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NAUTICAL: Effect of Natriuretic Peptide Augmentation on Cardiometabolic Health in Black Individuals
University of Alabama at Birmingham
Diabetes Mellitus
Cardiovascular Diseases
Insulin Sensitivity/Resistance
Metabolic Disease
Natriuretic Peptides
Black individuals are more likely to have decreased insulin sensitivity which results in
a high risk for the development of cardiometabolic disease. The reasons for this are
incompletely understood. Natriuretic peptides (NPs) are hormones produced by the heart
that play a role in regulating the metabolic... expand
Black individuals are more likely to have decreased insulin sensitivity which results in a high risk for the development of cardiometabolic disease. The reasons for this are incompletely understood. Natriuretic peptides (NPs) are hormones produced by the heart that play a role in regulating the metabolic health of an individual. Low circulating level of NPs is an important contributor to increased risk for diabetes. The NP levels are relatively lower among Black individuals thus affecting their metabolic health and putting them at a higher risk for diabetes. This study aims to test the hypothesis that by augmenting NP levels using sacubitril/valsartan, among Black Individuals one can improve their metabolic health (as measured by insulin sensitivity & energy expenditure) and help establish the role of NPs in the underlying mechanism behind increased risk for cardiometabolic disease in these population. Type: Interventional Start Date: Aug 2020 |
Optimizing Protein Patterns for Skeletal Muscle Preservation and Sleep in the Medical Management of Parkinson...
University of Alabama at Birmingham
Parkinson Disease
The purpose of this pilot study is to generate preliminary data on the impact of the
dietary protein pattern on markers of skeletal muscle health and drug efficacy in
Parkinson disease. expand
The purpose of this pilot study is to generate preliminary data on the impact of the dietary protein pattern on markers of skeletal muscle health and drug efficacy in Parkinson disease. Type: Interventional Start Date: Oct 2022 |
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 health... 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 |
Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis with Fibrosis
Zydus Therapeutics Inc.
Nonalcoholic Steatohepatitis
Fibrosis
Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis expand
Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis Type: Interventional Start Date: Aug 2021 |
Accessible and Inclusive Diabetes Telecoaching Self-Management Program
University of Alabama at Birmingham
Diabete Type 2
Disability Physical
The purpose of this study is to develop and pilot test an accessible and inclusive
Artificial Intelligence (AI)-assisted, individualized, family-focused lifestyle
modification intervention (AI4DM) for glycemic control in people with disabilities. expand
The purpose of this study is to develop and pilot test an accessible and inclusive Artificial Intelligence (AI)-assisted, individualized, family-focused lifestyle modification intervention (AI4DM) for glycemic control in people with disabilities. Type: Interventional Start Date: Oct 2022 |
Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial
Joseph Broderick, MD
Intracerebral Hemorrhage
The objective of the rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time
(FASTEST) Trial is to establish the first treatment for acute spontaneous intracerebral
hemorrhage (ICH) within a time window and subgroup of patients that is most likely to
benefit. The central hypothesis is that... expand
The objective of the rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial is to establish the first treatment for acute spontaneous intracerebral hemorrhage (ICH) within a time window and subgroup of patients that is most likely to benefit. The central hypothesis is that rFVIIa, administered within 120 minutes from stroke onset with an identified subgroup of patients most likely to benefit, will improve outcomes at 180 days as measured by the Modified Rankin Score (mRS) and decrease ongoing bleeding as compared to standard therapy. Type: Interventional Start Date: Dec 2021 |
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 the... 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 |
PRECISION-BP: Precision Chronopharamacotherapy Targeting NP-RAAS-BP Rhythm Axis
University of Alabama at Birmingham
Obesity
Cardiovascular Diseases
Hypertension
Nocturnal Blood Pressure
Natriuretic Peptides
Obese individuals have a higher prevalence of nocturnal hypertension and non-dipping
blood pressure (BP). These conditions are associated with an increased risk of
cardiovascular (CV) events and death. Natriuretic Peptides (NPs) are hormones produced by
the heart which directly regulate BP by causing... expand
Obese individuals have a higher prevalence of nocturnal hypertension and non-dipping blood pressure (BP). These conditions are associated with an increased risk of cardiovascular (CV) events and death. Natriuretic Peptides (NPs) are hormones produced by the heart which directly regulate BP by causing dilation of blood vessels and by removing sodium and water from the body. NPs have a 24-hour day-night rhythm and this controls the day-night rhythm of BP as well. The NP-BP rhythm relationship is broken down in obese individuals. Obese individuals also have lower circulating NP levels. Lower circulating levels of NPs and elevated renin hormone (a part of the Renin-Angiotensin-Aldosterone System [RAAS]) at nighttime may contribute to the high nocturnal blood pressure in obese individuals which puts them at a higher risk of developing CV events. This current study seeks to determine the biological implications of chronopharmacology for synchronizing NP-RAAS-based blood pressure therapy with the physiological diurnal rhythms to restore the normal diurnal rhythm of blood pressure in obese individuals. Type: Interventional Start Date: Feb 2022 |
Denosumab for Type 1 Diabetes
City of Hope Medical Center
Type 1 Diabetes
Type 1 diabetes (T1D) arises from abnormal immune cell-mediated injury to beta cells that
make insulin. The injured beta cells can then no longer make the needed amount of insulin
to stay healthy. However, in the early stages of T1D, some beta cells are still alive and
functioning. Treatment to protect... expand
Type 1 diabetes (T1D) arises from abnormal immune cell-mediated injury to beta cells that make insulin. The injured beta cells can then no longer make the needed amount of insulin to stay healthy. However, in the early stages of T1D, some beta cells are still alive and functioning. Treatment to protect the beta cells against injury at this time could slow the progress of disease. Denosumab is an approved treatment for osteoporosis (a disease that thins and weakens the bones), high blood calcium levels, bone cancer, and other bone problems in patients who have cancer. The research team has found that the bone pathway that denosumab works on to treat these bone conditions also has effects on the health of the beta cells. Lab studies suggest that denosumab may protect and/or increase the number of beta cells and improve how well they work. This study will test whether denosumab is safe and improves beta cell function and blood sugar control in people with early T1D. Type: Interventional Start Date: Sep 2024 |
Monitoring Blood Pressure at Home
University of Alabama at Birmingham
Hypertension
The overall goal of this project is to determine if measuring blood pressure at home and
staying in contact with a team of pharmacists and physicians to manage your blood
pressure is feasible. The study will enroll 24 participants at UAB who are seen at the
Emergency Department Post-Discharge Clinic.... expand
The overall goal of this project is to determine if measuring blood pressure at home and staying in contact with a team of pharmacists and physicians to manage your blood pressure is feasible. The study will enroll 24 participants at UAB who are seen at the Emergency Department Post-Discharge Clinic. Half of the participants (12 patients) will be asked to measure their blood pressure at home, and half of the participants (12 patients) will continue to receive usual care. Participants who measure their blood pressure at home will also meet with a pharmacist weekly over the phone to discuss blood pressure readings and have blood pressure medications prescribed if needed. This program will last 3 months. Type: Interventional Start Date: Jul 2024 |
A Study to Assess BMS-986453 in Participants With Relapsed and/or Refractory Multiple Myeloma
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Relapsed and/or Refractory Multiple Myeloma
The purpose of this study is to assess BMS-986453 in participants with relapsed and/or
refractory multiple myeloma (RRMM). expand
The purpose of this study is to assess BMS-986453 in participants with relapsed and/or refractory multiple myeloma (RRMM). Type: Interventional Start Date: Jan 2024 |
A Study of the THERMOCOOL SMARTTOUCH Surround Flow (SF) Catheter With the TRUPULSE Generator for Treatment...
Biosense Webster, Inc.
Drug Refractory Paroxysmal Atrial Fibrillation
The purpose of this study is to demonstrate safety and effectiveness of the Biosense
Webster (BWI) ablation system (THERMOCOOL SMARTTOUCH surround flow [STSF] catheter and
TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in
treatment of participants with paroxysmal atrial... expand
The purpose of this study is to demonstrate safety and effectiveness of the Biosense Webster (BWI) ablation system (THERMOCOOL SMARTTOUCH surround flow [STSF] catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF), an irregular heart rate that causing abnormal blood flow. Type: Interventional Start Date: Dec 2023 |
Pulsed Field Ablation (PFA) vs Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent...
Boston Scientific Corporation
Persistent Atrial Fibrillation
The purpose of this study is to establish the safety and effectiveness of pulsed field
ablation as a first-line ablation treatment for subjects with persistent atrial
fibrillation as compared to subjects who received an initial treatment with
anti-arrhythmic drugs. expand
The purpose of this study is to establish the safety and effectiveness of pulsed field ablation as a first-line ablation treatment for subjects with persistent atrial fibrillation as compared to subjects who received an initial treatment with anti-arrhythmic drugs. Type: Interventional Start Date: Dec 2023 |
A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung...
Sanofi
Lung Transplant Rejection
This double-blind, randomized, placebo-controlled, multinational, multicenter,
parallel-group, Phase 3, 2-arm, study will investigate the efficacy and safety of
belumosudil compared with placebo, both administered on top of azithromycin and
standard-of-care regimen of immunosuppression in male or... expand
This double-blind, randomized, placebo-controlled, multinational, multicenter, parallel-group, Phase 3, 2-arm, study will investigate the efficacy and safety of belumosudil compared with placebo, both administered on top of azithromycin and standard-of-care regimen of immunosuppression in male or female participants at least 1 year after bilateral lung transplant, who are at least 18 years of age and who have evidence of progressive CLAD despite azithromycin therapy. Study details include: The study duration will be up to 31 weeks for participants not entering the open-label extension (OLE) period and up to 57 weeks for participants entering the OLE period but not the long-term OLE. The treatment duration will be up to 26 weeks for participants not entering the OLE period and up to 52 weeks for participants entering the OLE period but not the long-term OLE. The number of visits will be up to 10 visits for participants not entering the OLE period and up to 16 visits for participants entering the OLE period but not the long-term OLE. For participants who enter the long-term OLE, treatment and study participation will continue with visits every 12 weeks per protocol specifications. Type: Interventional Start Date: Oct 2023 |
A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis...
Incyte Corporation
Prurigo Nodularis
The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream
in participants with Prurigo Nodularis (PN). expand
The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream in participants with Prurigo Nodularis (PN). Type: Interventional Start Date: Jun 2023 |
Study to Check the Safety of Fazirsiran and Learn if Fazirsiran Can Help People With Liver Disease and...
Takeda
Alpha1-Antitrypsin Deficiency
The main aim of this study is to learn if fazirsiran reduces liver scarring (fibrosis)
compared to placebo. Other aims are to learn if fazirsiran slows down the disease
worsening in the liver, to get information on how fazirsiran affects the body (called
pharmacodynamics), to learn if fazirsiran reduces... expand
The main aim of this study is to learn if fazirsiran reduces liver scarring (fibrosis) compared to placebo. Other aims are to learn if fazirsiran slows down the disease worsening in the liver, to get information on how fazirsiran affects the body (called pharmacodynamics), to learn if fazirsiran reduces other liver injury (inflammation) and the abnormal Z-AAT protein in the liver, to get information on how the body processes fazirsiran (called pharmacokinetics), to test how well fazirsiran works compared with a placebo in improving measures of liver scarring including imaging and liver biomarkers (substances in the blood that the body normally makes and help show if liver function is improving, staying the same, or getting worse) as well as to check for side effects in participants treated with fazirsiran compared with those who received placebo. Participants will either receive fazirsiran or placebo. Liver biopsies, a way of collecting a small tissue sample from the liver, will be taken twice during this study. Type: Interventional Start Date: Mar 2023 |
Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare
Olatec Therapeutics LLC
Acute Gout Flare
Gout Attack
Gout Flare
Gouty Arthritis
Gout
The purpose of this trial is to investigate the efficacy and safety of dapansutrile
(OLT1177®) tablets in subjects with an acute gout flare. expand
The purpose of this trial is to investigate the efficacy and safety of dapansutrile (OLT1177®) tablets in subjects with an acute gout flare. Type: Interventional Start Date: Jan 2023 |
A Study to Evaluate the Effect of Venglustat Tablets on Left Ventricular Mass Index in Male and Female...
Sanofi
Fabry Disease
This is an 18-month, multicenter, randomized, active-control, parallel-group Phase 3
study, in which participants will be randomized to venglustat versus standard of care
therapy (agalsidase alfa, agalsidase beta, or migalastat) to evaluate the effect of
venglustat on left ventricular mass index (LVMI)... expand
This is an 18-month, multicenter, randomized, active-control, parallel-group Phase 3 study, in which participants will be randomized to venglustat versus standard of care therapy (agalsidase alfa, agalsidase beta, or migalastat) to evaluate the effect of venglustat on left ventricular mass index (LVMI) in adult participants with Fabry disease and left ventricular hypertrophy. - Study visits will take place approximately every 3 to 6 months - Participants who complete the randomized period may continue to the long-term extension (LTE) to receive venglustat for up to additional 34 months with the total study duration up to 4.4 years maximum. Type: Interventional Start Date: May 2022 |
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients...
Hoffmann-La Roche
Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)
The main objective of the study is to evaluate the efficacy of satralizumab compared with
placebo based on time from randomization to the first occurrence of an adjudicated MOGAD
relapse in the double-blind (DB) treatment period expand
The main objective of the study is to evaluate the efficacy of satralizumab compared with placebo based on time from randomization to the first occurrence of an adjudicated MOGAD relapse in the double-blind (DB) treatment period Type: Interventional Start Date: Aug 2022 |
A Study of Itolizumab in Combination With Corticosteroids for the First-Line Treatment of Acute Graft...
Equillium
Graft Versus Host Disease
GVHD
Acute-graft-versus-host Disease
Acute GVHD
aGVHD
This is a multi-center study to compare the efficacy and safety of itolizumab versus
placebo as first-line therapy for subjects with Grade III-IV aGVHD or Grade II with LGI
involvement, in combination with corticosteroids expand
This is a multi-center study to compare the efficacy and safety of itolizumab versus placebo as first-line therapy for subjects with Grade III-IV aGVHD or Grade II with LGI involvement, in combination with corticosteroids Type: Interventional Start Date: Apr 2022 |
A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors
Seagen Inc.
Carcinoma, Non-Small-Cell Lung
Squamous Cell Carcinoma of the Head and Neck
Esophageal Squamous Cell Carcinoma
Ovarian Neoplasms
Melanoma
This study will test the safety of a drug called PF-08046054/SGN-PDL1V alone and with
pembrolizumab in participants with solid tumors. It will also study the side effects of
this drug. A side effect is anything a drug does to your body besides treating your
disease.
Participants will have solid... expand
This study will test the safety of a drug called PF-08046054/SGN-PDL1V alone and with pembrolizumab in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to your body besides treating your disease. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable). This study will have five parts. Parts A and B of the study will find out how much PF-08046054/SGN- PDL1V should be given to participants. Part C will use the dose found in Parts A and B to find out how safe PF-08046054/SGN-PDL1V is and if it works to treat solid tumor cancers. In Part D and E, participants will be given PF-08046054/SGN-PDL1V with pembrolizumab to find out how safe this combination is and if it works to treat solid tumor cancers. Type: Interventional Start Date: Oct 2022 |
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic...
Hoffmann-La Roche
Metastatic Colorectal Cancer
This open-label, exploratory study is designed to evaluate the safety and efficacy of
targeted therapies or immunotherapy as single agents or combinations, in participants
with metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per
treatment arm-specific definition. Eligible... expand
This open-label, exploratory study is designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or combinations, in participants with metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per treatment arm-specific definition. Eligible participants with mCRC will be enrolled into specific treatment arms based on their biomarker assay results. Type: Interventional Start Date: Oct 2021 |
A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive...
Janssen Research & Development, LLC
Urinary Bladder Neoplasms
The purpose of this study is to evaluate the anti-tumor effects of TAR-200 in combination
with intravenous (IV) cetrelimab and IV cetrelimab alone. expand
The purpose of this study is to evaluate the anti-tumor effects of TAR-200 in combination with intravenous (IV) cetrelimab and IV cetrelimab alone. Type: Interventional Start Date: Jul 2022 |
Ultrasound-facilitated, Catheter-directed, Thrombolysis in Intermediate-high Risk Pulmonary Embolism
Boston Scientific Corporation
Pulmonary Embolism
There are many available treatments for pulmonary embolism (PE), but the best treatment
for this condition is not known. The HI-PEITHO study will compare two treatment options
that are both available on the market for the treatment of PE.
Patients will be randomized 1:1 to receive either blood thinners... expand
There are many available treatments for pulmonary embolism (PE), but the best treatment for this condition is not known. The HI-PEITHO study will compare two treatment options that are both available on the market for the treatment of PE. Patients will be randomized 1:1 to receive either blood thinners (anticoagulation) or blood thinners (anticoagulation) in combination with a device called the EkoSonicTM Endovascular device to dissolve blood clots. Patients will be followed for 12 months after randomization and have assessments while in the hospital as well as at 7 days, 30 days, 6 months and 12 months after randomization. The study will try to find out if one of these treatments is better than the other at reducing the risk of death and other serious problems. Type: Interventional Start Date: Aug 2021 |
Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)
Genmab
Diffuse Large B-Cell Lymphoma
Follicular Lymphoma
The purpose of this trial is to measure the safety and effectiveness of epcoritamab
(EPKINLY™), either by itself or together with other therapies, when treating subjects
with B-cell non-Hodgkin Lymphoma (B-NHL). The aim of the first part of the trial is to
identify the most appropriate dose of epcoritamab,... expand
The purpose of this trial is to measure the safety and effectiveness of epcoritamab (EPKINLY™), either by itself or together with other therapies, when treating subjects with B-cell non-Hodgkin Lymphoma (B-NHL). The aim of the first part of the trial is to identify the most appropriate dose of epcoritamab, and the aim of the second part of the trial is to assess the selected epcoritamab dose in a larger group of participants with B-NHL. All participants in this trial will receive either epcoritamab alone, or epcoritamab combined with another standard treatment regimen, with a total of 10 different treatment arms being studied. Trial details include: - The total trial duration will be up to 6 years. - The treatment duration for each participant depends upon which arm of treatment they are assigned to receive, but will be no more than 3 years. - The visit frequency for each participant depends upon which arm of treatment they are assigned to receive, but will be weekly to start for all participants, then will decrease to either: every 2 weeks, or every 3 weeks, or every 4 weeks, or every 8 weeks. - All participants will receive active drug; no one will be given placebo. Participants who receive treatment with epcoritamab will have it injected right under the skin. Participants will receive a different regimen of epcoritamab depending upon which arm of treatment they are assigned. Participants who receive standard treatments will have IV infusions and/or oral administration of those treatments. Participants will receive a different standard treatment regimen depending upon which arm of treatment they are assigned. Arm 9 (follicular lymphoma (FL)) is still open for enrolment of new patients, while the other arms have closed their recruitment. Type: Interventional Start Date: Nov 2020 |
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