Fiche société
University of Alabama at Birmingham
Traitements, essais et publications liés.
Traitements36programmes
Essais15liés
Publications20liées
SourceDBlocale
Traitements
36| Molécule | Indication / population | Phase | Objectif | Pays | Résultat |
|---|---|---|---|---|---|
| [C-11]PiB-PET/MRIThe primary objective of this study is to measure the concentration and the regional brain distribution of pathologic amyloid deposition using the PET tracer \[C-11\]PiB in participants in the UAB Alzheimer's Disease Center cohort. Assessment of interactions between race and vascular risk factors, brain amyloid levels measured with \[C-11\]PiB-PET, and cognitive status will be the primary outcome of this imaging study. | Alzheimer | Phase 2 | À vérifier | United States | À vérifier |
| [F-18]AV-1451-PETThe primary objective of this study is to measure the concentration and the regional brain distribution of pathologic tau deposition using the PET tracer AV-1451 in participants in the UAB-ADC cohort. The amount and distribution of AV-1451 in the brain will be correlated to demographic, clinical, genetic, and biospecimen data acquired through the separate ongoing UAB-ADC study. Assessment of interactions between race and vascular risk factors, brain tau levels measured with AV-1451-PET, and cognitive status will be the primary outcome of this imaging study. Individuals participating in this AV-1451-PET/MRI study will also be enrolled in an ongoing \[C-11\]PiB-PET/MRI study (IRB-300001005, IND-138128), and their amyloid, tau and cognitive statuses will be compared in terms of race and vascular risk factors. | Alzheimer | Phase 1 | À vérifier | United States | À vérifier |
| [F-18]DPA714 administration IVThe overall goal of this protocol is to investigate \[18F\]DPA-714 binding in prodromal and early manifest Parkinson's Disease (PD) and to determine the baseline and change from baseline in \[18F\]DPA-714 binding in PD participants during a 24-month interval. Primary Objectives * To compare \[18F\]DPA-714 binding in prodromal and manifest PD and healthy volunteers. * To determine the longitudinal change in \[18F\]DPA-714 during a 24-month interval for prodromal and early initially untreated PD participants. Secondary Objectives * To evaluate the correlation between baseline \[18F\]DPA-714 and PPMI clinical and biomarker outcomes. * To evaluate the correlation between the longitudinal change of \[18F\]DPA-714 and PPMI clinical and biomarker outcomes * To acquire safety data following injection of \[18F\]DPA-714 | Parkinson | Phase 1 | À vérifier | United States | À vérifier |
| 5-year Follow-up DPA-714-PET/MRIThe primary objective of this substudy is to measure the concentration and the regional brain distribution of activated brain microglia/macrophages using the PET ligand \[18F\]DPA-714 in participants enrolled in the UAB Innate and Adaptive Immunity in Parkinson's Disease (Clinical Research Core) and Longitudinal \[18F\]DPA-714 Imaging in a Parkinson Disease Cohort studies. The PET tracer \[18F\]DPA-714 binds to the 18 kDa translocator protein (TSPO, also known as the peripheral benzodiazepine receptor) in the mitochondria of activated microglia/macrophages and provides a non-invasive measure of neuroinflammation. The amount and distribution of \[18F\]DPA-714 in the brain will be correlated to clinical data acquired through the separate ongoing UAB Innate and Adaptive Immunity in Parkinson Disease (Clinical Research Core) and Longitudinal \[18F\]DPA-714 Imaging in a Parkinson Disease Cohort studies. The primary objective of this study is to determine if patients with PD have higher levels of neuroinflammation than healthy controls as measured with \[18F\]DPA-714-PET/MRI. | Parkinson | Phase 1/2 | Immunomodulation + Remyélinisation indirecte / réparation | United States | À vérifier |
| Anti-hypertensive therapyThe purpose of this study is to evaluate whether a blood pressure treatment strategy during pregnancy to achieve targets that are recommended for non-pregnant reproductive-age adults (\<140/90 mmHg) compared ACOG- recommended standard during pregnancy (no treatment unless BP is severe) is effective and safe. | Hypertension | Phase 4 | À vérifier | United States | À vérifier |
| Assessing the Feasibility of the "Heart Care Pairs" InterventionThe researchers will invite 30 patients in primary care who have high blood pressure to participate in this health program with a supportive partner of their choosing (these will be the "participant pairs"). Participant pairs will be invited to complete the Heart Care Pairs health program that will include up to six sessions each including 1) some education on a health habit like physical activity and heart healthy foods, 2) goal setting together, and 3) talk about healthy communication to support one another with heart healthy habits. The researchers will work with participants to address things that get in the way of coming for visits like offering transportation and offering telehealth visits. The researchers are seeing how this program works in real life so participants will be asked to complete as many sessions as they want to and can attend. The researchers will be interested in what participants think about the sessions, if they were satisfied with the visits, and if they would recommend the program to others in their community. The researchers will ask these questions in interviews with participants. The researchers will also ask up to 25 primary care workers about how they view the program as helpful to their work with patients with high blood pressure and whether they would refer more patients to the program in the future. | Hypertension | Non applicable | À vérifier | United States | À vérifier |
| DPA-714 Metabolite AnalysisThe primary objective of this substudy is to measure the concentration and the regional brain distribution of activated brain microglia/macrophages using the PET ligand \[18F\]DPA-714 in participants enrolled in the UAB Innate and Adaptive Immunity in Parkinson's Disease (Clinical Research Core) and Longitudinal \[18F\]DPA-714 Imaging in a Parkinson Disease Cohort studies. The PET tracer \[18F\]DPA-714 binds to the 18 kDa translocator protein (TSPO, also known as the peripheral benzodiazepine receptor) in the mitochondria of activated microglia/macrophages and provides a non-invasive measure of neuroinflammation. The amount and distribution of \[18F\]DPA-714 in the brain will be correlated to clinical data acquired through the separate ongoing UAB Innate and Adaptive Immunity in Parkinson Disease (Clinical Research Core) and Longitudinal \[18F\]DPA-714 Imaging in a Parkinson Disease Cohort studies. The primary objective of this study is to determine if patients with PD have higher levels of neuroinflammation than healthy controls as measured with \[18F\]DPA-714-PET/MRI. | Parkinson | Phase 1/2 | Immunomodulation + Remyélinisation indirecte / réparation | United States | À vérifier |
| DPA-714-PET/MRIThe primary objective of this substudy is to measure the concentration and the regional brain distribution of activated brain microglia/macrophages using the PET ligand \[18F\]DPA-714 in participants enrolled in the UAB Innate and Adaptive Immunity in Parkinson's Disease (Clinical Research Core) and Longitudinal \[18F\]DPA-714 Imaging in a Parkinson Disease Cohort studies. The PET tracer \[18F\]DPA-714 binds to the 18 kDa translocator protein (TSPO, also known as the peripheral benzodiazepine receptor) in the mitochondria of activated microglia/macrophages and provides a non-invasive measure of neuroinflammation. The amount and distribution of \[18F\]DPA-714 in the brain will be correlated to clinical data acquired through the separate ongoing UAB Innate and Adaptive Immunity in Parkinson Disease (Clinical Research Core) and Longitudinal \[18F\]DPA-714 Imaging in a Parkinson Disease Cohort studies. The primary objective of this study is to determine if patients with PD have higher levels of neuroinflammation than healthy controls as measured with \[18F\]DPA-714-PET/MRI. | Parkinson | Phase 1/2 | Immunomodulation + Remyélinisation indirecte / réparation | United States | À vérifier |
| Intravenously administered pooled human immunoglobulin (IVIG)This is a randomized, placebo-controlled, double blinded phase 2 exploratory clinical trial of intravenously administered pooled human immunoglobulin (IVIG) in anti-3-hydroxy-3-methylglutaryl-CoA reductase (HMGCR) immune mediated necrotizing myopathy (IMNM). Planned enrollment is 12 individuals with active anti-HMGCR IMNM meeting inclusion and exclusion criteria. Assuming 20% drop-out, the investigators anticipate 10 participants will complete all study assessments. Enrolled participants will be randomized 1:1 to either IVIG 2g/kg or placebo (0.9% sodium chloride at equivalent volume) at weeks 0, 4, and 8. The primary efficacy and co-primary safety and tolerability endpoints will be assessed at week 12. After the randomized phase of the trial, all participants will be offered to continue on to an open-label extension phase in which participants will receive IVIG at weeks 12, 16, and 20. Participants will then return at week 24 for a final non-infusion visit to reassess safety, tolerability, and efficacy outcome. | Myopathies | Phase 2 | United States | À vérifier | |
| Labetalol or NifedipineThe CHAP2 study is designed to provide preliminary data for a larger multicenter study to assess whether treatment of stage 1 hypertension (HTN) in pregnancy improves maternal and or neonatal outcomes. The primary objective of this pilot study is to determine if anti-HTN treatment to BP\<130/80mmHg in pregnant patients with stage 1 HTN is associated with a difference in birthweight percentile at delivery. Patients with stage 1 hypertension in pregnancy will be randomized to BP goals of \<130/80mmHg or usual care to treatment only if BPs ≥140/90mmHg. For this pilot, the investigator will randomize a total of 74 eligible participants, 37 to active treatment to BP\<130/80mmHg and 37 to usual care. | Hypertension | Phase 1 | À vérifier | United States | À vérifier |
| Low-Dose Naltrexone, 1.5mgThis exploratory clinical trial tests low-dose naltrexone (LDN) for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). A remote trial approach is used, with eligibility open to the state of Alabama. | Myopathies | Phase 2 | Traitement symptomatique | United States | À vérifier |
| Low-Dose Naltrexone, 3.0mgThis exploratory clinical trial tests low-dose naltrexone (LDN) for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). A remote trial approach is used, with eligibility open to the state of Alabama. | Myopathies | Phase 2 | Traitement symptomatique | United States | À vérifier |
| Low-Dose Naltrexone, 4.5mgThis exploratory clinical trial tests low-dose naltrexone (LDN) for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). A remote trial approach is used, with eligibility open to the state of Alabama. | Myopathies | Phase 2 | Traitement symptomatique | United States | À vérifier |
| Low-Dose Naltrexone, 6.0mgThis exploratory clinical trial tests low-dose naltrexone (LDN) for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). A remote trial approach is used, with eligibility open to the state of Alabama. | Myopathies | Phase 2 | Traitement symptomatique | United States | À vérifier |
| MIGHT-SLE — Home-Based High-Intensity Interval Training in Systemic Lupus ErythematosusSystemic lupus erythematosus, or SLE, is a chronic autoimmune disease that can cause persistent fatigue, muscle pain, reduced physical function, and impaired quality of life, even when the disease is otherwise clinically stable. The biological mechanisms contributing to these symptoms are not fully understood. Abnormal energy production within skeletal muscle and increased fat accumulation within the muscle may contribute to fatigue and reduced physical performance in people with SLE. This pilot study will evaluate the effects of a 16-week personalized, home-based exercise program in 20 adults with stable SLE and clinically significant fatigue. The program will include three exercise sessions per week: bodyweight high-intensity interval training, strength training, and walking-based interval training. Sessions will be adapted to each participant's fitness, mobility, symptoms, and exercise tolerance. Some sessions will be supervised remotely by video, while others will be completed independently using personalized recorded instructions. Participants will undergo assessments before and after the 16-week program. These assessments will examine skeletal muscle mitochondrial function, fat accumulation within the thigh muscles, physical performance, fatigue, quality of life, and blood-based markers of mitochondrial function and inflammation. The study will help determine whether a personalized home-based exercise program can improve muscle health and physical function in people with SLE and will provide information needed to design larger future studies. | Lupus | Non applicable | Traitement symptomatique + Immunomodulation | United States | À vérifier |
| Passive Versus Active Music Therapy Parkinson's DiseaseThe purpose of this pilot study is to identify the effects of active versus passive music therapy on functional ability and psychophysiological responses to goal-directed exercise in people with Parkinson's disease. | Parkinson | NA | À vérifier | United States | À vérifier |
| Permanent Epidural Spinal Cord StimulationThe purpose of this study in patients undergoing routine care epidural spinal cord stimulation (SCS) is to determine 1) whether SCS reduces arterial blood pressure (BP) in patients which chronic low back pain and hypertension, 2) whether higher baseline BP (i.e., hypertension) predicts reductions in pain following SCS, and finally 3) whether different SCS waveforms elicits stimulus-evoked compound action potentials (ECAPs) in spinal cord and at the cortex (electroencephalography, and magnetoenchphalography). | Hypertension | Non applicable | Traitement symptomatique | United States | À vérifier |
| Retraining and Control Therapy (ReACT): Sense of Control and Symptom Expectations as Targets of a Treatment for PNESThe purpose of this study is to assess sense of control and catastrophic symptom expectations as targets for Retraining and Control Therapy (ReACT- an intervention focused on changing behaviors and thoughts) for treatment of pediatric psychogenic non-epileptic seizures (PNES, episodes resembling epileptic seizures but with no medical explanation). 11-18-year-olds diagnosed with PNES will engage in twelve sessions of ReACT. Sense of control over actions will be measured by the magic and turbulence task, a well-validated measure of sense of control. Participants will complete the cold pressor test (CPT) in which participants hold their hand in cool water for as long as possible up to 3 minutes. Catastrophic symptom expectations in response to the CPT will be measured by Pain Catastrophizing Scale for Children (PCS-C) pain tolerance (time with hand in water) and cortisol response. Target assessments will occur 7 days before treatment, 7 days after 8th treatment session and 7 days after 12th treatment session. Participants will also complete long term follow-up visits via HIPAA-compliant Zoom at 6 months and 12 months after the 12th treatment session where participants will complete questionnaires. PNES frequency will be measured from 30 days before to 12 months after treatment. | Épilepsie | Non applicable | Traitement symptomatique | United States | À vérifier |
| The FamilyStrong Pilot Randomized TrialWhen someone is diagnosed with advanced cancer, their family members and close friends often take on the role of caregiver, providing emotional support and complex medical care for their loved one, often for up to eight hours a day. This responsibility can take a significant toll, leaving family caregivers overwhelmed, highly stressed, and without access to the support they need. Research shows that when caregivers are struggling, both they and the patients they care for suffer. Caregiver distress has been linked to poor quality of life for patients and greater emotional strain on families. Despite the well-documented emotional and physical burdens on family caregivers, most cancer centers do not include structured support services to help them cope and navigate challenges. Many caregivers do not even realize help is available, leading to feelings of isolation and burnout. Yet, despite the critical role caregivers play in cancer care, there are very few programs designed to support them in ways that are both effective and widely accessible. To address this urgent need, our team has developed FamilyStrong, a novel intervention specifically designed to fill this gap and support family caregivers in real-world cancer care settings. FamilyStrong is a brief and easy-to-use program that helps family caregivers recognize and manage distress while connecting them to the right support. Unlike many caregiver support programs that require extensive time and highly trained specialists, FamilyStrong is led by lay navigators, who are trained individuals who can guide caregivers through challenges and connect them with appropriate resources. The program uses a simple distress screening tool to quickly assess how caregivers are coping and then tailors support to their specific needs. We will test FamilyStrong in a small pilot study with 60 caregivers of patients newly diagnosed with advanced cancer. Over a period of 24 weeks, we will evaluate how well the program works, whether caregivers find it helpful, and whether it improves caregiver and patient well-being compared to usual care. Specifically, we will measure whether caregivers experience lower stress, improved quality of life, and fewer unmet needs when they participate in the FamilyStrong program. After this study, we will use these results and our experiences to inform a larger clinical trial to confirm FamilyStrong's benefits and eventually expand the program nationwide. By providing caregivers with practical, effective support, FamilyStrong has the potential to improve the quality of life for both caregivers and cancer patients, ensuring that families facing cancer receive the help they need when they need it most. | Cancer | Non applicable | À vérifier | United States | À vérifier |
| Trans-auricular Vagus Nerve Stimulation: High IntensityThe purpose of this study is to compare two approaches to cognitive rehabilitation in adults with post-viral cognitive syndrome, which resulted in brain fog. All participants will be screened for eligibility prior to participation. Most of the procedures will take place over a phone call or secure telehealth platform (i.e., Zoom). However, participants will be asked to visit UAB on three occasions for blood sample collection and brain imaging (about 2 hours each). Online testing will happen one month before treatment, one day before treatment, one day afterwards, and 6 months afterwards. The study will utilize two different forms of rehabilitation training to improve participants' cognitive ability. Participants will be randomized to one of the two treatment groups. The first treatment approach, known as Constraint-Induced Cognitive Therapy (CICT), will feature (A) web-based computer "games" that trains how quickly individuals process information that they receive through their senses; (B) online training on everyday activities with important cognitive components, (C) procedures designed to transfer improvements in cognition from the treatment setting to everyday life, and (D) a non-invasive form of vagus nerve stimulation, also known as trans-auricular VNS (taVNS). The second approach, known as Brain Fitness Training (BFT), will include (A) web-based computer "games" that train reaction time and eye-hand coordination; (B) in-lab training on relaxation, breathing, healthy nutrition, and healthy sleep, (C) education about how relaxation, breathing, nutrition, and sleep are connected to thinking effectiveness, and (D) taVNS. Approximately 30 hours of training will be conducted over a secure telehealth platform (i.e., Zoom) in the span of two- to four- weeks. A typical CICT session will consist of one hour of gaming, with the bulk of the session being spent on cognitive training of the target behaviors and procedures designed to promote transfer of therapeutic gains to daily life. ta-VNS will be administered for 10 minutes before gaming and in-lab target behavior training. A typical BFT session will consist of one hour of gaming, training on healthy lifestyle behaviors (i.e., healthy sleep, nutrition, and relaxation habits), as well as procedures designed to promote transfer of behavior changes to daily life. Ta-VNS will be administered for 10 minutes before gaming and in-lab target behavior training. Training sessions in both conditions will be scheduled based on participants' availability, with the options for sessions scheduled to be as close as every weekday over 2 weeks or as loosely as every other weekday (i.e., over a 4-week span). If a caregiver is available, they will receive training on how to best support participants in their therapeutic program. After the training ends, both groups will receive 4 follow-up phone calls approximately one week apart to promote integration of the gained skills into everyday life. Outcomes measured will include cognitive processing speed, cognitive function on laboratory tests, and spontaneous performance of everyday activities with important cognitive components in daily life. | Myopathies | Non applicable | À vérifier | United States | À vérifier |
| Trans-auricular Vagus Nerve Stimulation: Low IntensityThe purpose of this study is to compare two approaches to cognitive rehabilitation in adults with post-viral cognitive syndrome, which resulted in brain fog. All participants will be screened for eligibility prior to participation. Most of the procedures will take place over a phone call or secure telehealth platform (i.e., Zoom). However, participants will be asked to visit UAB on three occasions for blood sample collection and brain imaging (about 2 hours each). Online testing will happen one month before treatment, one day before treatment, one day afterwards, and 6 months afterwards. The study will utilize two different forms of rehabilitation training to improve participants' cognitive ability. Participants will be randomized to one of the two treatment groups. The first treatment approach, known as Constraint-Induced Cognitive Therapy (CICT), will feature (A) web-based computer "games" that trains how quickly individuals process information that they receive through their senses; (B) online training on everyday activities with important cognitive components, (C) procedures designed to transfer improvements in cognition from the treatment setting to everyday life, and (D) a non-invasive form of vagus nerve stimulation, also known as trans-auricular VNS (taVNS). The second approach, known as Brain Fitness Training (BFT), will include (A) web-based computer "games" that train reaction time and eye-hand coordination; (B) in-lab training on relaxation, breathing, healthy nutrition, and healthy sleep, (C) education about how relaxation, breathing, nutrition, and sleep are connected to thinking effectiveness, and (D) taVNS. Approximately 30 hours of training will be conducted over a secure telehealth platform (i.e., Zoom) in the span of two- to four- weeks. A typical CICT session will consist of one hour of gaming, with the bulk of the session being spent on cognitive training of the target behaviors and procedures designed to promote transfer of therapeutic gains to daily life. ta-VNS will be administered for 10 minutes before gaming and in-lab target behavior training. A typical BFT session will consist of one hour of gaming, training on healthy lifestyle behaviors (i.e., healthy sleep, nutrition, and relaxation habits), as well as procedures designed to promote transfer of behavior changes to daily life. Ta-VNS will be administered for 10 minutes before gaming and in-lab target behavior training. Training sessions in both conditions will be scheduled based on participants' availability, with the options for sessions scheduled to be as close as every weekday over 2 weeks or as loosely as every other weekday (i.e., over a 4-week span). If a caregiver is available, they will receive training on how to best support participants in their therapeutic program. After the training ends, both groups will receive 4 follow-up phone calls approximately one week apart to promote integration of the gained skills into everyday life. Outcomes measured will include cognitive processing speed, cognitive function on laboratory tests, and spontaneous performance of everyday activities with important cognitive components in daily life. | Myopathies | Non applicable | À vérifier | United States | À vérifier |
| Low-Dose Naltrexone, 1.5mgThis exploratory clinical trial tests low-dose naltrexone (LDN) for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). A remote trial approach is used, with eligibility open to the state of Alabama. | Myopathies | Phase 2 | Traitement symptomatique | United States | À vérifier |
| Passive Versus Active Music Therapy Parkinson's DiseaseThe purpose of this pilot study is to identify the effects of active versus passive music therapy on functional ability and psychophysiological responses to goal-directed exercise in people with Parkinson's disease. | Parkinson | NA | À vérifier | United States | À vérifier |
| Anti-hypertensive therapyThe purpose of this study is to evaluate whether a blood pressure treatment strategy during pregnancy to achieve targets that are recommended for non-pregnant reproductive-age adults (\<140/90 mmHg) compared ACOG- recommended standard during pregnancy (no treatment unless BP is severe) is effective and safe. | Hypertension | Phase 4 | À vérifier | United States | À vérifier |
| [F-18]DPA714 administration IVThe overall goal of this protocol is to investigate \[18F\]DPA-714 binding in prodromal and early manifest Parkinson's Disease (PD) and to determine the baseline and change from baseline in \[18F\]DPA-714 binding in PD participants during a 24-month interval. Primary Objectives * To compare \[18F\]DPA-714 binding in prodromal and manifest PD and healthy volunteers. * To determine the longitudinal change in \[18F\]DPA-714 during a 24-month interval for prodromal and early initially untreated PD participants. Secondary Objectives * To evaluate the correlation between baseline \[18F\]DPA-714 and PPMI clinical and biomarker outcomes. * To evaluate the correlation between the longitudinal change of \[18F\]DPA-714 and PPMI clinical and biomarker outcomes * To acquire safety data following injection of \[18F\]DPA-714 | Parkinson | Phase 1 | À vérifier | United States | À vérifier |
| DPA-714-PET/MRIThe primary objective of this substudy is to measure the concentration and the regional brain distribution of activated brain microglia/macrophages using the PET ligand \[18F\]DPA-714 in participants enrolled in the UAB Innate and Adaptive Immunity in Parkinson's Disease (Clinical Research Core) and Longitudinal \[18F\]DPA-714 Imaging in a Parkinson Disease Cohort studies. The PET tracer \[18F\]DPA-714 binds to the 18 kDa translocator protein (TSPO, also known as the peripheral benzodiazepine receptor) in the mitochondria of activated microglia/macrophages and provides a non-invasive measure of neuroinflammation. The amount and distribution of \[18F\]DPA-714 in the brain will be correlated to clinical data acquired through the separate ongoing UAB Innate and Adaptive Immunity in Parkinson Disease (Clinical Research Core) and Longitudinal \[18F\]DPA-714 Imaging in a Parkinson Disease Cohort studies. The primary objective of this study is to determine if patients with PD have higher levels of neuroinflammation than healthy controls as measured with \[18F\]DPA-714-PET/MRI. | Parkinson | Phase 1/2 | Immunomodulation + Remyélinisation indirecte / réparation | United States | À vérifier |
| [F-18]AV-1451-PETThe primary objective of this study is to measure the concentration and the regional brain distribution of pathologic tau deposition using the PET tracer AV-1451 in participants in the UAB-ADC cohort. The amount and distribution of AV-1451 in the brain will be correlated to demographic, clinical, genetic, and biospecimen data acquired through the separate ongoing UAB-ADC study. Assessment of interactions between race and vascular risk factors, brain tau levels measured with AV-1451-PET, and cognitive status will be the primary outcome of this imaging study. Individuals participating in this AV-1451-PET/MRI study will also be enrolled in an ongoing \[C-11\]PiB-PET/MRI study (IRB-300001005, IND-138128), and their amyloid, tau and cognitive statuses will be compared in terms of race and vascular risk factors. | Alzheimer | Phase 1 | À vérifier | United States | À vérifier |
| [C-11]PiB-PET/MRIThe primary objective of this study is to measure the concentration and the regional brain distribution of pathologic amyloid deposition using the PET tracer \[C-11\]PiB in participants in the UAB Alzheimer's Disease Center cohort. Assessment of interactions between race and vascular risk factors, brain amyloid levels measured with \[C-11\]PiB-PET, and cognitive status will be the primary outcome of this imaging study. | Alzheimer | Phase 2 | À vérifier | United States | À vérifier |
| Assessing the Feasibility of the "Heart Care Pairs" InterventionThe researchers will invite 30 patients in primary care who have high blood pressure to participate in this health program with a supportive partner of their choosing (these will be the "participant pairs"). Participant pairs will be invited to complete the Heart Care Pairs health program that will include up to six sessions each including 1) some education on a health habit like physical activity and heart healthy foods, 2) goal setting together, and 3) talk about healthy communication to support one another with heart healthy habits. The researchers will work with participants to address things that get in the way of coming for visits like offering transportation and offering telehealth visits. The researchers are seeing how this program works in real life so participants will be asked to complete as many sessions as they want to and can attend. The researchers will be interested in what participants think about the sessions, if they were satisfied with the visits, and if they would recommend the program to others in their community. The researchers will ask these questions in interviews with participants. The researchers will also ask up to 25 primary care workers about how they view the program as helpful to their work with patients with high blood pressure and whether they would refer more patients to the program in the future. | Hypertension | Non applicable | À vérifier | United States | À vérifier |
| Labetalol or NifedipineThe CHAP2 study is designed to provide preliminary data for a larger multicenter study to assess whether treatment of stage 1 hypertension (HTN) in pregnancy improves maternal and or neonatal outcomes. The primary objective of this pilot study is to determine if anti-HTN treatment to BP\<130/80mmHg in pregnant patients with stage 1 HTN is associated with a difference in birthweight percentile at delivery. Patients with stage 1 hypertension in pregnancy will be randomized to BP goals of \<130/80mmHg or usual care to treatment only if BPs ≥140/90mmHg. For this pilot, the investigator will randomize a total of 74 eligible participants, 37 to active treatment to BP\<130/80mmHg and 37 to usual care. | Hypertension | Phase 1 | À vérifier | United States | À vérifier |
| Permanent Epidural Spinal Cord StimulationThe purpose of this study in patients undergoing routine care epidural spinal cord stimulation (SCS) is to determine 1) whether SCS reduces arterial blood pressure (BP) in patients which chronic low back pain and hypertension, 2) whether higher baseline BP (i.e., hypertension) predicts reductions in pain following SCS, and finally 3) whether different SCS waveforms elicits stimulus-evoked compound action potentials (ECAPs) in spinal cord and at the cortex (electroencephalography, and magnetoenchphalography). | Hypertension | Non applicable | Traitement symptomatique | United States | À vérifier |
| The FamilyStrong Pilot Randomized TrialWhen someone is diagnosed with advanced cancer, their family members and close friends often take on the role of caregiver, providing emotional support and complex medical care for their loved one, often for up to eight hours a day. This responsibility can take a significant toll, leaving family caregivers overwhelmed, highly stressed, and without access to the support they need. Research shows that when caregivers are struggling, both they and the patients they care for suffer. Caregiver distress has been linked to poor quality of life for patients and greater emotional strain on families. Despite the well-documented emotional and physical burdens on family caregivers, most cancer centers do not include structured support services to help them cope and navigate challenges. Many caregivers do not even realize help is available, leading to feelings of isolation and burnout. Yet, despite the critical role caregivers play in cancer care, there are very few programs designed to support them in ways that are both effective and widely accessible. To address this urgent need, our team has developed FamilyStrong, a novel intervention specifically designed to fill this gap and support family caregivers in real-world cancer care settings. FamilyStrong is a brief and easy-to-use program that helps family caregivers recognize and manage distress while connecting them to the right support. Unlike many caregiver support programs that require extensive time and highly trained specialists, FamilyStrong is led by lay navigators, who are trained individuals who can guide caregivers through challenges and connect them with appropriate resources. The program uses a simple distress screening tool to quickly assess how caregivers are coping and then tailors support to their specific needs. We will test FamilyStrong in a small pilot study with 60 caregivers of patients newly diagnosed with advanced cancer. Over a period of 24 weeks, we will evaluate how well the program works, whether caregivers find it helpful, and whether it improves caregiver and patient well-being compared to usual care. Specifically, we will measure whether caregivers experience lower stress, improved quality of life, and fewer unmet needs when they participate in the FamilyStrong program. After this study, we will use these results and our experiences to inform a larger clinical trial to confirm FamilyStrong's benefits and eventually expand the program nationwide. By providing caregivers with practical, effective support, FamilyStrong has the potential to improve the quality of life for both caregivers and cancer patients, ensuring that families facing cancer receive the help they need when they need it most. | Cancer | Non applicable | À vérifier | United States | À vérifier |
| Trans-auricular Vagus Nerve Stimulation: High IntensityThe purpose of this study is to compare two approaches to cognitive rehabilitation in adults with post-viral cognitive syndrome, which resulted in brain fog. All participants will be screened for eligibility prior to participation. Most of the procedures will take place over a phone call or secure telehealth platform (i.e., Zoom). However, participants will be asked to visit UAB on three occasions for blood sample collection and brain imaging (about 2 hours each). Online testing will happen one month before treatment, one day before treatment, one day afterwards, and 6 months afterwards. The study will utilize two different forms of rehabilitation training to improve participants' cognitive ability. Participants will be randomized to one of the two treatment groups. The first treatment approach, known as Constraint-Induced Cognitive Therapy (CICT), will feature (A) web-based computer "games" that trains how quickly individuals process information that they receive through their senses; (B) online training on everyday activities with important cognitive components, (C) procedures designed to transfer improvements in cognition from the treatment setting to everyday life, and (D) a non-invasive form of vagus nerve stimulation, also known as trans-auricular VNS (taVNS). The second approach, known as Brain Fitness Training (BFT), will include (A) web-based computer "games" that train reaction time and eye-hand coordination; (B) in-lab training on relaxation, breathing, healthy nutrition, and healthy sleep, (C) education about how relaxation, breathing, nutrition, and sleep are connected to thinking effectiveness, and (D) taVNS. Approximately 30 hours of training will be conducted over a secure telehealth platform (i.e., Zoom) in the span of two- to four- weeks. A typical CICT session will consist of one hour of gaming, with the bulk of the session being spent on cognitive training of the target behaviors and procedures designed to promote transfer of therapeutic gains to daily life. ta-VNS will be administered for 10 minutes before gaming and in-lab target behavior training. A typical BFT session will consist of one hour of gaming, training on healthy lifestyle behaviors (i.e., healthy sleep, nutrition, and relaxation habits), as well as procedures designed to promote transfer of behavior changes to daily life. Ta-VNS will be administered for 10 minutes before gaming and in-lab target behavior training. Training sessions in both conditions will be scheduled based on participants' availability, with the options for sessions scheduled to be as close as every weekday over 2 weeks or as loosely as every other weekday (i.e., over a 4-week span). If a caregiver is available, they will receive training on how to best support participants in their therapeutic program. After the training ends, both groups will receive 4 follow-up phone calls approximately one week apart to promote integration of the gained skills into everyday life. Outcomes measured will include cognitive processing speed, cognitive function on laboratory tests, and spontaneous performance of everyday activities with important cognitive components in daily life. | Myopathies | Non applicable | À vérifier | United States | À vérifier |
| MIGHT-SLE — Home-Based High-Intensity Interval Training in Systemic Lupus ErythematosusSystemic lupus erythematosus, or SLE, is a chronic autoimmune disease that can cause persistent fatigue, muscle pain, reduced physical function, and impaired quality of life, even when the disease is otherwise clinically stable. The biological mechanisms contributing to these symptoms are not fully understood. Abnormal energy production within skeletal muscle and increased fat accumulation within the muscle may contribute to fatigue and reduced physical performance in people with SLE. This pilot study will evaluate the effects of a 16-week personalized, home-based exercise program in 20 adults with stable SLE and clinically significant fatigue. The program will include three exercise sessions per week: bodyweight high-intensity interval training, strength training, and walking-based interval training. Sessions will be adapted to each participant's fitness, mobility, symptoms, and exercise tolerance. Some sessions will be supervised remotely by video, while others will be completed independently using personalized recorded instructions. Participants will undergo assessments before and after the 16-week program. These assessments will examine skeletal muscle mitochondrial function, fat accumulation within the thigh muscles, physical performance, fatigue, quality of life, and blood-based markers of mitochondrial function and inflammation. The study will help determine whether a personalized home-based exercise program can improve muscle health and physical function in people with SLE and will provide information needed to design larger future studies. | Lupus | Non applicable | Traitement symptomatique + Immunomodulation | United States | À vérifier |
| Intravenously administered pooled human immunoglobulin (IVIG)This is a randomized, placebo-controlled, double blinded phase 2 exploratory clinical trial of intravenously administered pooled human immunoglobulin (IVIG) in anti-3-hydroxy-3-methylglutaryl-CoA reductase (HMGCR) immune mediated necrotizing myopathy (IMNM). Planned enrollment is 12 individuals with active anti-HMGCR IMNM meeting inclusion and exclusion criteria. Assuming 20% drop-out, the investigators anticipate 10 participants will complete all study assessments. Enrolled participants will be randomized 1:1 to either IVIG 2g/kg or placebo (0.9% sodium chloride at equivalent volume) at weeks 0, 4, and 8. The primary efficacy and co-primary safety and tolerability endpoints will be assessed at week 12. After the randomized phase of the trial, all participants will be offered to continue on to an open-label extension phase in which participants will receive IVIG at weeks 12, 16, and 20. Participants will then return at week 24 for a final non-infusion visit to reassess safety, tolerability, and efficacy outcome. | Myopathies | Phase 2 | United States | À vérifier | |
| Retraining and Control Therapy (ReACT): Sense of Control and Symptom Expectations as Targets of a Treatment for PNESThe purpose of this study is to assess sense of control and catastrophic symptom expectations as targets for Retraining and Control Therapy (ReACT- an intervention focused on changing behaviors and thoughts) for treatment of pediatric psychogenic non-epileptic seizures (PNES, episodes resembling epileptic seizures but with no medical explanation). 11-18-year-olds diagnosed with PNES will engage in twelve sessions of ReACT. Sense of control over actions will be measured by the magic and turbulence task, a well-validated measure of sense of control. Participants will complete the cold pressor test (CPT) in which participants hold their hand in cool water for as long as possible up to 3 minutes. Catastrophic symptom expectations in response to the CPT will be measured by Pain Catastrophizing Scale for Children (PCS-C) pain tolerance (time with hand in water) and cortisol response. Target assessments will occur 7 days before treatment, 7 days after 8th treatment session and 7 days after 12th treatment session. Participants will also complete long term follow-up visits via HIPAA-compliant Zoom at 6 months and 12 months after the 12th treatment session where participants will complete questionnaires. PNES frequency will be measured from 30 days before to 12 months after treatment. | Épilepsie | Non applicable | Traitement symptomatique | United States | À vérifier |
Essais cliniques
15| Molécule | Indication / population | Phase | NCT | Titre | Statut |
|---|---|---|---|---|---|
| Retraining and Control Therapy (ReACT): Sense of Control and Symptom Expectations as Targets of a Treatment for PNES | Épilepsie | Non applicable | NCT05096273 | Retraining and Control Therapy (ReACT): Sense of Control and Symptom Expectations as Targets of a Treatment for PNES | RECRUITING |
| Intravenously administered pooled human immunoglobulin (IVIG) | Myopathies | Phase 2 | NCT06599697 | The MIGHT Trial - An Exploratory Clinical Trial of IVIG in Anti-HMGCR Immune Mediated Necrotizing Myopathy | RECRUITING |
| MIGHT-SLE — Home-Based High-Intensity Interval Training in Systemic Lupus Erythematosus | Lupus | Non applicable | NCT07716462 | MIGHT-SLE — Home-Based High-Intensity Interval Training in Systemic Lupus Erythematosus | NOT_YET_RECRUITING |
| Trans-auricular Vagus Nerve Stimulation: High Intensity | Myopathies | Non applicable | NCT07523113 | ME/CFS Brain Fog: Cognitive Rehabilitation Trial | RECRUITING |
| The FamilyStrong Pilot Randomized Trial | Cancer | Non applicable | NCT07761988 | The FamilyStrong Pilot Randomized Trial | NOT_YET_RECRUITING |
| Permanent Epidural Spinal Cord Stimulation | Hypertension | Non applicable | NCT05556902 | Therapeutic Mechanisms of Epidural Spinal Cord Stimulation | RECRUITING |
| Labetalol or Nifedipine | Hypertension | Phase 1 | NCT05989581 | Chronic Hypertension and Pregnancy 2 (CHAP2) Pilot Project | RECRUITING |
| Assessing the Feasibility of the "Heart Care Pairs" Intervention | Hypertension | Non applicable | NCT07760350 | Assessing the Feasibility of the "Heart Care Pairs" Intervention | NOT_YET_RECRUITING |
| [C-11]PiB-PET/MRI | Alzheimer | Phase 2 | NCT03503331 | PiB ADC — UAB Alzheimer's Disease Center Core Cohort - Imaging Substudy | RECRUITING |
| [F-18]AV-1451-PET | Alzheimer | Phase 1 | NCT03809351 | AV1451 ADC — UAB Alzheimer's Disease Center Core Cohort - Tau Imaging Substudy | RECRUITING |
| DPA-714-PET/MRI | Parkinson | Phase 1/2 | NCT03457493 | The University of Alabama at Birmingham (UAB) Neuroinflammation in Parkinson's Disease-TSPO- Positron Emission Tomography (PET) Substudy | RECRUITING |
| [F-18]DPA714 administration IV | Parkinson | Phase 1 | NCT06289582 | Longitudinal TSPO PET Imaging With [18F]DPA-714 in PPMI (PPMI DPA-714 PET Imaging) | RECRUITING |
| Anti-hypertensive therapy | Hypertension | Phase 4 | NCT02299414 | Chronic Hypertension and Pregnancy (CHAP) Project | COMPLETED |
| Passive Versus Active Music Therapy Parkinson's Disease | Parkinson | NA | NCT07661524 | Passive Versus Active Music Therapy Parkinson's Disease | NOT_YET_RECRUITING |
| Low-Dose Naltrexone, 1.5mg | Myopathies | Phase 2 | NCT07285473 | Low-Dose Naltrexone For ME/CFS: Dose-Finding | NOT_YET_RECRUITING |
Publications
20| Molécule | Indication / population | Titre | Journal | Date |
|---|---|---|---|---|
| Permanent Epidural Spinal Cord Stimulation | [Central invasive neuromodulation for the treatment of chronic pain : Epidural motor cortex stimulation and deep brain stimulation]. | Schmerz (Berlin, Germany) | ||
| Permanent Epidural Spinal Cord Stimulation | Minimally Invasive Spinal Cord Stimulator Paddle Electrode Placement: Technique and Complications in a Single Surgeon Cohort. | Operative neurosurgery (Hagerstown, Md.) | ||
| Permanent Epidural Spinal Cord Stimulation | A novel 14 gauge needle for 2 lead access for percutaneous spinal cord stimulator trials and permanent implants. | Pain medicine (Malden, Mass.) | ||
| Labetalol or Nifedipine | Lead-induced apoptosis in Sertoli cells is associated with Ca dysregulation. | Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association | ||
| Labetalol or Nifedipine | Transient conductive hearing loss as a notable and rare manifestation of preeclampsia: a case report. | The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians | ||
| Labetalol or Nifedipine | VA-ECMO and HIET for toxic cardiogenic shock in an elderly patient following severe poly-intoxication: A case report. | Toxicology reports | ||
| Assessing the Feasibility of the "Heart Care Pairs" Intervention | Feasibility and preliminary efficacy of a 12-week primary care-based behavioral counseling intervention among adults with cardiovascular disease risk factors. | Journal of behavioral medicine | ||
| Assessing the Feasibility of the "Heart Care Pairs" Intervention | Digital Health Monitoring and Intervention Suite for Stress in Frontline Nurses: Prospective Cohort Trial. | JMIR formative research | ||
| Assessing the Feasibility of the "Heart Care Pairs" Intervention | Frailty Status and Outcomes in Patients with Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: a multicentre retrospective cohort study. | European journal of cardiovascular nursing | ||
| Anti-hypertensive therapy | The Use of Ambulatory Blood Pressure Monitoring in Pediatric Heart Transplant Recipients. | Pediatric transplantation | ||
| Anti-hypertensive therapy | Effect of routinely tailoring anti-hypertensive therapy to hemodynamic profile in primary care. | The American journal of medicine | ||
| Anti-hypertensive therapy | Refractory arterial hypertension: important, but suboptimally characterized. | Current medical research and opinion | ||
| DPA-714 Metabolite Analysis | Validation of an automatic reference region extraction for the quantification of [F]DPA-714 in dynamic brain PET studies. | Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism | ||
| DPA-714-PET/MRI | Hybrid PET/MRI Imaging of 18F-Fluorodeoxyglucose and 18-kDa Translocator Protein for Presurgical Localization in Refractory Epilepsy. | CNS neuroscience & therapeutics | ||
| DPA-714 Metabolite Analysis | Impact of Endothelial 18-kDa Translocator Protein on the Quantification of F-DPA-714. | Journal of nuclear medicine : official publication, Society of Nuclear Medicine | ||
| DPA-714 Metabolite Analysis | Imaging the neuroimmune response to alcohol exposure in adolescent baboons: a TSPO PET study using F-DPA-714. | Addiction biology | ||
| DPA-714-PET/MRI | Neuroinflammation in GAD65 Antibody-Associated Epilepsy Measured Using [F]DPA-714 PET/MRI. | Annals of clinical and translational neurology | ||
| DPA-714-PET/MRI | 18F-DPA-714 PET/MRI reveals early and widespread neuroinflammation in sporadic Creutzfeldt-Jakob disease: a case report. | BMJ neurology open | ||
| Low-Dose Naltrexone, 4.5mg | Pilot trial of low-dose naltrexone and quality of life in multiple sclerosis. | Annals of neurology | ||
| Low-Dose Naltrexone, 4.5mg | Pilot RCT comparing low-dose naltrexone, gabapentin and placebo to reduce pain among people with HIV with alcohol problems. | PloS one |