Search Clinical Trials
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A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M)...
AVEO Pharmaceuticals, Inc.
Metastatic Head-and-neck Squamous-cell Carcinoma
Recurrent Head and Neck Squamous Cell Carcinoma
The purpose of this study is to compare the efficacy and safety of ficlatuzumab plus
cetuximab compared to placebo plus cetuximab in participants with recurrent/metastatic
(R/M) HPV-negative Head and Neck Cancer.
The primary hypothesis is that ficlatuzumab combined with cetuximab is superior to
cetuximab... expand
The purpose of this study is to compare the efficacy and safety of ficlatuzumab plus cetuximab compared to placebo plus cetuximab in participants with recurrent/metastatic (R/M) HPV-negative Head and Neck Cancer. The primary hypothesis is that ficlatuzumab combined with cetuximab is superior to cetuximab alone in terms of progression-free survival and/or overall survival. Type: Interventional Start Date: Jan 2024 |
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 |
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 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 |
Studying the Effect of Levocarnitine in Protecting the Liver From Chemotherapy for Leukemia or Lymphoma
Children's Oncology Group
B Acute Lymphoblastic Leukemia
B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
B Acute Lymphoblastic Leukemia, BCR-ABL1-Like
Lymphoblastic Lymphoma
Mixed Phenotype Acute Leukemia
This phase III trial compares the effect of adding levocarnitine to standard chemotherapy
vs. standard chemotherapy alone in protecting the liver in patients with leukemia or
lymphoma. Asparaginase is part of the standard of care chemotherapy for the treatment of
acute lymphoblastic leukemia (ALL),... expand
This phase III trial compares the effect of adding levocarnitine to standard chemotherapy vs. standard chemotherapy alone in protecting the liver in patients with leukemia or lymphoma. Asparaginase is part of the standard of care chemotherapy for the treatment of acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma (LL), and mixed phenotype acute leukemia (MPAL). However, in adolescent and young adults (AYA) ages 15-39 years, liver toxicity from asparaginase is common and often prevents delivery of planned chemotherapy, thereby potentially compromising outcomes. Some groups of people may also be at higher risk for liver damage due to the presence of fat in the liver even before starting chemotherapy. Patients who are of Japanese descent, Native Hawaiian, Hispanic or Latinx may be at greater risk for liver damage from chemotherapy for this reason. Carnitine is a naturally occurring nutrient that is part of a typical diet and is also made by the body. Carnitine is necessary for metabolism and its deficiency or absence is associated with liver and other organ damage. Levocarnitine is a drug used to provide extra carnitine. Laboratory and real-world usage of the dietary supplement levocarnitine suggests its potential to prevent or reduce liver toxicity from asparaginase. The overall goal of this study is to determine whether adding levocarnitine to standard of care chemotherapy will reduce the chance of developing severe liver damage from asparaginase chemotherapy in ALL, LL and/or MPAL patients. Type: Interventional Start Date: Aug 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 |
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 |
GammaTile and Stupp in Newly Diagnosed GBM
GT Medical Technologies, Inc.
Glioblastoma
In summary, standard of care postoperative chemoradiation for patients with newly
diagnosed GBM does not routinely provide durable local control or prolonged overall
survival. As discussed above it seems unlikely that patient outcomes will be
significantly improved with radiation dose escalation given... expand
In summary, standard of care postoperative chemoradiation for patients with newly diagnosed GBM does not routinely provide durable local control or prolonged overall survival. As discussed above it seems unlikely that patient outcomes will be significantly improved with radiation dose escalation given at the time of the EBRT boost. However, as most failures are local, improving LC could potentially improve the OS of patients. To do this, we propose a shift in the traditional radiation paradigm. This study will assess the feasibility and tolerability of adding GT radiation therapy as an upfront boost at the time of maximum safe resection, along with the backbone of the current standard of care approach, concomitant and adjuvant temozolomide +/- TTF, for patients with newly diagnosed GBM. GT, a novel brain brachytherapy device utilizing Cs-131 embedded in bioresorbable collagen tiles, offers a more sophisticated carrier and a shorter half-life radioisotope, Cs-131. Use of this device allows for radiation initiation at an earlier time point and a more rapid dose delivery and possibly more effective tumor control particularly for rapidly proliferating tumors such as GBM. Two prospective studies have demonstrated the safety and efficacy of re-irradiation with GT in patients with recurrent GBM. The overarching goal of this single-arm, open label phase 4 study is to determine the feasibility and tolerability of treating patients with GammaTile in combination with the Stupp Protocol and how to proceed with testing this treatment in a future, larger, randomized clinical study. The aims of the study are to demonstrate that the use of GammaTile at the time of surgery is well tolerated and does not delay the start of the Stupp protocol. Efficacy outcomes (e.g., LC, OS, PFS) will also be described. Type: Interventional Start Date: Aug 2022 |
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 |
Olorofim Aspergillus Infection Study
F2G Biotech GmbH
Invasive Aspergillosis
The purpose of this study is to compare treatment with olorofim versus treatment with
AmBisome® followed by standard of care (SOC) in patients with IFD caused by proven IA or
probable lower respiratory tract disease Aspergillus species (invasive aspergillosis,
IA). expand
The purpose of this study is to compare treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in patients with IFD caused by proven IA or probable lower respiratory tract disease Aspergillus species (invasive aspergillosis, IA). Type: Interventional Start Date: Mar 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 |
A Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma
National Cancer Institute (NCI)
Stage III Cutaneous Melanoma AJCC v7
Stage IV Cutaneous Melanoma AJCC v6 and v7
This phase II/III trial studies the side effects of nivolumab and ipilimumab when given
together with or without sargramostim and to see how well they work in treating patients
with stage III-IV melanoma that cannot be removed by surgery (unresectable) and that may
have spread from where it first... expand
This phase II/III trial studies the side effects of nivolumab and ipilimumab when given together with or without sargramostim and to see how well they work in treating patients with stage III-IV melanoma that cannot be removed by surgery (unresectable) and that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Colony-stimulating factors, such as sargramostim, may increase the production of white blood cells. It is not yet known whether nivolumab and ipilimumab are more effective with or without sargramostim in treating patients with melanoma. Type: Interventional Start Date: Nov 2015 |
Clinical Utility of Management of Patients With Pulmonary Nodules Using the Percepta Nasal Swab Classifier
Veracyte, Inc.
Pulmonary Nodule, Solitary
Lung Cancer
The goal of this observational study is to learn how a physician uses the results of the
Percepta® Nasal Swab test to manage people with a newly identified pulmonary nodule.
The main questions it aims to answer are:
- Does the use of the Percepta Nasal swab test reduce the number of invasive... expand
The goal of this observational study is to learn how a physician uses the results of the Percepta® Nasal Swab test to manage people with a newly identified pulmonary nodule. The main questions it aims to answer are: - Does the use of the Percepta Nasal swab test reduce the number of invasive procedures in people with a low-risk result and whose nodule is benign? - Does the use of the Percepta Nasal swab test decrease the time to treatment in people with a high-risk result and whose nodule is cancer? Participants will be randomly assigned to either a group where the test result is provided to the physician (test arm) or to a group where the test result is not provided (control arm). Researchers will compare management of participants in the two groups. Type: Observational Start Date: Jul 2022 |
Study of BBO-8520 in Adult Subjects with KRASG12C Non-small Cell Lung and Colorectal Cancer
TheRas, Inc., d/b/a BridgeBio Oncology Therapeutics
Non-small Cell Lung Cancer
Metastatic Non-Small Cell Lung Cancer
NSCLC
KRAS G12C
Metastatic Lung Cancer
A first in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of
BBO-8520, a KRAS G12C (ON) inhibitor, single agent and in combination with pembrolizumab
in patients with advanced non-small cell lung cancer and colorectal cancer expand
A first in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-8520, a KRAS G12C (ON) inhibitor, single agent and in combination with pembrolizumab in patients with advanced non-small cell lung cancer and colorectal cancer Type: Interventional Start Date: May 2024 |
AvoCog - the Effect of Daily Avocado Intake on Cognitive Function in Older Adults
University of Kansas Medical Center
Brain Aging
The goal of this clinical trial is to determine if adding avocados to the diet of impacts
cognition in 70 older adults, age 65-85, without dementia. We will test for change in
functional MRI, cognitive performance, and brain blood flow. Intervention group
participants will be asked to consume 1 avocado... expand
The goal of this clinical trial is to determine if adding avocados to the diet of impacts cognition in 70 older adults, age 65-85, without dementia. We will test for change in functional MRI, cognitive performance, and brain blood flow. Intervention group participants will be asked to consume 1 avocado per day for 12 weeks. Participants in the control group will be asked to continue their normal intake for 12 weeks. Throughout the study, participants will be asked to perform cognitive tests, MRI, blood tests, and questionnaires. Type: Interventional Start Date: Apr 2024 |
Enlighten Study: The EV-ICD Post Approval Registry
Medtronic
Ventricular Arrhythmia
Tachycardia
Medtronic is sponsoring Enlighten: The EV-ICD Post Approval Registry, to further confirm
safety and effectiveness of EV-ICD in routine clinical practice, following commercial
release of EV-ICD devices. expand
Medtronic is sponsoring Enlighten: The EV-ICD Post Approval Registry, to further confirm safety and effectiveness of EV-ICD in routine clinical practice, following commercial release of EV-ICD devices. Type: Observational Start Date: Sep 2023 |
Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid...
Kura Oncology, Inc.
AML
AML With Mutated NPM1
Hematologic Malignancy
KMT2Ar
NPM1 Mutation
The safety, tolerability, and antileukemic response of ziftomenib in combination with
standard of care treatments for patients with relapsed/refractory acute myeloid leukemia
will be examined with the following agents: FLAG-IDA, low-dose cytarabine, and
gilteritinib. expand
The safety, tolerability, and antileukemic response of ziftomenib in combination with standard of care treatments for patients with relapsed/refractory acute myeloid leukemia will be examined with the following agents: FLAG-IDA, low-dose cytarabine, and gilteritinib. Type: Interventional Start Date: Feb 2024 |
Testing Continuous Versus Intermittent Treatment With the Study Drug Zanubrutinib for Older Patients...
Alliance for Clinical Trials in Oncology
Mantle Cell Lymphoma
This phase III trial tests whether continuous or intermittent zanubrutinib after
achieving a complete remission (CR) with rituximab works in older adult patients with
mantle cell lymphoma (MCL) who have not received treatment in the past (previously
untreated). Rituximab is a monoclonal antibody that... expand
This phase III trial tests whether continuous or intermittent zanubrutinib after achieving a complete remission (CR) with rituximab works in older adult patients with mantle cell lymphoma (MCL) who have not received treatment in the past (previously untreated). Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Zanubrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. When zanubrutinib is used in MCL, the current standard of care is to continue administering the drug indefinitely until disease progression. This continuous treatment comes with clinical as well as financial toxicity, which could be especially detrimental in older patients. For patients who achieve a CR after initial zanubrutinib plus rituximab therapy, it may be safe and equally effective to stop treatment and restart zanubrutinib upon disease progression rather than continuing indefinitely in previously untreated older adult patients with MCL. Type: Interventional Start Date: Sep 2023 |
Observational Study for Patients at Risk for Chronic Graft-Versus-Host Disease
Incyte Corporation
cGVHD
The purpose of this prospective observational study is to collect data from participants
who have recently had an allogenic Stem Cell Transplant(alloSCT) and are at risk of
Chronic Graft Versus Host Disease(cGVHD) expand
The purpose of this prospective observational study is to collect data from participants who have recently had an allogenic Stem Cell Transplant(alloSCT) and are at risk of Chronic Graft Versus Host Disease(cGVHD) Type: Observational Start Date: Aug 2023 |
Safety and Efficacy of NMD670 in Ambulatory Adult Patients With Type 3 Spinal Muscular Atrophy
NMD Pharma A/S
Spinal Muscular Atrophy
The purpose of this study is to evaluate the efficacy, safety, tolerability and
pharmacokinetics of NMD670 in the treatment of ambulatory adults with spinal muscular
atrophy type 3 expand
The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of NMD670 in the treatment of ambulatory adults with spinal muscular atrophy type 3 Type: Interventional Start Date: Sep 2023 |
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