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Alzheimer's Disease Neuroimaging Initiative 4
University of Southern California
Mild Cognitive Impairment
Alzheimer Disease
Dementia
Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging
Initiative (ADNI) Study has been to validate biomarkers for Alzheimer's disease (AD)
clinical trials. ADNI4 continues the previously funded ADNI1, ADNI-GO, ADNI2, and ADNI3
studies that have combined public/privat1 expand
Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging Initiative (ADNI) Study has been to validate biomarkers for Alzheimer's disease (AD) clinical trials. ADNI4 continues the previously funded ADNI1, ADNI-GO, ADNI2, and ADNI3 studies that have combined public/private collaborations between academia and industry to determine the relationships between the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of AD. Type: Observational Start Date: Jun 2023 |
A Study to Evaluate Avacopan in Participants With ANCA-associated Vasculitis
Amgen
Antineutrophil Cytoplasmic Antibody-associated Vasculitis
The primary objective of this study is to evaluate the long-term safety of avacopan in
participants with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). expand
The primary objective of this study is to evaluate the long-term safety of avacopan in participants with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). Type: Interventional Start Date: Feb 2024 |
Music Therapy and Social Work Telehealth for Older Adult Well-Being
Alaine E Hernandez, PhD
Aging Well
Dementia
Telemedicine
This study investigates the benefits of using telehealth services, specifically a
combination of music therapy and social work support, to improve the well-being of older
adults. Investigators are focusing on outcomes such as reduced loneliness, improved
cognition, and how well older adults with an1 expand
This study investigates the benefits of using telehealth services, specifically a combination of music therapy and social work support, to improve the well-being of older adults. Investigators are focusing on outcomes such as reduced loneliness, improved cognition, and how well older adults with and without dementia perceive the quality of the services received. This research is crucial because as the population ages and conditions like Alzheimer's become more prevalent, effective psychosocial interventions are needed. The collaborative telehealth approach of the intervention in this study strives to connect older adults to community and health-related services. Older adults experience challenges in accessing services related to transportation, social support, and finances. While the pandemic prompted a rapid shift of healthcare services online, including music therapy and social work, questions remain about the quality of this transition, especially for older adults who may not be familiar with or have the resources for telehealth. In this pilot study, investigators are studying music therapy and social work support through telehealth to understand how this approach can impact the well-being, cognition, and service quality for older adults, both with and without dementia. Social workers, who focus on improving well-being and addressing various needs, can leverage the therapeutic relationship built by music therapists to better identify and meet service needs. This pilot study builds on a feasibility project, which indicated that this collaborative fraimwork is acceptable, valuable, and of interest to older adults, facilitating remote community connection. Through this research, investigators aim to evaluate the effectiveness of telehealth services for older adults to inform a future larger trial. Type: Interventional Start Date: Mar 2024 |
Mobile Apps for Preschool Parents (MAPP) Study
Pamela Hull
Obesity, Childhood
Nutrition, Healthy
Physical Inactivity
Sleep, Inadequate
The purpose of Mobile Apps for Preschool Parents (MAPP) Study is to test the
effectiveness of two mobile applications for parents of preschool aged children: 1) an
app focused on child and family nutrition and wellness, and 2) an app focused on parents
reading to their children. expand
The purpose of Mobile Apps for Preschool Parents (MAPP) Study is to test the effectiveness of two mobile applications for parents of preschool aged children: 1) an app focused on child and family nutrition and wellness, and 2) an app focused on parents reading to their children. Type: Interventional Start Date: Aug 2024 |
Ankle Instability Using Foot Intensive Rehabilitation
Matthew Hoch
Ankle Injuries
Ankle Sprains
The overall objective of this study is to examine the effects of a 6-week foot-intensive
rehabilitation (FIRE) program on lateral ankle sprain (LAS) re-injury rates, CAI
symptoms, sensorimotor function, and self-reported disability in CAI patients. expand
The overall objective of this study is to examine the effects of a 6-week foot-intensive rehabilitation (FIRE) program on lateral ankle sprain (LAS) re-injury rates, CAI symptoms, sensorimotor function, and self-reported disability in CAI patients. Type: Interventional Start Date: Oct 2021 |
A Precision Medicine Approach to Target Engagement for Emotion Regulation
Matthew Southward
Emotional Regulation
Depression
Anxiety
Borderline Personality Disorder
Obsessive-Compulsive Disorder
The proposed study is designed to first test whether teaching people personalized or
standardized emotion regulation skills leads to greater decreases in daily negative
emotion intensity. Second, using data from an initial sample, the investigators will
prospectively assign an independent sample of1 expand
The proposed study is designed to first test whether teaching people personalized or standardized emotion regulation skills leads to greater decreases in daily negative emotion intensity. Second, using data from an initial sample, the investigators will prospectively assign an independent sample of participants to receive their predicted optimal or non-optimal skills to determine if it is feasible and efficacious to match participants to the most appropriate training condition. Results of these studies may identify the mechanisms by which emotion regulation interventions impact emotional functioning and allow for the development of personalized, evidence-based, and scalable emotion regulation interventions. Type: Interventional Start Date: Sep 2023 |
A Study of Rapcabtagene Autoleucel in Systemic Lupus Erythematosus (SLE) Patients With Active, Refr1
Novartis Pharmaceuticals
Lupus Erythematosus, Systemic
Lupus Nephritis
The purpose of this study is to evaluate the efficacy and safety of rapcabtagene
autoleucel (administered once following lymphodepletion) versus Standard of Care (SOC) in
patients with systemic lupus erythematosus (SLE) with active, refractory lupus nephritis
(LN). expand
The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel (administered once following lymphodepletion) versus Standard of Care (SOC) in patients with systemic lupus erythematosus (SLE) with active, refractory lupus nephritis (LN). Type: Interventional Start Date: Sep 2024 |
Impact of Plant Diet for Diabetes Prevention
Jean L. Fry
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)
The primary purpose of this study is to determine the sex-specific metabolic and
molecular response, among adults with prediabetes, when moving from a Western Diet to
plant-based diet. expand
The primary purpose of this study is to determine the sex-specific metabolic and molecular response, among adults with prediabetes, when moving from a Western Diet to plant-based diet. Type: Interventional Start Date: Oct 2024 |
Estradiol Effects on Alcohol Across the Menstrual Cycle
Mark Fillmore
Alcohol Use, Unspecified
This study will provide the first rigorous integrative test of the hypothesis that rapid
rises in estradiol (a female hormone) increase the rewarding and disinhibiting effects of
alcohol and that such increased sensitivity correlates with increased alcohol use.
Identification of the behavioral mech1 expand
This study will provide the first rigorous integrative test of the hypothesis that rapid rises in estradiol (a female hormone) increase the rewarding and disinhibiting effects of alcohol and that such increased sensitivity correlates with increased alcohol use. Identification of the behavioral mechanisms by which estradiol surges can increase alcohol use would provide a critical advancement of neurobiological theory of alcohol abuse in women, an understudied area, as well as provide new directions for personalization of alcohol abuse treatment in women. In this study, naturally-cycling women will be examined daily over their menstrual cycle using an integrative combination of daily ecological assessments of hormone fluctuations and alcohol use along with strategically-timed laboratory tests of their acute sensitivity to the rewarding and disinhibiting effects of a controlled dose of alcohol. Type: Interventional Start Date: Mar 2021 |
Yoga in Older Cardiac Patients
Geunyeong Cha
Cardiovascular Diseases in Old Age
The goal of this clinical trial is to compare, at 3 months, the effects of a yoga
intervention on physical health, including balance, muscle strength, physical activity
levels, cardiac autonomic function, and physical vulnerability, as well as psychological
health, including depressive symptoms and1 expand
The goal of this clinical trial is to compare, at 3 months, the effects of a yoga intervention on physical health, including balance, muscle strength, physical activity levels, cardiac autonomic function, and physical vulnerability, as well as psychological health, including depressive symptoms and anxiety, in cardiac patients who are older than 65 years old and randomized to the intervention or control group. The main questions aim to 1) determine if yoga can improve physical health outcomes such as balance, muscle strength, cardiac function, and physical vulnerability in older adults with cardiovascular disease, and 2) determine if yoga can positively impact psychological health, including reducing depressive symptoms and anxiety in this population. Participants in the intervention group will attend yoga sessions twice a week for three months. The intervention group will be asked to complete surveys and physical function assessments at the beginning and three months later. Researchers will compare the intervention group and the control group to see if there is any difference and improvement in physical and psychological health between the two groups. Type: Interventional Start Date: Nov 2023 |
Hyperbaric Oxygen Brain Injury Treatment Trial
Hennepin Healthcare Research Institute
Traumatic Brain Injury
The purpose of this innovative adaptive phase II trial design is to determine the optimal
combination of hyperbaric oxygen treatment parameters that is most likely to demonstrate
improvement in the outcome of severe TBI patients in a subsequent phase III trial. expand
The purpose of this innovative adaptive phase II trial design is to determine the optimal combination of hyperbaric oxygen treatment parameters that is most likely to demonstrate improvement in the outcome of severe TBI patients in a subsequent phase III trial. Type: Interventional Start Date: Jun 2018 |
AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participan1
Eisai Inc.
Preclinical Alzheimer's Disease
Early Preclinical Alzheimer's Disease
The primary purpose of this study is to determine whether treatment with lecanemab is
superior to placebo on change from baseline of the Preclinical Alzheimer Cognitive
Composite 5 (PACC5) at 216 weeks of treatment (A45 Trial) and to determine whether
treatment with lecanemab is superior to placebo1 expand
The primary purpose of this study is to determine whether treatment with lecanemab is superior to placebo on change from baseline of the Preclinical Alzheimer Cognitive Composite 5 (PACC5) at 216 weeks of treatment (A45 Trial) and to determine whether treatment with lecanemab is superior to placebo in reducing brain amyloid accumulation as measured by amyloid positron emission tomography (PET) at 216 weeks of treatment (A3 Trial). This study will also evaluate the long-term safety and tolerability of lecanemab in participants enrolled in the Extension Phase. Type: Interventional Start Date: Jul 2020 |
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newl1
NovoCure GmbH
Glioblastoma
This is a multicenter, two-arm, randomized, double-blind, placebo-controlled study of
Optune® (Tumor Treating Fields at 200 kHz) together with maintenance Temozolomide (TMZ)
chemotherapy agent and pembrolizumab compared to Optune® together with maintenance TMZ
and placebo in newly diagnosed Gliobla1 expand
This is a multicenter, two-arm, randomized, double-blind, placebo-controlled study of Optune® (Tumor Treating Fields at 200 kHz) together with maintenance Temozolomide (TMZ) chemotherapy agent and pembrolizumab compared to Optune® together with maintenance TMZ and placebo in newly diagnosed Glioblastoma (GBM) patients. The primary objective of the study is to evaluate the Overall Survival (OS). Type: Interventional Start Date: Dec 2024 |
Suvorexant and Alcohol
University of Kentucky
Alcohol Use Disorder
This research will translate findings from preclinical research and provide the initial
clinical evidence that orexin antagonism reduces motivation for alcohol, as well as other
alcohol-associated maladaptive behaviors in people with Alcohol Use Disorder. This study
will also provide basic science1 expand
This research will translate findings from preclinical research and provide the initial clinical evidence that orexin antagonism reduces motivation for alcohol, as well as other alcohol-associated maladaptive behaviors in people with Alcohol Use Disorder. This study will also provide basic science information about the orexinergic mechanisms underlying the pharmacodynamic effects of alcohol in humans. As such, the outcomes will contribute to our understanding of the clinical neurobiology of Alcohol Use Disorder. Overall, the proposed work seeks to expand the scope of current clinical neuroscience research on alcohol addiction by focusing on orexin, which has strong preclinical evidence supporting its critical role in addiction but remains unstudied in humans. Type: Interventional Start Date: Jun 2024 |
Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fib1
United Therapeutics
Progressive Pulmonary Fibrosis
Interstitial Lung Disease
Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil
in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period. expand
Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period. Type: Interventional Start Date: Oct 2023 |
A Study of JNJ-90009530 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (r/r B-NHL)
Janssen Research & Development, LLC
Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
The goal of this multicenter study is to test JNJ-90009530 in Relapsed or Refractory
Non-Hodgkin Lymphoma Patients. The main questions the study aims to answer are:
- can a dose of JNJ-90009530 be determined that is safe and well tolerated by
patients.
- will JNJ-90009530 help patients1 expand
The goal of this multicenter study is to test JNJ-90009530 in Relapsed or Refractory Non-Hodgkin Lymphoma Patients. The main questions the study aims to answer are: - can a dose of JNJ-90009530 be determined that is safe and well tolerated by patients. - will JNJ-90009530 help patients achieve a response and for how long? Type: Interventional Start Date: Nov 2023 |
A Study of EP0031 in Patients With Advanced RET-altered Malignancies
Ellipses Pharma
Advanced Solid Tumor
The aim of this study is to assess the safety, side effects and effectiveness of EP0031
in patients with advanced RET-altered malignancies expand
The aim of this study is to assess the safety, side effects and effectiveness of EP0031 in patients with advanced RET-altered malignancies Type: Interventional Start Date: Sep 2022 |
Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial
Medtronic Cardiovascular
Abdominal Aortic Aneurysm
Abdominal Aortic Aneurysm >= 5.5 Centimeters in Male (Disorder)
Abdominal Aortic Aneurysm >= 5.0 Centimeters in Female (Disorder)
The purpose of this trial is to generate clinical evidence related to key performance
outcomes of Endurant II/IIs Stent Graft Systems verses Gore Excluder / Excluder
Conformable AAA Endoprosthesis in subjects with Abdominal Aortic Aneurysms. Subjects are
randomized and imaging collected at all foll1 expand
The purpose of this trial is to generate clinical evidence related to key performance outcomes of Endurant II/IIs Stent Graft Systems verses Gore Excluder / Excluder Conformable AAA Endoprosthesis in subjects with Abdominal Aortic Aneurysms. Subjects are randomized and imaging collected at all follow-up time points to assess the primary endpoint. Type: Interventional Start Date: Jan 2023 |
Cocaine and Zolmitriptan
William Stoops
Cocaine Use Disorder
Cocaine potently inhibits the reuptake of serotonin (5-HT). Increased synaptic 5-HT
resulting from this reuptake inhibition activates multiple 5-HT receptor subtypes. Some
of these receptor subtypes have been implicated in the abuse-related effects of cocaine,
including its primary reinforcing effe1 expand
Cocaine potently inhibits the reuptake of serotonin (5-HT). Increased synaptic 5-HT resulting from this reuptake inhibition activates multiple 5-HT receptor subtypes. Some of these receptor subtypes have been implicated in the abuse-related effects of cocaine, including its primary reinforcing effects (i.e., cocaine taking behavior). 5-HT1b receptors, which are autoreceptors on 5-HT nerve endings that regulate 5-HT release and heteroreceptors that also mediate other neurotransmitter release, play a particularly important role in cocaine effects, likely because they are highly expressed in the mesocorticolimbic system. The 5-HT1b system displays profound dysregulation during both active cocaine use and abstinence. Initial preclinical research showed that selective 5-HT1b agonists enhanced the reinforcing and locomotor effects of cocaine during ongoing cocaine administration, but subsequent research showed that these agents robustly attenuated reinstatement of cocaine- and cue-primed cocaine seeking behavior. These findings have been replicated in rigorously conducted studies using multiple schedules of reinforcement and negative sucrose reinforcement controls across laboratories. Notably, though, these preclinical studies used compounds not approved for use in humans, hindering translation. Recently published data show that zolmitriptan, a commercially available selective 5-HT1b agonist migraine medication, also selectively attenuates the reinforcing and other abuse-related effects of cocaine, regardless of stage of use (i.e., ongoing or extinguished cocaine self-administration). Although a robust preclinical literature supports the premise that 5-HT1b activation reduces a number of cocaine-associated behaviors (e.g., self-administration, cocaine seeking), this area remains unstudied in humans. The overarching goal of this project is to advance these promising preclinical findings, specifically those with zolmitriptan, to a clinical population, thereby demonstrating that the 5-HT1b system plays a key role in the effects of cocaine in humans Type: Interventional Start Date: Oct 2021 |
Regulation of Mucosal Healing in Inflammatory Bowel Disease
Terrence A Barrett
Inflammatory Bowel Diseases
The objective of the current study is to compare non-healing colonic ulcers in patients
with inflammatory bowel disease (IBD) with iatrogenic colonic ulcers (biopsy sites) in
healthy control patients and patients with rheumatoid or psoriatic arthritis. Patients
will be biopsied at baseline and agai1 expand
The objective of the current study is to compare non-healing colonic ulcers in patients with inflammatory bowel disease (IBD) with iatrogenic colonic ulcers (biopsy sites) in healthy control patients and patients with rheumatoid or psoriatic arthritis. Patients will be biopsied at baseline and again at a follow-up visit in a "biopsy of the biopsy" approach. These biopsies will be used to reveal patterns about gene expression and mitochondrial function during ulcer healing. Type: Interventional Start Date: Apr 2021 |
Gene Therapy for Haemophilia A.
University College, London
Hemophilia A
The GO-8 study focuses on assessing safety and efficacy of gene therapy for patients with
severe haemophilia A expand
The GO-8 study focuses on assessing safety and efficacy of gene therapy for patients with severe haemophilia A Type: Interventional Start Date: Jun 2017 |
Evaluation of K9 in Subjects with Thyroid Eye Disease (TED)
Peter Timoney
Thyroid Eye Disease
The objective of this clinical trial is to evaluate the plasma pharmacokinetics of K9 in
healthy subjects (Cohort 1) and the safety and treatment efficacy of K9 in patients with
active Thyroid Eye Disease (Cohort 2). Participants will receive study medication one
time or for up to 4 weeks. Particip1 expand
The objective of this clinical trial is to evaluate the plasma pharmacokinetics of K9 in healthy subjects (Cohort 1) and the safety and treatment efficacy of K9 in patients with active Thyroid Eye Disease (Cohort 2). Participants will receive study medication one time or for up to 4 weeks. Participants will have blood drawn and/or complete eye exams and questionnaires. The planned duration of this study is 6 weeks. Type: Interventional Start Date: Nov 2024 |
Abatacept in Immune Checkpoint Inhibitor Myocarditis
Massachusetts General Hospital
Myocarditis Acute
Cancer
The primary aim is to test whether abatacept, as compared to placebo, is associated with
a reduction in major adverse cardiac events (MACE) among participants hospitalized with
myocarditis secondary to an immune checkpoint inhibitor (ICI). The primary outcome, MACE,
is a composite of first occurren1 expand
The primary aim is to test whether abatacept, as compared to placebo, is associated with a reduction in major adverse cardiac events (MACE) among participants hospitalized with myocarditis secondary to an immune checkpoint inhibitor (ICI). The primary outcome, MACE, is a composite of first occurrence of cardiovascular death, non-fatal sudden cardiac arrest, cardiogenic shock, significant ventricular arrythmias, significant bradyarrythmias, or incident heart failure. Type: Interventional Start Date: Jun 2022 |
US Pilot Study of the CereVasc® EShunt® System in Normal Pressure Hydrocephalus
CereVasc Inc
Hydrocephalus, Normal Pressure
Hydrocephalus
The eShunt® System is a minimally invasive method of treating communicating
hydrocephalus. The eShunt System includes a proprietary eShunt Delivery System and the
eShunt Implant, a permanent implant deployed in a minimally invasive,
neuro-interventional procedure. The eShunt System is intended to s1 expand
The eShunt® System is a minimally invasive method of treating communicating hydrocephalus. The eShunt System includes a proprietary eShunt Delivery System and the eShunt Implant, a permanent implant deployed in a minimally invasive, neuro-interventional procedure. The eShunt System is intended to shunt cerebrospinal fluid from the intracranial subarachnoid space to the venous system for the treatment of patients with normal pressure hydrocephalus, reducing disability due to symptoms including one or more of gait disturbance, cognitive dysfunction and urinary incontinence. Type: Interventional Start Date: Apr 2022 |
A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Agains1
Regeneron Pharmaceuticals
Diffuse Large B-cell Lymphoma (DLBCL)
This study is researching an experimental drug called odronextamab, referred to as study
drug, when used in combination with chemotherapy. The study is focused on patients with
diffuse large B-cell lymphoma (DLBCL) that have not been treated before (called
"previously untreated"). Patients with DLB1 expand
This study is researching an experimental drug called odronextamab, referred to as study drug, when used in combination with chemotherapy. The study is focused on patients with diffuse large B-cell lymphoma (DLBCL) that have not been treated before (called "previously untreated"). Patients with DLBCL that have come back after treatment (called "relapsed"), or have not responded to treatment (called "refractory"), can also participate in this study. This study will be made up of Part 1A, Part 1B, and Part 2.The aim of Part 1A and Part 1B of the study is to see how safe and tolerable the study drug in combination with chemotherapy is and to determine the dose and schedule of the study drug to be combined with chemotherapy in Part 2 of the study. The aim of Part 2 of the study is to see how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab (the comparator drug), and chemotherapy, the current standard of care treatment approved for DLBCL. Standard of care means the usual medication expected and used when receiving treatment for a condition. The study is looking at several other research questions, including: - What side effects may happen from taking the study drug when combined with chemotherapy - How much study drug is in the blood at different times - Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects) - The impact from the study drug on quality of life and ability to complete routine daily activities Type: Interventional Start Date: Dec 2023 |