Traitements50programmes
Essais26liés
Publications38liées
SourceDBlocale

Traitements

50
MoléculeIndication / populationPhaseObjectifPaysRésultat
18F-MK-6240This multi-site study will be the first to evaluate the dose-dependent effects of t-PBM in amnestic Mild Cognitive Impairment (aMCI) and early Alzheimer's Disease (AD) (CDR of 0.5-1, FAST 1-4; age 65-85) in a randomized clinical trial of 8 weeks of t-PBM vs. sham. At baseline, all subjects will complete initial neuropsychological testing. To elucidate mechanisms of action of t-PBM, prior to treatment, subjects will undergo neuroimaging related to critical features of AD: tau 18F MK-6240 load (PET), measures of brain bioenergetics (31P-MRS), and functional connectivity (rs-fMRI). After undergoing target engagement testing (t-PBM session performed during fMRI to detect BOLD changes with active t-PBM), subjects will then be randomized to t-PBM/sham and complete 24 t-PBM/sham treatments, \~11 min per day, 3 days per week, for 8 weeks. t-PBM will be administered via continuous, 808 nm wavelength laser delivery to the forehead bilaterally (at standard EEG electrode positions F4, F3). Alzheimer Phase 2 Remyélinisation indirecte / réparation United States À vérifier
Active taVNSThe aim of this clinical trial is to determine if trans-auricular vagus nerve stimulation (taVNS) is effective in improving upper extremity function in stroke survivors. The primary objectives include: Investigating whether taVNS improves motor function in stroke survivors. The secondary objectives include: Assessing any potential side effects associated with the method. Investigating taVNS effects on daily routine functions and spasticity Researchers will conduct a comparative analysis between taVNS and a sham procedure (which mimics the stimulation without any actual effect) to assess its effectiveness. Participants in the trial will: Undergo taVNS combined with physical therapy or a sham procedure with physical therapy daily over a two-week period. Maladie rénale chronique, SEP Non applicable Traitement symptomatique United States À vérifier
Active tPBM-2.0This multi-site study will be the first to evaluate the dose-dependent effects of t-PBM in amnestic Mild Cognitive Impairment (aMCI) and early Alzheimer's Disease (AD) (CDR of 0.5-1, FAST 1-4; age 65-85) in a randomized clinical trial of 8 weeks of t-PBM vs. sham. At baseline, all subjects will complete initial neuropsychological testing. To elucidate mechanisms of action of t-PBM, prior to treatment, subjects will undergo neuroimaging related to critical features of AD: tau 18F MK-6240 load (PET), measures of brain bioenergetics (31P-MRS), and functional connectivity (rs-fMRI). After undergoing target engagement testing (t-PBM session performed during fMRI to detect BOLD changes with active t-PBM), subjects will then be randomized to t-PBM/sham and complete 24 t-PBM/sham treatments, \~11 min per day, 3 days per week, for 8 weeks. t-PBM will be administered via continuous, 808 nm wavelength laser delivery to the forehead bilaterally (at standard EEG electrode positions F4, F3). Alzheimer Phase 2 Remyélinisation indirecte / réparation United States À vérifier
Anodal tDCS of left or right AG or FCThe purpose of this protocol is to learn about movement intention and volition. To improve such knowledge, investigators will conduct sub-studies using multiple non-invasive methodologies. These results could provide preliminary data for subsequent studies evaluating local and global efficacy of plasticity-inducing treatments for PMD symptoms. Épilepsie Non applicable Traitement symptomatique United States À vérifier
Empagliflozin 10 MGA 12-week, phase II, randomized, double-blind, placebo-controlled, multi-center study to assess the safety, tolerability, and preliminary efficacy of empagliflozin versus placebo among patients initiating hemodialysis (n=60) for the treatment of end-stage kidney disease. Maladie rénale chronique Phase 2 À vérifier United States À vérifier
HEAL-SLE: Holistic Energy for Alleviating Lupus SymptomsThe purpose of this study is to assess the efficacy, feasibility, and acceptability of Virtual Reiki therapy as a complementary treatment for patients with systemic lupus erythematosus (SLE). The study also aims to investigate the feasibility, acceptability, and adherence of integrating Virtual Reiki therapy within the healthcare system for patients with SLE. Participants receiving standard of care (SOC) treatment for SLE will continue SOC while receiving research-specific Virtual Reiki therapy once per week for 8 weeks. Each study session will be delivered remotely by a Certified Reiki Practitioner Level II or higher. Lupus Non applicable Traitement symptomatique United States À vérifier
Herpes Zoster Subunit (HZ/su) VaccineThis randomized, double-blind, placebo-controlled, non-inferiority crossover study will evaluate the Herpes Zoster Sunbit (HZ/su) vaccine in SLE patients in order to evaluate safety and immunogenicity in patients with variable baseline clinical activities, ages and immunosuppressant exposures. The investigators hypothesize that HZ/su administration will be non-inferior to placebo with respect to the risk of moderate or severe SLE flare(s) occurring within 24 weeks of receiving the first dose of the assigned treatment. In addition, the investigators hypothesize that immunogenicity of the vaccine in SLE patients will be at least 50% of levels observed in healthy subjects from prior large clinical trials. Lupus Phase 4 À vérifier United States À vérifier
Home Urine TestingStudy participants enrolled in the SAMPLE Biorepository (s14-00487) who have provided permission to be contacted for future research will be enrolled and randomized (1:1) two-arm controlled) to either 1) perform weekly home-based proteinuria testing in addition to standard of care or 2) standard of care only. Participants randomized to the home-based proteinuria testing arm will perform weekly home-based proteinuria testing in addition to having standard of care and respond to study team's weekly text messages with urine test results for one year. Lupus Non applicable À vérifier United States À vérifier
HydroxychloroquineWomen with antibodies to proteins called SSA/Ro and or SSB/La face a 2% chance of having a child with a life threatening heart condition regardless of whether they have very active lupus, are in remission, or have only vague symptoms. This heart problem is referred to as congenital heart block (the most serious being third degree complete block) and represents damage thought to be caused by these autoantibodies. The heart beats abnormally slowly and almost all children require permanent pacemakers before the age of 20. Importantly, women who have had one child with heart block have a ten-fold higher risk of having another child with the same heart condition. Unfortunately, even close monitoring by special techniques during pregnancy does not reverse complete heart block once it is observed. Thus, treatments aimed at prevention are critical. This study will evaluate for the first time whether hydroxychloroquine, a drug used by many patients with SLE, prevents the development of this heart condition. Data from laboratory experiments suggests that this drug, which crosses the placenta, may decrease the inflammation initiated by the passage of anti-Ro antibodies to the fetus. The study uses a Simon's 2-Stage design, and plans to enroll 19 patients in Stage 1 and 35 patients in Stage 2 if Stage 1 is successful. Patients can already be on hydroxychloroquine or will be started as soon as pregnancy is confirmed. The hope is that fewer than 3 cases of heart block will occur in Stage 1, and fewer than 6 cases will occur out of all 54 patients if Stage 2 is reached. The results of this study are expected to become an integral part of the counseling of women with anti-Ro/La antibodies who are considering pregnancy. Lupus Phase 3 Immunomodulation + Traitement symptomatique United States À vérifier
Lumbar Puncture (LP)Growing evidence suggests that Alzheimer's disease (AD) pathological changes begin decades before clinical symptoms and tau abnormalities in the locus coeruleus (LC) can be observed since midlife. We have previously demonstrated functional vulnerability of the LC to aging and stress, as well as an association between higher cerebrospinal fluid (CSF) tau and impaired sleep phenomena influenced by the LC. We now aim to test whether LC dysfunction can be measured in preclinical AD stages by LC targeted imaging, and whether it objectively affects sleep architecture and attention. We will test this hypothesis in 30 cognitively normal older adults by performing a full clinical evaluation, one night of polysomnography, a lumbar puncture to obtain cerebrospinal fluid, \[11C\]MRB PET-MR, and attention testing. This study has the potential to identify a new mechanism by which tau pathology contributes to sleep and attention dysfunction and may provide a new therapeutic target for AD prevention. Alzheimer Non applicable Traitement symptomatique United States À vérifier
MemantineDescription non affichée : incohérence de maladie détectée. Consultez l’essai clinique officiel associé. Alzheimer, Migraine, Sclérose latérale amyotrophique Phase 4 Ralentissement de la progression United States À vérifier
MRI, VenipunctureThis study uses the cholesterol lowering drug atorvastatin, also known as lipitor, to show reduction of avascular necrosis in steroid treated lupus patients. Avascular necrosis is a disease resulting from the loss of blood supply to the bones which can cause the bone to collapse. The collapse of bone may require a surgical replacement of the joint and can be disabling for life. Avascular necrosis is presently not preventable but research has shown that lipid lowering drugs such as lipitor can reduce or prevent avascular necrosis in animals. We therefore hypothesize that lipitor will reduce the incidence of avascular necrosis in lupus patients taking high dose steroids. Lupus Phase 2 À vérifier United States À vérifier
Nocturnal polysomnography (NPSG)Growing evidence suggests that Alzheimer's disease (AD) pathological changes begin decades before clinical symptoms and tau abnormalities in the locus coeruleus (LC) can be observed since midlife. We have previously demonstrated functional vulnerability of the LC to aging and stress, as well as an association between higher cerebrospinal fluid (CSF) tau and impaired sleep phenomena influenced by the LC. We now aim to test whether LC dysfunction can be measured in preclinical AD stages by LC targeted imaging, and whether it objectively affects sleep architecture and attention. We will test this hypothesis in 30 cognitively normal older adults by performing a full clinical evaluation, one night of polysomnography, a lumbar puncture to obtain cerebrospinal fluid, \[11C\]MRB PET-MR, and attention testing. This study has the potential to identify a new mechanism by which tau pathology contributes to sleep and attention dysfunction and may provide a new therapeutic target for AD prevention. Alzheimer Non applicable Traitement symptomatique United States À vérifier
PBI Radiotherapy 6 GyThe purpose of this study is to test whether a radiotherapy regimen of 8 GY x 3 days over 5 days (every other day) is as safe (well-tolerated) and effective as 6 Gy x 5 over five consecutive days Cancer Non applicable À vérifier United States À vérifier
PBI Radiotherapy 8 GyThe purpose of this study is to test whether a radiotherapy regimen of 8 GY x 3 days over 5 days (every other day) is as safe (well-tolerated) and effective as 6 Gy x 5 over five consecutive days Cancer Non applicable À vérifier United States À vérifier
PET-MR ScanAfrican-Americans (AAs) have an increased prevalence of both Alzheimer's disease (AD) and vascular risk factors for AD such as diabetes and hypertension when compared to whites. However, in a recent community based study of non-demented elderly, black race was associated with higher amyloid burden after adjusting for vascular risk factors, suggesting the presence of additional physiological differences on AD-risk by race in the early stages of the disease. The purpose of this study is to test whether poor slow wave sleep (SWS) quantity (SWS duration) and quality (slow wave activity, SWA) is one of these physiological factors. To test these hypotheses, the investigators will perform community outreach in churches and community-based organizations in Brooklyn and other NYC boroughs with which we have created substantial ties in recent years. In consultation with community stakeholders, the investigators will recruit 150 cognitively normal AA elderly (age 60-75) and 60 age, sex, BMI, income and education matched non-Hispanic whites from the same geographical areas. Investigators will first perform a medical and cognitive evaluation (Visit 1). Participants will then undergo 2 nights of home sleep monitoring using an unattended device to exclude OSA, followed by 7 days of actigraphy with a sleep log to record sleep duration. Both devices will be returned by mail. Subjects with reported total sleep time (TST) between 5 and 10 hours and absence of moderate to severe OSA will be invited to perform a 2-night nocturnal polysomnography (NPSG) (Nights 1-2) and a PiB-PET MR scan (Visit 2). Alzheimer À vérifier À vérifier United States À vérifier
PiBAfrican-Americans (AAs) have an increased prevalence of both Alzheimer's disease (AD) and vascular risk factors for AD such as diabetes and hypertension when compared to whites. However, in a recent community based study of non-demented elderly, black race was associated with higher amyloid burden after adjusting for vascular risk factors, suggesting the presence of additional physiological differences on AD-risk by race in the early stages of the disease. The purpose of this study is to test whether poor slow wave sleep (SWS) quantity (SWS duration) and quality (slow wave activity, SWA) is one of these physiological factors. To test these hypotheses, the investigators will perform community outreach in churches and community-based organizations in Brooklyn and other NYC boroughs with which we have created substantial ties in recent years. In consultation with community stakeholders, the investigators will recruit 150 cognitively normal AA elderly (age 60-75) and 60 age, sex, BMI, income and education matched non-Hispanic whites from the same geographical areas. Investigators will first perform a medical and cognitive evaluation (Visit 1). Participants will then undergo 2 nights of home sleep monitoring using an unattended device to exclude OSA, followed by 7 days of actigraphy with a sleep log to record sleep duration. Both devices will be returned by mail. Subjects with reported total sleep time (TST) between 5 and 10 hours and absence of moderate to severe OSA will be invited to perform a 2-night nocturnal polysomnography (NPSG) (Nights 1-2) and a PiB-PET MR scan (Visit 2). Alzheimer À vérifier À vérifier United States À vérifier
POWERbreathe KH2The primary objective of this study is to evaluate the feasibility and safety of inspiratory muscle training (IMT) when implemented as part of routine inpatient physical therapy care in patients undergoing evaluation for advanced heart therapies. The secondary aim is to determine if IMT improves 6-minute walk test (6MWT), dyspnea, Maximal Inspiratory Pressure (MIP) pre-operatively. Thirdly, to determine if IMT decreases ICU and hospital length of stay post-operatively. Insuffisance cardiaque Non applicable À vérifier United States À vérifier
Remotely Supervised Transcranial Direct Current Stimulation (RS - tDCS)Growing evidence suggests that vagal nerve stimulation (VNS) may be novel and effective in the management of the symptom burden of multiple sclerosis (MS) potentially by reducing inflammation and emotional distress, therefore improving overall well-being. We will complete a pilot study comparing transcutaneous auricular vagus nerve stimulation (taVNS) and transcutaneous cervical vagus nerve stimulation (tcVNS) to a standard intervention of dorsolateral prefrontal cortex (DLPFC) transcranial direct current stimulation (tDCS) as an active control. The primary outcome will be feasibility and the preliminary efficacy data concerning self-reported symptom reduction to inform the design of an intervention, and estimated power needed to complete a larger sham-controlled RCT. We will also measure heart rate variability (HRV), an easily obtained biomarker of vagus nerve stimulation (VNS), in correspondence to intervention response. SEP Non applicable Immunomodulation + Traitement symptomatique United States À vérifier
Remotely Supervised Transcutaneous Auricular Vagus Nerve Stimulation (RS - taVNS)Growing evidence suggests that vagal nerve stimulation (VNS) may be novel and effective in the management of the symptom burden of multiple sclerosis (MS) potentially by reducing inflammation and emotional distress, therefore improving overall well-being. We will complete a pilot study comparing transcutaneous auricular vagus nerve stimulation (taVNS) and transcutaneous cervical vagus nerve stimulation (tcVNS) to a standard intervention of dorsolateral prefrontal cortex (DLPFC) transcranial direct current stimulation (tDCS) as an active control. The primary outcome will be feasibility and the preliminary efficacy data concerning self-reported symptom reduction to inform the design of an intervention, and estimated power needed to complete a larger sham-controlled RCT. We will also measure heart rate variability (HRV), an easily obtained biomarker of vagus nerve stimulation (VNS), in correspondence to intervention response. SEP Non applicable Immunomodulation + Traitement symptomatique United States À vérifier
Remotely Supervised Transcutaneous Cervical Vagus Nerve Stimulation (RS - tcVNS)Growing evidence suggests that vagal nerve stimulation (VNS) may be novel and effective in the management of the symptom burden of multiple sclerosis (MS) potentially by reducing inflammation and emotional distress, therefore improving overall well-being. We will complete a pilot study comparing transcutaneous auricular vagus nerve stimulation (taVNS) and transcutaneous cervical vagus nerve stimulation (tcVNS) to a standard intervention of dorsolateral prefrontal cortex (DLPFC) transcranial direct current stimulation (tDCS) as an active control. The primary outcome will be feasibility and the preliminary efficacy data concerning self-reported symptom reduction to inform the design of an intervention, and estimated power needed to complete a larger sham-controlled RCT. We will also measure heart rate variability (HRV), an easily obtained biomarker of vagus nerve stimulation (VNS), in correspondence to intervention response. SEP Non applicable Immunomodulation + Traitement symptomatique United States À vérifier
rTMS of left or right angular gyrus (AG) or frontal cortex (FC)The purpose of this protocol is to learn about movement intention and volition. To improve such knowledge, investigators will conduct sub-studies using multiple non-invasive methodologies. These results could provide preliminary data for subsequent studies evaluating local and global efficacy of plasticity-inducing treatments for PMD symptoms. Épilepsie Non applicable Traitement symptomatique United States À vérifier
SARS-COV-2 mRNA VaccineSevere acute respiratory coronavirus 2 (SARS-CoV-2) is a novel coronavirus and the causative agent of COVID 19 disease, whose presentation symptoms range from asymptomatic infection to mild flu-like symptoms to multi system failure and death, resulting in significant morbidity and mortality worldwide. Novel vaccines against the SARS-CoV-2 virus have very recently been developed; however, the effectiveness, immune response, and short- or long-term safety of these vaccines have not been tested in immunocompromised patients on anti-CD-20 therapy for multiple sclerosis (MS) or for other disorders. This study will examine the immune response of the Pfizer-BioNTech and Moderna messenger RNA (mRNA)-platform vaccines developed against SARS-CoV-2 virus given as standard of care (SOC) in MS patients on ocrelizumab. SEP À vérifier Traitement symptomatique United States À vérifier
Sham taVNSThe aim of this clinical trial is to determine if trans-auricular vagus nerve stimulation (taVNS) is effective in improving upper extremity function in stroke survivors. The primary objectives include: Investigating whether taVNS improves motor function in stroke survivors. The secondary objectives include: Assessing any potential side effects associated with the method. Investigating taVNS effects on daily routine functions and spasticity Researchers will conduct a comparative analysis between taVNS and a sham procedure (which mimics the stimulation without any actual effect) to assess its effectiveness. Participants in the trial will: Undergo taVNS combined with physical therapy or a sham procedure with physical therapy daily over a two-week period. Maladie rénale chronique, Parkinson, SEP Non applicable Traitement symptomatique United States À vérifier
Sham TMS3 stimulationThe purpose of this protocol is to learn about movement intention and volition. To improve such knowledge, investigators will conduct sub-studies using multiple non-invasive methodologies. These results could provide preliminary data for subsequent studies evaluating local and global efficacy of plasticity-inducing treatments for PMD symptoms. Épilepsie Non applicable Traitement symptomatique United States À vérifier
Sham tPBM-2.0This multi-site study will be the first to evaluate the dose-dependent effects of t-PBM in amnestic Mild Cognitive Impairment (aMCI) and early Alzheimer's Disease (AD) (CDR of 0.5-1, FAST 1-4; age 65-85) in a randomized clinical trial of 8 weeks of t-PBM vs. sham. At baseline, all subjects will complete initial neuropsychological testing. To elucidate mechanisms of action of t-PBM, prior to treatment, subjects will undergo neuroimaging related to critical features of AD: tau 18F MK-6240 load (PET), measures of brain bioenergetics (31P-MRS), and functional connectivity (rs-fMRI). After undergoing target engagement testing (t-PBM session performed during fMRI to detect BOLD changes with active t-PBM), subjects will then be randomized to t-PBM/sham and complete 24 t-PBM/sham treatments, \~11 min per day, 3 days per week, for 8 weeks. t-PBM will be administered via continuous, 808 nm wavelength laser delivery to the forehead bilaterally (at standard EEG electrode positions F4, F3). Alzheimer Phase 2 Remyélinisation indirecte / réparation United States À vérifier
Transcutaneous electrical nerve stimulation unit (TENS)The purpose of this pilot interventional study is to collect preliminary data on the application of a transcutaneous auricular vagal nerve stimulation (taVNS) device in patients with chronic kidney disease (CKD). This data will enhance understanding of the short-term safety, tolerability and effects of this novel therapeutic approach in the setting of CKD. The primary aims are to investigate the feasibility of the protocol and generate preliminary signals of efficacy and tolerability for two different doses of vagal nerve stimulation. The pilot estimates will be used to design a larger scale study that may lead to potentially targeted interventions to reduce cardiovascular (CV) mortality in the CKD population. Maladie rénale chronique Non applicable À vérifier United States À vérifier
YOPD — Young Onset Parkinson's Disease Subtypes and Pathogenic MechanismsYoung Onset Parkinson's disease (YOPD) refers to a group of patients in which the disease starts earlier in life (before the age of 50 years) and has a profound impact on most of patient's life. Current knowledge regarding the mechanisms leading to development of Parkinson's disease in younger individuals is lacking, but their understanding is crucial for the successful design of therapeutic strategies and stratifying patients for clinical trials. With this research the investigators aim to clarify the contribution of relevant biological processes in patients with Young onset Parkinson's disease to help understanding disease mechanisms and biomarkers. Parkinson À vérifier À vérifier United States À vérifier
HydroxychloroquineWomen with antibodies to proteins called SSA/Ro and or SSB/La face a 2% chance of having a child with a life threatening heart condition regardless of whether they have very active lupus, are in remission, or have only vague symptoms. This heart problem is referred to as congenital heart block (the most serious being third degree complete block) and represents damage thought to be caused by these autoantibodies. The heart beats abnormally slowly and almost all children require permanent pacemakers before the age of 20. Importantly, women who have had one child with heart block have a ten-fold higher risk of having another child with the same heart condition. Unfortunately, even close monitoring by special techniques during pregnancy does not reverse complete heart block once it is observed. Thus, treatments aimed at prevention are critical. This study will evaluate for the first time whether hydroxychloroquine, a drug used by many patients with SLE, prevents the development of this heart condition. Data from laboratory experiments suggests that this drug, which crosses the placenta, may decrease the inflammation initiated by the passage of anti-Ro antibodies to the fetus. The study uses a Simon's 2-Stage design, and plans to enroll 19 patients in Stage 1 and 35 patients in Stage 2 if Stage 1 is successful. Patients can already be on hydroxychloroquine or will be started as soon as pregnancy is confirmed. The hope is that fewer than 3 cases of heart block will occur in Stage 1, and fewer than 6 cases will occur out of all 54 patients if Stage 2 is reached. The results of this study are expected to become an integral part of the counseling of women with anti-Ro/La antibodies who are considering pregnancy. Lupus Phase 2 Immunomodulation + Traitement symptomatique United States À vérifier
PET-MR ScanAfrican-Americans (AAs) have an increased prevalence of both Alzheimer's disease (AD) and vascular risk factors for AD such as diabetes and hypertension when compared to whites. However, in a recent community based study of non-demented elderly, black race was associated with higher amyloid burden after adjusting for vascular risk factors, suggesting the presence of additional physiological differences on AD-risk by race in the early stages of the disease. The purpose of this study is to test whether poor slow wave sleep (SWS) quantity (SWS duration) and quality (slow wave activity, SWA) is one of these physiological factors. To test these hypotheses, the investigators will perform community outreach in churches and community-based organizations in Brooklyn and other NYC boroughs with which we have created substantial ties in recent years. In consultation with community stakeholders, the investigators will recruit 150 cognitively normal AA elderly (age 60-75) and 60 age, sex, BMI, income and education matched non-Hispanic whites from the same geographical areas. Investigators will first perform a medical and cognitive evaluation (Visit 1). Participants will then undergo 2 nights of home sleep monitoring using an unattended device to exclude OSA, followed by 7 days of actigraphy with a sleep log to record sleep duration. Both devices will be returned by mail. Subjects with reported total sleep time (TST) between 5 and 10 hours and absence of moderate to severe OSA will be invited to perform a 2-night nocturnal polysomnography (NPSG) (Nights 1-2) and a PiB-PET MR scan (Visit 2). Alzheimer À vérifier À vérifier United States À vérifier
MemantineDescription non affichée : incohérence de maladie détectée. Consultez l’essai clinique officiel associé. Sclérose latérale amyotrophique Phase 2 Ralentissement de la progression United States À vérifier
Remotely Supervised Transcranial Direct Current Stimulation (RS - tDCS)Growing evidence suggests that vagal nerve stimulation (VNS) may be novel and effective in the management of the symptom burden of multiple sclerosis (MS) potentially by reducing inflammation and emotional distress, therefore improving overall well-being. We will complete a pilot study comparing transcutaneous auricular vagus nerve stimulation (taVNS) and transcutaneous cervical vagus nerve stimulation (tcVNS) to a standard intervention of dorsolateral prefrontal cortex (DLPFC) transcranial direct current stimulation (tDCS) as an active control. The primary outcome will be feasibility and the preliminary efficacy data concerning self-reported symptom reduction to inform the design of an intervention, and estimated power needed to complete a larger sham-controlled RCT. We will also measure heart rate variability (HRV), an easily obtained biomarker of vagus nerve stimulation (VNS), in correspondence to intervention response. SEP Non applicable Immunomodulation + Traitement symptomatique United States À vérifier
YOPD — Young Onset Parkinson's Disease Subtypes and Pathogenic MechanismsYoung Onset Parkinson's disease (YOPD) refers to a group of patients in which the disease starts earlier in life (before the age of 50 years) and has a profound impact on most of patient's life. Current knowledge regarding the mechanisms leading to development of Parkinson's disease in younger individuals is lacking, but their understanding is crucial for the successful design of therapeutic strategies and stratifying patients for clinical trials. With this research the investigators aim to clarify the contribution of relevant biological processes in patients with Young onset Parkinson's disease to help understanding disease mechanisms and biomarkers. Parkinson À vérifier À vérifier United States À vérifier
MemantineThe purpose of this study is to determine if memantine at up to 20 mg twice a day when used in conjunction with riluzole, can slow down the disease progression of patients with ALS including potentially improving their neuropsychiatric changes, as well as determine if serum biomarkers can be used both as a diagnostic and a prognostic marker in patients with ALS. Funding Source: FDA - Orphan Products Development (OPD) Alzheimer Phase 4 Ralentissement de la progression United States À vérifier
HEAL-SLE: Holistic Energy for Alleviating Lupus SymptomsThe purpose of this study is to assess the efficacy, feasibility, and acceptability of Virtual Reiki therapy as a complementary treatment for patients with systemic lupus erythematosus (SLE). The study also aims to investigate the feasibility, acceptability, and adherence of integrating Virtual Reiki therapy within the healthcare system for patients with SLE. Participants receiving standard of care (SOC) treatment for SLE will continue SOC while receiving research-specific Virtual Reiki therapy once per week for 8 weeks. Each study session will be delivered remotely by a Certified Reiki Practitioner Level II or higher. Lupus Non applicable Traitement symptomatique United States À vérifier
HydroxychloroquineWomen with antibodies to proteins called SSA/Ro and or SSB/La face a 2% chance of having a child with a life threatening heart condition regardless of whether they have very active lupus, are in remission, or have only vague symptoms. This heart problem is referred to as congenital heart block (the most serious being third degree complete block) and represents damage thought to be caused by these autoantibodies. The heart beats abnormally slowly and almost all children require permanent pacemakers before the age of 20. Importantly, women who have had one child with heart block have a ten-fold higher risk of having another child with the same heart condition. Unfortunately, even close monitoring by special techniques during pregnancy does not reverse complete heart block once it is observed. Thus, treatments aimed at prevention are critical. This study will evaluate for the first time whether hydroxychloroquine, a drug used by many patients with SLE, prevents the development of this heart condition. Data from laboratory experiments suggests that this drug, which crosses the placenta, may decrease the inflammation initiated by the passage of anti-Ro antibodies to the fetus. The study uses a Simon's 2-Stage design, and plans to enroll 19 patients in Stage 1 and 35 patients in Stage 2 if Stage 1 is successful. Patients can already be on hydroxychloroquine or will be started as soon as pregnancy is confirmed. The hope is that fewer than 3 cases of heart block will occur in Stage 1, and fewer than 6 cases will occur out of all 54 patients if Stage 2 is reached. The results of this study are expected to become an integral part of the counseling of women with anti-Ro/La antibodies who are considering pregnancy. Lupus Phase 3 Immunomodulation + Traitement symptomatique United States À vérifier
Active taVNSThe aim of this clinical trial is to determine if trans-auricular vagus nerve stimulation (taVNS) is effective in improving upper extremity function in stroke survivors. The primary objectives include: Investigating whether taVNS improves motor function in stroke survivors. The secondary objectives include: Assessing any potential side effects associated with the method. Investigating taVNS effects on daily routine functions and spasticity Researchers will conduct a comparative analysis between taVNS and a sham procedure (which mimics the stimulation without any actual effect) to assess its effectiveness. Participants in the trial will: Undergo taVNS combined with physical therapy or a sham procedure with physical therapy daily over a two-week period. SEP Non applicable Traitement symptomatique Brazil À vérifier
MemantineThe purpose of this study is to determine if memantine at up to 20 mg twice a day when used in conjunction with riluzole, can slow down the disease progression of patients with ALS including potentially improving their neuropsychiatric changes, as well as determine if serum biomarkers can be used both as a diagnostic and a prognostic marker in patients with ALS. Funding Source: FDA - Orphan Products Development (OPD) Alzheimer Phase 2/3 Neuroprotection + Ralentissement de la progression Egypt À vérifier
Active taVNSThe aim of this clinical trial is to determine if trans-auricular vagus nerve stimulation (taVNS) is effective in improving upper extremity function in stroke survivors. The primary objectives include: Investigating whether taVNS improves motor function in stroke survivors. The secondary objectives include: Assessing any potential side effects associated with the method. Investigating taVNS effects on daily routine functions and spasticity Researchers will conduct a comparative analysis between taVNS and a sham procedure (which mimics the stimulation without any actual effect) to assess its effectiveness. Participants in the trial will: Undergo taVNS combined with physical therapy or a sham procedure with physical therapy daily over a two-week period. SEP Non applicable Traitement symptomatique Belgium À vérifier
Home Urine TestingStudy participants enrolled in the SAMPLE Biorepository (s14-00487) who have provided permission to be contacted for future research will be enrolled and randomized (1:1) two-arm controlled) to either 1) perform weekly home-based proteinuria testing in addition to standard of care or 2) standard of care only. Participants randomized to the home-based proteinuria testing arm will perform weekly home-based proteinuria testing in addition to having standard of care and respond to study team's weekly text messages with urine test results for one year. Lupus Non applicable À vérifier United States À vérifier
Sham TMS3 stimulationThe purpose of this protocol is to learn about movement intention and volition. To improve such knowledge, investigators will conduct sub-studies using multiple non-invasive methodologies. These results could provide preliminary data for subsequent studies evaluating local and global efficacy of plasticity-inducing treatments for PMD symptoms. Épilepsie Non applicable Traitement symptomatique United States À vérifier
POWERbreathe KH2The primary objective of this study is to evaluate the feasibility and safety of inspiratory muscle training (IMT) when implemented as part of routine inpatient physical therapy care in patients undergoing evaluation for advanced heart therapies. The secondary aim is to determine if IMT improves 6-minute walk test (6MWT), dyspnea, Maximal Inspiratory Pressure (MIP) pre-operatively. Thirdly, to determine if IMT decreases ICU and hospital length of stay post-operatively. Insuffisance cardiaque Non applicable À vérifier United States À vérifier
SARS-COV-2 mRNA VaccineSevere acute respiratory coronavirus 2 (SARS-CoV-2) is a novel coronavirus and the causative agent of COVID 19 disease, whose presentation symptoms range from asymptomatic infection to mild flu-like symptoms to multi system failure and death, resulting in significant morbidity and mortality worldwide. Novel vaccines against the SARS-CoV-2 virus have very recently been developed; however, the effectiveness, immune response, and short- or long-term safety of these vaccines have not been tested in immunocompromised patients on anti-CD-20 therapy for multiple sclerosis (MS) or for other disorders. This study will examine the immune response of the Pfizer-BioNTech and Moderna messenger RNA (mRNA)-platform vaccines developed against SARS-CoV-2 virus given as standard of care (SOC) in MS patients on ocrelizumab. SEP À vérifier Traitement symptomatique United States À vérifier
Active tPBM-2.0This multi-site study will be the first to evaluate the dose-dependent effects of t-PBM in amnestic Mild Cognitive Impairment (aMCI) and early Alzheimer's Disease (AD) (CDR of 0.5-1, FAST 1-4; age 65-85) in a randomized clinical trial of 8 weeks of t-PBM vs. sham. At baseline, all subjects will complete initial neuropsychological testing. To elucidate mechanisms of action of t-PBM, prior to treatment, subjects will undergo neuroimaging related to critical features of AD: tau 18F MK-6240 load (PET), measures of brain bioenergetics (31P-MRS), and functional connectivity (rs-fMRI). After undergoing target engagement testing (t-PBM session performed during fMRI to detect BOLD changes with active t-PBM), subjects will then be randomized to t-PBM/sham and complete 24 t-PBM/sham treatments, \~11 min per day, 3 days per week, for 8 weeks. t-PBM will be administered via continuous, 808 nm wavelength laser delivery to the forehead bilaterally (at standard EEG electrode positions F4, F3). Alzheimer Phase 2 Remyélinisation indirecte / réparation United States À vérifier
Herpes Zoster Subunit (HZ/su) VaccineThis randomized, double-blind, placebo-controlled, non-inferiority crossover study will evaluate the Herpes Zoster Sunbit (HZ/su) vaccine in SLE patients in order to evaluate safety and immunogenicity in patients with variable baseline clinical activities, ages and immunosuppressant exposures. The investigators hypothesize that HZ/su administration will be non-inferior to placebo with respect to the risk of moderate or severe SLE flare(s) occurring within 24 weeks of receiving the first dose of the assigned treatment. In addition, the investigators hypothesize that immunogenicity of the vaccine in SLE patients will be at least 50% of levels observed in healthy subjects from prior large clinical trials. Lupus Phase 4 À vérifier United States À vérifier
Active taVNSThe aim of this clinical trial is to determine if trans-auricular vagus nerve stimulation (taVNS) is effective in improving upper extremity function in stroke survivors. The primary objectives include: Investigating whether taVNS improves motor function in stroke survivors. The secondary objectives include: Assessing any potential side effects associated with the method. Investigating taVNS effects on daily routine functions and spasticity Researchers will conduct a comparative analysis between taVNS and a sham procedure (which mimics the stimulation without any actual effect) to assess its effectiveness. Participants in the trial will: Undergo taVNS combined with physical therapy or a sham procedure with physical therapy daily over a two-week period. Maladie rénale chronique Non applicable Traitement symptomatique United States À vérifier
Nocturnal polysomnography (NPSG)Growing evidence suggests that Alzheimer's disease (AD) pathological changes begin decades before clinical symptoms and tau abnormalities in the locus coeruleus (LC) can be observed since midlife. We have previously demonstrated functional vulnerability of the LC to aging and stress, as well as an association between higher cerebrospinal fluid (CSF) tau and impaired sleep phenomena influenced by the LC. We now aim to test whether LC dysfunction can be measured in preclinical AD stages by LC targeted imaging, and whether it objectively affects sleep architecture and attention. We will test this hypothesis in 30 cognitively normal older adults by performing a full clinical evaluation, one night of polysomnography, a lumbar puncture to obtain cerebrospinal fluid, \[11C\]MRB PET-MR, and attention testing. This study has the potential to identify a new mechanism by which tau pathology contributes to sleep and attention dysfunction and may provide a new therapeutic target for AD prevention. Alzheimer Non applicable Traitement symptomatique United States À vérifier
Empagliflozin 10 MGA 12-week, phase II, randomized, double-blind, placebo-controlled, multi-center study to assess the safety, tolerability, and preliminary efficacy of empagliflozin versus placebo among patients initiating hemodialysis (n=60) for the treatment of end-stage kidney disease. Maladie rénale chronique Phase 2 À vérifier United States À vérifier
Transcutaneous electrical nerve stimulation unit (TENS)The purpose of this pilot interventional study is to collect preliminary data on the application of a transcutaneous auricular vagal nerve stimulation (taVNS) device in patients with chronic kidney disease (CKD). This data will enhance understanding of the short-term safety, tolerability and effects of this novel therapeutic approach in the setting of CKD. The primary aims are to investigate the feasibility of the protocol and generate preliminary signals of efficacy and tolerability for two different doses of vagal nerve stimulation. The pilot estimates will be used to design a larger scale study that may lead to potentially targeted interventions to reduce cardiovascular (CV) mortality in the CKD population. Maladie rénale chronique Non applicable À vérifier United States À vérifier
PBI Radiotherapy 6 GyThe purpose of this study is to test whether a radiotherapy regimen of 8 GY x 3 days over 5 days (every other day) is as safe (well-tolerated) and effective as 6 Gy x 5 over five consecutive days Cancer Non applicable À vérifier United States À vérifier

Essais cliniques

26
MoléculeIndication / populationPhaseNCTTitreStatut
PBI Radiotherapy 6 Gy Cancer Non applicable NCT02276885 Prone Partial Breast Irradiation (PBI): a Prospective Randomized Trial COMPLETED
Transcutaneous electrical nerve stimulation unit (TENS) Maladie rénale chronique Non applicable NCT05981183 Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population RECRUITING
Empagliflozin 10 MG Maladie rénale chronique Phase 2 NCT05786443 SEED — Safety and Efficacy of Empagliflozin in Hemodialysis ACTIVE_NOT_RECRUITING
Nocturnal polysomnography (NPSG) Alzheimer Non applicable NCT04403165 LEAD — Locus-coeruleus Function in Normal Elderly and AD Risk COMPLETED
Active taVNS Maladie rénale chronique Non applicable NCT06927024 Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Chronic Kidney Disease (CKD) RECRUITING
Herpes Zoster Subunit (HZ/su) Vaccine Lupus Phase 4 NCT05559671 Safety of the Herpes Zoster Subunit Vaccine in Lupus RECRUITING
Active tPBM-2.0 Alzheimer Phase 2 NCT04784416 Transcranial Photobiomodulation for Alzheimer's Disease (TRAP-AD) COMPLETED
SARS-COV-2 mRNA Vaccine SEP À vérifier NCT04843774 Vaccine-generated Immunity in Ocrelizumab-treated Patients: Longitudinal Assessments (VIOLA) COMPLETED
POWERbreathe KH2 Insuffisance cardiaque Non applicable NCT07862738 Inspiratory Muscle Training in Hospitalized Patients With Heart Failure Awaiting Advanced Therapies NOT_YET_RECRUITING
Histotripsie — HistoSonics Edison System Cancer Non applicable NCT07853690 Histotripsy in Biliary Tract Cancer RECRUITING
Ocrelizumab SEP À vérifier NCT04855617 Symptom Burden in Patients Treated With Ocrelizumab for Multiple Sclerosis COMPLETED
Sham TMS3 stimulation Épilepsie Non applicable NCT03233399 Modulating Movement Intention Via Cortical Stimulation RECRUITING
Home Urine Testing Lupus Non applicable NCT07823478 HEALTH Home Urinalysis Testing RECRUITING
Active taVNS SEP Non applicable NCT07017257 taVNS-PPCS — Transcutaneous Auricular Vagus Nerve Stimulation for Persistent Post-concussion Symptoms RECRUITING
Memantine Alzheimer Phase 2/3 NCT07504198 Neuroprotection of Memantine and Rosuvastatin NOT_YET_RECRUITING
Active taVNS SEP Non applicable NCT07132021 Efficacy of Trans-auricular Vagus Nerve Stimulation on Upper Extremity Motor Recovery in Stroke Survivors RECRUITING
Hydroxychloroquine Lupus Phase 3 NCT05799378 SHIELD — Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease RECRUITING
HEAL-SLE: Holistic Energy for Alleviating Lupus Symptoms Lupus Non applicable NCT07203157 HEAL-SLE: Holistic Energy for Alleviating Lupus Symptoms ACTIVE_NOT_RECRUITING
Memantine Alzheimer Phase 4 NCT00933608 Effects of Memantine on Magnetic Resonance (MR) Spectroscopy in Subjects at Risk for Alzheimer's Disease COMPLETED
YOPD — Young Onset Parkinson's Disease Subtypes and Pathogenic Mechanisms Parkinson À vérifier NCT07752355 YOPD — Young Onset Parkinson's Disease Subtypes and Pathogenic Mechanisms RECRUITING
Remotely Supervised Transcranial Direct Current Stimulation (RS - tDCS) SEP Non applicable NCT06816004 VANISH-MS — Noninvasive Vagal Nerve Stimulation ACTIVE_NOT_RECRUITING
Memantine Sclérose latérale amyotrophique Phase 2 NCT02118727 Therapy in Amyotrophic Lateral Sclerosis (TAME) COMPLETED
PET-MR Scan Alzheimer À vérifier NCT03814603 Sleep AWARE — The Sleep Amyloid, Slow WAve Race and Ethnicity Study COMPLETED
Atorvastatin Lupus Phase 2 NCT00412841 Atorvastatin to Prevent Avascular Necrosis of Bone in Steroid Treated Exacerbated Systemic Lupus Erythematosus TERMINATED
Transcranial Direct Current Stimulation (TDCS) Épilepsie NA NCT02263274 Direct Cortical Measurement of the Intensity and Pattern of Current Flow Produced by TDCS COMPLETED
Hydroxychloroquine Lupus Phase 2 NCT01379573 Preventive Approach to Congenital Heart Block With Hydroxychloroquine COMPLETED

Publications

38
MoléculeIndication / populationTitreJournalDate
Transcutaneous electrical nerve stimulation unit (TENS) Transcutaneous auricular vagus nerve stimulation improves dysautonomia in patients with hypermobile Ehlers-Danlos syndrome. Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology
Transcutaneous electrical nerve stimulation unit (TENS) Optimizing Percutaneous Tibial Nerve Stimulation Intensity for Overactive Bladder Using a Motion Capture System. Neuromodulation : journal of the International Neuromodulation Society
Transcutaneous electrical nerve stimulation unit (TENS) Effects of continuous vs. intermittent transcutaneous electrical stimulation of the auriculotemporal nerve on nociceptive processing: a pilot randomized controlled double-blind crossover trial in asymptomatic volunteers. Cranio : the journal of craniomandibular practice
Memantine Treatment of animal models of Alzheimer's disease with extracellular vesicles or exosomes and involvement of microRNAs. Neural regeneration research
Memantine The multivariate genetic architecture of psychiatric and insulin resistance multimorbidity. European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology
Memantine Pressure-induced suppression of supramolecular dynamics in hydrogen-bonded adamantane derivative. Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy
Hydroxychloroquine Divergent neurobehavioral effects of hydroxychloroquine and leflunomide in a rat model of rheumatoid arthritis. Neuropharmacology
Hydroxychloroquine Treatment of discoid lupus erythematosus with crisaborole. The Journal of dermatological treatment
Hydroxychloroquine An explainable machine learning model for predicting in-hospital infection in patients with systemic lupus erythematosus. Renal failure
Remotely Supervised Transcranial Direct Current Stimulation (RS - tDCS) Telehealth tDCS to reduce cannabis use: A pilot RCT in multiple sclerosis as a framework for generalized use. Drug and alcohol dependence
Memantine Docking Analysis of Drugs Used in the Treatment of Alzheimer's Disease, Using Cell Membrane Receptors and Enzymes of the Kynurenine Pathway: A Pilot Study. International journal of molecular sciences
MRI, Venipuncture Secondary polycythemia as a rare cause of ischemic stroke: A case report. Radiology case reports
MRI, Venipuncture Iron overload cardiomyopathy. Heart failure reviews
Hydroxychloroquine Eosinophilic Annular Erythema Completely Reactive to Dapson: A Case Report. The Journal of dermatology
Hydroxychloroquine Hydroxychloroquine Exposure Intensity During Early Pregnancy and Composite Fetal Adverse Pregnancy Outcomes in Systemic Lupus Erythematosus: A Retrospective Cohort Study. Journal of clinical medicine
Remotely Supervised Transcranial Direct Current Stimulation (RS - tDCS) Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines (2017-2025: An update) - endorsed by the European Society for Brain Stimulation (ESBS) and by the International Federation for Clinical Neurophysiology (IFCN). Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology
Remotely Supervised Transcranial Direct Current Stimulation (RS - tDCS) Exploring the Effects of Remotely Supervised Transcranial Direct Current Stimulation on Motor Outcomes in Multiple Sclerosis: A Systematic Review. NeuroRehabilitation
PiB Defect-Regulated Cubic Prussian Blue Analog Cathodes With Exceptional Stability for Potassium-Ion Batteries. Small (Weinheim an der Bergstrasse, Germany)
PiB High prevalence of tau pathologies in late-onset psychosis: A PET study. Molecular psychiatry
PET-MR Scan Angiogenesis PET/MRI predicts initial growth of sporadic vestibular schwannomas: a prospective study with follow-up in 29 patients using [Ga]Ga-NODAGA-E[c(RGDyK)]. EJNMMI research
PET-MR Scan Multimodal topographic properties of white matter functional segregation in Alzheimer's disease: A simultaneous PET/MR study. European journal of radiology
Hydroxychloroquine Symbiosis modulates pharmaceutical toxicity and contaminant fate in the Azolla-Nostoc system. Chemosphere
Hydroxychloroquine [Sarcoidosis-associated uveitis: Current status and future prospects]. La Revue de medecine interne
Hydroxychloroquine Cardiopulmonary Manifestations of Systemic Sclerosis: Pathophysiology, Clinical Presentation, and Management. Cardiology in review
Hydroxychloroquine A Rare Diagnostic Dilemma of P-ANCA/MPO Positive Crescentic Glomerulonephritis in an Immunosuppressed Lupus Patient. Case reports in nephrology
Hydroxychloroquine Hydroxychloroquine Retinopathy in Systemic Lupus Erythematosus: Risk Factors, Screening, and Emerging Biomarkers. Journal of ophthalmology
MRI, Venipuncture Interesting neuroimaging findings in a child with hyperlipidemia: a case report. BMC pediatrics
MRI, Venipuncture Nurse led first seizure clinics-a dangerous experiment or an effective alternative to the norm? Epilepsy & behavior : E&B
Hydroxychloroquine Purpura as the initial manifestation of IgG4-related disease with concomitant systemic lupus erythematosus: a case report. Frontiers in medicine
Hydroxychloroquine Management of Uncomplicated Plasmodium vivax Malaria in a Pregnant Patient With G6PD Deficiency. Cureus
Hydroxychloroquine Nasal Manifestations of Immunoglobulin A (IgA) Vasculitis in an Adolescent Patient: A Case Report. Cureus
Hydroxychloroquine Atypical Lower Extremity Discoid Lupus Erythematosus Associated With Newly Diagnosed Systemic Lupus Erythematosus in a Male Patient: A Case Report. Cureus
Hydroxychloroquine Hydroxychloroquine-induced retinopathy in Puerto Ricans with systemic lupus erythematosus: Associated factors and early-onset risk. Lupus
Hydroxychloroquine Zeaxanthin Mitigates Hydroxychloroquine-Induced Retinal Toxicity and Metabolic Reprogramming in ARPE-19 Cells. Journal of biochemical and molecular toxicology
Hydroxychloroquine Diagnosis to dialogue: Reproductive health conversations and guideline adherence in women with lupus. Lupus
Hydroxychloroquine Treatments in oral lichen planus: a review. Frontiers in oral health
Hydroxychloroquine Agomelatine for Sjögren's syndrome: a study on its therapeutic effects and mechanisms. Inflammopharmacology
Hydroxychloroquine Targeting lysosomes with a novel chloroquine derivative induces irreversible lysosomal damage and disrupts autophagosome and lysosome assembly in cancer. Autophagy