Search Clinical Trials
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Comparing Telehealth-Delivered CBT-I to Web-Based CBT-I to Enhance Sleep, Reduce Fatigue, and Promo1
University of Kansas Medical Center
Multiple Sclerosis
Insomnia
The objective of this RCT is to assess the efficacy of one-on-one telehealth CBT-I
(tCBT-I) compared to web-based CBT-I (wCBT-I) and treatment as usual (TAU) to improve
sleep outcomes (Aim 1), fatigue and quality of life (Aim 2), and promote neuroprotection
(Exploratory Aim 3), and to explore the c1 expand
The objective of this RCT is to assess the efficacy of one-on-one telehealth CBT-I (tCBT-I) compared to web-based CBT-I (wCBT-I) and treatment as usual (TAU) to improve sleep outcomes (Aim 1), fatigue and quality of life (Aim 2), and promote neuroprotection (Exploratory Aim 3), and to explore the characteristics of participants that predict improvement in sleep outcomes (Exploratory Aim 4). Reassessment of outcomes will be completed after the 6-week intervention and 6 months following completion of interventions. Type: Interventional Start Date: Oct 2024 |
EPPIC-Net: Novaremed Painful Diabetic Peripheral Neuropathy ISA
James P. Rathmell, MD
Painful Diabetic Neuropathy
The purpose of this study is to investigate the safety and efficacy of the current hard
gelatin capsule formulation of NRD135S.E1 80 mg once daily in the treatment of PDPN when
administered for 13 weeks. expand
The purpose of this study is to investigate the safety and efficacy of the current hard gelatin capsule formulation of NRD135S.E1 80 mg once daily in the treatment of PDPN when administered for 13 weeks. Type: Interventional Start Date: Sep 2022 |
Trial-Ready Cohort-Down Syndrome (TRC-DS)
University of Southern California
Down Syndrome
Alzheimer Disease
Dementia
The purpose of the Trial-Ready Cohort - Down Syndrome (TRC-DS) is to enroll 120 healthy
adults with Down syndrome (DS), between the ages of 25-55, into a trial ready cohort
(TRC), and up to 450 participants in total including co-enrolled in the Alzheimer
Biomarkers Consortium - Down Syndrome (ABC-D1 expand
The purpose of the Trial-Ready Cohort - Down Syndrome (TRC-DS) is to enroll 120 healthy adults with Down syndrome (DS), between the ages of 25-55, into a trial ready cohort (TRC), and up to 450 participants in total including co-enrolled in the Alzheimer Biomarkers Consortium - Down Syndrome (ABC-DS) study. Participants enrolled in the TRC-DS will undergo longitudinal cognitive and clinical assessment, genetic and biomarker testing, as well as imaging and biospecimen collection. Using these outcome measures, researchers will analyze the relationships between cognitive measures and biomarkers of Alzheimer's disease (AD) to identify endpoints for AD clinical trials in DS that best reflect disease progression. To learn more about the study and participating sites, visit our study website at: https://www.trcds.org/. TRC-DS is collaborating with the Alzheimer's Disease Biomarker Consortium-Down Syndrome (ABC-DS) to allow study participants to be concurrently enrolled in both ABC-DS and TRC-DS, referred to as "co-enrollment". ABC-DS is a longitudinal, observational research study that is overseen at University of Pittsburgh Coordinating Center. ABC-DS participants who express interest in potentially joining a clinical trial in the future and who meet TRC-DS eligibility criteria, may choose to co-enroll in TRC-DS at an ABC-DS Site. Co-enrolled participants will adhere to the ABC-DS protocol and schedule of activities, but agree to share their data with the TRC-DS team and to receive invitations for future participation in clinical trials. Fore more information on ABC-DS please visit https://www.nia.nih.gov/research/abc-ds or http://abcds.pitt.edu/. Type: Observational Start Date: Jun 2021 |
A Trial to Learn if Dupilumab is Safe for and Helps Adult and Adolescent Participants With Eosinoph1
Regeneron Pharmaceuticals
Eosinophilic Gastritis
Eosinophilic Duodenitis
Eosinophilic Gastrointestinal Disease
The study is researching an experimental drug called dupilumab. The study is focused on
participants with active eosinophilic gastritis (EoG) with or without eosinophilic
duodenitis (EoD). Participants with EoD only are not eligible for enrollment. EoG and EoD
are uncommon, persistent, allergic/imm1 expand
The study is researching an experimental drug called dupilumab. The study is focused on participants with active eosinophilic gastritis (EoG) with or without eosinophilic duodenitis (EoD). Participants with EoD only are not eligible for enrollment. EoG and EoD are uncommon, persistent, allergic/immune diseases in which eosinophils (a type of white blood cell) gather in large numbers in the stomach and small intestine and cause inflammation and damage. The aim of the study is to evaluate the effect of dupilumab on relieving EoG (with or without EoD) symptoms and reducing inflammation in the stomach and, if applicable, small intestine in adults and adolescents aged 12 years and older, compared to placebo. The study is looking at several other research questions, including: - What side effects may happen from taking the study drug - How much study drug is in your blood at different times - Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) Type: Interventional Start Date: May 2023 |
American Lung Association (ALA) Lung Health Cohort
Johns Hopkins University
Lung Diseases
The ALA-LHC is a longitudinal, multi-center cohort study that will enroll approximately
4,000 young adults between the ages of 25-35 who do not have severe lung disease. The
overarching objective of the ALA-LHC is to establish a national cohort of young adults
for the purpose of defining lung healt1 expand
The ALA-LHC is a longitudinal, multi-center cohort study that will enroll approximately 4,000 young adults between the ages of 25-35 who do not have severe lung disease. The overarching objective of the ALA-LHC is to establish a national cohort of young adults for the purpose of defining lung health and developing targets to intercept chronic lung disease at its earliest stages. Type: Observational Start Date: Oct 2021 |
A Study to Learn About the Safety of BIIB091 and Its Effect on Brain Inflammation When Taken Alone1
Biogen
Relapsing Forms of Multiple Sclerosis
In this study, researchers will learn more about a study drug called BIIB091 in
participants with MS who may be experiencing relapses. It is a 2-part study.
In Part 1, one set of participants will take either BIIB091 or diroximel fumarate (DRF).
In Part 2, a different set of participants will take1 expand
In this study, researchers will learn more about a study drug called BIIB091 in participants with MS who may be experiencing relapses. It is a 2-part study. In Part 1, one set of participants will take either BIIB091 or diroximel fumarate (DRF). In Part 2, a different set of participants will take either a combination of BIIB091 and DRF or DRF alone. The goal of the study is to learn more about the safety of BIIB091 and to compare the effects of the study drug when taken alone or together with DRF. The main question researchers are trying to answer are: - How many participants have new or worsening medical problems (adverse events) after taking BIIB091 or DRF? - How many new areas of inflammation occur in the brain after treatment with BIIB091 and DRF? Researchers will use magnetic resonance imaging (MRI) scans to compare images of the brain before and after treatment. They will also explore the effect of BIIB091 and DRF on the heart using electrocardiograms (ECGs). The study will be done as follows: - After screening, participants who joined Part 1 will be randomly assigned to receive either a high or low dose of BIIB091, or the standard dose of DRF. - The results of Part 1 will be used to choose the best dose of BIIB091 to use in Part 2. - Participants who join Part 2 will be randomly assigned to receive either a standard dose of DRF, a combo of BIIB091 and the standard dose of DRF, or a combo of BIIB91 with a low dose of DRF. - Neither the researchers nor the participants will know which drug or dose the participants will receive in either part of the study. - The treatment period will last 48 weeks in each part of the study. Participants will take the drugs by mouth 2 times a day. - Each part will also have a follow-up safety period that lasts up to 2 weeks. - In total, participants in each part will have 20 study visits, or more if they have a relapse. The total study duration for participants will be up to 54 weeks. Type: Interventional Start Date: Jul 2023 |
More and Less Social Comprehension
University of Kansas Medical Center
Autism Spectrum Disorder
The goal of this early Phase 1 clinical trial is to assess if the social content of a
story impacts autistic children's listening comprehension of stories. The main questions
this study aims to answer are:
- Does removing social content from a story improve listening comprehension in
autis1 expand
The goal of this early Phase 1 clinical trial is to assess if the social content of a story impacts autistic children's listening comprehension of stories. The main questions this study aims to answer are: - Does removing social content from a story improve listening comprehension in autistic children? - Does listening comprehension of more social versus less social stories differentially predict performance on a standardized reading comprehension measure? Participants will listen to more social and less social stories while viewing accompanying pictures and answer comprehension questions about the stories and complete a standardized assessment of reading comprehension. In addition, participants complete measures of their nonverbal cognition, hearing status, autism severity, language abilities, and social communication abilities to help characterize individual differences in participants. Type: Interventional Start Date: Jul 2023 |
EPPIC-Net: Platform Protocol to Assess Treatments for Painful Diabetic Peripheral Neuropathy
James P. Rathmell, MD
Painful Diabetic Neuropathy
This is a Platform Protocol to perform Phase II clinical trials in The Early Phase Pain
Investigation Clinical Network (EPPIC-Net), under The Helping to End Addiction
Long-termSM Initiative, or NIH HEAL InitiativeSM, related to the treatment of Painful
Diabetic Peripheral Neuropathy (PDPN) in a pla1 expand
This is a Platform Protocol to perform Phase II clinical trials in The Early Phase Pain Investigation Clinical Network (EPPIC-Net), under The Helping to End Addiction Long-termSM Initiative, or NIH HEAL InitiativeSM, related to the treatment of Painful Diabetic Peripheral Neuropathy (PDPN) in a platform setting to test multiple assets under a single protocol. Type: Interventional Start Date: Sep 2022 |
A Study of TCD601 in de Novo Renal Transplant Recipients
ITB-Med LLC
Renal Transplantation
The purpose of this study is to evaluate the safety and efficacy of TCD601 in combination
with Belatacept when compared to standard of care immunosuppression therapy in de novo
renal transplant patients. expand
The purpose of this study is to evaluate the safety and efficacy of TCD601 in combination with Belatacept when compared to standard of care immunosuppression therapy in de novo renal transplant patients. Type: Interventional Start Date: Dec 2023 |
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 |
Open-label Study to Evaluate the Safety of Various Dosing Regimens of MuSK-CAART for MuSK Myastheni1
Cabaletta Bio
MuSK Myasthenia Gravis
Muscle-specific tyrosine kinase (MuSK) myasthenia gravis (MG) is a rare but potentially
severe disease, in which patients develop pathogenic autoantibodies that specifically
target the MuSK protein in the neuromuscular junction. This phase 1 study is being
conducted to evaluate the safety of variou1 expand
Muscle-specific tyrosine kinase (MuSK) myasthenia gravis (MG) is a rare but potentially severe disease, in which patients develop pathogenic autoantibodies that specifically target the MuSK protein in the neuromuscular junction. This phase 1 study is being conducted to evaluate the safety of various dosing regimens of an investigational cell therapy, MuSK-CAART, that can be given to patients with anti-MuSK antibody positive Myasthenia Gravis (MuSK MG), who have active disease. Various dosing regimens of MuSK-CAART alone, in combination with cyclophosphamide (CY), and in combination with CY and fludarabine (FLU) will be evaluated. Treatment with MuSK-CAART may potentially lead to complete and durable remission of disease. Type: Interventional Start Date: Nov 2022 |
Pragmatic Evaluation of Events And Benefits of Lipid-lowering in Older Adults
Duke University
Cognitive Impairment, Mild
Dementia
Cardiovascular Diseases
PREVENTABLE is a multi-center, randomized, parallel group, placebo-controlled superiority
study. Participants will be randomized 1:1 to atorvastatin 40 mg or placebo. This large
study conducted in community-dwelling older adults without cardiovascular disease (CVD)
or dementia will demonstrate the1 expand
PREVENTABLE is a multi-center, randomized, parallel group, placebo-controlled superiority study. Participants will be randomized 1:1 to atorvastatin 40 mg or placebo. This large study conducted in community-dwelling older adults without cardiovascular disease (CVD) or dementia will demonstrate the benefit of statins for reducing the primary composite of death, dementia, and persistent disability and secondary composites including mild cognitive impairment (MCI) and cardiovascular events. Type: Interventional Start Date: Sep 2020 |
Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients1
NRG Oncology
Metastatic Malignant Neoplasm in the Bone
Prostate Adenocarcinoma
Stage III Prostate Cancer AJCC v8
Stage IIIA Prostate Cancer AJCC v8
Stage IIIB Prostate Cancer AJCC v8
This phase III trial compares less intense hormone therapy and radiation therapy to usual
hormone therapy and radiation therapy in treating patients with high risk prostate cancer
and low gene risk score. This trial also compares more intense hormone therapy and
radiation therapy to usual hormone t1 expand
This phase III trial compares less intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in treating patients with high risk prostate cancer and low gene risk score. This trial also compares more intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in patients with high risk prostate cancer and high gene risk score. Apalutamide may help fight prostate cancer by blocking the use of androgen by the tumor cells. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving a shorter hormone therapy treatment may work the same at controlling prostate cancer compared to the usual 24 month hormone therapy treatment in patients with low gene risk score. Adding apalutamide to the usual treatment may increase the length of time without prostate cancer spreading as compared to the usual treatment in patients with high gene risk score. Type: Interventional Start Date: Dec 2020 |
ICoN-1 Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101, Clofazimine Inhalation1
Mannkind Corporation
MAC Lung Disease
Treatment Refractory MAC Lung Disease
Mycobacterium Infections, Nontuberculous
This clinical trial is designed to compare the efficacy and safety of Clofazimine
Inhalation Suspension versus placebo when added to guideline-based therapy (GBT) expand
This clinical trial is designed to compare the efficacy and safety of Clofazimine Inhalation Suspension versus placebo when added to guideline-based therapy (GBT) Type: Interventional Start Date: Sep 2024 |
Regenn® Therapy System Safety Study
Progenerative Medical, Inc
Surgical Wound
The goal of this clinical trial is to evaluate the safety of the investigational device,
Regenn® Negative Pressure Therapy System (Regenn® Therapy), a form of Negative Pressure
Wound Therapy (NPWT), in the post-operative surgical wounds of patients undergoing lumbar
spinal fusion surgeries. The mai1 expand
The goal of this clinical trial is to evaluate the safety of the investigational device, Regenn® Negative Pressure Therapy System (Regenn® Therapy), a form of Negative Pressure Wound Therapy (NPWT), in the post-operative surgical wounds of patients undergoing lumbar spinal fusion surgeries. The main questions the study aims to answer are: - The device-related serious adverse event rate. - Patient post-operative pain as assessed using a validated pain measurement scoring system. - The number and type of adverse events. - The rate of delayed seroma formation. Participants will - Be screened for their suitability to participate in the investigational study using questions about their health, medical history, and current medications. - Undergo a physical exam, an assessment of patient vital signs and routine blood analyses. - Complete an Informed Consent Form if selected to participate in the investigational study. - Be randomly assigned to the different study arms. - Not change the operation of their respective device or to disturb components of their device. - Notify their surgeon or designated healthcare provider should they have any questions or encounter any issues with their device. - Attend two post-operative visits at approximately one month and three months. Type: Interventional Start Date: Oct 2024 |
Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer
Curium US LLC
Prostate Cancer
Prostate Adenocarcinoma
This is a prospective, open-label Phase 3 study to evaluate copper Cu 64 PSMA I&T
injection for PET/CT imaging in patients with newly diagnosed unfavorable intermediate
high-risk, high-risk or very high-risk prostate cancer. expand
This is a prospective, open-label Phase 3 study to evaluate copper Cu 64 PSMA I&T injection for PET/CT imaging in patients with newly diagnosed unfavorable intermediate high-risk, high-risk or very high-risk prostate cancer. 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 |
Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine The1
NRG Oncology
Breast Cancer
This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian
function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in
improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage
breast cancer (EBC) patients with es1 expand
This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients). Type: Interventional Start Date: Aug 2023 |
Strategies and Treatments for Respiratory Infections &Amp; Viral Emergencies (STRIVE): Immune Modul1
University of Minnesota
COVID-19
COVID-19 can trigger a dysregulated immune response, and previous studies have shown that
immune modulation can improve outcomes in hospitalized patients. This trial is designed
to determine whether intensification of immune modulation early in the course of the
disease (while patients are on low f1 expand
COVID-19 can trigger a dysregulated immune response, and previous studies have shown that immune modulation can improve outcomes in hospitalized patients. This trial is designed to determine whether intensification of immune modulation early in the course of the disease (while patients are on low flow oxygen) with abatacept (active arm) combined with standard of care (SOC) improves recovery as compared with placebo + SOC (placebo arm). For both groups, intensification of immunomodulation will be provided as part of SOC in case of signs of disease progression (patient requires high flow nasal oxygen (HFNO) or more support) and/or if the patient has rapidly increasing oxygen requirement. Type: Interventional Start Date: Jul 2023 |
A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertri1
Ionis Pharmaceuticals, Inc.
Severe Hypertriglyceridemia
The purpose of this study is to evaluate the safety and tolerability of olezarsen in
participants with SHTG. expand
The purpose of this study is to evaluate the safety and tolerability of olezarsen in participants with SHTG. Type: Interventional Start Date: Dec 2022 |
An Extension Study to Assess Long-Term Safety of Eplontersen in Adults With Transthyretin-Mediated1
Ionis Pharmaceuticals, Inc.
Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)
The purpose of this study is to evaluate the safety and tolerability of extended dosing
with eplontersen in participants with ATTR-CM. expand
The purpose of this study is to evaluate the safety and tolerability of extended dosing with eplontersen in participants with ATTR-CM. Type: Interventional Start Date: Nov 2022 |
A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures
Xenon Pharmaceuticals Inc.
Primary Generalized Tonic-Clonic Seizures
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to
evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as
adjunctive treatment in primary generalized tonic-clonic seizures (PGTCS). expand
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as adjunctive treatment in primary generalized tonic-clonic seizures (PGTCS). Type: Interventional Start Date: Feb 2023 |
Testing the Addition of the AKT Inhibitor, Ipatasertib, to Treatment With the Hormonal Agent Megest1
National Cancer Institute (NCI)
FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma
FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma
Metastatic Endometrial Endometrioid Adenocarcinoma
Recurrent Endometrial Endometrioid Adenocarcinoma
This phase Ib/II trial tests the safety, side effects, best dose, and effectiveness of
the combination of ipatasertib with megestrol acetate to megestrol acetate alone in
patients with endometrial cancer that has come back (recurrent) or has spread to other
places in the body (metastatic). Ipataser1 expand
This phase Ib/II trial tests the safety, side effects, best dose, and effectiveness of the combination of ipatasertib with megestrol acetate to megestrol acetate alone in patients with endometrial cancer that has come back (recurrent) or has spread to other places in the body (metastatic). Ipatasertib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for cell growth. Megestrol acetate lowers the amount of estrogen and also blocks the use of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. The combination of ipatasertib and megestrol acetate may be more effective in treating endometrial cancer than megestrol acetate alone. Type: Interventional Start Date: Mar 2023 |
Phase 2 Study of EDG-5506 in Becker Muscular Dystrophy (GRAND CANYON)
Edgewise Therapeutics, Inc.
Becker Muscular Dystrophy
A study of sevasemten (EDG-5506) in Becker muscular dystrophy (known as CANYON) and
pivotal cohort (known as GRAND CANYON). The EDG-5506-201 CANYON study was expanded to
include an additional 120 adult participants in a cohort called GRAND CANYON, that is a
multicenter, randomized, double-blind, pl1 expand
A study of sevasemten (EDG-5506) in Becker muscular dystrophy (known as CANYON) and pivotal cohort (known as GRAND CANYON). The EDG-5506-201 CANYON study was expanded to include an additional 120 adult participants in a cohort called GRAND CANYON, that is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of sevasemten in adults with Becker. CANYON is fully enrolled; GRAND CANYON is currently enrolling. Type: Interventional Start Date: Jul 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 |