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Influence of Metabolic Syndrome on Endogenous Oxalate Synthesis
University of Alabama at Birmingham
MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease
This study aims to determine the daily rate of endogenous synthesis of oxalate using
fasted urine collection and a low-oxalate controlled diet in patients with Metabolic
Dysfunction-Associated Steatotic Liver Disease (MASLD). expand
This study aims to determine the daily rate of endogenous synthesis of oxalate using fasted urine collection and a low-oxalate controlled diet in patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). Type: Interventional Start Date: Apr 2023 |
PREVENT ALL ALS Study
St. Joseph's Hospital and Medical Center, Phoenix
Amyotrophic Lateral Sclerosis
The ALL ALS Clinical Research Consortium is establishing research to collect a wide range
of samples, clinical information and measurements from Amyotrophic Lateral Sclerosis
(ALS) symptomatic, ALS gene carriers and control cohorts. This consortium is begin funded
by the National Institutes of Heal1 expand
The ALL ALS Clinical Research Consortium is establishing research to collect a wide range of samples, clinical information and measurements from Amyotrophic Lateral Sclerosis (ALS) symptomatic, ALS gene carriers and control cohorts. This consortium is begin funded by the National Institutes of Health/National Institute of Neurological Disorders and Stroke (NIH/NINDS) and managed by two clinical coordinating centers (CCC) at Barrow Neurological Institute and Massachusetts General Hospital. The clinical sites are distributed across the country, and led by a group of collaborative principal investigators. Once data and samples are collected and harmonized, it will be made available to research community for future research into ALS and related neurological diseases. PREVENT protocol is specific for asymptomatic participants who are genetically at risk for ALS. The participants will be followed for upto 36 months (3 years), and will include 4 in-person on-site visits once a year and 6 off-site(remote) visits once in 4 months. The study includes collection of medical history, clinical outcomes, and blood samples once in 4 months. Additionally, the participants will complete patient reported outcomes and speech recordings once in 4 months. Participants may also provide optional Cerebrospinal Fluid (CSF) samples.The participants may also opt into a sub-study if they are interested in genetic testing for ALS causative genes. The sub-study will involve a minimum of 3 visits over a course of 2-3 months. This will include a screening/pre-test genetic counseling visit, a return of genetic results and a post-test counseling visit. Type: Observational Start Date: Jul 2024 |
A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of S1
Boston Scientific Corporation
In-Stent Restenosis
The purpose of the AGENT IDE study is to assess the safety and effectiveness of the Agent
Paclitaxel Coated PTCA Balloon Catheter in patients with in-stent restenosis (ISR) of a
previously treated lesion of up to 36 mm in length (by visual estimate) in a native
coronary artery 2.0 mm to 4.0 mm in d1 expand
The purpose of the AGENT IDE study is to assess the safety and effectiveness of the Agent Paclitaxel Coated PTCA Balloon Catheter in patients with in-stent restenosis (ISR) of a previously treated lesion of up to 36 mm in length (by visual estimate) in a native coronary artery 2.0 mm to 4.0 mm in diameter. Type: Interventional Start Date: Oct 2024 |
A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti-IL-331
Sanofi
Bronchiectasis
ACT18018 is a multinational, randomized, double-blind, placebo-controlled,
parallel-group, Phase 2 study with 3 treatment groups. The purpose of this study is to
evaluate efficacy, safety and tolerability with 2 dosing regimens of itepekimab compared
with placebo in male and/or female participants1 expand
ACT18018 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study with 3 treatment groups. The purpose of this study is to evaluate efficacy, safety and tolerability with 2 dosing regimens of itepekimab compared with placebo in male and/or female participants with NCFB aged 18 years of age up to 85 years of age (inclusive). Study details include: - The study duration (screening, 24-52-week treatment, 20-week safety follow-up) will be up to 47-77 weeks. - The treatment duration will be up to 24-52 weeks. - The follow-up duration will be 20 weeks. - Site/phone visits are at a monthly interval. Type: Interventional Start Date: Feb 2024 |
A Trial to Investigate the Non-inferiority of Pegloticase Administered Every 4 Weeks (Q4W) With MTX1
Amgen
Gout
The study consists of 24-week double-blind trial to evaluate the non-inferiority of the
efficacy and safety of pegloticase Q4W with MTX versus pegloticase Q2W with MTX, followed
by a 24-week open-label extension of pegloticase Q4W with MTX, in participants with
uncontrolled refractory gout.
The ma1 expand
The study consists of 24-week double-blind trial to evaluate the non-inferiority of the efficacy and safety of pegloticase Q4W with MTX versus pegloticase Q2W with MTX, followed by a 24-week open-label extension of pegloticase Q4W with MTX, in participants with uncontrolled refractory gout. The main objective of the study is to evaluate the effect of pegloticase 16 mg administered Q4W with MTX versus pegloticase 8 mg administered Q2W with MTX, on the response rate during Month 6, as measured by the sustained normalization of sUA to < 6 mg/dL for at least 80% of the time. Type: Interventional Start Date: Mar 2024 |
A Study to Evaluate the Safety, Tolerability, Efficacy, and Drug Levels of CC-97540 in Participants1
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Multiple Sclerosis
The purpose of this study is to evaluate the safety, tolerability, efficacy, and drug
levels of CC-97540 in participants with Relapsing Forms of Multiple Sclerosis (RMS) or
Progressive Forms of Multiple Sclerosis (PMS). expand
The purpose of this study is to evaluate the safety, tolerability, efficacy, and drug levels of CC-97540 in participants with Relapsing Forms of Multiple Sclerosis (RMS) or Progressive Forms of Multiple Sclerosis (PMS). Type: Interventional Start Date: Mar 2024 |
RESTORE: An RCT to Evaluate the Efficacy of the Revi System
BlueWind Medical
Urinary Urge Incontinence
The Revi System is indicated for the treatment of patients with symptoms of urgency
incontinence alone or in combination with urinary urgency. expand
The Revi System is indicated for the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency. Type: Interventional Start Date: Feb 2024 |
Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sc1
Sanofi
Multiple Sclerosis
The purpose of each study is to independently measure the annualized relapse rate (ARR)
with administration of frexalimab compared to a daily oral dose of teriflunomide in male
and female participants with relapsing forms of multiple sclerosis (aged 18 to 55 years
at the time of enrollment). People1 expand
The purpose of each study is to independently measure the annualized relapse rate (ARR) with administration of frexalimab compared to a daily oral dose of teriflunomide in male and female participants with relapsing forms of multiple sclerosis (aged 18 to 55 years at the time of enrollment). People diagnosed with relapsing forms of multiple sclerosis are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include: - This event-driven study will have variable duration of approximately 40 months for the first participant being randomized and approximately 20 months for the last participant randomized. - The study intervention duration will vary ranging from approximately 12 to 40 months. - The assessment of scheduled visits will include 1 common end of study [EOS] visit and 3 follow-up visits) with a visit frequency of every 4 weeks for the first 6 months and then every 3 months. Type: Interventional Start Date: Dec 2023 |
A Study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo1
Incyte Corporation
NonSegmental Vitiligo
This study is being conducted to determine the efficacy and safety of povorcitinib in
participants with nonsegmental vitiligo. expand
This study is being conducted to determine the efficacy and safety of povorcitinib in participants with nonsegmental vitiligo. Type: Interventional Start Date: Nov 2023 |
Randomized, Double-blind Study of Efficacy and Safety of Bexotegrast (PLN-74809) for Idiopathic Pul1
Pliant Therapeutics, Inc.
Idiopathic Pulmonary Fibrosis
A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the
efficacy and safety of bexotegrast (PLN-74809) for the treatment of idiopathic pulmonary
fibrosis (BEACON-IPF). expand
A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of bexotegrast (PLN-74809) for the treatment of idiopathic pulmonary fibrosis (BEACON-IPF). Type: Interventional Start Date: Nov 2023 |
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and i1
Genentech, Inc.
Locally Advanced Solid Tumors
Recurrent Solid Tumors
Metastatic Solid Tumors
This is a first-in-human Phase I, open-label, dose-escalation and expansion study
designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity,
pharmacodynamic, and preliminary anti-tumor activity of RO7566802 as a single agent and
in combination with atezolizumab in participants1 expand
This is a first-in-human Phase I, open-label, dose-escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamic, and preliminary anti-tumor activity of RO7566802 as a single agent and in combination with atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid tumor malignancies. Participants will be enrolled in 2 stages: dose escalation and expansion. Type: Interventional Start Date: Nov 2023 |
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progr1
Bristol-Myers Squibb
Progressive Pulmonary Fibrosis
The purpose of this study is to evaluate the efficacy, safety, and tolerability of
BMS-986278 in Participants with Progressive Pulmonary Fibrosis. expand
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis. Type: Interventional Start Date: Oct 2023 |
Efficacy and Safety of Seralutinib in Adult Subjects With PAH (PROSERA)
GB002, Inc.
Pulmonary Arterial Hypertension
The primary objective of the study is to determine the effect of seralutinib on improving
exercise capacity in subjects with WHO Group 1 PAH who are FC II or III. The secondary
objective for this trial is to determine time to clinical worsening. expand
The primary objective of the study is to determine the effect of seralutinib on improving exercise capacity in subjects with WHO Group 1 PAH who are FC II or III. The secondary objective for this trial is to determine time to clinical worsening. Type: Interventional Start Date: Dec 2023 |
A Study to Evaluate the Efficacy and Safety of RO7434656 in Participants With Primary Immunoglobuli1
Hoffmann-La Roche
Primary IgA Nephropathy
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of
RO7434656, a novel Antisense Oligonucleotide (ASO) therapy in participants with primary
IgA nephropathy (IgAN) who are at high risk of progressive kidney disease despite
optimized supportive care. expand
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of RO7434656, a novel Antisense Oligonucleotide (ASO) therapy in participants with primary IgA nephropathy (IgAN) who are at high risk of progressive kidney disease despite optimized supportive care. Type: Interventional Start Date: Aug 2023 |
A Study Evaluating the Efficacy and Safety of Vixarelimab in Participants With Idiopathic Pulmonary1
Genentech, Inc.
Idiopathic Pulmonary Fibrosis
Systemic Sclerosis With Lung Involvement
The main purpose of the study is to evaluate the efficacy of vixarelimab compared with
placebo on lung function in participants with idiopathic pulmonary fibrosis (IPF) and in
participants with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
Participants who complete 52-weeks of1 expand
The main purpose of the study is to evaluate the efficacy of vixarelimab compared with placebo on lung function in participants with idiopathic pulmonary fibrosis (IPF) and in participants with systemic sclerosis-associated interstitial lung disease (SSc-ILD). Participants who complete 52-weeks of treatment in the Double-blind Treatment (DBT) period can choose to enroll in the optional Open-label Extension (OLE) period to receive treatment with vixarelimab for another 52 weeks. Type: Interventional Start Date: May 2023 |
Positron Emission Tomography (PET) Imaging of Neuroinflammation in Patients with Neurological Dysfu1
University of Alabama at Birmingham
SARS CoV-2 Post-Acute Sequelae
This clinical imaging study will use the small molecule translocator protein (TSPO)
ligand, Fluorodeoxyglucose(18F)-labeled DPA-714, to visualize and quantify
neuroinflammation in individuals with post-acute sequelae of SARS-CoV-2 (PASC) . The
brain uptake of DPA-714 will be contrasted with healthy1 expand
This clinical imaging study will use the small molecule translocator protein (TSPO) ligand, Fluorodeoxyglucose(18F)-labeled DPA-714, to visualize and quantify neuroinflammation in individuals with post-acute sequelae of SARS-CoV-2 (PASC) . The brain uptake of DPA-714 will be contrasted with healthy subjects. Type: Interventional Start Date: Nov 2023 |
Multiparametic Metabolic and Hypoxic PET/MRI for Disease Assessment in High Grade Glioma
University of Alabama at Birmingham
High Grade Glioma
This feasibility study will assess the clinical potential of a new imaging approach to
detect viable high grade glioma (HGG) in pediatric and adult patients after standard of
care radiation therapy (RT) with or without concurrent temozolomide (TMZ). Study
participants will undergo simultaneous posi1 expand
This feasibility study will assess the clinical potential of a new imaging approach to detect viable high grade glioma (HGG) in pediatric and adult patients after standard of care radiation therapy (RT) with or without concurrent temozolomide (TMZ). Study participants will undergo simultaneous positron emission tomography/magnetic resonance imaging (PET/MRI) with O-([2-[F-18]fluoroethyl)-L-tyrosine (FET, amino acid transport) and 1H-1-(3-[F-18]fluoro-2-hydroxypropyl)-2-nitroimidazole (FMISO, hypoxia) at the time of standard of care imaging after completion of RT. The presence of viable tumor at this time point will be assessed on a per patient basis. Study participants will be followed clinically and with standard of care (SOC) imaging for up to 2 years after completion of PET/MRI to determine the nature of lesions seen on investigational imaging and to obtain patient outcome data. The imaging data will also be used to develop a semi-automated workflow suitable for implementation in clinical trials and standard of care PET/MRI studies. Type: Interventional Start Date: Mar 2024 |
Executive Functioning Training Study
University of Alabama at Birmingham
Aging
Cognitive Function Abnormal
Cognitive Performance
Cognitive Training
Older Adults
Cognitive aging in people with HIV (PWH) is of increasing concern for several reasons: 1)
between 52%-59% of PWH experience cognitive impairment known as HIV-Associated
Neurocognitive Disorder (HAND) which impacts everyday functioning and quality of life; 2)
HAND increases in severity and prevalenc1 expand
Cognitive aging in people with HIV (PWH) is of increasing concern for several reasons: 1) between 52%-59% of PWH experience cognitive impairment known as HIV-Associated Neurocognitive Disorder (HAND) which impacts everyday functioning and quality of life; 2) HAND increases in severity and prevalence with age; and 3) 70% of PWH in the United States will be 50 and older by 2030. Fortunately, cognitive training programs can individually target specific cognitive impairments in PWH and possibly reduce the severity and prevalence of HAND and improve everyday functioning and quality of life. This approach is based around the underlying concept of intra-individual variability as controlled through higher level allocation of cognitive resources, known as executive functioning. This feasibility study will use a two-group pre-post experimental design of adults with HAND including: 1) a 20-hours of Executive Functioning Training group (enroll 60, n=48 with attrition), and 2) a no-contact control (enroll 60, n=48 with attrition). Aim 1 - Feasibility: To determine feasibility and acceptability of the intervention (i.e., attrition, feedback). Exploratory Aim 1 - Cognition: Compare adults who receive Executive Functioning Training to those who receive no training to determine whether they improve in global cognitive ability and overall cognitive IIV. This high impact study is innovative in the following ways: 1) This is the first study aimed to reduce cognitive IIV in PWH. 2) This is the first study to use IIV as a guide to target solely executive functioning training to improve global cognitive ability, which may reduce the severity and prevalence of HAND. 3) Over the last decade, the epicenter of HIV has emerged in the Deep South where this study will occur. Most participants in this study will be older PWH who identify as lower social economic status (SES) and/or African Americans and experience HAND symptoms. Type: Interventional Start Date: Jun 2023 |
A Study of Aticaprant 10 Milligrams (mg) as Adjunctive Therapy in Adult Participants With MDD With1
Janssen Research & Development, LLC
Depressive Disorder, Major
Anhedonia
The purpose of this study is to evaluate the efficacy of aticaprant compared with placebo
as adjunctive therapy to an antidepressant in improving depressive symptoms in adult
participants with major depressive disorder (MDD) with moderate to severe anhedonia
(ANH+) who have had an inadequate respon1 expand
The purpose of this study is to evaluate the efficacy of aticaprant compared with placebo as adjunctive therapy to an antidepressant in improving depressive symptoms in adult participants with major depressive disorder (MDD) with moderate to severe anhedonia (ANH+) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI). Type: Interventional Start Date: Dec 2022 |
A Study of Aticaprant in Adult and Elderly Participants With Major Depressive Disorder (MDD)
Janssen Research & Development, LLC
Depressive Disorder, Major
The purpose of this study is to assess the long-term safety and tolerability of
aticaprant administered as adjunctive therapy to a current antidepressant (selective
serotonin reuptake inhibitor [SSRI] or serotonin and norepinephrine reuptake inhibitor
[SNRI]) in all participants with major depressi1 expand
The purpose of this study is to assess the long-term safety and tolerability of aticaprant administered as adjunctive therapy to a current antidepressant (selective serotonin reuptake inhibitor [SSRI] or serotonin and norepinephrine reuptake inhibitor [SNRI]) in all participants with major depressive disorder (MDD). Type: Interventional Start Date: Sep 2022 |
Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of P1
Celcuity Inc
Breast Cancer
This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and
safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of
patients with locally advanced or metastatic HR+/HER2- breast cancer following
progression on or after CDK4/6 and aromatase i1 expand
This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy. Type: Interventional Start Date: Dec 2022 |
Curcumin, Resveratrol, and Stinging Nettle as Treatments for GWI
University of Alabama at Birmingham
Gulf War Illness
This project's objective is to identify effective treatments for Gulf War Illness (GWI).
The project tests three potential treatments: curcumin, stinging nettle, and resveratrol.
The project uses a decentralized clinical trial (DCT) design in which individuals can
participate from anywhere in the U1 expand
This project's objective is to identify effective treatments for Gulf War Illness (GWI). The project tests three potential treatments: curcumin, stinging nettle, and resveratrol. The project uses a decentralized clinical trial (DCT) design in which individuals can participate from anywhere in the United States. Recruitment efforts will be designed to obtain a geographically and demographically diverse study sample. Type: Interventional Start Date: May 2023 |
Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)
University of Michigan
Cardiac Arrest, Out-Of-Hospital
Hypothermia, Induced
Hypoxia-Ischemia, Brain
This is a multicenter trial to establish the efficacy of cooling and the optimal duration
of induced hypothermia for neuroprotection in pediatric comatose survivors of cardiac
arrest.
The study team hypothesizes that longer durations of cooling may improve either the
proportion of children that at1 expand
This is a multicenter trial to establish the efficacy of cooling and the optimal duration of induced hypothermia for neuroprotection in pediatric comatose survivors of cardiac arrest. The study team hypothesizes that longer durations of cooling may improve either the proportion of children that attain a good neurobehavioral recovery or may result in better recovery among the proportion already categorized as having a good outcome. Type: Interventional Start Date: Aug 2022 |
Neuroinflammation in Asymptomatic Carotid Artery Disease - Imaging Substudy
University of Alabama at Birmingham
Critical Asymptomatic Carotid Artery Disease
Non-Critical Asymptomatic Carotid Artery Disease
This clinical imaging substudy will use the small molecule translocator protein (TSPO)
ligand, Fludeoxyglucose(18F)-labeled DPA-714, to compare neuroinflammation in individuals
with high or low grade asymptomatic carotid artery stenosis (aCAD) who are participating
in the separate Neuroinflammation1 expand
This clinical imaging substudy will use the small molecule translocator protein (TSPO) ligand, Fludeoxyglucose(18F)-labeled DPA-714, to compare neuroinflammation in individuals with high or low grade asymptomatic carotid artery stenosis (aCAD) who are participating in the separate Neuroinflammation in Asymptomatic Carotid Artery Disease study lead by Dr. Ron Lazar (IRB-300007806). The positron emission tomography (PET) tracer [18F]DPA-714 binds to the 18 kDa translocator protein (TSPO, also known as the peripheral benzodiazepine receptor) in the mitochondria of activated microglia/macrophages and provides a non-invasive measure of neuroinflammation. Type: Interventional Start Date: Apr 2026 |
Sequential Therapy in Multiple Myeloma Guided by MRD Assessments
University of Alabama at Birmingham
Multiple Myeloma
This research study will determine the proportion of patients with lowest minimal
residual disease (MRD) response obtainable after receiving 6 cycles of study treatment.
Minimal residual disease is multiple myeloma cells below the level of 1 cancer cell out
of 100,000 in the bone marrow.
For patie1 expand
This research study will determine the proportion of patients with lowest minimal residual disease (MRD) response obtainable after receiving 6 cycles of study treatment. Minimal residual disease is multiple myeloma cells below the level of 1 cancer cell out of 100,000 in the bone marrow. For patients who become MRD "negative" (i.e. less than 1 cancer cell out of 100,000) at the end of 6 cycles of therapy, this study will study if that good response can be maintained with 3 additional cycles of treatment instead of use of autologous hematopoietic cell transplantation (AHCT). For patients who are MRD "positive" at the end of 6 cycles of therapy, this study will answer whether more patients can become and remain MRD "negative" with AHCT plus teclistamab in combination with daratumumab when compared with patients who undergo AHCT followed by lenalidomide (an established anti-myeloma drug) plus daratumumab. Type: Interventional Start Date: Dec 2023 |
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