VA Office of Research and Development

Traitements25programmes

Essais13liés

Publications19liées

SourceDBlocale

Traitements

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
DarbepoetinThe investigators hypothesize that compared to untreated controls, erythropoietin (EPO) therapy in anemic patients with chronic kidney disease will raise diastolic blood pressure (BP). The magnitude of increase in diastolic BP at 12 weeks after treatment will be related to two factors. First, endothelial dysfunction and worsening of endothelial function from baseline to 4 weeks and second, the change of forearm blood flow in response to breathing oxygen and the change in this measure from baseline to 4 weeks. Study procedures include fasting blood draws, ambulatory blood pressure, urine collection, and forearm blood flow tests. The study hopes to accrue 160 subjects.	Hypertension	Phase 2	À vérifier	United States	À vérifier
EMPOWER — Enhancing Mental and Physical Health of Women VeteransWomen Veterans are the fastest growing segment of VA users. This dramatic growth has created challenges for VA to ensure that appropriate services are available to meet women Veterans' needs, and that they will want and be able to use those services. The EMPOWER QUERI 2.0 Program is a cluster randomized type 3 hybrid implementation-effectiveness trial testing two strategies designed to support implementation and sustainment of evidence-based practices for women Veterans in at least 20 VA facilities from 4 regions.	Hypertension	Non applicable	À vérifier	United States	À vérifier
EMSTRespiratory difficulty is one of the primary factors leading to death in patients with Parkinson's Disease (PD) and Multiple Sclerosis. Both diseases are progressive degenerating diseases that cause difficulties in breathing, airway protection and swallowing. Patients with PD and MS typically become sedentary and lose endurance, maximal fitness levels and overall pulmonary function. Much of the research focus has been on the motor symptoms of PD and MS yet the pulmonary and swallowing complications are perhaps ultimately the most important disability as the diseases progress. The inability to generate adequate respiratory pressure is responsible for reduced cough magnitudes and cough response times. Cough is critical for the clearance of foreign materials in the airway helping to reduce infiltration of bacteria and subsequent respiratory infection. With reduced cough function an increased risk for pulmonary disease occurs due to a reduced ability to protect the airways. There are a number of promising outcomes from an expiratory strength-training program. By increasing expiratory muscle strength and expiratory pressure generation, effective breathing, clearance of the airway, and improved swallowing can occur. These explicit outcomes are predicted based on our experience with the use of an innovative device-driven, home-based expiratory strength training program focused on the expiratory muscles of respiration. This project focuses on following patients with PD and MS for an initial 5 weeks of strength training and them testing the outcome of a caregiver program for maintaining treatment effects.	SEP	Phase 2	Traitement symptomatique	United States	À vérifier
Gamification and Physical Activity in PDDespite overwhelming evidence that exercise can improve motor and non-motor symptoms of Parkinson's Disease (PD), less than 25% of Veterans with PD meet recommended activity goals. Interventions to increase PA that are scalable and can be deployed in the community represent a major opportunity. The investigators' preliminary work has demonstrated that gamification, a method commonly used for health promotion, can lead to increases in physical activity in PD. In this study, the investigators will test the effectiveness of gamification in a randomized trial to increase activity. Importantly, the investigators will also examine the effect of step count and exercise intensity on clinical outcomes and explore factors important to widespread implementation of the program VA.	Parkinson	Non applicable	Traitement symptomatique	United States	À vérifier
Mobile neural decoding platform (mobile iBCI)Description non affichée : incohérence de maladie détectée. Consultez l’essai clinique officiel associé.	Myopathies, Sclérose latérale amyotrophique	Non applicable	À vérifier	United States	À vérifier
MOTIVATE_IIR — MOTIVATE to Improve Outcomes for Older Veterans With Musculoskeletal Pain and DepressionThe proposed study seeks to evaluate effectiveness, implementation processes, and cost of MOTIVATE among older Veterans with chronic musculoskeletal (MSK) pain and comorbid depressive symptoms.	Myopathies	Non applicable	Traitement symptomatique	United States	À vérifier
nVNSMild traumatic brain injury (mTBI) and posttraumatic stress disorder (PTSD) are important conditions for the Veterans Administration (VA) that frequently occur together in combat Veterans from the conflicts in Afghanistan and Iraq. In many Veterans these become chronic, raising the risk the burden of neurotrauma can worsen over time. This study will examine a new intervention called non-invasive Vagal Nerve Stimulation (nVNS) and its effects on memory and symptoms of PTSD and mTBI as well as brain and physiology in Veterans with mTBI and PTSD.	SEP	Non applicable	Traitement symptomatique	United States	À vérifier
Piloting a Novel Peer Support Pain Self-Management Intervention (Project CONNECT)The proposed study will test the feasibility and acceptability of an 8-week home-based reciprocal peer support pain self-management intervention (CONNECT) for women Veterans with chronic musculoskeletal pain. The use of this format will improve the accessibility of treatment to women Veterans who experience logistical, healthcare delivery and psychosocial barriers to care. To address these barriers women Veterans who enroll in CONNECT will be paired and work together to learn/practice pain coping skills, set meaningful activity goals, and participate in a graduated walking program; they will exchange nightly text messages and engage in a weekly 20 minute phone call to reinforce each other and provide support for pain self-management efforts. This is a single-arm pilot project; all eligible and interested women with chronic musculoskeletal pain will receive CONNECT. The primary outcome will be post-treatment and long-term follow-up retention rates.	Myopathies	Non applicable	Traitement symptomatique	United States	À vérifier
prazosin hydrochlorideThe purpose of this study is to determine if prazosin is more effective than placebo in decreasing frequency, severity, disability, and other negative effects of headaches related to mild traumatic brain injury in Service Members and Veterans.	Migraine	Phase 1/2	À vérifier	United States	À vérifier
sham stimulationAttaining goals or rewards commonly entails response costs. In light of cost and benefits, how do participants decide what effort should be put in to give it a shot? Figuratively, you may "go with your gut", but the literal contribution of the gut-brain axis in allocating effort is poorly understood to date. Here, the investigators propose to investigate non-invasive transcutaneous vagal nerve stimulation (tVNS) as a potential modulator of energy metabolism and response vigor. Since the neural mechanisms causing the diverse cognitive and behavioral effects of the stimulation remain largely elusive, the investigators will use computational modeling of instrumental behavior and determine the primary metabolic effects of the stimulation. The investigators hypothesize that tVNS will lead to activation of afferent targets in the brain. In turn, the elicited brain activation is expected to mediate the cognitive effects of the stimulation. This may affect both sides of the utility equation because anti-depressive effects may correspond to boosting the benefit of effort whereas anti-nociceptive effects may reduce perceived costs of effort. Collectively, dissecting the cognitive effects of non-invasive tVNS in healthy individuals may facilitate the more widespread use as a treatment in mental disorders that are characterized by metabolic alterations such as depression.	Migraine, SEP	Non applicable	À vérifier	United States	À vérifier
STEP 4 Vets — A Randomized Trial of Behaviorally Designed Gamification and Social Incentives to Increase Physical Activity Among Overweight and Obese VeteransDespite the many associated health benefits, more than half of Veterans do not achieve enough regular physical activity. The investigators' prior work has demonstrated that gamification, a method commonly used for health promotion, can lead to sustained increases in physical activity if it is designed using insights from behavioral economics to enhance social incentives. In this study, the investigators will compare the effectiveness of behaviorally designed gamification that encourages Veterans to collaborate or compete on physical activity levels and examine clinical outcomes as well as costs, barriers and facilitators to implementation of the program within Veterans Affairs.	Hypertension	Non applicable	À vérifier	United States	À vérifier
Vitamin D3A trial to measure the effects of vitamin D (versus a placebo) on balance, gait, falls, strength, and cognition in persons with Parkinson's disease.	Parkinson	Phase 2	À vérifier	United States	À vérifier
WATER-VET — Water-based Activity to Enhance Recall in Veterans: A Randomized Clinical TrialThis four-year study will evaluate the efficacy of an exercise training augmentation for cognitive training intervention to improve memory performance in Veterans with a diagnosis of amnestic Mild Cognitive Impairment (aMCI). This is a two-phased trial: 1) an exercise phase and 2) a cognitive training program. The exercise phase will be an aquatic based exercise program. A combination of exercise and cognitive training programs designed for persons without cognitive impairment have significantly improved memory more than other single intervention groups (exercise only, cognitive training only) and given the success of combination training programs with healthy older adults, it is important to adapt these programs for persons beginning to exhibit clinically significant memory problems, such as those with aMCI.	Alzheimer	Phase 4	À vérifier	United States	À vérifier
Vitamin D3A trial to measure the effects of vitamin D (versus a placebo) on balance, gait, falls, strength, and cognition in persons with Parkinson's disease.	Parkinson	Phase 2	À vérifier	United States	À vérifier
EMSTRespiratory difficulty is one of the primary factors leading to death in patients with Parkinson's Disease (PD) and Multiple Sclerosis. Both diseases are progressive degenerating diseases that cause difficulties in breathing, airway protection and swallowing. Patients with PD and MS typically become sedentary and lose endurance, maximal fitness levels and overall pulmonary function. Much of the research focus has been on the motor symptoms of PD and MS yet the pulmonary and swallowing complications are perhaps ultimately the most important disability as the diseases progress. The inability to generate adequate respiratory pressure is responsible for reduced cough magnitudes and cough response times. Cough is critical for the clearance of foreign materials in the airway helping to reduce infiltration of bacteria and subsequent respiratory infection. With reduced cough function an increased risk for pulmonary disease occurs due to a reduced ability to protect the airways. There are a number of promising outcomes from an expiratory strength-training program. By increasing expiratory muscle strength and expiratory pressure generation, effective breathing, clearance of the airway, and improved swallowing can occur. These explicit outcomes are predicted based on our experience with the use of an innovative device-driven, home-based expiratory strength training program focused on the expiratory muscles of respiration. This project focuses on following patients with PD and MS for an initial 5 weeks of strength training and them testing the outcome of a caregiver program for maintaining treatment effects.	SEP	Phase 2	Traitement symptomatique	United States	À vérifier
DarbepoetinThe investigators hypothesize that compared to untreated controls, erythropoietin (EPO) therapy in anemic patients with chronic kidney disease will raise diastolic blood pressure (BP). The magnitude of increase in diastolic BP at 12 weeks after treatment will be related to two factors. First, endothelial dysfunction and worsening of endothelial function from baseline to 4 weeks and second, the change of forearm blood flow in response to breathing oxygen and the change in this measure from baseline to 4 weeks. Study procedures include fasting blood draws, ambulatory blood pressure, urine collection, and forearm blood flow tests. The study hopes to accrue 160 subjects.	Hypertension	Phase 2	À vérifier	United States	À vérifier
STEP 4 Vets — A Randomized Trial of Behaviorally Designed Gamification and Social Incentives to Increase Physical Activity Among Overweight and Obese VeteransDespite the many associated health benefits, more than half of Veterans do not achieve enough regular physical activity. The investigators' prior work has demonstrated that gamification, a method commonly used for health promotion, can lead to sustained increases in physical activity if it is designed using insights from behavioral economics to enhance social incentives. In this study, the investigators will compare the effectiveness of behaviorally designed gamification that encourages Veterans to collaborate or compete on physical activity levels and examine clinical outcomes as well as costs, barriers and facilitators to implementation of the program within Veterans Affairs.	Hypertension	Non applicable	À vérifier	United States	À vérifier
Mobile neural decoding platform (mobile iBCI)Description non affichée : incohérence de maladie détectée. Consultez l’essai clinique officiel associé.	Sclérose latérale amyotrophique	Non applicable	À vérifier	United States	À vérifier
prazosin hydrochlorideThe purpose of this study is to determine if prazosin is more effective than placebo in decreasing frequency, severity, disability, and other negative effects of headaches related to mild traumatic brain injury in Service Members and Veterans.	Migraine	Phase 1/2	À vérifier	United States	À vérifier
sham stimulationAttaining goals or rewards commonly entails response costs. In light of cost and benefits, how do participants decide what effort should be put in to give it a shot? Figuratively, you may "go with your gut", but the literal contribution of the gut-brain axis in allocating effort is poorly understood to date. Here, the investigators propose to investigate non-invasive transcutaneous vagal nerve stimulation (tVNS) as a potential modulator of energy metabolism and response vigor. Since the neural mechanisms causing the diverse cognitive and behavioral effects of the stimulation remain largely elusive, the investigators will use computational modeling of instrumental behavior and determine the primary metabolic effects of the stimulation. The investigators hypothesize that tVNS will lead to activation of afferent targets in the brain. In turn, the elicited brain activation is expected to mediate the cognitive effects of the stimulation. This may affect both sides of the utility equation because anti-depressive effects may correspond to boosting the benefit of effort whereas anti-nociceptive effects may reduce perceived costs of effort. Collectively, dissecting the cognitive effects of non-invasive tVNS in healthy individuals may facilitate the more widespread use as a treatment in mental disorders that are characterized by metabolic alterations such as depression.	SEP	Non applicable	À vérifier	United States	À vérifier
MOTIVATE_IIR — MOTIVATE to Improve Outcomes for Older Veterans With Musculoskeletal Pain and DepressionThe proposed study seeks to evaluate effectiveness, implementation processes, and cost of MOTIVATE among older Veterans with chronic musculoskeletal (MSK) pain and comorbid depressive symptoms.	Myopathies	Non applicable	Traitement symptomatique	United States	À vérifier
Piloting a Novel Peer Support Pain Self-Management Intervention (Project CONNECT)The proposed study will test the feasibility and acceptability of an 8-week home-based reciprocal peer support pain self-management intervention (CONNECT) for women Veterans with chronic musculoskeletal pain. The use of this format will improve the accessibility of treatment to women Veterans who experience logistical, healthcare delivery and psychosocial barriers to care. To address these barriers women Veterans who enroll in CONNECT will be paired and work together to learn/practice pain coping skills, set meaningful activity goals, and participate in a graduated walking program; they will exchange nightly text messages and engage in a weekly 20 minute phone call to reinforce each other and provide support for pain self-management efforts. This is a single-arm pilot project; all eligible and interested women with chronic musculoskeletal pain will receive CONNECT. The primary outcome will be post-treatment and long-term follow-up retention rates.	Myopathies	Non applicable	Traitement symptomatique	United States	À vérifier
Gamification and Physical Activity in PDDespite overwhelming evidence that exercise can improve motor and non-motor symptoms of Parkinson's Disease (PD), less than 25% of Veterans with PD meet recommended activity goals. Interventions to increase PA that are scalable and can be deployed in the community represent a major opportunity. The investigators' preliminary work has demonstrated that gamification, a method commonly used for health promotion, can lead to increases in physical activity in PD. In this study, the investigators will test the effectiveness of gamification in a randomized trial to increase activity. Importantly, the investigators will also examine the effect of step count and exercise intensity on clinical outcomes and explore factors important to widespread implementation of the program VA.	Parkinson	Non applicable	Traitement symptomatique	United States	À vérifier
WATER-VET — Water-based Activity to Enhance Recall in Veterans: A Randomized Clinical TrialThis four-year study will evaluate the efficacy of an exercise training augmentation for cognitive training intervention to improve memory performance in Veterans with a diagnosis of amnestic Mild Cognitive Impairment (aMCI). This is a two-phased trial: 1) an exercise phase and 2) a cognitive training program. The exercise phase will be an aquatic based exercise program. A combination of exercise and cognitive training programs designed for persons without cognitive impairment have significantly improved memory more than other single intervention groups (exercise only, cognitive training only) and given the success of combination training programs with healthy older adults, it is important to adapt these programs for persons beginning to exhibit clinically significant memory problems, such as those with aMCI.	Alzheimer	Phase 4	À vérifier	United States	À vérifier
EMPOWER — Enhancing Mental and Physical Health of Women VeteransWomen Veterans are the fastest growing segment of VA users. This dramatic growth has created challenges for VA to ensure that appropriate services are available to meet women Veterans' needs, and that they will want and be able to use those services. The EMPOWER QUERI 2.0 Program is a cluster randomized type 3 hybrid implementation-effectiveness trial testing two strategies designed to support implementation and sustainment of evidence-based practices for women Veterans in at least 20 VA facilities from 4 regions.	Hypertension	Non applicable	À vérifier	United States	À vérifier

Essais cliniques

Molécule	Indication / population	Phase	NCT	Titre	Statut
EMPOWER — Enhancing Mental and Physical Health of Women Veterans	Hypertension	Non applicable	NCT05050266	EMPOWER — Enhancing Mental and Physical Health of Women Veterans	ACTIVE_NOT_RECRUITING
WATER-VET — Water-based Activity to Enhance Recall in Veterans: A Randomized Clinical Trial	Alzheimer	Phase 4	NCT04296565	WATER-VET — Water-based Activity to Enhance Recall in Veterans: A Randomized Clinical Trial	COMPLETED
Intermittent theta burst stimulation	Myopathies	Phase 3	NCT07158567	Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low BackPaiN Treatment: VIBRANT	NOT_YET_RECRUITING
Gamification and Physical Activity in PD	Parkinson	Non applicable	NCT07286994	Gamification and Physical Activity in PD	NOT_YET_RECRUITING
Piloting a Novel Peer Support Pain Self-Management Intervention (Project CONNECT)	Myopathies	Non applicable	NCT04229134	Piloting a Novel Peer Support Pain Self-Management Intervention (Project CONNECT)	COMPLETED
MOTIVATE_IIR — MOTIVATE to Improve Outcomes for Older Veterans With Musculoskeletal Pain and Depression	Myopathies	Non applicable	NCT05220202	MOTIVATE_IIR — MOTIVATE to Improve Outcomes for Older Veterans With Musculoskeletal Pain and Depression	COMPLETED
sham stimulation	SEP	Non applicable	NCT04437498	VNS mTBI — Vagal Nerve Stimulation in mTBI	RECRUITING
prazosin hydrochloride	Migraine	Phase 1/2	NCT02266329	Chronic Postconcussive Headache: A Placebo-Controlled Treatment Trial of Prazosin	COMPLETED
Mobile neural decoding platform (mobile iBCI)	Sclérose latérale amyotrophique	Non applicable	NCT05470478	iBCI Optimization for Veterans With Paralysis	NOT_YET_RECRUITING
STEP 4 Vets — A Randomized Trial of Behaviorally Designed Gamification and Social Incentives to Increase Physical Activity Among Overweight and Obese Veterans	Hypertension	Non applicable	NCT05554601	STEP 4 Vets — A Randomized Trial of Behaviorally Designed Gamification and Social Incentives to Increase Physical Activity Among Overweight and Obese Veterans	ACTIVE_NOT_RECRUITING
Darbepoetin	Hypertension	Phase 2	NCT03810911	EPIC — Mechanisms of EPO-induced Hypertension	TERMINATED
EMST	SEP	Phase 2	NCT00856518	EMST — Expiratory Muscle Training for Persons With Neurodegenerative Disease	COMPLETED
Vitamin D3	Parkinson	Phase 2	NCT01119131	Effects of Vitamin D in Parkinson's Disease (PD)	COMPLETED

Publications

Molécule	Titre	Journal
Piloting a Novel Peer Support Pain Self-Management Intervention (Project CONNECT)	How Do Patients with Chronic Pain Benefit from a Peer-Supported Pain Self-Management Intervention? A Qualitative Investigation.	Pain medicine (Malden, Mass.)
Darbepoetin	Association of anemia and necrotizing enterocolitis in neonates: Systematic review and meta-analysis of transfusion thresholds, erythropoietin trials, and observational studies.	Journal of neonatal-perinatal medicine
Darbepoetin	Site-specific enrichment of highly sialylated N-glycans in an erythropoietin-hybrid Fc fusion protein.	European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V
Vitamin D3	Metabolomic analysis of follicular fluid in women with unexplained infertility.	Systems biology in reproductive medicine
Vitamin D3	Differential modulation of gentamicin antibacterial activity by vitamin B12 and vitamin D3 against Gram-positive and Gram-negative bacteria: an study.	Annals of medicine
Vitamin D3	Effects of vitamin D supplementation on cardiac, muscle, and immune responses after a marathon race: a single-blind, placebo-controlled trial.	Journal of the International Society of Sports Nutrition
sham stimulation	Transcranial direct current stimulation enhances cognitive performance and modulates QEEG beta- and theta-band power in patients undergoing whole-brain radiotherapy.	IBRO neuroscience reports
EMST	Evaluating mucosal and systemic immunity in an observational cohort of South African children hospitalized with acute respiratory tract infections.	International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases
Vitamin D3	Effects of Probiotics and Vitamin D Deficiency Correction on Clinical, Inflammatory, Metabolic, and Microbiota Profiles in Older Adults with Oral Lichen Planus: A Multi-Omics Study.	International journal of molecular sciences
sham stimulation	Automated intermittent olfactory stimulation to reduce apnea in preterm infants: results of the PREMODEUR randomized clinical trial.	European journal of pediatrics
sham stimulation	Corticospinal Excitability After Continuous and Intermittent Theta Burst Stimulation Applied on the Lateral Cerebellum: A Study on Healthy Individuals.	Noro psikiyatri arsivi
Darbepoetin	Adsorption characteristics of erythropoietin in two β2-microglobulin absorption systems: a preliminary in vitro study using FILTOR and Lixelle.	Journal of artificial organs : the official journal of the Japanese Society for Artificial Organs
Darbepoetin	Drugs and Cell-Based Therapies for the Prevention and Treatment of Neonatal Brain Injury.	Clinics in perinatology
Vitamin D3	Association between serum vitamin D3 levels and gingival crevicular fluid osteocalcin and N-terminal telopeptide levels in periodontal health and disease.	Journal of applied oral science : revista FOB
Vitamin D3	Association between serum biomarkers and clinical stage in treatment-naïve chronic lymphocytic leukemia.	Hematology, transfusion and cell therapy
EMST	Physiologic Adaptations to Modifying Resistive Load and Time Under Tension During Expiratory Muscle Strength Training.	Journal of speech, language, and hearing research : JSLHR
EMST	Mind the dog: real dogs elicit emotional and mental state language in parent-child conversations.	Journal of experimental child psychology
Vitamin D3	DFDBA plus T-PRF with and without vitamin D3 gel in intrabony defects: a randomized controlled trial.	Odontology
Vitamin D3	Vitamin D3 reverses intestinal epithelial cell injury in septic rats by alleviating toll-like receptor 4 mediated endoplasmic reticulum stress.	Scientific reports