Brigham and Women's Hospital — Biomedical Watch V2

Traitements23programmes

Essais12liés

Publications9liées

SourceDBlocale

Traitements

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
[C-11]PBR28The specific aims of the study are: Primary: To determine the presence and regional distribution of microglial activation, as assessed by Fluorine-18 (18F) labeled "Peripheral Benzodiazepine Receptor 06" (PBR06) -PET, in subjects with active Relapsing Remitting Multiple Sclerosis (RRMS), Secondary Progressive Multiple Sclerosis (SPMS), and Alzheimer's Disease (AD) as compared to healthy controls Secondary: 1. To assess the relationship between microglial activation and clinical variables including disease severity and comorbidities (such as pain, fatigue and/or depression), as well as clinical MRI findings (such as lesions and atrophy) 2. A pilot substudy aims to establish the non-inferiority of \[F-18\]PBR06 as compared with Carbon-11 \[C-11\] labeled "Peripheral Benzodiazepine Receptor 28" (PBR28) PET in patients with RRMS. Hypothesis: The working hypothesis is that there is microglial activation in multiple sclerosis and Alzheimer's disease as compared to healthy controls and that the pattern/ regional distribution of microglial activation is different in Multiple Sclerosis (MS) versus AD and correlates with disease severity and comorbidities. In addition, the investigators hypothesize that \[F-18\]PBR06-PET scans will be at least as good as \[C-11\]PBR28-PET scans, the current gold standard.	SEP	Phase 1/2	Traitement symptomatique	United States	À vérifier
[F-18]PBR06The specific aims of the study are: Primary: To determine the presence and regional distribution of microglial activation, as assessed by Fluorine-18 (18F) labeled "Peripheral Benzodiazepine Receptor 06" (PBR06) -PET, in subjects with active Relapsing Remitting Multiple Sclerosis (RRMS), Secondary Progressive Multiple Sclerosis (SPMS), and Alzheimer's Disease (AD) as compared to healthy controls Secondary: 1. To assess the relationship between microglial activation and clinical variables including disease severity and comorbidities (such as pain, fatigue and/or depression), as well as clinical MRI findings (such as lesions and atrophy) 2. A pilot substudy aims to establish the non-inferiority of \[F-18\]PBR06 as compared with Carbon-11 \[C-11\] labeled "Peripheral Benzodiazepine Receptor 28" (PBR28) PET in patients with RRMS. Hypothesis: The working hypothesis is that there is microglial activation in multiple sclerosis and Alzheimer's disease as compared to healthy controls and that the pattern/ regional distribution of microglial activation is different in Multiple Sclerosis (MS) versus AD and correlates with disease severity and comorbidities. In addition, the investigators hypothesize that \[F-18\]PBR06-PET scans will be at least as good as \[C-11\]PBR28-PET scans, the current gold standard.	SEP	Phase 1/2	Traitement symptomatique	United States	À vérifier
ACT for High Frequency Migraine; A Virtual Mindfulness InterventionMindfulness Training specifically for pain to be offered to migraine patients	Migraine	Non applicable	Traitement symptomatique	United States	À vérifier
Chiropractic CareMigraine, a chronic intermittent headache disorder, ranks in the top five causes of years lived with disability. One promising non-pharmacologic and integrative treatment for migraine may be chiropractic care due to the co-occurrence of migraine and musculoskeletal complaints. The goal of this application is to perform a pilot study of chiropractic care for episodic migraine to help inform the design of a future, full-scale pragmatic effectiveness trial.	Migraine	Non applicable	À vérifier	United States	À vérifier
CORAL — Cocoa Extract for Migraine TrialThe goal of this clinical trial is to assess the feasibility of recruitment and adherence to a high-dose cocoa extract supplement in individuals diagnosed with episodic migraine. The main questions it aims to answer are: * Will we be able to enroll 114 participants during the recruitment period? * Will participants take study pills daily during the pill-taking period? Researchers will compare two doses of cocoa extract to placebo to determine the acceptability of higher doses of cocoa extract supplementation in this patient population. Participants will be asked to: * Provide two urine samples * Complete daily questionnaires * Take four study pills a day for 12 weeks	Migraine	Non applicable	À vérifier	United States	À vérifier
Emtricitabine and tenofovir disoproxil fumarate combinationThe goal of this clinical trial is to determine the safety, tolerability, drug levels and biological effects of two doses of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) combination administered daily for 4 weeks in older adults with early Alzheimer's disease. The main questions it aims to answer are: * Is FTC-TDF combination safe in older adults who have early Alzheimer's disease. * To measure the FTC-TDF levels at different times. * To measure the biological effects of FTC-TDF combination. * To measure the effects of FTC-TDF combination on inflammation. Researchers will compare two doses of FTC-TDF combination to a placebo (a look-alike substance that contains no drug) to see if FTC-TDF combination is safe in older adults who have early Alzheimer's disease. Participants will: * Take FTC-TDF combination or a placebo every day for 28 days. * Have 10 clinic visits over approximately 3 months. * Undergo blood tests, physical exams, cognitive testing, and scans of their brain.	Alzheimer	Phase 1	Immunomodulation	United States	À vérifier
Fixed-Dose Combinations Pragmatic Randomized Implementation Trial for Blood Pressure ControlThe proposed study is an effectiveness-implementation hybrid type II trial designed to evaluate the impact of provider- and patient-directed interventions on FDC use. The trial will test the effectiveness of theory-driven nudges tailored to address provider and patient barriers. All interventions will be pharmacist-driven, with pharmacists delivering information via nudges to providers and via nudges or more intensive interventions (i.e., CPA) to patients. Data to evaluate outcomes will be extracted from electronic health records.	Hypertension	Non applicable	À vérifier	United States	À vérifier
Immune Profiling During Ocrelizumab Treatment in Multiple SclerosisThe purpose of this study is to assess effects of B cell depletion on the immune system in patients with relapsing forms of multiple sclerosis (MS) treated with ocrelizumab. This will be done by collecting blood from patients starting treatment with ocrelizumab before the first infusion and before the infusions at 6 and 12 months. The effects on the immune system will be assessed by performing transcriptome profiling of immune cells, measuring serum levels of microRNAs, and analyzing serum autoantibody immune signatures using antigen arrays. In addition, blood will be collected once from a group of healthy individuals to serve as controls.	SEP	À vérifier	Immunomodulation	United States	À vérifier
JOGO Digital Therapeutics EMG Biofeedback for Lower Back PainThe purpose of this pilot efficacy study is to examine the effects of EMG-biofeedback (EMG-BF) on pain-related outcomes in Chronic Low Back Pain (CLBP) patients, Recent mastectomy and lumpectomy patients, and patients with episodic migraine. EMG-BF facilitates neuromuscular retraining and muscle relaxation by using audio and visual stimuli using an EMG surface electrode-based biosensor and a software installed on a tablet or smart phone. For this pilot efficacy study, we will recruit 125 patients with chronic low back pain, 125 patients who are expected to undergo mastectomy and 80 patients with episodic migraine. Participants will be randomly assigned to either the JOGO Digital Therapeutics EMG Biofeedback device or treatment as usual control group. Patients assigned to the intervention group will be asked to complete self-report questionnaires assessing demographics, pain intensity, negative affect, physical function, pain catastrophizing and sleep, will undergo QST and will be asked to wear Actiwatches to keep track of health behaviors, prior to and after completing the intervention. The intervention consists of weekly sessions during which participants will be instructed on how to use the device by a trained biofeedback instructor. Patients in the control group will undergo sensory testing procedures at baseline and after treatment period but will receive no active treatment. The aims of this study are to examine the impact of EMG-BF on pain and QST and the impact of EMG-BF on psychosocial function. We hypothesize that patients that will undergo the EMG-BF will demonstrate reductions in pain, physical functioning, sleep, pain catastrophizing, anxiety and depression.	Migraine	Non applicable	Traitement symptomatique	United States	À vérifier
JOGO Digital Therapeutics EMG Biofeedback for MigraineThe purpose of this pilot efficacy study is to examine the effects of EMG-biofeedback (EMG-BF) on pain-related outcomes in Chronic Low Back Pain (CLBP) patients, Recent mastectomy and lumpectomy patients, and patients with episodic migraine. EMG-BF facilitates neuromuscular retraining and muscle relaxation by using audio and visual stimuli using an EMG surface electrode-based biosensor and a software installed on a tablet or smart phone. For this pilot efficacy study, we will recruit 125 patients with chronic low back pain, 125 patients who are expected to undergo mastectomy and 80 patients with episodic migraine. Participants will be randomly assigned to either the JOGO Digital Therapeutics EMG Biofeedback device or treatment as usual control group. Patients assigned to the intervention group will be asked to complete self-report questionnaires assessing demographics, pain intensity, negative affect, physical function, pain catastrophizing and sleep, will undergo QST and will be asked to wear Actiwatches to keep track of health behaviors, prior to and after completing the intervention. The intervention consists of weekly sessions during which participants will be instructed on how to use the device by a trained biofeedback instructor. Patients in the control group will undergo sensory testing procedures at baseline and after treatment period but will receive no active treatment. The aims of this study are to examine the impact of EMG-BF on pain and QST and the impact of EMG-BF on psychosocial function. We hypothesize that patients that will undergo the EMG-BF will demonstrate reductions in pain, physical functioning, sleep, pain catastrophizing, anxiety and depression.	Migraine	Non applicable	Traitement symptomatique	United States	À vérifier
JOGO Digital Therapeutics EMG Biofeedback for Persistent Post Mastectomy PainThe purpose of this pilot efficacy study is to examine the effects of EMG-biofeedback (EMG-BF) on pain-related outcomes in Chronic Low Back Pain (CLBP) patients, Recent mastectomy and lumpectomy patients, and patients with episodic migraine. EMG-BF facilitates neuromuscular retraining and muscle relaxation by using audio and visual stimuli using an EMG surface electrode-based biosensor and a software installed on a tablet or smart phone. For this pilot efficacy study, we will recruit 125 patients with chronic low back pain, 125 patients who are expected to undergo mastectomy and 80 patients with episodic migraine. Participants will be randomly assigned to either the JOGO Digital Therapeutics EMG Biofeedback device or treatment as usual control group. Patients assigned to the intervention group will be asked to complete self-report questionnaires assessing demographics, pain intensity, negative affect, physical function, pain catastrophizing and sleep, will undergo QST and will be asked to wear Actiwatches to keep track of health behaviors, prior to and after completing the intervention. The intervention consists of weekly sessions during which participants will be instructed on how to use the device by a trained biofeedback instructor. Patients in the control group will undergo sensory testing procedures at baseline and after treatment period but will receive no active treatment. The aims of this study are to examine the impact of EMG-BF on pain and QST and the impact of EMG-BF on psychosocial function. We hypothesize that patients that will undergo the EMG-BF will demonstrate reductions in pain, physical functioning, sleep, pain catastrophizing, anxiety and depression.	Migraine	Non applicable	Traitement symptomatique	United States	À vérifier
MIRAGE — Using Virtual Reality to Teach Mindfulness to People With MigraineThe aim of this clinical trial is to learn if people with migraine can learn a type of biobehavioral therapy called Acceptance and Commitment Therapy (ACT) by using a virtual reality headset. Researchers are studying if this type of mindfulness therapy helps to decrease migraine-related disability. Participants will be randomized to treatment as usual or active virtual reality groups for four weeks. Everyone will keep symptom diaries, complete surveys, attend two clinic visits, and have two blood draws.	Migraine	Non applicable	Traitement symptomatique	United States	À vérifier
Study SubjectsThe goal of this study is to assess the performance of a commercial sheet sensor in determining body position after generalized tonic-clonic (GTC) seizures. If a sheet sensor could accurately detect GTC seizures, this could be a step towards autonomously repositioning patients with the aid of a smart mattress. Primary Objective Milestones: Feasibility objective: Monitor 50 patients with the objective of capturing at least 20 GTCS events. Primary analytic objective: Achieve detection of anatomical landmarks with body position change within 5 seconds with an accuracy of 75% both interictally and post-GTCS. Secondary Objective Detect the postictal prone position with an accuracy of 100%.	Épilepsie	Non applicable	À vérifier	United States	À vérifier
[F-18]PBR06The specific aims of the study are: Primary: To determine the presence and regional distribution of microglial activation, as assessed by Fluorine-18 (18F) labeled "Peripheral Benzodiazepine Receptor 06" (PBR06) -PET, in subjects with active Relapsing Remitting Multiple Sclerosis (RRMS), Secondary Progressive Multiple Sclerosis (SPMS), and Alzheimer's Disease (AD) as compared to healthy controls Secondary: 1. To assess the relationship between microglial activation and clinical variables including disease severity and comorbidities (such as pain, fatigue and/or depression), as well as clinical MRI findings (such as lesions and atrophy) 2. A pilot substudy aims to establish the non-inferiority of \[F-18\]PBR06 as compared with Carbon-11 \[C-11\] labeled "Peripheral Benzodiazepine Receptor 28" (PBR28) PET in patients with RRMS. Hypothesis: The working hypothesis is that there is microglial activation in multiple sclerosis and Alzheimer's disease as compared to healthy controls and that the pattern/ regional distribution of microglial activation is different in Multiple Sclerosis (MS) versus AD and correlates with disease severity and comorbidities. In addition, the investigators hypothesize that \[F-18\]PBR06-PET scans will be at least as good as \[C-11\]PBR28-PET scans, the current gold standard.	SEP	Phase 1/2	Traitement symptomatique	United States	À vérifier
Chiropractic CareMigraine, a chronic intermittent headache disorder, ranks in the top five causes of years lived with disability. One promising non-pharmacologic and integrative treatment for migraine may be chiropractic care due to the co-occurrence of migraine and musculoskeletal complaints. The goal of this application is to perform a pilot study of chiropractic care for episodic migraine to help inform the design of a future, full-scale pragmatic effectiveness trial.	Migraine	Non applicable	À vérifier	United States	À vérifier
MIRAGE — Using Virtual Reality to Teach Mindfulness to People With MigraineThe aim of this clinical trial is to learn if people with migraine can learn a type of biobehavioral therapy called Acceptance and Commitment Therapy (ACT) by using a virtual reality headset. Researchers are studying if this type of mindfulness therapy helps to decrease migraine-related disability. Participants will be randomized to treatment as usual or active virtual reality groups for four weeks. Everyone will keep symptom diaries, complete surveys, attend two clinic visits, and have two blood draws.	Migraine	Non applicable	Traitement symptomatique	United States	À vérifier
ACT for High Frequency Migraine; A Virtual Mindfulness InterventionMindfulness Training specifically for pain to be offered to migraine patients	Migraine	Non applicable	Traitement symptomatique	United States	À vérifier
Fixed-Dose Combinations Pragmatic Randomized Implementation Trial for Blood Pressure ControlThe proposed study is an effectiveness-implementation hybrid type II trial designed to evaluate the impact of provider- and patient-directed interventions on FDC use. The trial will test the effectiveness of theory-driven nudges tailored to address provider and patient barriers. All interventions will be pharmacist-driven, with pharmacists delivering information via nudges to providers and via nudges or more intensive interventions (i.e., CPA) to patients. Data to evaluate outcomes will be extracted from electronic health records.	Hypertension	Non applicable	À vérifier	United States	À vérifier
Study SubjectsThe goal of this study is to assess the performance of a commercial sheet sensor in determining body position after generalized tonic-clonic (GTC) seizures. If a sheet sensor could accurately detect GTC seizures, this could be a step towards autonomously repositioning patients with the aid of a smart mattress. Primary Objective Milestones: Feasibility objective: Monitor 50 patients with the objective of capturing at least 20 GTCS events. Primary analytic objective: Achieve detection of anatomical landmarks with body position change within 5 seconds with an accuracy of 75% both interictally and post-GTCS. Secondary Objective Detect the postictal prone position with an accuracy of 100%.	Épilepsie	Non applicable	À vérifier	United States	À vérifier
CORAL — Cocoa Extract for Migraine TrialThe goal of this clinical trial is to assess the feasibility of recruitment and adherence to a high-dose cocoa extract supplement in individuals diagnosed with episodic migraine. The main questions it aims to answer are: * Will we be able to enroll 114 participants during the recruitment period? * Will participants take study pills daily during the pill-taking period? Researchers will compare two doses of cocoa extract to placebo to determine the acceptability of higher doses of cocoa extract supplementation in this patient population. Participants will be asked to: * Provide two urine samples * Complete daily questionnaires * Take four study pills a day for 12 weeks	Migraine	Non applicable	À vérifier	United States	À vérifier
JOGO Digital Therapeutics EMG Biofeedback for Lower Back PainThe purpose of this pilot efficacy study is to examine the effects of EMG-biofeedback (EMG-BF) on pain-related outcomes in Chronic Low Back Pain (CLBP) patients, Recent mastectomy and lumpectomy patients, and patients with episodic migraine. EMG-BF facilitates neuromuscular retraining and muscle relaxation by using audio and visual stimuli using an EMG surface electrode-based biosensor and a software installed on a tablet or smart phone. For this pilot efficacy study, we will recruit 125 patients with chronic low back pain, 125 patients who are expected to undergo mastectomy and 80 patients with episodic migraine. Participants will be randomly assigned to either the JOGO Digital Therapeutics EMG Biofeedback device or treatment as usual control group. Patients assigned to the intervention group will be asked to complete self-report questionnaires assessing demographics, pain intensity, negative affect, physical function, pain catastrophizing and sleep, will undergo QST and will be asked to wear Actiwatches to keep track of health behaviors, prior to and after completing the intervention. The intervention consists of weekly sessions during which participants will be instructed on how to use the device by a trained biofeedback instructor. Patients in the control group will undergo sensory testing procedures at baseline and after treatment period but will receive no active treatment. The aims of this study are to examine the impact of EMG-BF on pain and QST and the impact of EMG-BF on psychosocial function. We hypothesize that patients that will undergo the EMG-BF will demonstrate reductions in pain, physical functioning, sleep, pain catastrophizing, anxiety and depression.	Migraine	Non applicable	Traitement symptomatique	United States	À vérifier
Immune Profiling During Ocrelizumab Treatment in Multiple SclerosisThe purpose of this study is to assess effects of B cell depletion on the immune system in patients with relapsing forms of multiple sclerosis (MS) treated with ocrelizumab. This will be done by collecting blood from patients starting treatment with ocrelizumab before the first infusion and before the infusions at 6 and 12 months. The effects on the immune system will be assessed by performing transcriptome profiling of immune cells, measuring serum levels of microRNAs, and analyzing serum autoantibody immune signatures using antigen arrays. In addition, blood will be collected once from a group of healthy individuals to serve as controls.	SEP	À vérifier	Immunomodulation	United States	À vérifier
Emtricitabine and tenofovir disoproxil fumarate combinationThe goal of this clinical trial is to determine the safety, tolerability, drug levels and biological effects of two doses of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) combination administered daily for 4 weeks in older adults with early Alzheimer's disease. The main questions it aims to answer are: * Is FTC-TDF combination safe in older adults who have early Alzheimer's disease. * To measure the FTC-TDF levels at different times. * To measure the biological effects of FTC-TDF combination. * To measure the effects of FTC-TDF combination on inflammation. Researchers will compare two doses of FTC-TDF combination to a placebo (a look-alike substance that contains no drug) to see if FTC-TDF combination is safe in older adults who have early Alzheimer's disease. Participants will: * Take FTC-TDF combination or a placebo every day for 28 days. * Have 10 clinic visits over approximately 3 months. * Undergo blood tests, physical exams, cognitive testing, and scans of their brain.	Alzheimer	Phase 1	Immunomodulation	United States	À vérifier

Essais cliniques

Molécule	Indication / population	Phase	NCT	Titre	Statut
Emtricitabine and tenofovir disoproxil fumarate combination	Alzheimer	Phase 1	NCT07795307	Repurposing a Combination Antiretroviral Drug Therapy to Target Retrotransposons and Treat Early Alzheimer's Disease	NOT_YET_RECRUITING
Fremanezumab	Migraine	Phase 4	NCT06173661	Fremanezumab Treatment of Migraine in Women With Menstrual Migraine Ages 18-45	COMPLETED
Immune Profiling During Ocrelizumab Treatment in Multiple Sclerosis	SEP	À vérifier	NCT03138525	Immune Profiling During Ocrelizumab Treatment in Multiple Sclerosis	COMPLETED
JOGO Digital Therapeutics EMG Biofeedback for Lower Back Pain	Migraine	Non applicable	NCT04607460	BEAT-Pain — EMG Biofeedback Treatment for Chronic Low Back Pain, Cancer Pain and Migraines	COMPLETED
CORAL — Cocoa Extract for Migraine Trial	Migraine	Non applicable	NCT06808230	CORAL — Cocoa Extract for Migraine Trial	RECRUITING
Study Subjects	Épilepsie	Non applicable	NCT06135285	A Device to Prevent Sudden Unexpected Death in Epilepsy: Detecting Peri-Ictal Body Position	NOT_YET_RECRUITING
Fixed-Dose Combinations Pragmatic Randomized Implementation Trial for Blood Pressure Control	Hypertension	Non applicable	NCT07228065	Fixed-Dose Combinations Pragmatic Randomized Implementation Trial for Blood Pressure Control	ENROLLING_BY_INVITATION
ACT for High Frequency Migraine; A Virtual Mindfulness Intervention	Migraine	Non applicable	NCT05003362	ACT for High Frequency Migraine; A Virtual Mindfulness Intervention	COMPLETED
MIRAGE — Using Virtual Reality to Teach Mindfulness to People With Migraine	Migraine	Non applicable	NCT07599228	MIRAGE — Using Virtual Reality to Teach Mindfulness to People With Migraine	NOT_YET_RECRUITING
Chiropractic Care	Migraine	Non applicable	NCT06229834	Chiropractic Care for Episodic Migraine	RECRUITING
Ocrelizumab	SEP	À vérifier	NCT05131984	Ocrelizumab Access by Socio-Economic Status	COMPLETED
[F-18]PBR06	SEP	Phase 1/2	NCT02649985	MAPET — PET Brain Imaging in Multiple Sclerosis, Alzheimer's Disease, and Other Neurological and Neuropsychiatric Diseases	RECRUITING

Publications

Molécule	Titre	Journal
Chiropractic Care	Latent Patterns of Complementary and Integrative Health Therapy Utilization Among VHA Patients on Long-Term Opioid Therapy.	Pain medicine (Malden, Mass.)
Chiropractic Care	Resolution of Treatment-Resistant Vertigo and Suspected Ménière's Disease Following Knee Chest Upper Cervical Chiropractic Care: A Case Report.	Cureus
Chiropractic Care	L5-S1 basivertebral nerve ablation for chronic vertebrogenic low back pain following lumbar fusion: a case report.	Journal of spine surgery (Hong Kong)
Study Subjects	Suicidality risk of cancer caregivers: a systematic review and meta-analysis of observational studies.	Annals of medicine
Study Subjects	Antenatal psychological interventions may ameliorate postpartum depression: a systematic review and meta-analysis.	Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology
Study Subjects	ICSI shows no advantage over conventional IVF in patients with unexpected low oocyte yield.	Annals of medicine
Fixed-Dose Combinations Pragmatic Randomized Implementation Trial for Blood Pressure Control	Frontiers of cardiovascular polypills: From atherosclerosis and beyond.	Trends in cardiovascular medicine
Fixed-Dose Combinations Pragmatic Randomized Implementation Trial for Blood Pressure Control	A Randomized Feasibility Trial of a Multicomponent Quality Improvement Strategy for Chronic Care of Cardiovascular Diseases: Findings from the C-QIP Trial in India.	medRxiv : the preprint server for health sciences
[C-11]PBR28	PET Imaging of Human Brown Adipose Tissue with the TSPO Tracer [C]PBR28.	Molecular imaging and biology