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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 |
Mobile Apps for Preschool Parents (MAPP) Study
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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 |
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 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
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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 |
Assessing the Impact of a Plant-Based Diet for Diabetes Prevention
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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 |
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 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
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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 |
A Study to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's Disease
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Cognition Therapeutics
Early Alzheimer's Disease
This is a multicenter randomized, double-blind, placebo-controlled Phase 2 study designed
to evaluate the efficacy, safety, and tolerability of two doses of CT1812 compared to
placebo in participants diagnosed with early Alzheimer's disease. expand
This is a multicenter randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the efficacy, safety, and tolerability of two doses of CT1812 compared to placebo in participants diagnosed with early Alzheimer's disease. Type: Interventional Start Date: Jun 2023 |
Life's End Benefits of cannaBidiol and tetrahYdrocannabinol
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University of Southern California
Agitation
Dementia
This is a multicenter randomized double-blind placebo-controlled Phase 2 study of an oral
combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) compared to placebo over
12 weeks. This study is designed to test the hypothesis that treatment with an oral
combination of THC/CBD will reduce a1 expand
This is a multicenter randomized double-blind placebo-controlled Phase 2 study of an oral combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) compared to placebo over 12 weeks. This study is designed to test the hypothesis that treatment with an oral combination of THC/CBD will reduce agitation hospice care-eligible patients with agitation and dementia as measured by the Cohen Mansfield Agitation Inventory (CMAI) when compared to placebo at 2 weeks. This study will enroll approximately 120 participants of any gender at least 40 years of age who are hospice care-eligible with agitation and dementia (HAD). Participants will be randomized (50:50) to either active study drug (T2:C100) or placebo. The double-blind period of this study is 12 weeks. A 12 week optional open-label extension will be offered to participants who complete the double-blind period. Type: Interventional Start Date: Dec 2023 |
TRAC-ER Intervention to Reduce Risky Alcohol Use and HIV Risk
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University of Kentucky
Risk Behavior
Alcohol Use Disorder
HIV Infections
Ecological momentary interventions (EMI), which use phones to deliver messages to reduce
alcohol use and related risk behaviors during or prior to drinking events, can help to
address triggers in real-time. GPS tracking can determine when individuals visit places
they have previously reported drink1 expand
Ecological momentary interventions (EMI), which use phones to deliver messages to reduce alcohol use and related risk behaviors during or prior to drinking events, can help to address triggers in real-time. GPS tracking can determine when individuals visit places they have previously reported drinking or triggers to drink and then EMI messages can be delivered upon arrival to prevent risky alcohol use. A mobile app has been developed that uses GPS tracking to determine when individuals visit "risky" places and then delivers a survey asking what behaviors they engaged in while at the location. The goal of the proposed study is to use this app to enhance the Tracking and Reducing Alcohol Consumption (TRAC) intervention by delivering messages that encourage participants to employ strategies discussed during TRAC sessions when arriving at risky places. When they leave these places, they will complete a survey and breathalyzer reading in order to collect event-level self-report and biological data on alcohol use and HIV risk. If their breathalyzer result indicates alcohol use, they will receive harm reduction messaging. It is expected that combining TRAC with EMI ("TRAC-ER") will increase effectiveness by reinforcing topics discussed during these sessions, providing in-the-moment messaging to address triggers, and collecting real-time alcohol use data. Type: Interventional Start Date: Dec 2024 |
Evaluation of K9 in Subjects With Diabetic Macular Edema (DME)
Michelle Abou-Jaoude
Diabetic Macular Edema
A non-randomized study evaluating the safety of an orally administered inflammasome
inhibitor, K9, for the treatment of diabetic macular edema (DME). expand
A non-randomized study evaluating the safety of an orally administered inflammasome inhibitor, K9, for the treatment of diabetic macular edema (DME). Type: Interventional Start Date: Mar 2025 |
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 treatment will be admin1 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. Number of participants has been expanded to 30. 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 |
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 |
Strength and Muscle Related Outcomes for Nutrition and Lung Function in CF
Jaeb Center for Health Research
Cystic Fibrosis
The goal of the study is to examine multiple markers of anthropometrics, body
composition, sarcopenia and frailty and compare them to dual energy X-ray absorptiometry
(DXA) output, which is considered the current clinical gold-standard tool to measure body
composition. The result of this study will1 expand
The goal of the study is to examine multiple markers of anthropometrics, body composition, sarcopenia and frailty and compare them to dual energy X-ray absorptiometry (DXA) output, which is considered the current clinical gold-standard tool to measure body composition. The result of this study will provide detailed data regarding the nutrition and body composition within this Cystic Fibrosis population and also provide a baseline evaluation for use of these biomarkers in the future studies including evaluation of nutritional intervention. Further, the study will also include psychosocial and other patient-reported outcomes and medical contributors to understand their contributions to the nutritional failure in the adult advanced lung disease population. Finally, the study will evaluate both established and emerging nutritional and body composition parameters and link them to clinical outcomes in adults with CF across the spectrum of pulmonary function. Type: Observational Start Date: Apr 2023 |
A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin,1
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 stud1 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 |
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 incidence of hypoglycemi1 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 |
tDCS and Urge in BFRBs
Gopalkumar Rakesh
Repetitive Compulsive Behavior
The goal of this study is to find out if brain stimulation can help people stop
skin-picking or nail-biting. The study wants to answer two main questions:
1. Does brain stimulation reduce the urge to pick skin or bite nails after those urges
are triggered?
2. Does brain stimulation reduc1 expand
The goal of this study is to find out if brain stimulation can help people stop skin-picking or nail-biting. The study wants to answer two main questions: 1. Does brain stimulation reduce the urge to pick skin or bite nails after those urges are triggered? 2. Does brain stimulation reduce how often people pick their skin or bite their nails? Participants will: - Talk about their skin-picking, nail-biting, and other mental health concerns - Be placed in situations that make them want to pick or bite - Rate how strong their urges are before and after brain stimulation Researchers will compare real brain stimulation to a placebo (a fake version that looks the same but has no effect) to see if the real stimulation works to reduce skin-picking and nail-biting urges and behaviors. Type: Interventional Start Date: Jul 2025 |
Methamphetamine and Troriluzole
University of Kentucky
Methamphetamine Use Disorder
This will be a human laboratory study evaluating the influence of troriluzole treatment
on the effects of methamphetamine. expand
This will be a human laboratory study evaluating the influence of troriluzole treatment on the effects of methamphetamine. Type: Interventional Start Date: Aug 2025 |
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: Feb 2025 |
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 |
Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer
Janssen Research & Development, LLC
Urinary Bladder Neoplasms
Receptors, Fibroblast Growth Factor
The purpose of the study in Part 1 (dose escalation) and in Part 2 (dose expansion) is to
determine the recommended Phase 2 dose(s) (RP2D[s]) and evaluate preliminary clinical
efficacy. Part 3 (dose expansion) will confirm safety and preliminary clinical activity
at the RP2D. Part 4 (RP2D expansion1 expand
The purpose of the study in Part 1 (dose escalation) and in Part 2 (dose expansion) is to determine the recommended Phase 2 dose(s) (RP2D[s]) and evaluate preliminary clinical efficacy. Part 3 (dose expansion) will confirm safety and preliminary clinical activity at the RP2D. Part 4 (RP2D expansion) will assess the overall complete response (CR) in participants with intermediate-risk-non-muscle invasive bladder cancer (IR-NMIBC; means the cancer cells are only in the bladder's inner lining). Type: Interventional Start Date: Apr 2022 |
BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis
Penumbra Inc.
Deep Vein Thrombosis
DVT
The objective of this study is to demonstrate the safety and efficacy of the Indigo
Aspiration system for percutaneous mechanical thrombectomy in a population presenting
with obstruction due to deep vein thrombosis (DVT) who are eligible for treatment. expand
The objective of this study is to demonstrate the safety and efficacy of the Indigo Aspiration system for percutaneous mechanical thrombectomy in a population presenting with obstruction due to deep vein thrombosis (DVT) who are eligible for treatment. Type: Interventional Start Date: Sep 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. expand
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 |
Hydrocolloid Dressings for Oculofacial Plastic and Reconstructive Wound Healing
Janice Hernandez, MD
Wound Healing
Mohs Micrographic Surgery
Oculofacial Reconstruction
This study aims to explore the use of a hydrocolloid dressing (DuoDERM EXTRA THIN) as an
alternative to the current standard of care. The dressing would be applied immediately
after surgery and removed at a post-operative week 1 appointment. The dressing would
eliminate the need for antibiotic oint1 expand
This study aims to explore the use of a hydrocolloid dressing (DuoDERM EXTRA THIN) as an alternative to the current standard of care. The dressing would be applied immediately after surgery and removed at a post-operative week 1 appointment. The dressing would eliminate the need for antibiotic ointment application and reduce the burden of post-operative care on the patient. Type: Interventional Start Date: Jul 2025 |
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 |