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Evaluating an mHealth Intervention for Reducing Alcohol Use Among Rural Adolescent and Young Adult Cancer...
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... 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
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.
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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... 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 |
AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants...
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... 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 |
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... 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.
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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
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... 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 |
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... 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 |
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.
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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,... 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.
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Development of a central repository for PD-related genomic data for future research. Type: Observational [Patient Registry] Start Date: Dec 2020 |
Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion
IDEAYA Biosciences
Solid Tumor
This is a Phase 1, open-label, multicenter, dose escalation and expansion study of the
safety, PK, PD, and preliminary anti-tumor activity of IDE397 as a single agent and in
combination with other anticancer agents including taxanes (docetaxel, paclitaxel), or
sacituzumab... expand
This is a Phase 1, open-label, multicenter, dose escalation and expansion study of the safety, PK, PD, and preliminary anti-tumor activity of IDE397 as a single agent and in combination with other anticancer agents including taxanes (docetaxel, paclitaxel), or sacituzumab govitecan (SG), in adult patients with selected advanced or metastatic MTAP-deleted advanced solid tumors who are unresponsive to standard of care therapy. IDE397 is a small molecule inhibitor of methionine adenosyltransferase 2 alpha (MAT2A). Type: Interventional Start Date: Apr 2021 |
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... 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 |
Alternatives to Dental Opioid Prescribing After Tooth Extraction
Douglas Oyler
Analgesics, Opioid
Acute Pain
Tooth Extraction
Adolescent
Acetaminophen
The goal of this clinical trial is to test a three-item intervention in oral surgeons who
remove teeth. The main questions it aims to answer are:
- Can the intervention reduce opioid prescriptions to adolescents and young adults after
tooth removal?
-... expand
The goal of this clinical trial is to test a three-item intervention in oral surgeons who remove teeth. The main questions it aims to answer are: - Can the intervention reduce opioid prescriptions to adolescents and young adults after tooth removal? - Do oral surgeons' beliefs about the intervention and opioid prescribing change? - Do patients that report using opioids after tooth removal have different experiences than patients that do not? Oral surgeon participants will: - Attend a 1-hour education session with a trained pharmacist - Receive patient instructions and blister packs of pain medicine to give to patients - Complete 2 surveys about feasibility and appropriateness Patient participants will complete a survey about pain and medication use after having a tooth removed. Researchers will compare the intervention to usual care to see if it reduces opioid prescribing. Type: Interventional Start Date: Apr 2024 |
A Trial to Evaluate the Safety and Efficacy of Benfotiamine in Patients With Early Alzheimer's Disease...
Alzheimer's Disease Cooperative Study (ADCS)
Alzheimer Disease
The purpose of this study is to learn more about the safety, effectiveness and tolerability
of the study drug called Benfotiamine which may delay or slow the progression of the symptoms
of early Alzheimer's disease.
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The purpose of this study is to learn more about the safety, effectiveness and tolerability of the study drug called Benfotiamine which may delay or slow the progression of the symptoms of early Alzheimer's disease. Type: Interventional Start Date: Mar 2024 |
Evaluation of Kamuvudine-8 in Subjects With Geographic Atrophy
University of Kentucky
Geographic Atrophy
Age-Related Macular Degeneration
This interventional study is a single-center, open label, 26-week study, designed to evaluate
the safety and treatment efficacy of K8 in patients with geographic atrophy (GA) due to
age-related macular degeneration (AMD). Up to 5 subjects will receive study medication. Study... expand
This interventional study is a single-center, open label, 26-week study, designed to evaluate the safety and treatment efficacy of K8 in patients with geographic atrophy (GA) due to age-related macular degeneration (AMD). Up to 5 subjects will receive study medication. Study treatment will be administered by intravitreal injections. Participants will have 7 scheduled visits - Screening with baseline (injection), safety visit 2 days after injection, week 4, week 13 (injection), safety visit 2 days after injection, week 17, week 26. Exams will look for continuous changes in visual acuity, change in area of geographic atrophy lesions in diagnostic imaging, response measured by multifocal electroretinogram, change in reading speed, and change in microperimetry response. Type: Interventional Start Date: Apr 2024 |
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.... 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 |
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... 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: May 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
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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... 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 |
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... 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 |
Study to Evaluate the Safety, Tolerability and Efficacy of CT1812 in Subjects With Mild to Moderate Dementia...
Cognition Therapeutics
Dementia With Lewy Bodies
Multi-center, randomized, double-blind, placebo-controlled, 6- month study in subjects with
mild to moderate Dementia with Lewy Bodies.
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Multi-center, randomized, double-blind, placebo-controlled, 6- month study in subjects with mild to moderate Dementia with Lewy Bodies. Type: Interventional Start Date: May 2022 |
DFMO as Maintenance Therapy for Molecular High/Very High Risk and Relapsed Medulloblastoma
Giselle Sholler
Medulloblastoma
Difluoromethylornithine (DFMO) will be used in an open label, multicenter, study as
Maintenance Therapy for Molecular High Risk/Very High Risk and Relapsed/Refractory
Medulloblastoma.
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Difluoromethylornithine (DFMO) will be used in an open label, multicenter, study as Maintenance Therapy for Molecular High Risk/Very High Risk and Relapsed/Refractory Medulloblastoma. Type: Interventional Start Date: Mar 2021 |
Blood Flow Restriction Training After Patellar INStability
Caitlin Conley
Patellar Dislocation
Knee Injuries
Leg Injury
Wounds and Injuries
This research study is designed to allow health care professionals and researchers to answer
many questions about whether a new type of physical therapy called blood flow restriction
training (called BFRT) will improve recovery for those with patellar instability.
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This research study is designed to allow health care professionals and researchers to answer many questions about whether a new type of physical therapy called blood flow restriction training (called BFRT) will improve recovery for those with patellar instability. Type: Interventional Start Date: Sep 2020 |
Restoration of Hypoglycemia Awareness With Metoclopramide
Simon Fisher
Hypoglycemia Unawareness
Metoclopramide is a drug approved by the FDA for gastroesophageal reflux and to relieve
symptoms in adults with acute and recurrent diabetic gastroparesis. The objective of this
study is to determine whether metoclopramide can improve hypoglycemia awareness and decrease
the... expand
Metoclopramide is a drug approved by the FDA for gastroesophageal reflux and to relieve symptoms in adults with acute and recurrent diabetic gastroparesis. The objective of this study is to determine whether metoclopramide can improve hypoglycemia awareness and decrease the incidence of hypoglycemia in type 1 diabetes patients with hypoglycemia unawareness. Type: Interventional Start Date: May 2019 |