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A Study to Evaluate Avacopan in Participants With ANCA-associated Vasculitis
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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 |
Evaluating an mHealth Intervention for Reducing Alcohol Use Among Rural Adolescent and Young Adult Cancer...
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Carolyn Lauckner
Cancer
Alcohol Use
The objective of this study is to adapt and test the feasibility of a 4-week motivational
interviewing mHealth intervention, Tracking and Reducing Alcohol Consumption (TRAC), to
reduce alcohol use among rural adolescent and young adult (AYA) cancer survivors during
post-treatment survivorship.
At... expand
The objective of this study is to adapt and test the feasibility of a 4-week motivational interviewing mHealth intervention, Tracking and Reducing Alcohol Consumption (TRAC), to reduce alcohol use among rural adolescent and young adult (AYA) cancer survivors during post-treatment survivorship. At the end of this study, the feasibility data gathered will inform a definitive randomized controlled trial of TRAC-AYA to test the efficacy of the adapted intervention. Type: Interventional Start Date: Nov 2022 |
Ankle Instability Using Foot Intensive Rehabilitation
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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
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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 of... 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 |
Yoga in Older Cardiac Patients
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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 and... 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
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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 |
Estradiol Effects on Alcohol Across the Menstrual Cycle
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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 mechanisms... 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 |
AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants...
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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 placebo... 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 |
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 safe dose of JNJ-90009530 be determined that is safe and well tolerated by
patients.
- will JNJ-90009530 help... 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 safe 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 |
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/private... 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 |
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... 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 |
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 science... 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 Fibrosis...
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 |
INTERCOSTAL NERVE BLOCK: Efficacy of CINB for Patients With Multiple Rib Fractures
Zachary Warriner
Rib Fractures
This is a prospective, randomized, non-blinded study comparing CINB plus medical therapy
versus standard medical care (non-steroidals and opioids intravenous/oral inpatient and
oral outpatient) alone for patients with multiple rib fractures. The objective of this
study is to analyze the effect of... expand
This is a prospective, randomized, non-blinded study comparing CINB plus medical therapy versus standard medical care (non-steroidals and opioids intravenous/oral inpatient and oral outpatient) alone for patients with multiple rib fractures. The objective of this study is to analyze the effect of continuous intercostal nerve block (CINB) in the treatment of patients admitted to the adult trauma service with rib fractures. The effectiveness of CINB as adjunctive treatment will be compared to standard medical therapy involving nonsteroidal and intravenous/oral opioid medications. Type: Interventional Start Date: Jul 2024 |
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 |
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 effects... 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 |
Nilotinib Plus Dabrafenib/Trametinib in Metastatic Melanoma
Ruta Arays
Metastatic Melanoma
BRAF Gene Mutation
This is a phase 1 dose-escalation study of nilotinib in combination with fixed-dose
dabrafenib and trametinib regimen for patients with metastatic or unresectable melanoma
carrying a BRAF V600 mutation and have relapsed on a BRAF/MEK inhibitor therapy. The goal
is to assess the toxicity and tolerability... expand
This is a phase 1 dose-escalation study of nilotinib in combination with fixed-dose dabrafenib and trametinib regimen for patients with metastatic or unresectable melanoma carrying a BRAF V600 mutation and have relapsed on a BRAF/MEK inhibitor therapy. The goal is to assess the toxicity and tolerability and determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of the combination of nilotinib with dabrafenib and trametinib. Additionally, this study will assess pharmacokinetic parameters of dabrafenib and nilotinib when used in combination. Type: Interventional Start Date: Jun 2022 |
Spinal Decompression Plus Nerve Graft Implantation Following TSCI
H. Francis Farhadi
Spinal Cord Injuries
Acute Traumatic Spinal Cord Injury
This is a single-blinded (with outcome assessors blinded to treatment allocation),
12-month pilot study to evaluate of the safety, feasibility, and preliminary efficacy of
dorsal myelotomy and expansive duraplasty performed either without or with autologous
nerve graft implantation after acute traumatic... expand
This is a single-blinded (with outcome assessors blinded to treatment allocation), 12-month pilot study to evaluate of the safety, feasibility, and preliminary efficacy of dorsal myelotomy and expansive duraplasty performed either without or with autologous nerve graft implantation after acute traumatic spinal cord injury. Ten participants will be allocated to receive either DMED (n=5) or DMED + ANGI (n=5) based on a block design. Participants and assessors will be blinded to group allocation. Excess sural nerve samples will be collected for banking/analysis (may include proteomic, culturing, genomic, cellular analysis). Type: Interventional Start Date: Apr 2024 |
Improving Medication Adherence Using Family-focused and Literacy-sensitive Strategies
Jia-Rong Wu
Medication Adherence
Heart Failure
People with heart failure who do not take their medications as prescribed are at high
risk of complications leading to hospitalization, death and poor quality of life. In the
proposed intervention, nurses will use easy-to-understand language to coach patients and
their care partners to help them work... expand
People with heart failure who do not take their medications as prescribed are at high risk of complications leading to hospitalization, death and poor quality of life. In the proposed intervention, nurses will use easy-to-understand language to coach patients and their care partners to help them work together and build skills to overcome their individual barriers to adherence in order to 1) improve and sustain patient medication adherence; 2) reduce hospitalization; 3) improve quality of life. If effective, this intervention will support long-term medication adherence, thus reducing hospitalizations related to heart failure and quality of life. Type: Interventional Start Date: Jan 2023 |
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 follow-up... 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 |
Piloting 'mPal,' a Multilevel Strategy for Palliative Care Implementation
Laurie McLouth
Lung Cancer
The purpose of this study is to assess the feasibility and acceptability of mPal, a
multilevel implementation strategy to improve palliative care use among advanced stage
lung cancer patients receiving cancer treatment. expand
The purpose of this study is to assess the feasibility and acceptability of mPal, a multilevel implementation strategy to improve palliative care use among advanced stage lung cancer patients receiving cancer treatment. Type: Interventional Start Date: Jul 2022 |
A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin, Etoposide...
Novartis Pharmaceuticals
Extensive Stage Small Cell Lung Cancer
This study aims to establish a safe and well tolerated dose of [177Lu]Lu-DOTA-TATE in
combination with carboplatin, etoposide and atezolizumab in this setting and to assess
preliminary efficacy of this combination treatment versus the combination of carboplatin,
etoposide, and atezolizumab.The study... expand
This study aims to establish a safe and well tolerated dose of [177Lu]Lu-DOTA-TATE in combination with carboplatin, etoposide and atezolizumab in this setting and to assess preliminary efficacy of this combination treatment versus the combination of carboplatin, etoposide, and atezolizumab.The study will be essential to assess a new potential therapeutic option in participants with this aggressive cancer type. Type: Interventional Start Date: Jul 2022 |
Parkinson's Foundation PD GENEration Genetic Registry
Parkinson's Foundation
Parkinson's Disease
Development of a central repository for PD-related genomic data for future research. expand
Development of a central repository for PD-related genomic data for future research. Type: Observational [Patient Registry] Start Date: Dec 2020 |
Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells
Celgene
Neoplasms
This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for
all pediatric and adult participants exposed to Gene-modified (GM) T cell therapy
participating in a previous Celgene sponsored or Celgene alliance partner sponsored
study.
Participants who received at least... expand
This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult participants exposed to Gene-modified (GM) T cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study. Participants who received at least one GM T cell infusion will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol. Type: Interventional Start Date: Jun 2018 |
K23- Physical Self Regulation vs Placebo
Ian Boggero, PhD
Temporomandibular Disorder
This study will use a between-person design. Participants will be treatment-seeking
patients with chronic masticatory muscle pain. Participants who are eligible for the
study and consent to participate will be randomly assigned to receive a brief behavioral
intervention for chronic orofacial pain... expand
This study will use a between-person design. Participants will be treatment-seeking patients with chronic masticatory muscle pain. Participants who are eligible for the study and consent to participate will be randomly assigned to receive a brief behavioral intervention for chronic orofacial pain called Physical Self-Regulation or a control intervention. Interventions will be administered via telehealth in both arms. Both interventions will consist of 2 50-minute sessions scheduled approximately two weeks apart. Participants will be contacted two weeks and three months after completing the interventions to provide additional follow-up data. Investigators hypothesize that both PSR-TH and the control intervention will demonstrate strong feasibility (i.e., recruitment of at least 1 participant per week, >75% retention, >95% interventionist fidelity, and adequate acceptability, credibility, and burden). Investigators also hypothesize that specific biopsychosocial variables will moderate PSR-TH-related changes in outcomes, and that PSR-TH-related changes in perceived control over pain, self-efficacy, coping, parafunctional habits, and relaxation will mediate treatment effects. Type: Interventional Start Date: Apr 2024 |