Search Clinical Trials
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Testing the Combination of the Anti-Cancer Drugs Temozolomide and M1774 to Evaluate Their Safety and...
National Cancer Institute (NCI)
Advanced Malignant Solid Neoplasm
Advanced Microsatellite Stable Colorectal Carcinoma
Hematopoietic and Lymphatic System Neoplasm
Metastatic Malignant Solid Neoplasm
Metastatic Microsatellite Stable Colorectal Carcinoma
This phase I/II trial studies the side effects and best dose of temozolomide and M1774
and how well they works in treating patients with cancer that has spread from where it
first started (primary site) to other places in the body (metastatic) and may have spread
to nearby tissue, lymph nodes, or... expand
This phase I/II trial studies the side effects and best dose of temozolomide and M1774 and how well they works in treating patients with cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and may have spread to nearby tissue, lymph nodes, or distant parts of the body (advanced). Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill tumor cells and slow down or stop tumor growth. M1774 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Adding M1774 to temozolomide may shrink or stabilize cancer for longer than temozolomide alone. Type: Interventional Start Date: Sep 2023 |
Study of M5049 in DM and PM Participants (NEPTUNIA)
EMD Serono Research & Development Institute, Inc.
Dermatomyositis
Polymyositis
The purpose of this study is to evaluate the efficacy and safety of orally administered
M5049 in idiopathic inflammatory myopathies, specifically dermatomyositis (DM) and
polymyositis (PM) participants for 24 weeks. expand
The purpose of this study is to evaluate the efficacy and safety of orally administered M5049 in idiopathic inflammatory myopathies, specifically dermatomyositis (DM) and polymyositis (PM) participants for 24 weeks. Type: Interventional Start Date: Jan 2023 |
The Impact of Menthol Flavoring on Switching in Adult Menthol Smokers
Nikki Nollen, PhD, MA
Smoking Reduction
This study will compare the efficacy of menthol-flavored versus tobacco-flavored 4th
generation nicotine salt-based pod-system e-cigarettes in facilitating a switch from
combustible cigarettes to e-cigarettes in adult menthol smokers. expand
This study will compare the efficacy of menthol-flavored versus tobacco-flavored 4th generation nicotine salt-based pod-system e-cigarettes in facilitating a switch from combustible cigarettes to e-cigarettes in adult menthol smokers. Type: Interventional Start Date: Nov 2022 |
Phase 1/2 Study of BDTX-1535 in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations
Black Diamond Therapeutics, Inc.
Non-Small Cell Lung Cancer
Advanced Non-Small Cell Squamous Lung Cancer
Metastatic Lung Non-Small Cell Carcinoma
Metastatic Lung Cancer
NSCLC
BDTX-1535-101 is an open-label, Phase 1 dose escalation and Phase 2 multiple cohort study
designed to evaluate the safety, pharmacokinetics (PK), optimal dosage, central nervous
system (CNS) activity, and antitumor activity of BDTX-1535. The study population
comprises adults with either advanced/metastatic... expand
BDTX-1535-101 is an open-label, Phase 1 dose escalation and Phase 2 multiple cohort study designed to evaluate the safety, pharmacokinetics (PK), optimal dosage, central nervous system (CNS) activity, and antitumor activity of BDTX-1535. The study population comprises adults with either advanced/metastatic non-small cell lung cancer (NSCLC) with non-classical or acquired epidermal growth factor receptor (EGFR) resistance (EGFR C797S) mutations with or without CNS disease (in Phase 1 and Phase 2), or glioblastoma (GBM) expressing EGFR alterations (Phase 1 only). All patients will self-administer BDTX-1535 monotherapy by mouth in 21-day cycles. Phase 1 enrollment is now complete. Phase 2 is currently enrolling. Type: Interventional Start Date: Mar 2022 |
MRI for Screening and Monitoring Scleroderma ILD
University of Kansas Medical Center
Scleroderma
The purpose of this study is to test MRI methods for evaluating patients with
Scleroderma-associated interstitial lung disease. expand
The purpose of this study is to test MRI methods for evaluating patients with Scleroderma-associated interstitial lung disease. Type: Observational Start Date: May 2022 |
The SLEEPR Study: SLEep Effects on Post-stroke Rehabilitation
State University of New York - Upstate Medical University
Stroke
Sleep Wake Disorders
Rehabilitation
Recovery of Function
Sleep is critical for health and quality of life; however, little is known about the
prevalence or impact of non obstructive sleep apnea (non-OSA) sleep disorders in people
with stroke. The proposed study aims to characterize the proportion of people with stroke
that have non-OSA sleep disorders and... expand
Sleep is critical for health and quality of life; however, little is known about the prevalence or impact of non obstructive sleep apnea (non-OSA) sleep disorders in people with stroke. The proposed study aims to characterize the proportion of people with stroke that have non-OSA sleep disorders and their impact on recovery of activities of daily living, functional mobility, and participation along the continuum of recovery in people with stroke. Type: Observational Start Date: Mar 2021 |
An Assessment of Cognitive Improvement Training Among Mid-life Individuals
University of Kansas
Delay Discounting
Many health-relevant decisions involve intertemporal (now vs. later) tradeoffs. Extensive
literature indicates that many negative health and financial consequences suffered in
mid-life are linked to adversity and disadvantage during early developmental periods of
life. Individuals who continue to... expand
Many health-relevant decisions involve intertemporal (now vs. later) tradeoffs. Extensive literature indicates that many negative health and financial consequences suffered in mid-life are linked to adversity and disadvantage during early developmental periods of life. Individuals who continue to engage in these types of unhealthy behaviors despite awareness of the health consequences are exhibiting an inability to delay gratification. Delay discounting (DD) is quantified in human studies by determining the rate at which an individual discounts a delayed reward, while executive function (EF) is defined as the set of cognitive processes that are responsible for helping individuals manage life tasks and achieve goals. This research will attempt to reduce DD via EF training in a population of mid-life individuals with risk factors established during early-life disadvantage. Type: Interventional Start Date: Nov 2014 |
A Study of RGLS8429 in Patients With Autosomal Dominant Polycystic Kidney Disease
Regulus Therapeutics Inc.
Autosomal Dominant Polycystic Kidney Disease
ADPKD
Polycystic Kidney, Autosomal Dominant
Primary Objectives
- To assess the safety and tolerability of RGLS8429
- To assess the impact of RGLS8429 on ADPKD biomarkers
Secondary Objectives
- To assess the impact of RGLS8429 on height-adjusted total kidney volume (htTKV)
- To characterize the pharmacokinetic (PK) properties... expand
Primary Objectives - To assess the safety and tolerability of RGLS8429 - To assess the impact of RGLS8429 on ADPKD biomarkers Secondary Objectives - To assess the impact of RGLS8429 on height-adjusted total kidney volume (htTKV) - To characterize the pharmacokinetic (PK) properties of RGLS8429 - To assess the impact of RGLS8429 on renal function Type: Interventional Start Date: Oct 2022 |
MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study
Microvention-Terumo, Inc.
Intracranial Aneurysm
The objective of this study is to generate contemporaneous clinical data to facilitate a
reasonable comparison of the performance of the FRED™ X™ device with the performance of
the FRED™ device. The data generated from this study will be compared to the safety and
effectiveness of the FRED™ device... expand
The objective of this study is to generate contemporaneous clinical data to facilitate a reasonable comparison of the performance of the FRED™ X™ device with the performance of the FRED™ device. The data generated from this study will be compared to the safety and effectiveness of the FRED™ device by meeting the same performance goals (PGs) established for the FRED™ pivotal study. Type: Interventional Start Date: Sep 2022 |
Clinical Trial to Evaluate the Safety and Efficacy of DWN12088 in Patients With IPF
Daewoong Pharmaceutical Co. LTD.
Idiopathic Pulmonary Fibrosis
This is a randomized, double-blinded, placebo-controlled multicenter study to evaluate
the safety and efficacy of DWN12088 in patients with Idiopathic Pulmonary Fibrosis. expand
This is a randomized, double-blinded, placebo-controlled multicenter study to evaluate the safety and efficacy of DWN12088 in patients with Idiopathic Pulmonary Fibrosis. Type: Interventional Start Date: Jul 2022 |
Outcomes Database to prospectivelY aSSEss the Changing TherapY Landscape in Renal Cell Carcinoma
Duke University
Metastatic Renal Cell Carcinoma
ODYSSEY RCC is a prospective, observational Phase IV study is to understand the cancer
management and health-related quality of life in patients with mRCC in routine real-world
clinical practice in the United States, including both community and academic treatment
settings. expand
ODYSSEY RCC is a prospective, observational Phase IV study is to understand the cancer management and health-related quality of life in patients with mRCC in routine real-world clinical practice in the United States, including both community and academic treatment settings. Type: Observational Start Date: Apr 2022 |
DALY II USA/ MB-CART2019.1 for DLBCL
Miltenyi Biomedicine GmbH
Refractory Diffuse Large B Cell Lymphoma (DLBCL)
Relapsed Diffuse Large B Cell Lymphoma
High Grade B-cell Lymphoma (HGBCL)
Primary Mediastinal B-cell Lymphoma (PMBCL)
Transformed Lymphoma
DALY II USA is a phase II, multi-center, single arm study to evaluate the efficacy,
safety, and pharmacokinetics of zamtocabtagene autoleucel (MB-CART2019.1) in patients
with relapsed and/or refractory diffuse large B cell lymphoma (DLBCL) after receiving at
least two lines of therapy. expand
DALY II USA is a phase II, multi-center, single arm study to evaluate the efficacy, safety, and pharmacokinetics of zamtocabtagene autoleucel (MB-CART2019.1) in patients with relapsed and/or refractory diffuse large B cell lymphoma (DLBCL) after receiving at least two lines of therapy. Type: Interventional Start Date: May 2021 |
Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity: A Multi-Center Study...
International Spine Study Group Foundation
Cervical Deformity
Multi-center, prospective, non-randomized study to evaluate outcomes of surgically
treated patients with adult cervical spinal deformity. expand
Multi-center, prospective, non-randomized study to evaluate outcomes of surgically treated patients with adult cervical spinal deformity. Type: Observational Start Date: Aug 2019 |
A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness...
LivaNova
Treatment Resistant Depression
Objectives of this study are to determine whether active VNS Therapy treatment is
superior to a no stimulation control in producing a reduction in baseline depressive
symptom severity, based on multiple depression scale assessment tools at 12 months from
randomization. expand
Objectives of this study are to determine whether active VNS Therapy treatment is superior to a no stimulation control in producing a reduction in baseline depressive symptom severity, based on multiple depression scale assessment tools at 12 months from randomization. Type: Interventional Start Date: Sep 2019 |
Lifileucel With Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion and Interleukin-2 for the Treatment...
University of Kansas Medical Center
Clinical Stage IV Cutaneous Melanoma AJCC v8
Metastatic Melanoma
Pathologic Stage IIIC Cutaneous Melanoma AJCC v8
Unresectable Melanoma
This phase II trial tests how well lifileucel, with reduce dose fludarabine and
cyclophosphamide for lymphodepletion and interleukin-2, work for treating patients with
melanoma that cannot be removed by surgery (unresectable) or that has spread from where
it first started (primary site) to other places... expand
This phase II trial tests how well lifileucel, with reduce dose fludarabine and cyclophosphamide for lymphodepletion and interleukin-2, work for treating patients with melanoma that cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic).Lifileucel is made up of specialized immune cells called lymphocytes or T cells that are taken from a patient's tumor, grown in a manufacturing facility and infused back into the preconditioned patient to attack the tumor. Giving Lifileucel with a reduced dose of fludarabine and cyclophosphamide for lymphodepletion and interleukin -2 is being studied in patients with unresectable or metastatic melanoma. Type: Interventional Start Date: Dec 2023 |
Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment...
NRG Oncology
Prostate Adenocarcinoma
This phase III trial uses the Decipher risk score to guide intensification (for higher
Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment to
better match therapies to an individual patient's cancer aggressiveness. The Decipher
risk score evaluates a prostate cancer... expand
This phase III trial uses the Decipher risk score to guide intensification (for higher Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment to better match therapies to an individual patient's cancer aggressiveness. The Decipher risk score evaluates a prostate cancer tumor for its potential for spreading. In patients with low risk scores, this trial compares radiation therapy alone to the usual treatment of radiation therapy and hormone therapy (androgen deprivation therapy). Radiation therapy uses high energy x-rays or particles to kill tumor cells and shrink tumors. Androgen deprivation therapy blocks the production or interferes with the action of male sex hormones such as testosterone, which plays a role in prostate cancer development. Giving radiation treatment alone may be the same as the usual approach in controlling the cancer and preventing it from spreading, while avoiding the side effects associated with hormonal therapy. In patients with higher Decipher gene risk, this trial compares the addition of darolutamide to usual treatment radiation therapy and hormone therapy, to usual treatment. Darolutamide blocks the actions of the androgens (e.g. testosterone) in the tumor cells and in the body. The addition of darolutamide to the usual treatment may better control the cancer and prevent it from spreading. Type: Interventional Start Date: Nov 2021 |
The Purpose of This Trial is to Determine if Regorafenib Plus Durvalumab (MEDI4736) is Safe and Effective...
University of Kansas Medical Center
Advanced Biliary Tract Cancer
The purpose of this study is to measure how effective combining Durvalumab and
Regorafenib will be for participants with advance stage biliary track carcinoma who have
received one line of prior treatment expand
The purpose of this study is to measure how effective combining Durvalumab and Regorafenib will be for participants with advance stage biliary track carcinoma who have received one line of prior treatment Type: Interventional Start Date: Mar 2022 |
Testing the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After...
NRG Oncology
Prostate Adenocarcinoma
Stage I Prostate Cancer AJCC v8
Stage II Prostate Cancer AJCC v8
Stage IIA Prostate Cancer AJCC v8
Stage IIB Prostate Cancer AJCC v8
This phase III trial studies whether adding apalutamide to the usual treatment improves
outcome in patients with lymph node positive prostate cancer after surgery. Radiation
therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgens, or male
sex hormones, can cause the growth... expand
This phase III trial studies whether adding apalutamide to the usual treatment improves outcome in patients with lymph node positive prostate cancer after surgery. Radiation therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgens, or male sex hormones, can cause the growth of prostate cancer cells. Drugs, such as apalutamide, may help stop or reduce the growth of prostate cancer cell growth by blocking the attachment of androgen to its receptors on cancer cells, a mechanism similar to stopping the entrance of a key into its lock. Adding apalutamide to the usual hormone therapy and radiation therapy after surgery may stabilize prostate cancer and prevent it from spreading and extend time without disease spreading compared to the usual approach. Type: Interventional Start Date: Mar 2020 |
Testing the Addition of the Chemotherapy Drug Lomustine (Gleostine®) to the Usual Treatment (Temozolomide...
NRG Oncology
Glioblastoma
Gliosarcoma
This phase III trial compares the effect of adding lomustine to temozolomide and
radiation therapy versus temozolomide and radiation therapy alone in shrinking or
stabilizing newly diagnosed MGMT methylated glioblastoma. Chemotherapy drugs, such as
lomustine and temozolomide, work in different ways... expand
This phase III trial compares the effect of adding lomustine to temozolomide and radiation therapy versus temozolomide and radiation therapy alone in shrinking or stabilizing newly diagnosed MGMT methylated glioblastoma. Chemotherapy drugs, such as lomustine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy photons to kill tumor cells and shrink tumors. Adding lomustine to usual treatment of temozolomide and radiation therapy may help shrink and stabilize glioblastoma. Type: Interventional Start Date: Nov 2021 |
Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens
University of Kansas Medical Center
Risk Reduction
Breast Cancer
Women at risk for development of breast cancer and experiencing vasomotor menopausal
symptoms (hot flashes) will be randomized to bazedoxifene (BZA) plus conjugated estrogens
(CE) for 6 months versus a wait list control. Two risk factors for development of breast
cancer will be studied pre-study and... expand
Women at risk for development of breast cancer and experiencing vasomotor menopausal symptoms (hot flashes) will be randomized to bazedoxifene (BZA) plus conjugated estrogens (CE) for 6 months versus a wait list control. Two risk factors for development of breast cancer will be studied pre-study and after 6 months: fibroglandular volume (FGV) on mammogram as assessed by Volpara software and proliferation by Ki-67 immunocytochemistry in benign breast tissue acquired by random periareolar fine needle aspiration (RPFNA). Change in biomarkers will be compared between groups. Type: Interventional Start Date: Dec 2021 |
The Acute Burn ResUscitation Multicenter Prospective Trial
American Burn Association
Burn Injury
This is a prospective randomized multi-center study which will compare acute fluid
resuscitation using a colloid strategy (LR + 5% Albumin) to a crystalloid strategy (LR
alone), in adults with an acute burn involving at least 25% of their total body surface
area. expand
This is a prospective randomized multi-center study which will compare acute fluid resuscitation using a colloid strategy (LR + 5% Albumin) to a crystalloid strategy (LR alone), in adults with an acute burn involving at least 25% of their total body surface area. Type: Interventional Start Date: Apr 2021 |
Study of CYR-064 Versus Placebo in Patients.
Cyrano Therapeutics, Inc.
Hyposmia
Randomized, double-blinded, placebo-controlled trial to determine the safety and efficacy
of CYR-064. expand
Randomized, double-blinded, placebo-controlled trial to determine the safety and efficacy of CYR-064. Type: Interventional Start Date: Sep 2023 |
A Trial to Learn if Dupilumab is Safe for and Helps Adult and Adolescent Participants With Eosinophilic...
Regeneron Pharmaceuticals
Eosinophilic Gastritis
Eosinophilic Duodenitis
Eosinophilic Gastrointestinal Disease
The study is researching an experimental drug called dupilumab. The study is focused on
participants with active eosinophilic gastritis (EoG) with or without eosinophilic
duodenitis (EoD). Participants with EoD only are not eligible for enrollment. EoG and EoD
are uncommon, persistent, allergic/immune... expand
The study is researching an experimental drug called dupilumab. The study is focused on participants with active eosinophilic gastritis (EoG) with or without eosinophilic duodenitis (EoD). Participants with EoD only are not eligible for enrollment. EoG and EoD are uncommon, persistent, allergic/immune diseases in which eosinophils (a type of white blood cell) gather in large numbers in the stomach and small intestine and cause inflammation and damage. The aim of the study is to evaluate the effect of dupilumab on relieving EoG (with or without EoD) symptoms and reducing inflammation in the stomach and, if applicable, small intestine in adults and adolescents aged 12 years and older, compared to placebo. The study is looking at several other research questions, including: - What side effects may happen from taking the study drug - How much study drug is in your blood at different times - Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) Type: Interventional Start Date: May 2023 |
Stroke Thrombectomy and Aneurysm Registry
Medical University of South Carolina
Stroke
Thromboses, Intracranial
Aneurysm, Brain
This international multi-center registry is used to collect existing information and
outcomes for patients undergoing an operation for treatment of injuries to the brain
including the blockage of blood flow to an area of the brain, an abnormal ballooning of
an artery, abnormal tangling of blood vessels,... expand
This international multi-center registry is used to collect existing information and outcomes for patients undergoing an operation for treatment of injuries to the brain including the blockage of blood flow to an area of the brain, an abnormal ballooning of an artery, abnormal tangling of blood vessels, abnormal formation of blood vessels, tearing of vein, and bleeding in the brain. This information is used to help predict outcomes that undergo an operation for treatment of the above-listed brain injuries. Additionally, the information is used to compare techniques and devices' effects on technical and clinical outcomes. Type: Observational [Patient Registry] Start Date: Sep 2019 |
Ipatasertib and Docetaxel in Metastatic NSCLC Patients Who Have Failed 1st Line Immunotherapy
Jun Zhang, MD, PhD
NSCLC Stage IV
NSCLC Stage IIIB
For metastatic/advanced NSCLC patients who do not have targetable mutations, either
immunotherapy targeting the programmed death-1 and its ligand (PD-1/L1) pathway alone or
in combination with platinum doublet chemotherapy is now a standard of care. However,
still about half of the patients do not... expand
For metastatic/advanced NSCLC patients who do not have targetable mutations, either immunotherapy targeting the programmed death-1 and its ligand (PD-1/L1) pathway alone or in combination with platinum doublet chemotherapy is now a standard of care. However, still about half of the patients do not benefit due to treatment resistance. It is therefore critically important to find novel therapies and combinations to benefit patients who have failed or are intolerant to 1st line immunotherapy. This study hypothesizes that ipatasertib in combination with taxane (e.g. docetaxel) can be an effective strategy. Ipatasertib is a novel adenosine triphosphate (ATP)-competitive inhibitor that has demonstrated robust and selective targeting of protein kinase B (PKB, also known as AKT) in cancer patients. Importantly, evidence from preclinical studies has demonstrated that AKT inhibitors (e.g. ipatasertib) can enhance the therapeutic effect of chemotherapy as well as immunotherapy via modulating Phosphatidylinositol 3-kinase (PI3'K)-AKT activity. Type: Interventional Start Date: Sep 2021 |
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