Search Clinical Trials
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Rural Alliance for Diabetes Prevention
University of Kansas Medical Center
PreDiabetes
The purpose of this randomized controlled trial is to compare the effectiveness of
Cooperative Extension implementing two delivery methods (group video vs. self-directed)
and participant recruitment strategies of the National Diabetes Prevention Program (NDPP)
to adults in rural communities. Exploratory... expand
The purpose of this randomized controlled trial is to compare the effectiveness of Cooperative Extension implementing two delivery methods (group video vs. self-directed) and participant recruitment strategies of the National Diabetes Prevention Program (NDPP) to adults in rural communities. Exploratory assessments of implementation facilitators and barriers will be completed to determine strategies that may impact intervention effectiveness and that may support or impede the implementation, dissemination, and effectiveness of Cooperative Extension to deliver the NDPP to prediabetic adults in rural areas. Type: Interventional Start Date: Jul 2024 |
RESET-Myositis: an Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects with...
Cabaletta Bio
Idiopathic Inflammatory Myopathy
Dermatomyositis
Anti-Synthetase Syndrome
Immune-Mediated Necrotizing Myopathy
RESET-Myositis: Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in
Subjects with Active Idiopathic Inflammatory Myopathy expand
RESET-Myositis: Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects with Active Idiopathic Inflammatory Myopathy Type: Interventional Start Date: Dec 2023 |
Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive...
Sanofi
Multiple Sclerosis
The purpose of this randomized, double-blind, placebo-controlled, parallel group study is
to determine the efficacy of frexalimab in delaying the disability progression and the
safety up to approximately 51 months administration of study intervention compared to
placebo in male and female participants... expand
The purpose of this randomized, double-blind, placebo-controlled, parallel group study is to determine the efficacy of frexalimab in delaying the disability progression and the safety up to approximately 51 months administration of study intervention compared to placebo in male and female participants with nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with nrSPMS 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 ranging from approximately 27 to 51 months. - The study intervention duration will vary ranging from approximately 12 to 51 months. - The number of scheduled visits will be up to 27 (including 3 follow-up visits) with a visit frequency of every month for the first 6 months and then every 3 months. Type: Interventional Start Date: Dec 2023 |
The Society for Obstetric Anesthesia and Perinatology Research Network General Anesthesia Registry
Yale University
Cesarean Delivery
General Anesthesia
The SOAP registry is a prospective, multicenter, electronic registry. The goal is to
investigate the indications, mode of airway management, predisposing factors, and
obstetric and anesthetic outcomes of pregnant patients who receive general anesthesia for
cesarean delivery. expand
The SOAP registry is a prospective, multicenter, electronic registry. The goal is to investigate the indications, mode of airway management, predisposing factors, and obstetric and anesthetic outcomes of pregnant patients who receive general anesthesia for cesarean delivery. Type: Observational Start Date: Feb 2024 |
Optimizing Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome (OPTimize NOW): A Symptom-Based...
HELP for NOWS Consortium
Neonatal Opiate Withdrawal Syndrome
This clinical trial will help us learn more about how to best care for babies with
Neonatal Opioid Withdrawal Syndrome, also called NOWS. Babies with NOWS often have
tremors, a hard time sleeping, excessive crying, and trouble feeding. Some babies that
have NOWS need medicine. Doctors have two ways... expand
This clinical trial will help us learn more about how to best care for babies with Neonatal Opioid Withdrawal Syndrome, also called NOWS. Babies with NOWS often have tremors, a hard time sleeping, excessive crying, and trouble feeding. Some babies that have NOWS need medicine. Doctors have two ways of providing medicine that are widely used today: 1. Scheduled opioid taper approach. The baby gets medicine at regular times. As symptoms get better, the amount of medicine the baby gets decreases until the baby no longer needs medicine. This is called a medicine taper. 2. Symptom-based approach. The baby will only get medicine when they show signs of NOWS, instead of at regular times. If the baby is showing no signs of NOWS, no medicine will be given. We are doing the OPTimize NOW study to figure out the best way to give medicine to babies with NOWS. Type: Interventional Start Date: Mar 2024 |
Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors
NRG Oncology
Breast Cancer
Cognitive Impairments
This Phase III trial will examine the efficacy of computerized cognitive training methods
on perceived cognitive impairment in breast cancer survivors. expand
This Phase III trial will examine the efficacy of computerized cognitive training methods on perceived cognitive impairment in breast cancer survivors. Type: Interventional Start Date: Apr 2024 |
A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory...
Pfizer
Myositis
The purpose of the study is to understand how the study medicine PF-06823859 works in
people with idiopathic inflammatory myopathies (DM and PM). These disorders cause
inflammation that weakens the muscles that are important for movement and may also cause
skin rash in people with DM.
This study... expand
The purpose of the study is to understand how the study medicine PF-06823859 works in people with idiopathic inflammatory myopathies (DM and PM). These disorders cause inflammation that weakens the muscles that are important for movement and may also cause skin rash in people with DM. This study is seeking participants who: - Are 18 years of age or older or minimum legal adult age as defined per local regulation, whichever is greater - Have active DM or active PM. - Are receiving a stable dose of 1 corticosteroid taken by mouth and/or 1 traditional immunosuppressant. - Note: Corticosteroids and immunosuppressants are medicines that help reduce inflammation and may signal to the immune system not to attack the body. Dermatomyositis (DM) is a rare disease that causes muscle inflammation that results in muscle weakness and low muscle stamina. Patients with DM have a characteristic skin rash. Polymyositis (PM) is a rare disease that involves mainly muscle inflammation resulting in muscle weakness, that can sometimes be painful. Patients with DM and PM may have trouble going up the steps, walking or getting to a standing position. Some of the participants will receive the study medicine (PF-06823859) and some will receive placebo (which is similar to study medicine but contains no medicine in it). The study medicine or placebo will be given as an intravenous (IV) infusion (directly into the veins), which takes about1 hour; every 4 weeks from Day 1 to Week 48 of the study. Both PF-06823859 and placebo and will be given at the study site. The study will compare the experiences of people receiving study medication to those of the people who do not. This will help to see if PF-06823859 is safe and effective. Participants will take part in this study for about 13 months. During this time, participants will have 15 study visits. These visits will be performed at the study site. Type: Interventional Start Date: May 2023 |
Activity and Safety of Danvatirsen and Pembrolizumab in HNSCC
Flamingo Therapeutics NV
HNSCC
Open-label, Phase II, randomized, controlled study evaluating the efficacy and safety of
danvatirsen in combination with pembrolizumab compared with pembrolizumab alone as
first-line treatment of patients with recurrent/metastatic (R/M) HNSCC. Two-thirds of
patients will be randomized to receive danvatirsen... expand
Open-label, Phase II, randomized, controlled study evaluating the efficacy and safety of danvatirsen in combination with pembrolizumab compared with pembrolizumab alone as first-line treatment of patients with recurrent/metastatic (R/M) HNSCC. Two-thirds of patients will be randomized to receive danvatirsen and pembrolizumab and one-third will be randomized to receive pembrolizumab alone. Type: Interventional Start Date: May 2023 |
A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With Hormone...
Bayer
Biochemically Recurrent Prostate Cancer
Researchers are looking for a better way to treat men at high-risk of biochemical
recurrence (BCR) of prostate cancer.
BCR means that in men who had prostate cancer and were treated by either surgery and/ or
radiation therapy, the blood level of a specific protein called PSA rises. PSA is a
marker... expand
Researchers are looking for a better way to treat men at high-risk of biochemical recurrence (BCR) of prostate cancer. BCR means that in men who had prostate cancer and were treated by either surgery and/ or radiation therapy, the blood level of a specific protein called PSA rises. PSA is a marker of prostate cancer cells activity. The PSA increase means that the cancer has come back even though conventional imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans does not show any lesion of prostate cancer. Recently a more sensitive imaging method called prostate-specific membrane antigen [PSMA] positron emission tomography [PET]) /computed tomography [CT]) scan may identify prostate cancer lesions not detectable by conventional imaging. Men with BCR have a higher risk of their cancer spreading to other parts of the body, particularly when PSA levels raised to a certain limit within a short period of time after local therapies. Once the cancer spreads to other parts of the body, it can become even harder to treat. In men with prostate cancer, male sex hormones (also called androgens) like testosterone can help the cancer grow and spread. To reduce androgens levels in these patients, there are treatments that block androgens production in the body called androgen deprivation therapy (ADT). ADT is often used to stop prostate cancer. Another way to stop prostate cancer growth and spread is to block the action of androgen receptors on prostate cancer cells called androgen receptor inhibitors (ARIs). The new generation ARIs including darolutamide can block the action of androgens receptors and are available for the treatment of prostate cancer in addition to ADT. It is already known that men with prostate cancer benefit from these treatments. The main objective of this study is to learn if the combination of darolutamide and ADT prolongs the time that the participants live without their cancer getting worse, or to death due to any cause, compared to placebo (which is a treatment that looks like a medicine but does not have any medicine in it) and ADT given for a pre-specified duration of 24 months. To do this, the study team will measure the time from the date of treatment allocation to the finding of new cancer spread in the participants by using PSMA PET/CT, or death due to any cause. The PSMA PET/CT scans is performed using a radioactive substance called a "tracer" that specifically binds to the prostate-specific membrane antigen (PSMA) which is a protein often found in large amounts on prostate cancer cells. To avoid bias in treatment, the study participants will be randomly (by chance) allocated to one of two treatment groups. Based on the allocated treatment group, the participants will either take darolutamide plus ADT or placebo plus ADT twice daily as tablets by mouth. The study will consist of a test (screening) phase, a treatment phase and a follow-up phase. The treatment duration is pre-specified to be 24 months unless the cancer gets worse, the participants have medical problems, or they leave the study for any reason. In addition, image guided radiotherapy (IGRT) or surgery is allowed and your doctor will explain the benefits and risks of this type of therapy. During the study, the study team will: - take blood and urine samples. - measure PSA and testosterone levels in the blood samples - do physical examinations - check the participants' overall health - examine heart health using electrocardiogram (ECG) - check vital signs - check cancer status using PSMA PET/CT scans, CT, MRI and bone scans - take tumor samples (if required) - ask the participants if they have medical problems About 30 days after the participants have taken their last treatment, the study doctors and their team will check the participants' health and if their cancer worsened. The study team will continue to check this and regularly ask the participants questions about medical problems and subsequent therapies until they leave the study for any reason or until they leave the study for any reason or until the end of the study, whatever comes first. Type: Interventional Start Date: Apr 2023 |
A Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack-...
Janssen Research & Development, LLC
Ischemic Stroke; Ischemic Attack, Transient
The purpose of this study is to evaluate whether milvexian compared to placebo reduce the
risk of recurrent ischemic stroke. expand
The purpose of this study is to evaluate whether milvexian compared to placebo reduce the risk of recurrent ischemic stroke. Type: Interventional Start Date: Feb 2023 |
A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures
Xenon Pharmaceuticals Inc.
Focal Onset Seizures
The X-TOLE2 Phase 3 clinical trial is a randomized, double-blind, placebo-controlled
study that will evaluate the clinical efficacy, safety and tolerability of XEN1101
administered as adjunctive therapy in focal-onset seizures. expand
The X-TOLE2 Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive therapy in focal-onset seizures. Type: Interventional Start Date: Nov 2022 |
MK-5475-013 INSIGNIA-PH-COPD: A Study of the Efficacy and Safety of MK-5475 (an Inhaled sGC Stimulator)...
Merck Sharp & Dohme LLC
Pulmonary Hypertension
Chronic Obstructive Pulmonary Disease
Researchers are looking for ways to treat pulmonary hypertension (PH) caused by chronic
obstructive pulmonary disease (COPD). The goal of the study is to learn if people who
take MK-5475 can walk farther in 6 minutes at Week 24 compared to people who take
placebo. expand
Researchers are looking for ways to treat pulmonary hypertension (PH) caused by chronic obstructive pulmonary disease (COPD). The goal of the study is to learn if people who take MK-5475 can walk farther in 6 minutes at Week 24 compared to people who take placebo. Type: Interventional Start Date: Mar 2023 |
Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants...
Kite, A Gilead Company
High-risk Large B-cell Lymphoma (LBCL)
The goal of this clinical study is to compare the study drug, axicabtagene ciloleucel,
versus standard of care (SOC) in first-line therapy in participants with high-risk large
B-cell lymphoma. expand
The goal of this clinical study is to compare the study drug, axicabtagene ciloleucel, versus standard of care (SOC) in first-line therapy in participants with high-risk large B-cell lymphoma. Type: Interventional Start Date: Feb 2023 |
Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax...
National Cancer Institute (NCI)
Acute Myeloid Leukemia
This phase II MyeloMATCH treatment trial compares cytarabine with daunorubicin versus
cytarabine with daunorubicin and venetoclax versus venetoclax with azacitidine for the
treatment of younger patients with intermediate risk acute myeloid leukemia (AML).
Cytarabine is a drug that inhibits some of... expand
This phase II MyeloMATCH treatment trial compares cytarabine with daunorubicin versus cytarabine with daunorubicin and venetoclax versus venetoclax with azacitidine for the treatment of younger patients with intermediate risk acute myeloid leukemia (AML). Cytarabine is a drug that inhibits some of the enzymes needed for deoxyribonucleic acid (DNA) replication and repair and can slow or stop the growth of cancer cells. Daunorubicin is a drug that blocks a certain enzyme needed for cell division and DNA repair, and it may kill cancer cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Azacitidine is a drug that interacts with DNA to activate tumor-suppressing genes, resulting in an anti-tumor effect. Adding venetoclax to cytarabine and daunorubicin, and adding venetoclax to azacitidine, may work better than the usual treatment of cytarabine with daunorubicin alone. To decide if they are better, the study doctors are looking to see if venetoclax increases the rate of elimination of AML in participants by 20% or more compared to the usual approach. Type: Interventional Start Date: Sep 2024 |
A Study of EDG-5506 in Children with Duchenne Muscular Dystrophy (LYNX)
Edgewise Therapeutics, Inc.
Duchenne Muscular Dystrophy
The LYNX study is a 2-part, multicenter, Phase 2 study of safety, pharmacokinetics and
biomarkers in children with Duchenne muscular dystrophy including a randomized,
double-blind, placebo-controlled part A, followed by an open-label part B. expand
The LYNX study is a 2-part, multicenter, Phase 2 study of safety, pharmacokinetics and biomarkers in children with Duchenne muscular dystrophy including a randomized, double-blind, placebo-controlled part A, followed by an open-label part B. Type: Interventional Start Date: Oct 2022 |
A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and...
Janssen Research & Development, LLC
Relapsed or Refractory Multiple Myeloma
The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC)
in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in
combination with daratumumab SC (Tal-D), respectively, with daratumumab SC in combination
with pomalidomide and dexamethasone... expand
The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC) in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in combination with daratumumab SC (Tal-D), respectively, with daratumumab SC in combination with pomalidomide and dexamethasone (DPd). Type: Interventional Start Date: Oct 2022 |
THUNDER: Acute Ischemic Stroke Study with the Penumbra System® Including Thunderbolt™ Aspiration Tubing
Penumbra Inc.
Acute Ischemic Stroke
Large Vessel Occlusion
The objective of this study is to demonstrate the safety and efficacy of the Penumbra
System including Thunderbolt Aspiration Tubing (Thunderbolt) in a population presenting
with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO)
who are eligible for mechanical thrombectomy. expand
The objective of this study is to demonstrate the safety and efficacy of the Penumbra System including Thunderbolt Aspiration Tubing (Thunderbolt) in a population presenting with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO) who are eligible for mechanical thrombectomy. Type: Interventional Start Date: Aug 2022 |
Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory...
Kite, A Gilead Company
Relapsed/Refractory Follicular Lymphoma
The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel,
works in participants with relapsed/refractory follicular lymphoma expand
The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel, works in participants with relapsed/refractory follicular lymphoma Type: Interventional Start Date: Sep 2022 |
An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice
Bristol-Myers Squibb
Colitis, Ulcerative
The purpose of this study is to explore the safety, efficacy, effects on quality of life
(QOL), and biomarker response of ozanimod in participants with moderate to severely
active ulcerative colitis (UC) in clinical practice. expand
The purpose of this study is to explore the safety, efficacy, effects on quality of life (QOL), and biomarker response of ozanimod in participants with moderate to severely active ulcerative colitis (UC) in clinical practice. Type: Interventional Start Date: Jan 2023 |
Mechanistic Study of the Effect of Itepekimab on Airway Inflammation in Patients With COPD
Sanofi
Chronic Obstructive Pulmonary Disease
This study is an exploratory, two-part, 12-week, Phase 2a study to evaluate the mechanism
of action of Itepekimab (anti-IL-33-mAb) and its impact on airway inflammation in former
and current smokers with COPD, aged 40 to 70 years.
This study consists of participants who have been on a standard-of-care... expand
This study is an exploratory, two-part, 12-week, Phase 2a study to evaluate the mechanism of action of Itepekimab (anti-IL-33-mAb) and its impact on airway inflammation in former and current smokers with COPD, aged 40 to 70 years. This study consists of participants who have been on a standard-of-care (SoC) mono (long-acting β2-agonist [LABA]) or long-acting muscarinic antagonist [LAMA]), double (inhaled corticosteroid [ICS] + LABA, LABA + LAMA or ICS + LAMA), or triple (ICS + LABA + LAMA) controller therapy for COPD for at least 3 months prior to Screening (Visit 1) with stable dose and regimen for controller therapy for ≥1 month prior to Screening (Visit 1) and during the screening period. Participants will stay on their established controller medications for COPD throughout the duration of the study, with the exception of systemic corticosteroids and/or antibiotics used for acute exacerbation of COPD (AECOPD). The total study duration for each part (Part A and Part B) is approximately 36 weeks: - 4-week screening period - 12-week treatment period - 20-week followup period Type: Interventional Start Date: May 2022 |
Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants...
Novartis Pharmaceuticals
Lupus Nephritis
This trial will evaluate efficacy, safety, and tolerability of subcutaneous (s.c.)
ianalumab given every 4 weeks (q4w) or every 12 weeks (q12w) compared to placebo, in
combination with SoC, in adult participants with active LN expand
This trial will evaluate efficacy, safety, and tolerability of subcutaneous (s.c.) ianalumab given every 4 weeks (q4w) or every 12 weeks (q12w) compared to placebo, in combination with SoC, in adult participants with active LN Type: Interventional Start Date: Jul 2022 |
Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis
University of Florida
Intracranial Arteriosclerosis
Stroke
The primary goal of the trial is to determine if the experimental arms (rivaroxaban or
ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of
ischemic stroke, intracerebral hemorrhage, or vascular death. expand
The primary goal of the trial is to determine if the experimental arms (rivaroxaban or ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of ischemic stroke, intracerebral hemorrhage, or vascular death. Type: Interventional Start Date: Aug 2022 |
NP-G2-044 As Monotherapy and Combination Therapy in Patients with Advanced or Metastatic Solid Tumor...
Novita Pharmaceuticals, Inc.
Advanced or Metastatic Solid Tumor Malignancies
Multicenter, open-label study in patients with advanced or metastatic solid tumor
malignancies to evaluate the safety, tolerability, and preliminary anti-tumor efficacy,
PK, and pharmacodynamics of continuously dosed NP-G2-044 monotherapy and NP-G2-044 in
combination with anti-PD-1 therapy. expand
Multicenter, open-label study in patients with advanced or metastatic solid tumor malignancies to evaluate the safety, tolerability, and preliminary anti-tumor efficacy, PK, and pharmacodynamics of continuously dosed NP-G2-044 monotherapy and NP-G2-044 in combination with anti-PD-1 therapy. Type: Interventional Start Date: Dec 2021 |
Post Approval Study - Evaluate the Long-Term Safety and Effectiveness of the WEB Device
Microvention-Terumo, Inc.
Wide Neck Bifurcation Intracranial Aneurysms
A prospective, multicenter, single arm, interventional study. The target patient
population for this study are adult subjects with WNBAs of the anterior and posterior
intracranial circulation. The primary effectiveness outcome of the study is adequate
intracranial aneurysm occlusion on the 1 year... expand
A prospective, multicenter, single arm, interventional study. The target patient population for this study are adult subjects with WNBAs of the anterior and posterior intracranial circulation. The primary effectiveness outcome of the study is adequate intracranial aneurysm occlusion on the 1 year angiogram as adjudicated by a core laboratory. Type: Interventional Start Date: Aug 2022 |
Pan Tumor Rollover Study
Bristol-Myers Squibb
Cancer
Main Objective of this study is to examine long-term safety of nivolumab monotherapy
including combinations and other cancer therapies in various tumor types. expand
Main Objective of this study is to examine long-term safety of nivolumab monotherapy including combinations and other cancer therapies in various tumor types. Type: Interventional Start Date: Aug 2019 |
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