Wake Forest University Health Sciences — Biomedical Watch V2

Traitements18programmes

Essais11liés

Publications8liées

SourceDBlocale

Traitements

18

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
BE WELL With Migraine: Brain Education and WELLness With MigraineThe goal of this randomized clinical trial is to evaluate two different non-drug, virtual treatment options designed to improve the lives of patients with migraine. Both interventions involve 8 weekly sessions and an online platform with additional content and learning. Participants can stay on all their medications during this study. Information from this study may help determine how to better treat migraine.	Migraine	Non applicable	À vérifier	United States	À vérifier
BEAT-AD — Brain Energy for Amyloid Transformation in Alzheimer's Disease StudyThe Brain Energy for Amyloid Transformation in AD (Alzheimer's disease) or BEAT-AD study will compare the effects of a ketogenic low-carbohydrate diet and a low-fat diet in adults with mild cognitive impairment. The data collected will help determine whether diet interventions induce changes in cognitive function, cerebral blood flow, and levels of certain proteins and hormones in body fluids. The study will include volunteers who have mild cognitive impairment, who will be randomly assigned to receive either a ketogenic low-carbohydrate diet or a low-fat diet for 16-weeks, with follow-up assessment 8 weeks after diet completion. Study measures, clinic visits and phone sessions will occur at baseline and throughout the 24-week study. Participant will follow either a low-carbohydrate or low-fat diet that will be individually planned with help from a study dietitian. After completing the study diet for 16 weeks, participants will resume their normal diet. The final visits will occur at week 24 (8 weeks after the completing the diet). At the end of the 24-week study, participants will be given the opportunity to meet with the study dietitian for education and assistance with planning a healthy diet.	Alzheimer	Non applicable	À vérifier	United States	À vérifier
BraCE-DM2 — Brain Structure and Clinical Endpoints in Myotonic Dystrophy Type 2Nearly two-third of patients with myotonic dystrophy type 2 (DM2) report that impaired cognition is among the most disabling symptoms and deeply affects their quality of life. Yet, relatively little is known about how DM2 affects brain structure and cognitive function as brain imaging studies in DM2 are extremely limited. This is a prospective, cross-sectional study of brain structure and function on cognitive and motor performance in patients with DM2 \& DM1 compared to healthy controls. All participants will undergo magnetic resonance imaging (MRI) to evaluate brain structure and white matter integrity, a comprehensive battery of cognitive and motor measures, self-reported questionnaires, and blood collection for brain-based biomarker analysis. A subset of participants will undergo lumbar puncture for cerebrospinal fluid (CSF) collection for additional biomarker analysis and validation. This work is critical to inform the development of rigorous clinical trial designs and plan for a longitudinal study to evaluate MRI measures as imaging biomarkers of disease progression and therapeutic response in DM2 \& DM1.	Myopathies	À vérifier	Ralentissement de la progression + Traitement symptomatique	United States	À vérifier
Collaborative Care for Anxiety and Depression in EpilepsyThis is a randomized effectiveness/implementation trial comparing a 24-week neurology-based collaborative care intervention to usual neurology care among 60 adults with epilepsy.	Épilepsie	Non applicable	À vérifier	United States	À vérifier
Collaborative Care in Posttraumatic EpilepsyThe purpose of this research is to evaluate a 6 month change in quality of life in subjects who receive collaborative care calls compared to those subjects who receive usual neurology care. This is a 2-site trial comparing a 24 week neurology-based collaborative care program to usual neurology care among a total of 60 adults with post-traumatic epilepsy.	Épilepsie	Non applicable	À vérifier	United States	À vérifier
HELP-VM — Healthy Living Partnerships for Veterans With MigraineThis pilot study, modeled upon the successful and empirically validated HELP Prevent Diabetes Intervention, incorporates a migraine education component describing the links between lifestyle behaviors and migraine activity (e.g., frequency, impairment) into an existing lifestyle intervention used previously for Veterans at risk for developing Type II diabetes. The principal objectives of this research are to assess the feasibility, acceptability (recruitment), engagement (retention, adherence), and promise of implementing the HELP-VM at the Salisbury. To achieve our objectives, the investigators propose to assess the acceptability of HELP-VM by determining our ability to recruit Veterans to participate in the HELP-VM intervention as administered through the existing structure of the Salisbury VAMC's Whole Health Program, to evaluate the feasibility of implementing HELP-VM by assessing Veterans' adherence to HELP-VM and our capacity to retain them in a clinical trial, and to evaluate the promise of HELP-VM by obtaining preliminary data to estimate variances of primary (headache frequency, headache-related impairment) and secondary/exploratory outcome measures (e.g., emotional distress, use of analgesics/opiates, headache self-efficacy, pain catastrophizing) to inform a future, large-scale trial.	Migraine	Non applicable	Traitement symptomatique		À vérifier
Hepatic resectionThis single-center, prospective, randomized clinical trial is designed to compare the clinical characteristics and outcomes of hepatic resection and microwave ablation (MWA) to determine the optimal operative intervention for the local treatment of resectable colorectal cancer liver metastases. The primary aim of this study is to test the following hypothesis: 2-year local disease control is equivalent between patients receiving the experimental therapy (MWA) and patients receiving the standard therapy (hepatic resection) as treatment for colorectal cancer liver metastases determined to be resectable by radiographic imaging. Secondarily, the investigators expect that 2-year intrahepatic (regional) and metastatic disease recurrence rates are equivalent between the two treatment arms in this study.	Cancer	Non applicable	À vérifier	United States	À vérifier
InsulinThe purpose of this study is to find out what effects (good and bad) the study medications (insulin or Empagliflozin) have on adults with mild memory impairment or early Alzheimer's disease who are clinically prescribed an anti-amyloid therapy compared to placebo.	Alzheimer	Phase 2	À vérifier	United States	À vérifier
Mindfulness and Mechanisms of Pain Processing in Adults With MigrainesAlthough many adults with migraines use non-pharmacological treatment options, there is a lack of research on the use of many mind/body techniques specifically for headache. This research will further the understanding of the mechanisms, efficacy, and predictors of mind-body practices in adults with migraines.	Migraine	Non applicable	Traitement symptomatique	United States	À vérifier
Optimizing Sustainable Cuff Access and Training Pathways for Self-Measured Blood Pressure Monitoring in Primary CareThe goal of this study is to identify what cuff delivery and BP log return modality most effectively achieve successful delivery of a self-measured blood pressure (SMBP) intervention in routine care, among adult primary care patients with uncontrolled hypertension?	Hypertension	Non applicable	À vérifier	United States	À vérifier
BE WELL With Migraine: Brain Education and WELLness With MigraineThe goal of this randomized clinical trial is to evaluate two different non-drug, virtual treatment options designed to improve the lives of patients with migraine. Both interventions involve 8 weekly sessions and an online platform with additional content and learning. Participants can stay on all their medications during this study. Information from this study may help determine how to better treat migraine.	Migraine	Non applicable	À vérifier	United States	À vérifier
HELP-VM — Healthy Living Partnerships for Veterans With MigraineThis pilot study, modeled upon the successful and empirically validated HELP Prevent Diabetes Intervention, incorporates a migraine education component describing the links between lifestyle behaviors and migraine activity (e.g., frequency, impairment) into an existing lifestyle intervention used previously for Veterans at risk for developing Type II diabetes. The principal objectives of this research are to assess the feasibility, acceptability (recruitment), engagement (retention, adherence), and promise of implementing the HELP-VM at the Salisbury. To achieve our objectives, the investigators propose to assess the acceptability of HELP-VM by determining our ability to recruit Veterans to participate in the HELP-VM intervention as administered through the existing structure of the Salisbury VAMC's Whole Health Program, to evaluate the feasibility of implementing HELP-VM by assessing Veterans' adherence to HELP-VM and our capacity to retain them in a clinical trial, and to evaluate the promise of HELP-VM by obtaining preliminary data to estimate variances of primary (headache frequency, headache-related impairment) and secondary/exploratory outcome measures (e.g., emotional distress, use of analgesics/opiates, headache self-efficacy, pain catastrophizing) to inform a future, large-scale trial.	Migraine	Non applicable	Traitement symptomatique		À vérifier
Optimizing Sustainable Cuff Access and Training Pathways for Self-Measured Blood Pressure Monitoring in Primary CareThe goal of this study is to identify what cuff delivery and BP log return modality most effectively achieve successful delivery of a self-measured blood pressure (SMBP) intervention in routine care, among adult primary care patients with uncontrolled hypertension?	Hypertension	Non applicable	À vérifier	United States	À vérifier
Collaborative Care in Posttraumatic EpilepsyThe purpose of this research is to evaluate a 6 month change in quality of life in subjects who receive collaborative care calls compared to those subjects who receive usual neurology care. This is a 2-site trial comparing a 24 week neurology-based collaborative care program to usual neurology care among a total of 60 adults with post-traumatic epilepsy.	Épilepsie	Non applicable	À vérifier	United States	À vérifier
Mindfulness and Mechanisms of Pain Processing in Adults With MigrainesAlthough many adults with migraines use non-pharmacological treatment options, there is a lack of research on the use of many mind/body techniques specifically for headache. This research will further the understanding of the mechanisms, efficacy, and predictors of mind-body practices in adults with migraines.	Migraine	Non applicable	Traitement symptomatique	United States	À vérifier
BraCE-DM2 — Brain Structure and Clinical Endpoints in Myotonic Dystrophy Type 2Nearly two-third of patients with myotonic dystrophy type 2 (DM2) report that impaired cognition is among the most disabling symptoms and deeply affects their quality of life. Yet, relatively little is known about how DM2 affects brain structure and cognitive function as brain imaging studies in DM2 are extremely limited. This is a prospective, cross-sectional study of brain structure and function on cognitive and motor performance in patients with DM2 \& DM1 compared to healthy controls. All participants will undergo magnetic resonance imaging (MRI) to evaluate brain structure and white matter integrity, a comprehensive battery of cognitive and motor measures, self-reported questionnaires, and blood collection for brain-based biomarker analysis. A subset of participants will undergo lumbar puncture for cerebrospinal fluid (CSF) collection for additional biomarker analysis and validation. This work is critical to inform the development of rigorous clinical trial designs and plan for a longitudinal study to evaluate MRI measures as imaging biomarkers of disease progression and therapeutic response in DM2 \& DM1.	Myopathies	À vérifier	Ralentissement de la progression + Traitement symptomatique	United States	À vérifier
BEAT-AD — Brain Energy for Amyloid Transformation in Alzheimer's Disease StudyThe Brain Energy for Amyloid Transformation in AD (Alzheimer's disease) or BEAT-AD study will compare the effects of a ketogenic low-carbohydrate diet and a low-fat diet in adults with mild cognitive impairment. The data collected will help determine whether diet interventions induce changes in cognitive function, cerebral blood flow, and levels of certain proteins and hormones in body fluids. The study will include volunteers who have mild cognitive impairment, who will be randomly assigned to receive either a ketogenic low-carbohydrate diet or a low-fat diet for 16-weeks, with follow-up assessment 8 weeks after diet completion. Study measures, clinic visits and phone sessions will occur at baseline and throughout the 24-week study. Participant will follow either a low-carbohydrate or low-fat diet that will be individually planned with help from a study dietitian. After completing the study diet for 16 weeks, participants will resume their normal diet. The final visits will occur at week 24 (8 weeks after the completing the diet). At the end of the 24-week study, participants will be given the opportunity to meet with the study dietitian for education and assistance with planning a healthy diet.	Alzheimer	Non applicable	À vérifier	United States	À vérifier
Collaborative Care for Anxiety and Depression in EpilepsyThis is a randomized effectiveness/implementation trial comparing a 24-week neurology-based collaborative care intervention to usual neurology care among 60 adults with epilepsy.	Épilepsie	Non applicable	À vérifier	United States	À vérifier

Essais cliniques

11

Molécule	Indication / population	Phase	NCT	Titre	Statut
Microwave Ablation	Cancer	Non applicable	NCT02866344	Resection Versus Microwave Ablation for Resectable Colorectal Cancer Liver Metastases	TERMINATED
Collaborative Care for Anxiety and Depression in Epilepsy	Épilepsie	Non applicable	NCT05559749	Collaborative Care for Anxiety and Depression in Epilepsy	ACTIVE_NOT_RECRUITING
Middle Meningeal Artery embolization	Migraine	Non applicable	NCT07044648	Middle Meningeal Artery Embolization for Chronic Migraine	WITHDRAWN
BEAT-AD — Brain Energy for Amyloid Transformation in Alzheimer's Disease Study	Alzheimer	Non applicable	NCT03472664	BEAT-AD — Brain Energy for Amyloid Transformation in Alzheimer's Disease Study	COMPLETED
BraCE-DM2 — Brain Structure and Clinical Endpoints in Myotonic Dystrophy Type 2	Myopathies	À vérifier	NCT05854433	BraCE-DM2 — Brain Structure and Clinical Endpoints in Myotonic Dystrophy Type 2	ENROLLING_BY_INVITATION
Mindfulness and Mechanisms of Pain Processing in Adults With Migraines	Migraine	Non applicable	NCT02695498	Mindfulness and Mechanisms of Pain Processing in Adults With Migraines	COMPLETED
Collaborative Care in Posttraumatic Epilepsy	Épilepsie	Non applicable	NCT05353452	Collaborative Care in Posttraumatic Epilepsy	COMPLETED
Optimizing Sustainable Cuff Access and Training Pathways for Self-Measured Blood Pressure Monitoring in Primary Care	Hypertension	Non applicable	NCT07693699	Optimizing Sustainable Cuff Access and Training Pathways for Self-Measured Blood Pressure Monitoring in Primary Care	RECRUITING
HELP-VM — Healthy Living Partnerships for Veterans With Migraine	Migraine	Non applicable	NCT04373330	HELP-VM — Healthy Living Partnerships for Veterans With Migraine	WITHDRAWN
Empagliflozin	Alzheimer	Phase 2	NCT07756294	REVITAA-ALZ — Restoring Vascular and Insulin Function To Augment Anti-Amyloid Therapy in Alzheimer's Disease	NOT_YET_RECRUITING
BE WELL With Migraine: Brain Education and WELLness With Migraine	Migraine	Non applicable	NCT05987592	BE WELL With Migraine: Brain Education and WELLness With Migraine	RECRUITING

Publications

8

Molécule	Indication / population	Titre	Journal	Date
BE WELL With Migraine: Brain Education and WELLness With Migraine		Global prevalence and disability burden of brain disorders: Impact of neurological, mental, and substance use disorders.	Neuroscience and biobehavioral reviews
Collaborative Care in Posttraumatic Epilepsy		Antiseizure Medication Prescription Patterns for Treatment of Post-Traumatic Epilepsy.	Neurology. Clinical practice
Collaborative Care in Posttraumatic Epilepsy		Prophylactic anti-seizure medication for post-traumatic seizures in Chinese PICUs: current practices and knowledge gaps.	BMC neurology
Collaborative Care in Posttraumatic Epilepsy		A consensus roadmap for post-traumatic epilepsy: Clinical biomarkers, research priorities, policy barriers, and pathways to interventional trials.	Epilepsia
BraCE-DM2 — Brain Structure and Clinical Endpoints in Myotonic Dystrophy Type 2		Establishing biomarkers and clinical endpoints in myotonic dystrophy type 1 (END-DM1): Protocol of an international natural history study.	PloS one
BraCE-DM2 — Brain Structure and Clinical Endpoints in Myotonic Dystrophy Type 2		Large-scale proteomics profiling of peripheral blood of DM1 patients identifies biomarkers for disease severity and functional capacity.	Journal of neuromuscular diseases
BE WELL With Migraine: Brain Education and WELLness With Migraine		Weight loss with atogepant in the long-term treatment of migraine: An interim analysis of a safety endpoint from a phase 3, multicenter, open-label, 156-week extension study.	Headache
BE WELL With Migraine: Brain Education and WELLness With Migraine		Plasma Phosphorylated Tau 217 in Participants at Risk for Chronic Traumatic Encephalopathy.	JAMA network open