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Duke University
Traitements, essais et publications liés.
Traitements42programmes
Essais22liés
Publications21liées
SourceDBlocale
Traitements
42| Molécule | Indication / population | Phase | Objectif | Pays | Résultat |
|---|---|---|---|---|---|
| 5% lidocaine/5 mg/ml 0.02% estradiol compound creamVestibulodynia (VBD) is a complex chronic vulvar pain condition that impairs the psychological, physical, and sexual health of 1 in 6 reproductive aged women in the United States. Here, the investigators plan to conduct a randomized, double-blinded, placebo-controlled clinical trial to 1) compare the efficacy of peripheral (lidocaine/estradiol cream), centrally-targeted (nortriptyline), and combined treatments in alleviating pain and improving patient-reported outcomes and 2) determine cytokine and microRNA biomarkers that predict treatment response in women with distinct VBD subtypes. Positive findings from this study will readily translate to improved patient care, permitting the millions of women with VBD, their partners, and their clinicians to make more informed decisions about pain management. | Migraine | Phase 2 | Traitement symptomatique | United States | À vérifier |
| ADRC Clinical Cohort (Alzheimer's Disease)The purpose of the study is to establish a clinical cohort for the Duke/UNC Alzheimer's Disease Research Center (ADRC). The cohort will be composed of subjects ages 25 to 44 at enrollment with normal cognition and subjects ages 45 to 80 at enrollment with normal cognition, mild cognitive impairment, or a dementia diagnosis. Initial data including demographics, medical and family history, physical exam, and neuropsychological testing will be obtained. Participants will be asked to contribute a blood sample, a urine sample, a cerebrospinal fluid sample, and undergo a MRI scan. The cohort ages 45 to 80 will be seen yearly until death to evaluate medical status, undergo neuropsychological testing and possibly collect additional samples or undergo additional imaging. All data will be de-identified and stored by the ADRC. The purpose of this study is to examine normal cognition, mild cognitive impairment and Alzheimer's disease and related dementias (ADRD) as people get older. The investigators also hope to be able to assess risk factor information of the role of genes and environmental exposures (for example health conditions, diet, and medications) in Alzheimer's disease and related disorders (ADRD) and other conditions of aging. The biological samples collected in the study will create a repository. A repository is a collection of blood and tissue samples from people with certain diseases and conditions. For the purpose of this research, the investigators hope to help researchers learn more about Alzheimer's disease and related disorders and other conditions of aging. | Alzheimer | À vérifier | À vérifier | United States | À vérifier |
| Alarm systemEpilepsy affects millions worldwide, with 40% of patients experiencing uncontrolled seizures despite medication. Comprehensive epilepsy centers recommend continuous video-electroencephalography monitoring to define seizure type and distinguish mimickers. This process, however, is resource-intensive, with lengthy hospital stays. The investigators' recent study identified a heightened association between arousals and epileptic activity in drug-resistant focal epilepsy patients. Building on these findings, the investigators aim to explore whether disrupting sleep with an alarm system triggers earlier occurrence of seizures, potentially offering insights to reduce hospital stay durations in epilepsy monitoring units. | Épilepsie | Non applicable | À vérifier | À vérifier | |
| ANT recording and stimulationIn this study, the investigator aims to perform cortical stereo electroencephalogram (sEEG) recordings during simultaneous anterior nucleus of the thalamus (ANT) recording and stimulation to better understand the following: 1) how the ANT is involved in various seizure types; 2) which cortical regions are modulated by established ANT stimulation patterns; and 3) how novel ANT stimulation patterns modify epileptogenic cortical activity. Together, this knowledge will advance ANT deep brain stimulation (DBS) therapy by providing a physiologic basis for patient selection for ANT DBS, while identifying brain signals and stimulation patterns that can be used to develop novel methods for ANT DBS. Up to 15 adult patients (18 and older) who present to Duke Neurosurgery for routine seizure localization using sEEG will be asked to enroll in this pilot study of ANT recording and stimulation. In the course of surgical epilepsy treatment, patients routinely undergo surgical placement of sEEG electrodes for the purposes of seizure localization. During this procedure, 2 additional leads will be placed in the ANT. These patients remain hospitalized for 7-14 days after sEEG placement, during which time their seizure medications are tapered. Concurrent video monitoring is performed while continuous neural recordings are made through the sEEG electrodes. Additionally, continuous recordings will be performed through the electrodes placed in the thalamus. Periodically, standard intermittent high-frequency stimulation (130 Hz, 90-ms pulse width, and 2 mA intensity) will be performed with a 60-s on and a 300-s off cycle after surgery. These standard ANT stimulation parameters are employed clinically. Data will include the sEEG recordings marked for ANT stimulation, any side effects, medications, past medical history (PMH), and tests/procedures during the hospital stay. Risks involved are as described for the standard depth electrode surgery with the addition of the possible side effects from the stimulation which include sensations of numbness and tingling, and possibly increased seizure activity. | Épilepsie | NA | À vérifier | United States | À vérifier |
| AzathioprineThis study is designed to address the evidence gaps in a real-world setting and help patients with MG choose treatments that are best suited to them. It is a prospective, multicenter observational cohort study of comparative effectiveness of MG treatments, with a patient-centered primary outcome measure, to guide clinicians, patients and payers regarding the choice of treatment options for this chronic and serious disease. Primary: To compare the effectiveness of azathioprine (AZT) and mycophenolate mofetil (MMF). Secondary: To compare the outcomes in patients receiving an adequate dose and duration of AZT or MMF over the 2-3 year study period, vs. patients not receiving adequate doses and duration of these agents | Myasthénie | À vérifier | À vérifier | United States, Canada | À vérifier |
| BALANCE — B6 Administration for Levetiracetam-Associated Neurobehavioral Changes and EpilepsyThis is a supportive care study to assess the effect of Vitamin B6 supplementation on mood-related side effects of levetiracetam in patients with brain tumors, who have already been prescribed levetiracetam for the prevention of seizures. This study will assess this effect from the perspective of both the patient and the patient's caregiver. Patients will receive Vitamin B6 as a supplement to take daily for 8 to 12 weeks, in addition to the already prescribed levetiracetam and will undergo study assessments as well as complete self-reported questionnaires to evaluate their mood during the course of the study. Additionally, each patient will be asked to optionally identify a designated caregiver, who will complete questionnaires assessing the patient's mood changes, at the same time interval as the patient. | Épilepsie | Non applicable | À vérifier | United States | À vérifier |
| Cerebellothalamic optimized deep brain stimulationThe objective of this research is to use advanced connectomic imaging models to identify disease-relevant axonal pathway targets for better tremor control in Parkinson's disease patients while avoiding undesirable side effects, with the goal of increasing precision and facilitating the choice of optimal DBS parameters for certain disease phenotypes. The investigators hypothesize that patient centered subthalamic nucleus deep brain stimulation of cerebellothalamic axonal pathways and pallidothalamic tract activation can provide better tremor control while avoiding worsening dyskinesias in patients with Parkinson's disease with significant tremor. | Parkinson | Non applicable | Neuroprotection | United States | À vérifier |
| DesipramineThis is a research study to find out if clinically prescribed desipramine is effective at improving the symptoms and slowing the progression of Infantile Neuroaxonal Dystrophy (INAD) in affected children. Participants will receive an initial oral dose of study drug once a day. This dose may be changed depending on response to study drug Clinically collected data will be recorded for up to 5 years. Investigators will also ask for participant permission to obtain a sample of child's skin biopsy from unused clinical sample previously collected for standard of care. | Myopathies | Phase 4 | Neuroprotection + Ralentissement de la progression + Traitement symptomatique | United States | À vérifier |
| Direct Electrical StimulationThis study evaluates whether a non-invasive brain stimulation technique called Temporal Interference (TI) can reduce epilepsy-related abnormal brain activity and influence sleep-related brain rhythms in adults with focal drug-resistant epilepsy undergoing stereo-EEG monitoring for clinical care. Up to 30 participants will complete stimulation sessions during wakefulness and, when possible, natural non-REM sleep. Brain activity will be recorded using scalp EEG and implanted sEEG electrodes before, during, and after TI stimulation. Some participants may also receive subthreshold direct stimulation through implanted electrodes for comparison. The study aims to determine whether TI can reduce epilepsy biomarkers, alter sleep-related brain activity, and compare favorably with conventional direct electrical stimulation while remaining within established safety limits. | Épilepsie | Non applicable | À vérifier | À vérifier | |
| DUKE PREVENT — Duke Cardiometabolic Prevention Clinic's Impact on High-risk Cardiovascular Patients With Uncontrolled Risk FactorsThis project is studying whether a team-based specialty clinic can help people with type 2 diabetes and heart disease better manage their blood pressure and cholesterol. The clinic includes coordinated care from heart doctors, kidney doctors, diabetes specialists, and liver doctors. The study will compare two groups of patients: one receiving usual care from their primary care provider, and one referred to the Duke Cardiometabolic Prevention Clinic for multidisciplinary care. The main goals are to find out if this clinic improves blood pressure and cholesterol control over 12 months, increases use of recommended heart medications, and reduces hospital visits and other healthcare use. Participants will be randomly assigned to one of the two groups. Those referred to the clinic will: 1) Meet with a cardiologist for an initial evaluation. 2) Be referred to other specialists (such as endocrinology, nephrology, or hepatology) based on their needs. 3) Receive ongoing, coordinated care from a team of specialists working together to improve their heart and metabolic health. | Hypertension | Non applicable | À vérifier | United States | À vérifier |
| Evaluation of Advanced Imaging and Visualization for Clinical Deep Brain StimulationThe objective of this project is to evaluate next generation visualization tools and surgical targeting models for clinical deep brain stimulation (DBS). This study will evaluate the performance of HoloDBS software in comparison to the current standard (SOC) clinical planning tools to prepare for DBS surgery. The investigators hypothesize that HoloDBS will provide more detailed and anatomically useful information to the neurosurgeon and neurologist than the current clinical standard. The study team reviews electronic medical records (EMR) from patients who are undergoing DBS surgery. There are no study visits involved in this study as only data from standard clinical care will be used. All study activities are executed by the study team and there are no interventions. | Parkinson | À vérifier | À vérifier | United States | À vérifier |
| GBPDC: Gut-Brain in PD Consortium Master ProtocolThe purpose of this research study is to identify the role that the gut-brain axis, the group of nerves that connect the brain and gut, plays in Parkinson's disease (PD). The National Institute of Diabetes and Digestive and Kidney Diseases is sponsoring this research study. During this study, specific groups of participants, also known as "cohorts", will be identified based on the severity of their PD. There will also be a cohort enrolling participants who do not have Parkinson's and a cohort enrolling participants that are at risk for developing PD. Each of these cohorts will be compared to the others to assess the differences in the gut-brain connection. Participants in this study will: * meet with a medical provider * answer questionnaires * give samples of blood, stool, and saliva * have X-rays taken while swallowing different foods (swallowing study) * have X-rays taken to see how long it takes markers to move through their colon (colon transit study) * have a flexible sigmoidoscopy, where a doctor looks inside the lower part of the colon and takes small tissue samples (biopsies) from the mucosa (lining) * have samples taken of their skin * have an anorectal manometry and a balloon expulsion test, where a small tube and balloon are placed in the rectum to measure muscle function. Participation in the study will last up to 24 months (2 years). | Parkinson | À vérifier | À vérifier | United States | À vérifier |
| Health Literacy ProjectEvaluating changes in knowledge, attitude, and practices (KAP) related to epilepsy and its treatment as a result of an educational intervention among adolescents with epilepsy to determine if improved KAP about epilepsy results in improved medication adherence and less perceived stigma. | Épilepsie | Non applicable | À vérifier | Uganda | À vérifier |
| High density micro-electrocorticography for neural speech prothesisThe overall purpose of this study is to better understand human cognition and human epilepsy by working with patients undergoing clinical treatment for pharmacologically resistant epilepsy. The investigators will investigate human cognition by conducting controlled experiments that focus on sensory, motor, and cognitive phenomena such as sensory processing, memory, and language. The investigators will also examine the neural underpinnings of epilepsy during both sleep and wakefulness to better understand both the foundations of epilepsy and how epilepsy affects cognition. The investigators hope to use these data to have a better understanding of cognition, epilepsy, and how the two interact. This will potentially lead to better markers for seizure onsets as well as epilepsy more generally. For this research, the investigators will use μECoG arrays manufactured by commercial partners. These arrays have passed all major ISO 10993 bio-compatibility tests. Based on this characterization and use in the intraoperative setting (limited duration and supervised usage), these devices pose a minimal risk to participants. Data will be analyzed and protected using the Duke SSRI protected research data network. | Épilepsie | Non applicable | À vérifier | À vérifier | |
| HOP-STEPsIRB — The HOP-STEP Intervention: Improving Maternal Health in Women With Lupus sIRBWhile the HOP-STEP (Healthy Outcomes in Pregnancy with SLE Through Education of Providers) program has been demonstrated to be effective in improving provider confidence, increasing contraception documentation, and facilitating equitable pregnancy planning care in a single sub-specialty clinic here at Duke, the delivery of HOP-STEP may need to be changed to increase its fit with the local context at the University of Chicago Medical Center (UCMC) and subsequent locations. Thus, the investigators will now fit the intervention into a high-minority, high-poverty academic rheumatology center, and later pilot it through a randomized trial to identify and overcome existing barriers to equitable pregnancy prevention and planning at another institution (The University of Chicago Medical Center). The objective of this study is to prepare for a multi-center trial of the HOP-STEP intervention by fitting and then piloting its implementation and measuring its potential impact on maternal outcomes. | Lupus | Non applicable | À vérifier | United States | À vérifier |
| levetiracetamThe purpose of this study is to determine the feasibility, efficacy and safety of intravenous and oral antiepileptic treatment with levetiracetam in patients with primary brain tumors and symptomatic epilepsy in the period of neurosurgical intervention. | Épilepsie, Sclérose latérale amyotrophique | Phase 2 | Traitement symptomatique | United States | À vérifier |
| mSaada: A Mobile Health ToolIn the R21 phase of this project, investigators will: (1) work with key stakeholders and local and international developers to finalize the mSaada platform, building on the existing prototype to add patient and specimen tracking functionality; and (2) carry out a pilot to identify the patient, provider and health system factors necessary to design a trial to evaluate mSaada effectiveness in assisting community health volunteer-led home-based HPV screening, and implementation factors. Investigators will carry out a six-month pilot of mSaada with community units in two health facilities providing HPV-based screening, and use performance metrics including system usage rates, workflow observations and qualitative data to guide the planning of a to determine effectiveness. In the R33 phase of the project, investigators plan to: (1) conduct an 18-month c-RCT across 12 health facilities to determine the impact of mSaada on cervical cancer screening uptake, treatment acquisition and cervical cancer knowledge levels among women in the community; and (2) measure the requisite implementation factors for mSaada effectiveness, sustainability, and scale-up. The rigorous study design will allow us to determine the clinical impact of mSaada, ensure the local and regional infrastructure has the capacity necessary for sustainability and develop strategies for widespread implementation and scale-up. Collaboration with key stakeholders from the Kenya Ministry of Health will facilitate the development of a long-term sustainability plan as the country moves toward HPV-based cervical cancer screening. Investigators anticipate the mSaada platform will play a pivotal role in facilitating the introduction of HPV-based screening programs that can reach women in settings with limited health care infrastructure. | Cancer | Non applicable | À vérifier | Kenya | À vérifier |
| MTP-101CDescription non affichée : incohérence de maladie détectée. Consultez l’essai clinique officiel associé. | Sclérose latérale amyotrophique | Phase 1/2 | À vérifier | United States | À vérifier |
| Multimodal Management of Neck and Back Pain in the Emergency Department (Multi-ED)The purpose of this study is to assess the feasibility and acceptability of psychologically-informed physical therapy (PIPT) in the ED in a pilot study of ED patients with neck or back pain. We will conduct a single-site, prospective trial comparing the combined program in one group with a usual care-only group. Primary outcomes will focus on feasibility based on recruitment and retention rates, and acceptability based on a 5-point patient satisfaction scale, while secondary outcomes will include pain severity, pain interference, anxiety, physical function, opioid use, repeat ED visits, and hospitalizations at 1 hour and at 24 hours, 1 month and 3 months after ED discharge. We will use pilot study results to develop a protocol for a larger pragmatic randomized clinical trial designed to rigorously evaluate PIPT in the ED combined with Spine Health follow up for ED patients with neck or back pain. We will perform a process evaluation of our proposed clinical trial study design, including characterizing and quantifying the degree of CBT and PT components used by treating PTs while in the ED and during Spine Health follow up, number of Spine Health visits attended in the first month, and integration into usual ED care. Qualitative interviews will be used to identify facilitators, barriers and potential solutions to intervention and research study procedures based on the patients' experience. | Myopathies | Non applicable | Traitement symptomatique | United States | À vérifier |
| Pallidothalamic optimized deep brain stimulationThe objective of this research is to use advanced connectomic imaging models to identify disease-relevant axonal pathway targets for better tremor control in Parkinson's disease patients while avoiding undesirable side effects, with the goal of increasing precision and facilitating the choice of optimal DBS parameters for certain disease phenotypes. The investigators hypothesize that patient centered subthalamic nucleus deep brain stimulation of cerebellothalamic axonal pathways and pallidothalamic tract activation can provide better tremor control while avoiding worsening dyskinesias in patients with Parkinson's disease with significant tremor. | Parkinson | Non applicable | Neuroprotection | United States | À vérifier |
| PiCASO — Peer i-Coaching for Activated Self-Management Optimization in Adolescents and Young Adults With Chronic ConditionsThe purpose of this study is to test the efficacy of a peer support coaching intervention to improve activated chronic illness self-management versus an attention control group in 225 adolescents and young adults with childhood onset chronic conditions. | Lupus | NA | À vérifier | United States | À vérifier |
| β-hydroxy-β-methylbutyrate (HMB)Description non affichée : incohérence de maladie détectée. Consultez l’essai clinique officiel associé. | Sclérose latérale amyotrophique | Phase 1 | Ralentissement de la progression | United States | À vérifier |
| Evaluation of Advanced Imaging and Visualization for Clinical Deep Brain StimulationThe objective of this project is to evaluate next generation visualization tools and surgical targeting models for clinical deep brain stimulation (DBS). This study will evaluate the performance of HoloDBS software in comparison to the current standard (SOC) clinical planning tools to prepare for DBS surgery. The investigators hypothesize that HoloDBS will provide more detailed and anatomically useful information to the neurosurgeon and neurologist than the current clinical standard. The study team reviews electronic medical records (EMR) from patients who are undergoing DBS surgery. There are no study visits involved in this study as only data from standard clinical care will be used. All study activities are executed by the study team and there are no interventions. | Parkinson | À vérifier | À vérifier | United States | À vérifier |
| DesipramineThis is a research study to find out if clinically prescribed desipramine is effective at improving the symptoms and slowing the progression of Infantile Neuroaxonal Dystrophy (INAD) in affected children. Participants will receive an initial oral dose of study drug once a day. This dose may be changed depending on response to study drug Clinically collected data will be recorded for up to 5 years. Investigators will also ask for participant permission to obtain a sample of child's skin biopsy from unused clinical sample previously collected for standard of care. | Myopathies | Phase 4 | Neuroprotection + Ralentissement de la progression + Traitement symptomatique | United States | À vérifier |
| ANT recording and stimulationIn this study, the investigator aims to perform cortical stereo electroencephalogram (sEEG) recordings during simultaneous anterior nucleus of the thalamus (ANT) recording and stimulation to better understand the following: 1) how the ANT is involved in various seizure types; 2) which cortical regions are modulated by established ANT stimulation patterns; and 3) how novel ANT stimulation patterns modify epileptogenic cortical activity. Together, this knowledge will advance ANT deep brain stimulation (DBS) therapy by providing a physiologic basis for patient selection for ANT DBS, while identifying brain signals and stimulation patterns that can be used to develop novel methods for ANT DBS. Up to 15 adult patients (18 and older) who present to Duke Neurosurgery for routine seizure localization using sEEG will be asked to enroll in this pilot study of ANT recording and stimulation. In the course of surgical epilepsy treatment, patients routinely undergo surgical placement of sEEG electrodes for the purposes of seizure localization. During this procedure, 2 additional leads will be placed in the ANT. These patients remain hospitalized for 7-14 days after sEEG placement, during which time their seizure medications are tapered. Concurrent video monitoring is performed while continuous neural recordings are made through the sEEG electrodes. Additionally, continuous recordings will be performed through the electrodes placed in the thalamus. Periodically, standard intermittent high-frequency stimulation (130 Hz, 90-ms pulse width, and 2 mA intensity) will be performed with a 60-s on and a 300-s off cycle after surgery. These standard ANT stimulation parameters are employed clinically. Data will include the sEEG recordings marked for ANT stimulation, any side effects, medications, past medical history (PMH), and tests/procedures during the hospital stay. Risks involved are as described for the standard depth electrode surgery with the addition of the possible side effects from the stimulation which include sensations of numbness and tingling, and possibly increased seizure activity. | Épilepsie | NA | À vérifier | United States | À vérifier |
| PiCASO — Peer i-Coaching for Activated Self-Management Optimization in Adolescents and Young Adults With Chronic ConditionsThe purpose of this study is to test the efficacy of a peer support coaching intervention to improve activated chronic illness self-management versus an attention control group in 225 adolescents and young adults with childhood onset chronic conditions. | Lupus | NA | À vérifier | United States | À vérifier |
| levetiracetamThe purpose of this study is to determine the feasibility, efficacy and safety of intravenous and oral antiepileptic treatment with levetiracetam in patients with primary brain tumors and symptomatic epilepsy in the period of neurosurgical intervention. | Épilepsie | Phase 4 | Traitement symptomatique | Germany | À vérifier |
| Multimodal Management of Neck and Back Pain in the Emergency Department (Multi-ED)The purpose of this study is to assess the feasibility and acceptability of psychologically-informed physical therapy (PIPT) in the ED in a pilot study of ED patients with neck or back pain. We will conduct a single-site, prospective trial comparing the combined program in one group with a usual care-only group. Primary outcomes will focus on feasibility based on recruitment and retention rates, and acceptability based on a 5-point patient satisfaction scale, while secondary outcomes will include pain severity, pain interference, anxiety, physical function, opioid use, repeat ED visits, and hospitalizations at 1 hour and at 24 hours, 1 month and 3 months after ED discharge. We will use pilot study results to develop a protocol for a larger pragmatic randomized clinical trial designed to rigorously evaluate PIPT in the ED combined with Spine Health follow up for ED patients with neck or back pain. We will perform a process evaluation of our proposed clinical trial study design, including characterizing and quantifying the degree of CBT and PT components used by treating PTs while in the ED and during Spine Health follow up, number of Spine Health visits attended in the first month, and integration into usual ED care. Qualitative interviews will be used to identify facilitators, barriers and potential solutions to intervention and research study procedures based on the patients' experience. | Myopathies | Non applicable | Traitement symptomatique | United States | À vérifier |
| levetiracetamThe purpose of this study is to determine the feasibility, efficacy and safety of intravenous and oral antiepileptic treatment with levetiracetam in patients with primary brain tumors and symptomatic epilepsy in the period of neurosurgical intervention. | Sclérose latérale amyotrophique | Phase 2 | Traitement symptomatique + Neuroprotection | United States | À vérifier |
| BALANCE — B6 Administration for Levetiracetam-Associated Neurobehavioral Changes and EpilepsyThis is a supportive care study to assess the effect of Vitamin B6 supplementation on mood-related side effects of levetiracetam in patients with brain tumors, who have already been prescribed levetiracetam for the prevention of seizures. This study will assess this effect from the perspective of both the patient and the patient's caregiver. Patients will receive Vitamin B6 as a supplement to take daily for 8 to 12 weeks, in addition to the already prescribed levetiracetam and will undergo study assessments as well as complete self-reported questionnaires to evaluate their mood during the course of the study. Additionally, each patient will be asked to optionally identify a designated caregiver, who will complete questionnaires assessing the patient's mood changes, at the same time interval as the patient. | Épilepsie | Non applicable | À vérifier | United States | À vérifier |
| 5% lidocaine/5 mg/ml 0.02% estradiol compound creamVestibulodynia (VBD) is a complex chronic vulvar pain condition that impairs the psychological, physical, and sexual health of 1 in 6 reproductive aged women in the United States. Here, the investigators plan to conduct a randomized, double-blinded, placebo-controlled clinical trial to 1) compare the efficacy of peripheral (lidocaine/estradiol cream), centrally-targeted (nortriptyline), and combined treatments in alleviating pain and improving patient-reported outcomes and 2) determine cytokine and microRNA biomarkers that predict treatment response in women with distinct VBD subtypes. Positive findings from this study will readily translate to improved patient care, permitting the millions of women with VBD, their partners, and their clinicians to make more informed decisions about pain management. | Migraine | Phase 2 | Traitement symptomatique | United States | À vérifier |
| mSaada: A Mobile Health ToolIn the R21 phase of this project, investigators will: (1) work with key stakeholders and local and international developers to finalize the mSaada platform, building on the existing prototype to add patient and specimen tracking functionality; and (2) carry out a pilot to identify the patient, provider and health system factors necessary to design a trial to evaluate mSaada effectiveness in assisting community health volunteer-led home-based HPV screening, and implementation factors. Investigators will carry out a six-month pilot of mSaada with community units in two health facilities providing HPV-based screening, and use performance metrics including system usage rates, workflow observations and qualitative data to guide the planning of a to determine effectiveness. In the R33 phase of the project, investigators plan to: (1) conduct an 18-month c-RCT across 12 health facilities to determine the impact of mSaada on cervical cancer screening uptake, treatment acquisition and cervical cancer knowledge levels among women in the community; and (2) measure the requisite implementation factors for mSaada effectiveness, sustainability, and scale-up. The rigorous study design will allow us to determine the clinical impact of mSaada, ensure the local and regional infrastructure has the capacity necessary for sustainability and develop strategies for widespread implementation and scale-up. Collaboration with key stakeholders from the Kenya Ministry of Health will facilitate the development of a long-term sustainability plan as the country moves toward HPV-based cervical cancer screening. Investigators anticipate the mSaada platform will play a pivotal role in facilitating the introduction of HPV-based screening programs that can reach women in settings with limited health care infrastructure. | Cancer | Non applicable | À vérifier | Kenya | À vérifier |
| MTP-101CDescription non affichée : incohérence de maladie détectée. Consultez l’essai clinique officiel associé. | Sclérose latérale amyotrophique | Phase 1/2 | À vérifier | United States | À vérifier |
| GBPDC: Gut-Brain in PD Consortium Master ProtocolThe purpose of this research study is to identify the role that the gut-brain axis, the group of nerves that connect the brain and gut, plays in Parkinson's disease (PD). The National Institute of Diabetes and Digestive and Kidney Diseases is sponsoring this research study. During this study, specific groups of participants, also known as "cohorts", will be identified based on the severity of their PD. There will also be a cohort enrolling participants who do not have Parkinson's and a cohort enrolling participants that are at risk for developing PD. Each of these cohorts will be compared to the others to assess the differences in the gut-brain connection. Participants in this study will: * meet with a medical provider * answer questionnaires * give samples of blood, stool, and saliva * have X-rays taken while swallowing different foods (swallowing study) * have X-rays taken to see how long it takes markers to move through their colon (colon transit study) * have a flexible sigmoidoscopy, where a doctor looks inside the lower part of the colon and takes small tissue samples (biopsies) from the mucosa (lining) * have samples taken of their skin * have an anorectal manometry and a balloon expulsion test, where a small tube and balloon are placed in the rectum to measure muscle function. Participation in the study will last up to 24 months (2 years). | Parkinson | À vérifier | À vérifier | United States | À vérifier |
| High density micro-electrocorticography for neural speech prothesisThe overall purpose of this study is to better understand human cognition and human epilepsy by working with patients undergoing clinical treatment for pharmacologically resistant epilepsy. The investigators will investigate human cognition by conducting controlled experiments that focus on sensory, motor, and cognitive phenomena such as sensory processing, memory, and language. The investigators will also examine the neural underpinnings of epilepsy during both sleep and wakefulness to better understand both the foundations of epilepsy and how epilepsy affects cognition. The investigators hope to use these data to have a better understanding of cognition, epilepsy, and how the two interact. This will potentially lead to better markers for seizure onsets as well as epilepsy more generally. For this research, the investigators will use μECoG arrays manufactured by commercial partners. These arrays have passed all major ISO 10993 bio-compatibility tests. Based on this characterization and use in the intraoperative setting (limited duration and supervised usage), these devices pose a minimal risk to participants. Data will be analyzed and protected using the Duke SSRI protected research data network. | Épilepsie | Non applicable | À vérifier | À vérifier | |
| DUKE PREVENT — Duke Cardiometabolic Prevention Clinic's Impact on High-risk Cardiovascular Patients With Uncontrolled Risk FactorsThis project is studying whether a team-based specialty clinic can help people with type 2 diabetes and heart disease better manage their blood pressure and cholesterol. The clinic includes coordinated care from heart doctors, kidney doctors, diabetes specialists, and liver doctors. The study will compare two groups of patients: one receiving usual care from their primary care provider, and one referred to the Duke Cardiometabolic Prevention Clinic for multidisciplinary care. The main goals are to find out if this clinic improves blood pressure and cholesterol control over 12 months, increases use of recommended heart medications, and reduces hospital visits and other healthcare use. Participants will be randomly assigned to one of the two groups. Those referred to the clinic will: 1) Meet with a cardiologist for an initial evaluation. 2) Be referred to other specialists (such as endocrinology, nephrology, or hepatology) based on their needs. 3) Receive ongoing, coordinated care from a team of specialists working together to improve their heart and metabolic health. | Hypertension | Non applicable | À vérifier | United States | À vérifier |
| HOP-STEPsIRB — The HOP-STEP Intervention: Improving Maternal Health in Women With Lupus sIRBWhile the HOP-STEP (Healthy Outcomes in Pregnancy with SLE Through Education of Providers) program has been demonstrated to be effective in improving provider confidence, increasing contraception documentation, and facilitating equitable pregnancy planning care in a single sub-specialty clinic here at Duke, the delivery of HOP-STEP may need to be changed to increase its fit with the local context at the University of Chicago Medical Center (UCMC) and subsequent locations. Thus, the investigators will now fit the intervention into a high-minority, high-poverty academic rheumatology center, and later pilot it through a randomized trial to identify and overcome existing barriers to equitable pregnancy prevention and planning at another institution (The University of Chicago Medical Center). The objective of this study is to prepare for a multi-center trial of the HOP-STEP intervention by fitting and then piloting its implementation and measuring its potential impact on maternal outcomes. | Lupus | Non applicable | À vérifier | United States | À vérifier |
| Cerebellothalamic optimized deep brain stimulationThe objective of this research is to use advanced connectomic imaging models to identify disease-relevant axonal pathway targets for better tremor control in Parkinson's disease patients while avoiding undesirable side effects, with the goal of increasing precision and facilitating the choice of optimal DBS parameters for certain disease phenotypes. The investigators hypothesize that patient centered subthalamic nucleus deep brain stimulation of cerebellothalamic axonal pathways and pallidothalamic tract activation can provide better tremor control while avoiding worsening dyskinesias in patients with Parkinson's disease with significant tremor. | Parkinson | Non applicable | Neuroprotection | United States | À vérifier |
| ADRC Clinical Cohort (Alzheimer's Disease)The purpose of the study is to establish a clinical cohort for the Duke/UNC Alzheimer's Disease Research Center (ADRC). The cohort will be composed of subjects ages 25 to 44 at enrollment with normal cognition and subjects ages 45 to 80 at enrollment with normal cognition, mild cognitive impairment, or a dementia diagnosis. Initial data including demographics, medical and family history, physical exam, and neuropsychological testing will be obtained. Participants will be asked to contribute a blood sample, a urine sample, a cerebrospinal fluid sample, and undergo a MRI scan. The cohort ages 45 to 80 will be seen yearly until death to evaluate medical status, undergo neuropsychological testing and possibly collect additional samples or undergo additional imaging. All data will be de-identified and stored by the ADRC. The purpose of this study is to examine normal cognition, mild cognitive impairment and Alzheimer's disease and related dementias (ADRD) as people get older. The investigators also hope to be able to assess risk factor information of the role of genes and environmental exposures (for example health conditions, diet, and medications) in Alzheimer's disease and related disorders (ADRD) and other conditions of aging. The biological samples collected in the study will create a repository. A repository is a collection of blood and tissue samples from people with certain diseases and conditions. For the purpose of this research, the investigators hope to help researchers learn more about Alzheimer's disease and related disorders and other conditions of aging. | Alzheimer | À vérifier | À vérifier | United States | À vérifier |
| Health Literacy ProjectEvaluating changes in knowledge, attitude, and practices (KAP) related to epilepsy and its treatment as a result of an educational intervention among adolescents with epilepsy to determine if improved KAP about epilepsy results in improved medication adherence and less perceived stigma. | Épilepsie | Non applicable | À vérifier | Uganda | À vérifier |
| Alarm systemEpilepsy affects millions worldwide, with 40% of patients experiencing uncontrolled seizures despite medication. Comprehensive epilepsy centers recommend continuous video-electroencephalography monitoring to define seizure type and distinguish mimickers. This process, however, is resource-intensive, with lengthy hospital stays. The investigators' recent study identified a heightened association between arousals and epileptic activity in drug-resistant focal epilepsy patients. Building on these findings, the investigators aim to explore whether disrupting sleep with an alarm system triggers earlier occurrence of seizures, potentially offering insights to reduce hospital stay durations in epilepsy monitoring units. | Épilepsie | Non applicable | À vérifier | À vérifier | |
| β-hydroxy-β-methylbutyrate (HMB)Description non affichée : incohérence de maladie détectée. Consultez l’essai clinique officiel associé. | Sclérose latérale amyotrophique | Phase 1 | Ralentissement de la progression | United States | À vérifier |
Essais cliniques
22| Molécule | Indication / population | Phase | NCT | Titre | Statut |
|---|---|---|---|---|---|
| β-hydroxy-β-methylbutyrate (HMB) | Sclérose latérale amyotrophique | Phase 1 | NCT07589764 | ROAR HMB — Pilot Trial Utilizing β-hydroxy-β-methylbutyrate to Lower IGFBP7 Levels in People With ALS | NOT_YET_RECRUITING |
| Alarm system | Épilepsie | Non applicable | NCT06581133 | Sleep Disruption Pattern - Epilepsy Monitoring Unit | NOT_YET_RECRUITING |
| Health Literacy Project | Épilepsie | Non applicable | NCT06634901 | Health Literacy Project | NOT_YET_RECRUITING |
| ADRC Clinical Cohort (Alzheimer's Disease) | Alzheimer | À vérifier | NCT06703541 | ADRC Clinical Cohort (Alzheimer's Disease) | RECRUITING |
| Cerebellothalamic optimized deep brain stimulation | Parkinson | Non applicable | NCT06618157 | Connectomic Guided DBS for Parkinson's Disease | ENROLLING_BY_INVITATION |
| HOP-STEPsIRB — The HOP-STEP Intervention: Improving Maternal Health in Women With Lupus sIRB | Lupus | Non applicable | NCT05818254 | HOP-STEPsIRB — The HOP-STEP Intervention: Improving Maternal Health in Women With Lupus sIRB | COMPLETED |
| DUKE PREVENT — Duke Cardiometabolic Prevention Clinic's Impact on High-risk Cardiovascular Patients With Uncontrolled Risk Factors | Hypertension | Non applicable | NCT07117695 | DUKE PREVENT — Duke Cardiometabolic Prevention Clinic's Impact on High-risk Cardiovascular Patients With Uncontrolled Risk Factors | NOT_YET_RECRUITING |
| High density micro-electrocorticography for neural speech prothesis | Épilepsie | Non applicable | NCT05132543 | Neural Basis of Cognition | NOT_YET_RECRUITING |
| GBPDC: Gut-Brain in PD Consortium Master Protocol | Parkinson | À vérifier | NCT07567794 | GBPDC: Gut-Brain in PD Consortium Master Protocol | RECRUITING |
| Temporal Interference Stimulation | Épilepsie | Non applicable | NCT07764718 | Temporal Interference Brain Stimulation for Adults With Drug-Resistant Epilepsy Undergoing Stereo-EEG Monitoring | NOT_YET_RECRUITING |
| MTP-101C | Sclérose latérale amyotrophique | Phase 1/2 | NCT07017946 | Intestinal Microbiome Transplant in ALS | RECRUITING |
| mSaada: A Mobile Health Tool | Cancer | Non applicable | NCT05848557 | mSaada: A Mobile Health Tool | RECRUITING |
| 5% lidocaine/5 mg/ml 0.02% estradiol compound cream | Migraine | Phase 2 | NCT03844412 | Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments | COMPLETED |
| BALANCE — B6 Administration for Levetiracetam-Associated Neurobehavioral Changes and Epilepsy | Épilepsie | Non applicable | NCT07271966 | BALANCE — B6 Administration for Levetiracetam-Associated Neurobehavioral Changes and Epilepsy | RECRUITING |
| levetiracetam | Sclérose latérale amyotrophique | Phase 2 | NCT00324454 | Levetiracetam for Cramps, Spasticity and Neuroprotection in Motor Neuron Disease | COMPLETED |
| Mycophenolate Mofetil | Myasthénie | À vérifier | NCT03490539 | PROMISE-MG — Disease-Modifying Treatments for Myasthenia Gravis | COMPLETED |
| Multimodal Management of Neck and Back Pain in the Emergency Department (Multi-ED) | Myopathies | Non applicable | NCT05221125 | Multimodal Management of Neck and Back Pain in the Emergency Department (Multi-ED) | COMPLETED |
| levetiracetam | Épilepsie | Phase 4 | NCT00571155 | Trial of Levetiracetam in Patients With Primary Brain Tumors and Symptomatic Seizures Who Undergo Surgery | COMPLETED |
| PiCASO — Peer i-Coaching for Activated Self-Management Optimization in Adolescents and Young Adults With Chronic Conditions | Lupus | NA | NCT03938324 | PiCASO — Peer i-Coaching for Activated Self-Management Optimization in Adolescents and Young Adults With Chronic Conditions | COMPLETED |
| ANT recording and stimulation | Épilepsie | NA | NCT04102254 | Thalamic Stimulation for Epilepsy Study | WITHDRAWN |
| Desipramine | Myopathies | Phase 4 | NCT03726996 | Desipramine in Infantile Neuroaxonal Dystrophy (INAD). | TERMINATED |
| Evaluation of Advanced Imaging and Visualization for Clinical Deep Brain Stimulation | Parkinson | À vérifier | NCT06191874 | Evaluation of Advanced Imaging and Visualization for Clinical Deep Brain Stimulation | COMPLETED |
Publications
21| Molécule | Indication / population | Titre | Journal | Date |
|---|---|---|---|---|
| Direct Electrical Stimulation | Interpreting Intraoperative Facial Nerve Signals: A Surgeon-focused Comparison of TcFMEP and Direct Electrical Stimulation During Acoustic Neuroma Surgery. | Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology | ||
| Direct Electrical Stimulation | Causal evidence from invasive recordings reveals distributed acoustic feature encoding underlying categorical voice perception. | NeuroImage | ||
| Direct Electrical Stimulation | Disruption of the claustrum-ACC pathway contributes to human mind blanking. | Neurobiology of disease | ||
| ANT recording and stimulation | Deep brain stimulation of the thalamus for intractable epilepsy (FRANCE study): A randomized clinical trial. | Epilepsia | ||
| MTP-101C | Novel Microbial Engraftment Trajectories Following Microbiota Transplant Therapy in Ulcerative Colitis. | Journal of Crohn's & colitis | ||
| levetiracetam | Fluorine and nitrogen co-doped carbon dots (F, N-CDs) for enhanced luminol chemiluminescence and sensitive detection of levetiracetam. | Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy | ||
| Desipramine | Beyond rodents: A systematic review of antidepressant-like effects in as an alternative model in psychopharmacology. | Alternatives to laboratory animals : ATLA | ||
| mSaada: A Mobile Health Tool | Iterative Development of a Mobile Phone App to Support Community Health Volunteers During Cervical Cancer Screening in Western Kenya: Qualitative Study. | JMIR formative research | ||
| mSaada: A Mobile Health Tool | Experience with the mobile health application 'mSaada' to facilitate home-based human papillomavirus testing in Western Kenya. | BMC global and public health | ||
| Evaluation of Advanced Imaging and Visualization for Clinical Deep Brain Stimulation | A technology framework for distributed preoperative planning and medical training in deep brain stimulation. | Computerized medical imaging and graphics : the official journal of the Computerized Medical Imaging Society | ||
| levetiracetam | Concomitant Antiseizure Medications' Influence on Valproic Acid and Levetiracetam Pharmacokinetics in Pediatric Patients. | Pediatrics international : official journal of the Japan Pediatric Society | ||
| Desipramine | A pharmacometric framework for norepinephrine transporter occupancy and dose equivalence across psychotropic medications. | Journal of psychopharmacology (Oxford, England) | ||
| Desipramine | Stepwise Translational Validation of the Screening Hit Desipramine Reveals Limits of Fibroblast-State Modulation in Lung Fibrosis. | Cells | ||
| levetiracetam | Risk of cutaneous adverse reactions to lamotrigine and levetiracetam by age, sex, and reproductive status. | Epilepsy & behavior : E&B | ||
| ANT recording and stimulation | Effects of pulvinar and combined pulvinar/anterior thalamic deep-brain stimulation on sleep: preliminary results. | Journal of neurology | ||
| ANT recording and stimulation | Long-term neuropsychiatric outcomes after neuromodulation in epilepsy patients: a systematic review and meta-analysis. | Acta neurologica Belgica | ||
| Desipramine | From Visceral Pain to Emotional Distress: Comparative Effectiveness of Antispasmodics and Antidepressants in Irritable Bowel Syndrome - Systematic Review and Network Meta-analysis. | Journal of gastrointestinal and liver diseases : JGLD | ||
| Desipramine | Desipramine treatment disrupts phagocytic and intracellular survival of 544 in RAW 264.7 cells and promotes bacterial resistance with enhanced immune responses in ICR mice. | Frontiers in veterinary science | ||
| Desipramine | The efficacy and safety of hyoscyamine, dicyclomine, and desipramine in the treatment of irritable pouch syndrome-a retrospective cohort study. | Crohn's & colitis 360 | ||
| Evaluation of Advanced Imaging and Visualization for Clinical Deep Brain Stimulation | Comparison of Two Methods of Deep Brain Stimulation Lead Reconstruction and Their Prediction Capacities. | Neuromodulation : journal of the International Neuromodulation Society | ||
| Evaluation of Advanced Imaging and Visualization for Clinical Deep Brain Stimulation | From Velasco to NAUTILUS: an evolution of centromedian nucleus targeting in epilepsy. | Journal of neurosurgery |