as mild cognitive impairment (MCI), Alzheimer's Disease (AD), Multiple Sclerosis (MS), Spinal Cord Injury (SCI) and Spinal radiculopathy (SR).	Alzheimer, SEP	Phase 1	À vérifier	United States	À vérifier
[18F]MK6240The overall objective is to obtain an assessment of the pharmacokinetics of \[18F\]3F4AP in healthy volunteers and subjects with demyelinating diseases such as mild cognitive impairment (MCI), Alzheimer's Disease (AD), Multiple Sclerosis (MS), Spinal Cord Injury (SCI) and Spinal radiculopathy (SR).	Alzheimer, SEP	Phase 1	À vérifier	United States	À vérifier
AdalimumabThis is a phase 2 study to assess the ability of adalimumab as compared to placebo to reduce or prevent progression of synuclein-related neurodegeneration in persons with idiopathic REM Sleep Behavior Disorder (RBD). The Primary Endpoint will be change from baseline in expression of the Parkinson Disease Related Pattern (PDRP) will be assessed using change in 18-flurodeoxyglucose (FDG) Positron Emission Tomography (PET) imaging.	Parkinson	Phase 2	Ralentissement de la progression	United States, Canada	À vérifier
AnakinraThe goal of this clinical trial is to find out whether two existing medications-anakinra and tocilizumab-can effectively treat a rare and life-threatening brain condition called NORSE (New-Onset Refractory Status Epilepticus). NORSE causes continuous seizures in previously healthy children and adults and does not respond to standard treatments. It often leads to long-term disability or death. Doctors currently use anakinra and tocilizumab as second-line treatments when first-line therapies fail, but there is no clear evidence showing which drug works better or when it should be given. This study aims to answer those questions. The study will enroll patients across 33 hospitals in the United States, Canada, Europe, and Asia. It includes two groups: 1. Randomized Cohort Patients will be randomly assigned to receive either anakinra or tocilizumab within the first 7 days of their illness. Only patients whose doctors were already planning to use one of these medications as part of standard care will be eligible for randomization. Researchers will monitor their recovery and compare outcomes between the two treatments. 2. Observational Cohort Patients who cannot be randomized-usually because they were diagnosed too late-will still be followed to study how the timing of treatment affects recovery. Participants will: * Receive one of the two medications (depending on their group assignment). * Take part in follow-up assessments over the course of one year, including medical evaluations and surveys. Some participants may be followed annually beyond one year. * Optionally participate in a 60-minute interview to share their or their caregiver's experience with NORSE.	Épilepsie	Phase 3	À vérifier	United States, Canada, France, Italy, South Korea, Sweden, United Kingdom	À vérifier
Behavioral taskThe study consists of prospective enrollment of healthy participants and patients with epilepsy, as well as analysis of an existing data set. Healthy participants will be studied with fMRI, eye metrics and behavioral testing at Yale. Patients will be studied with intracranial thalamic and cortical recording and stimulation, eye metrics and behavioral testing.	Épilepsie	Non applicable	À vérifier	United States	À vérifier
BHV-700This is an open label study to assess the biological effect of BHV-7000 on abnormal activity recorded by the RNS System in patients with focal epilepsy implanted with the RNS System. BHV-7000 is a potassium channel activator being evaluated for use in epilepsy. Participants are offered the drug for 4 weeks. Activity during that treatment period is compared to a 90-day retrospective baseline period in which other medications and device settings were stable, and also to a 4-week withdrawal period after treatment is discontinued. The study is open to patients with RNS regardless of whether they report clinical seizures, as long as the device recordings continue to show epileptiform activity.	Épilepsie	Phase 1	À vérifier	United States	À vérifier
Brave-Mind — Behavioral Resources and Awareness for Veterans With Episodic Migraine: Impact on Neurological Disability and Quality of Life- PilotThe current study will evaluate effectiveness of cognitive behavioral therapy for migraine compared to migraine education (ME) to improve migraine-related quality of life in the real-world setting of the Veterans Health Administration (VHA).	Migraine	Non applicable	À vérifier	United States	À vérifier
DREAM — Identifying and Characterizing Preclinical MSThe purpose of this research study is to try and identify risk factors and biologic changes that suggest that someone may go on to develop multiple sclerosis before a person has shown any symptoms of the disease.	SEP	À vérifier	Traitement symptomatique	United States	À vérifier
EXPLORE-MG2 — Exploring Outcomes and Characteristics of Myasthenia Gravis 2The goal of this prospective observational study is to create a network repository of clinical data and biological samples to help researchers learn more about myasthenia gravis.	Myasthénie	À vérifier	À vérifier	United States	À vérifier
Eye TrackingThe study consists of prospective enrollment of healthy participants and patients with epilepsy, as well as analysis of an existing data set. Healthy participants will be studied with fMRI, eye metrics and behavioral testing at Yale. Patients will be studied with intracranial thalamic and cortical recording and stimulation, eye metrics and behavioral testing.	Épilepsie	Non applicable	À vérifier	United States	À vérifier
Neurophysiological Benefits of Live Music for Early Alzheimer's Patients and Their CaregiversThis study aims to investigate the neurophysiological effects of live music on individuals with early Alzheimer's Disease (AD), dementia, and/or mild cognitive impairment (MCI) and their caregivers. Heart rate (HR), heart rate variability (HRV), and brain activity will be measured as participant-caregiver dyads listen to preferred and improvised music performed by professional musicians. Investigators will leverage various measurement techniques including, but not limited to, electroencephalography (EEG), behavioral, surveys, and physiological monitoring to study the impact of live music on anxiety in AD and inter-dyad synchrony.	Alzheimer	Non applicable	À vérifier	United States	À vérifier
PhenylephrineAn open label, prospective, single center, pilot trial to assess feasibility and tolerability of short term blood pressure augmentation to minimize infarct progression in acute LVO stroke patients undergoing endovascular therapy.	Accident vasculaire cérébral	Phase 1	Ralentissement de la progression	United States	À vérifier
Serotonergic PsychedelicThis is an observational study which does NOT directly administer a psychedelic substance but rather recruits participants who are already participating in another clinical trial in which they may receive a serotonergic psychedelic. The goal of this observational study is to learn how the brain's information processing changes during and following administration of serotonergic psychedelics (psilocybin, N,N-Dimethyltryptamine/DMT, Lystergic Acid Diethylamide/LSD, etc.) for people with and without mental illness receiving serotonergic psychedelics through any clinical trial at Yale University. The main questions it aims to answer are: 1. Do serotonergic psychedelics cause the brain to rely on new information more than previously learned information while under the influence? What about 1 day, 5-14 days, and 4-6 weeks after use? 2. Do serotonergic psychedelics cause long-lasting side-effects in how people perceive (see, hear, feel, etc.) the world and how easily people change their beliefs? 3. How does the brain's electrical activity change after using serotonergic psychedelics? How does the balance between excitation and inhibition change while under their effect? 4. Can changes in how the brain uses information predict who will benefit from a psychedelic and who will have side effects from psychedelics? Researchers will compare with people given placebos to see what changes in brain processing are unique to serotonergic psychedelics. Participants will have the opportunity to do some combination of the following: 1. Online computer assessments consisting of games and questionnaires that probe how participants think. 2. Magnetoencephalography (MEG) or electroencephalography (EEG) with eyes closed and with repeated clicks, images, or sensations delivered. 3. A magnetic resonance imaging (MRI) scan. 4. Semi-structured qualitative interviews about their experience after taking a serotonergic psychedelic recorded via Zoom.	Migraine	À vérifier	À vérifier	United States	À vérifier
Syndemic-Adapted Medly Uganda (SAMU)The purpose of this study is to evaluate the effectiveness of the Syndemic-Adapted Medly Uganda (SAMU) in improving mental health care among adults living with HIV and hypertension in Uganda. In sub-Saharan Africa (SSA), there is a high prevalence of depression and anxiety among people living with HIV (PLHIV) as well as alcohol use disorder (AUD). PLHIV who experience depression are less likely to link to HIV care, adhere to antiretroviral therapy, and achieve viral suppression. Building on research conducted to adapt Medly Uganda for mental health using a syndemic framework, this study aims to assess the effectiveness of SAMU on mental health screening and diagnosis. This will be accomplished through a two-arm trial in which 1. participants will be enrolled, screened, re-screened, and assessed for diagnosis and linkage to care for depression, anxiety and AUD and 2. evaluate the factors impacting sustained engagement in the SAMU program, through mixed methods.	Hypertension	Non applicable	À vérifier	Uganda	À vérifier
The EXPLORE MG Registry for Myasthenia GravisThe purpose of this study is to create a Yale University Department of Neurology Myasthenia Gravis (MG) registry that will be used for current and future research projects involving the study of Myasthenia Gravis.	Myasthénie	À vérifier	À vérifier	United States	À vérifier
The EXPLORE MG Registry for Myasthenia GravisThe purpose of this study is to create a Yale University Department of Neurology Myasthenia Gravis (MG) registry that will be used for current and future research projects involving the study of Myasthenia Gravis.	Myasthénie	À vérifier	À vérifier	United States	À vérifier
AdalimumabThis is a phase 2 study to assess the ability of adalimumab as compared to placebo to reduce or prevent progression of synuclein-related neurodegeneration in persons with idiopathic REM Sleep Behavior Disorder (RBD). The Primary Endpoint will be change from baseline in expression of the Parkinson Disease Related Pattern (PDRP) will be assessed using change in 18-flurodeoxyglucose (FDG) Positron Emission Tomography (PET) imaging.	Parkinson	Phase 2	Ralentissement de la progression	United States, Canada	À vérifier
Serotonergic PsychedelicThis is an observational study which does NOT directly administer a psychedelic substance but rather recruits participants who are already participating in another clinical trial in which they may receive a serotonergic psychedelic. The goal of this observational study is to learn how the brain's information processing changes during and following administration of serotonergic psychedelics (psilocybin, N,N-Dimethyltryptamine/DMT, Lystergic Acid Diethylamide/LSD, etc.) for people with and without mental illness receiving serotonergic psychedelics through any clinical trial at Yale University. The main questions it aims to answer are: 1. Do serotonergic psychedelics cause the brain to rely on new information more than previously learned information while under the influence? What about 1 day, 5-14 days, and 4-6 weeks after use? 2. Do serotonergic psychedelics cause long-lasting side-effects in how people perceive (see, hear, feel, etc.) the world and how easily people change their beliefs? 3. How does the brain's electrical activity change after using serotonergic psychedelics? How does the balance between excitation and inhibition change while under their effect? 4. Can changes in how the brain uses information predict who will benefit from a psychedelic and who will have side effects from psychedelics? Researchers will compare with people given placebos to see what changes in brain processing are unique to serotonergic psychedelics. Participants will have the opportunity to do some combination of the following: 1. Online computer assessments consisting of games and questionnaires that probe how participants think. 2. Magnetoencephalography (MEG) or electroencephalography (EEG) with eyes closed and with repeated clicks, images, or sensations delivered. 3. A magnetic resonance imaging (MRI) scan. 4. Semi-structured qualitative interviews about their experience after taking a serotonergic psychedelic recorded via Zoom.	Migraine	À vérifier	À vérifier	United States	À vérifier
EXPLORE-MG2 — Exploring Outcomes and Characteristics of Myasthenia Gravis 2The goal of this prospective observational study is to create a network repository of clinical data and biological samples to help researchers learn more about myasthenia gravis.	Myasthénie	À vérifier	À vérifier	United States	À vérifier
AnakinraThe goal of this clinical trial is to find out whether two existing medications-anakinra and tocilizumab-can effectively treat a rare and life-threatening brain condition called NORSE (New-Onset Refractory Status Epilepticus). NORSE causes continuous seizures in previously healthy children and adults and does not respond to standard treatments. It often leads to long-term disability or death. Doctors currently use anakinra and tocilizumab as second-line treatments when first-line therapies fail, but there is no clear evidence showing which drug works better or when it should be given. This study aims to answer those questions. The study will enroll patients across 33 hospitals in the United States, Canada, Europe, and Asia. It includes two groups: 1. Randomized Cohort Patients will be randomly assigned to receive either anakinra or tocilizumab within the first 7 days of their illness. Only patients whose doctors were already planning to use one of these medications as part of standard care will be eligible for randomization. Researchers will monitor their recovery and compare outcomes between the two treatments. 2. Observational Cohort Patients who cannot be randomized-usually because they were diagnosed too late-will still be followed to study how the timing of treatment affects recovery. Participants will: * Receive one of the two medications (depending on their group assignment). * Take part in follow-up assessments over the course of one year, including medical evaluations and surveys. Some participants may be followed annually beyond one year. * Optionally participate in a 60-minute interview to share their or their caregiver's experience with NORSE.	Épilepsie	Phase 3	À vérifier	United States, Canada, France, Italy, South Korea, Sweden, United Kingdom	À vérifier
DREAM — Identifying and Characterizing Preclinical MSThe purpose of this research study is to try and identify risk factors and biologic changes that suggest that someone may go on to develop multiple sclerosis before a person has shown any symptoms of the disease.	SEP	À vérifier	Traitement symptomatique	United States	À vérifier
Brave-Mind — Behavioral Resources and Awareness for Veterans With Episodic Migraine: Impact on Neurological Disability and Quality of Life- PilotThe current study will evaluate effectiveness of cognitive behavioral therapy for migraine compared to migraine education (ME) to improve migraine-related quality of life in the real-world setting of the Veterans Health Administration (VHA).	Migraine	Non applicable	À vérifier	United States	À vérifier
[ 18F]3F4APThe overall objective is to obtain an assessment of the pharmacokinetics of \[18F\]3F4AP in healthy volunteers and subjects with demyelinating diseases such as mild cognitive impairment (MCI), Alzheimer's Disease (AD), Multiple Sclerosis (MS), Spinal Cord Injury (SCI) and Spinal radiculopathy (SR).	SEP	Phase 1	À vérifier	United States	À vérifier
Neurophysiological Benefits of Live Music for Early Alzheimer's Patients and Their CaregiversThis study aims to investigate the neurophysiological effects of live music on individuals with early Alzheimer's Disease (AD), dementia, and/or mild cognitive impairment (MCI) and their caregivers. Heart rate (HR), heart rate variability (HRV), and brain activity will be measured as participant-caregiver dyads listen to preferred and improvised music performed by professional musicians. Investigators will leverage various measurement techniques including, but not limited to, electroencephalography (EEG), behavioral, surveys, and physiological monitoring to study the impact of live music on anxiety in AD and inter-dyad synchrony.	Alzheimer	Non applicable	À vérifier	United States	À vérifier
PhenylephrineAn open label, prospective, single center, pilot trial to assess feasibility and tolerability of short term blood pressure augmentation to minimize infarct progression in acute LVO stroke patients undergoing endovascular therapy.	Accident vasculaire cérébral	Phase 1	Ralentissement de la progression	United States	À vérifier
BHV-700This is an open label study to assess the biological effect of BHV-7000 on abnormal activity recorded by the RNS System in patients with focal epilepsy implanted with the RNS System. BHV-7000 is a potassium channel activator being evaluated for use in epilepsy. Participants are offered the drug for 4 weeks. Activity during that treatment period is compared to a 90-day retrospective baseline period in which other medications and device settings were stable, and also to a 4-week withdrawal period after treatment is discontinued. The study is open to patients with RNS regardless of whether they report clinical seizures, as long as the device recordings continue to show epileptiform activity.	Épilepsie	Phase 1	À vérifier	United States	À vérifier
Syndemic-Adapted Medly Uganda (SAMU)The purpose of this study is to evaluate the effectiveness of the Syndemic-Adapted Medly Uganda (SAMU) in improving mental health care among adults living with HIV and hypertension in Uganda. In sub-Saharan Africa (SSA), there is a high prevalence of depression and anxiety among people living with HIV (PLHIV) as well as alcohol use disorder (AUD). PLHIV who experience depression are less likely to link to HIV care, adhere to antiretroviral therapy, and achieve viral suppression. Building on research conducted to adapt Medly Uganda for mental health using a syndemic framework, this study aims to assess the effectiveness of SAMU on mental health screening and diagnosis. This will be accomplished through a two-arm trial in which 1. participants will be enrolled, screened, re-screened, and assessed for diagnosis and linkage to care for depression, anxiety and AUD and 2. evaluate the factors impacting sustained engagement in the SAMU program, through mixed methods.	Hypertension	Non applicable	À vérifier	Uganda	À vérifier

Essais cliniques

Molécule	Indication / population	Phase	NCT	Titre	Statut
Syndemic-Adapted Medly Uganda (SAMU)	Hypertension	Non applicable	NCT07525271	SAMU — Trial Phase: Syndemic Adapted Medly Uganda	RECRUITING
BHV-700	Épilepsie	Phase 1	NCT07125261	BHV-7000 Responsive Neurostimulation System (RNS) Study	COMPLETED
Phenylephrine	Accident vasculaire cérébral	Phase 1	NCT04218773	Blood PREssure Augmentation in Large-vessel Occlusion Stroke Study	TERMINATED
Ocrelizumab	SEP	Phase 4	NCT04877457	CELLO — Ocrelizumab for Preventing Clinical Multiple Sclerosis in Individuals With Radiologically Isolated Disease.	TERMINATED
Neurophysiological Benefits of Live Music for Early Alzheimer's Patients and Their Caregivers	Alzheimer	Non applicable	NCT06940687	Neurophysiological Benefits of Live Music for Early Alzheimer's Patients and Their Caregivers	ACTIVE_NOT_RECRUITING
[ 18F]3F4AP	SEP	Phase 1	NCT06999434	Exploring the Utility of [18F]3F4AP for Demyelination Imaging	RECRUITING
Trastuzumab deruxtecan	Cancer	Phase 2	NCT06750484	Trial of Trastuzumab Deruxtecan in Previously Treated HER2	RECRUITING
Brave-Mind — Behavioral Resources and Awareness for Veterans With Episodic Migraine: Impact on Neurological Disability and Quality of Life- Pilot	Migraine	Non applicable	NCT07792291	Brave-Mind — Behavioral Resources and Awareness for Veterans With Episodic Migraine: Impact on Neurological Disability and Quality of Life- Pilot	NOT_YET_RECRUITING
DREAM — Identifying and Characterizing Preclinical MS	SEP	À vérifier	NCT05787795	DREAM — Identifying and Characterizing Preclinical MS	RECRUITING
Anakinra	Épilepsie	Phase 3	NCT07281027	COMparison Between Anakinra and Tocilizumab in NORSE - "COMBAT-NORSE"	NOT_YET_RECRUITING
EXPLORE-MG2 — Exploring Outcomes and Characteristics of Myasthenia Gravis 2	Myasthénie	À vérifier	NCT06002945	EXPLORE-MG2 — Exploring Outcomes and Characteristics of Myasthenia Gravis 2	COMPLETED
Serotonergic Psychedelic	Migraine	À vérifier	NCT06624137	Computer Game, Qualitative, and MEG/EEG Assessment of Serotonergic Psychedelics	TERMINATED
Psilocybin	Migraine	Phase 1	NCT06464367	Mechanistic Studies of Psilocybin in Headache Disorders	RECRUITING
Adalimumab	Parkinson	Phase 2	NCT06996652	PRISMS — An Exploratory Study of the Potential for Rational Immune System Manipulation to Prevent Emergence of Synucleinopathy Manifestations in Persons With REM Sleep Behavior Disorder (RBD)	RECRUITING
BOTOX	Migraine	Phase 2	NCT00660192	Investigation of Efficacy and Safety of Botulinum Toxin A (Botox-Allergan Inc) in Migraine Headaches	COMPLETED
EEG	Épilepsie	Non applicable	NCT06934356	Subcortical Arousal in Perceptual Awareness	RECRUITING
The EXPLORE MG Registry for Myasthenia Gravis	Myasthénie	À vérifier	NCT03792659	The EXPLORE MG Registry for Myasthenia Gravis	RECRUITING

Publications

Molécule	Titre	Journal
[11C]PIB	Decomposition-based harmonization for quantitative PET imaging across scanners and radiotracers.	Medical physics
[11C]PIB	Evaluation of increased oxidative stress in the brain of patients with early Alzheimer's disease by Cu-ATSM PET/MRI.	Journal of neural transmission (Vienna, Austria : 1996)
[11C]PIB	Cognitive training effects in mild cognitive impairment with and without amyloid pathology.	Dementia & neuropsychologia
Serotonergic Psychedelic	Decoding the serotonin-alcohol crosstalk: the role of central serotonergic dysregulation in alcohol use disorder.	Pharmacological reports : PR
Serotonergic Psychedelic	Proliferative Effects of the Psychedelic N,N-Dimethyltryptamine (DMT) in Human Neural Stem Cells.	ACS chemical neuroscience
Serotonergic Psychedelic	Feasibility and Tolerability of Psilocybin for Phantom Limb Pain.	The journal of pain
Adalimumab	Increasing formulary adoption of adalimumab biosimilars and differential cost-sharing in Medicare Part D plans.	The Journal of dermatological treatment
Adalimumab	Experimental and computational analysis of glycan processing at increased monoclonal antibody productivities.	Metabolic engineering communications
Adalimumab	Performance evaluation of an adalimumab biosimilar autoinjector and its reference device: comparative use human factors study in patients with rheumatoid arthritis and juvenile idiopathic arthritis.	Drug delivery
Behavioral task	Cuprizone-induced demyelination model mice exhibit antisocial maltreating behavior: an experimental animal study.	Encephalitis (Seoul, Korea)
Behavioral task	Effects of Youth Sport Participation on Neural Processing During Response Inhibition in Children.	Medicine and science in sports and exercise
Behavioral task	Identifying coping strategies that regulate negative climate emotions without reducing pro-environmental behavior.	Journal of affective disorders
Eye Tracking	Patterns of attentional and cognitive biases in community trauma survivors: an eye tracking study.	European journal of psychotraumatology
Eye Tracking	Eye-tracking and behavioral measures of mind-wandering relate to depressive symptoms in children: a preliminary study.	Journal of experimental child psychology
The EXPLORE MG Registry for Myasthenia Gravis	Remote Monitoring in Myasthenia Gravis: Exploring Symptom Variability.	Annals of clinical and translational neurology
The EXPLORE MG Registry for Myasthenia Gravis	Steroid-Sparing Effect of Efgartigimod in Generalized Myasthenia Gravis: Study Protocol for a Single-Arm, Open-Label Clinical Trial.	Neurology and therapy