Search Clinical Trials
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Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)
University of Michigan
Cardiac Arrest, Out-Of-Hospital
Hypothermia, Induced
Hypoxia-Ischemia, Brain
This is a multicenter trial to establish the efficacy of cooling and the optimal duration
of induced hypothermia for neuroprotection in pediatric comatose survivors of cardiac
arrest.
The study team hypothesizes that longer durations of cooling may improve either the
proportion of children that at1 expand
This is a multicenter trial to establish the efficacy of cooling and the optimal duration of induced hypothermia for neuroprotection in pediatric comatose survivors of cardiac arrest. The study team hypothesizes that longer durations of cooling may improve either the proportion of children that attain a good neurobehavioral recovery or may result in better recovery among the proportion already categorized as having a good outcome. Type: Interventional Start Date: Aug 2022 |
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Trifecta-Kidney cfDNA-MMDx Study
University of Alberta
Kidney Transplant Rejection
Demonstrate the relationship between DD-cfDNA levels and HLA antibodies in blood, and the
Molecular Microscope® (MMDx) Diagnostic System results in indication biopsies. expand
Demonstrate the relationship between DD-cfDNA levels and HLA antibodies in blood, and the Molecular Microscope® (MMDx) Diagnostic System results in indication biopsies. Type: Observational Start Date: Dec 2019 |
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A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effec1
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 |
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A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination Wit1
Bristol-Myers Squibb
Advanced Renal Cell Carcinoma (RCC)
The purpose of this study is to evaluate the safety, tolerability, and efficacy of
Pumitamig alone or in combination with Ipilimumab or Cabozantinib in participants with
advanced Renal Cell Carcinoma (RCC) expand
The purpose of this study is to evaluate the safety, tolerability, and efficacy of Pumitamig alone or in combination with Ipilimumab or Cabozantinib in participants with advanced Renal Cell Carcinoma (RCC) Type: Interventional Start Date: Mar 2026 |
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Advancing Biopsychosocial Care Training Initiative
Washington University School of Medicine
Weight Management
Obesity Prevention
Obesity and Obesity-related Medical Conditions
Obesity and Overweight
Obesity
This project will compare two training approaches for US Preventive Services Task Force
recommended obesity care in Federally Qualified Health Centers (FQHC) across four aims.
Aim 1 compares patient-level effectiveness [i.e., patient relative weight change and the
proportion of patients who achieve1 expand
This project will compare two training approaches for US Preventive Services Task Force recommended obesity care in Federally Qualified Health Centers (FQHC) across four aims. Aim 1 compares patient-level effectiveness [i.e., patient relative weight change and the proportion of patients who achieve clinically significant weight loss]. Aim 2 compares reach (patient treatment utilization). Aim 3 compares primary care provider (PCP) referrals to USPSTF-recommended care at 12 (adoption) and 24 months (maintenance) and short- and long-term changes in provider obesity care competencies . Aim 4 compares implementation and service costs. Type: Interventional Start Date: Jul 2025 |
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A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstr1
Imbria Pharmaceuticals, Inc.
Non-obstructive Hypertrophic Cardiomyopathy
FORTITUDE-HCM is a global, multicenter, double-blind, parallel-group, placebo-controlled
Phase 2b study that will assess the efficacy and safety of ninerafaxstat compared to
placebo on top of Standard of Care in patients with symptomatic nHCM expand
FORTITUDE-HCM is a global, multicenter, double-blind, parallel-group, placebo-controlled Phase 2b study that will assess the efficacy and safety of ninerafaxstat compared to placebo on top of Standard of Care in patients with symptomatic nHCM Type: Interventional Start Date: Oct 2025 |
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ONT01 and Gemcitabine/Nab-paclitaxel as Second Line Therapy for Metastatic Pancreatic Ductal Adenoc1
Washington University School of Medicine
Metastatic Pancreatic Ductal Adenocarcinoma
The investigators hypothesize that CD11b agonism reprograms the tumor microenvironment
(TME) to overcome resistance to checkpoint immunotherapy in pancreatic ductal
adenocarcinoma (PDAC). Therefore, the investigators propose an open label phase I/II
clinical trial of ONT01 with gemcitabine and nab-1 expand
The investigators hypothesize that CD11b agonism reprograms the tumor microenvironment (TME) to overcome resistance to checkpoint immunotherapy in pancreatic ductal adenocarcinoma (PDAC). Therefore, the investigators propose an open label phase I/II clinical trial of ONT01 with gemcitabine and nab-paclitaxel in unresectable pancreatic ductal adenocarcinoma prior to future studies incorporating anti-PD1 checkpoint immunotherapy. Type: Interventional Start Date: Mar 2026 |
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Neoadjuvant Chemoradiotherapy With or Without Concurrent Azeliragon in Patients With Newly Diagnose1
Washington University School of Medicine
Glioblastoma
Preclinical data have demonstrated the combination of azeliragon, a RAGE inhibitor, with
radiation therapy (RT) can effectively reduce immune-suppressive myeloid cells and
restore T-cell activation to improve tumor control in murine glioma models. Ongoing
clinical studies of azeliragon with RT alon1 expand
Preclinical data have demonstrated the combination of azeliragon, a RAGE inhibitor, with radiation therapy (RT) can effectively reduce immune-suppressive myeloid cells and restore T-cell activation to improve tumor control in murine glioma models. Ongoing clinical studies of azeliragon with RT alone and RT plus temozolomide (TMZ) to treat patients with newly diagnosed glioblastoma (GBM) have demonstrated safety and tolerability. The purpose of this window-of-opportunity study is to validate that the combination of azeliragon with RT and TMZ would modulate immune-suppressive myeloid and T cells in the tumor microenvironment in patients with GBM. Type: Interventional Start Date: Nov 2025 |
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Open-label Study Comparing AAA817 Versus Standard of Care in the Treatment of Previously Treated PS1
Novartis Pharmaceuticals
Prostate Cancer
This is a Phase II/III study. Patient population is adult participants with PSMA-positive
mCRPC who had treatments with androgen receptor pathway inhibitor (ARPI) and taxane-based
chemotherapy and progressed on or after [177Lu]Lu-PSMA targeted therapy.
Treatment of interest: the investigational tr1 expand
This is a Phase II/III study. Patient population is adult participants with PSMA-positive mCRPC who had treatments with androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy and progressed on or after [177Lu]Lu-PSMA targeted therapy. Treatment of interest: the investigational treatment is AAA817 regardless of subsequent anti-neoplastic treatment. The control treatment is investigator's choice of Standard of Care, regardless of subsequent anti-neoplastic treatment Type: Interventional Start Date: Feb 2025 |
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Acoramidis Transthyretin Amyloidosis Prevention Trial in the Young (ACT-EARLY) Study in Asymptomati1
Eidos Therapeutics, a BridgeBio company
Amyloidosis
Amyloid Cardiomyopathy
Transthyretin Amyloidosis
Cardiomyopathies
Heart Diseases
Transthyretin amyloidosis (ATTR) is a disease where the normally occurring transthyretin
(TTR) protein falls apart and forms amyloid, a sticky plaque-like substance that
accumulates in different organs in the body and can cause damage to the organ. There are
two ways that the TTR protein can fall a1 expand
Transthyretin amyloidosis (ATTR) is a disease where the normally occurring transthyretin (TTR) protein falls apart and forms amyloid, a sticky plaque-like substance that accumulates in different organs in the body and can cause damage to the organ. There are two ways that the TTR protein can fall apart. One way occurs as a person ages, where the normal TTR protein can fall apart and form amyloid that may no longer be sufficiently cleared by the body. This type of ATTR is known as wild-type ATTR (ATTRwt). The other way occurs when a person inherits a defective TTR gene that causes the TTR protein to spontaneously fall apart. This form of the disease is known as variant ATTR (ATTRv) and can be detected in adults by a genetic test of their TTR gene before they age. Amyloid build-up in the heart causes the heart wall to become thick and stiff and can result in heart failure and even death. Accumulation of TTR amyloid in the heart is known as transthyretin amyloid cardiomyopathy or ATTR-CM. Amyloid can also deposit in the nerve tissues leading to nerve problems. Accumulation of TTR in the nerves is known as transthyretin amyloid polyneuropathy or ATTR-PN. Acoramidis is an experimental drug designed to bind tightly to TTR in the blood and stabilize its structure, so it does not form the harmful amyloid plaques that can cause damage to organs. This study is intended to determine if treatment with acoramidis in participants with ATTRv who have not yet developed any symptoms of disease can prevent or delay the development of ATTR-CM or ATTR-PN disease. If adults with an inherited defective TTR gene are treated early before any of the symptoms of disease have developed, it may be possible to delay the onset or prevent the disease entirely. Type: Interventional Start Date: May 2025 |
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A Phase 2, Open-Label Study to Evaluate the Safety and Effects of HLX-1502 in Patients With Neurofi1
Healx Limited
Neurofibromatosis Type 1
The trial will be an open label, single arm, phase 2 study to assess the tolerability and
efficacy of HLX-1502 in participants with NF1 that are 16 years or older in age with
progressive and/or symptomatic PN. This study will also investigate the safety and
efficacy of HLX-1502 in a small cohort of1 expand
The trial will be an open label, single arm, phase 2 study to assess the tolerability and efficacy of HLX-1502 in participants with NF1 that are 16 years or older in age with progressive and/or symptomatic PN. This study will also investigate the safety and efficacy of HLX-1502 in a small cohort of 12 to 15 year olds. Type: Interventional Start Date: Feb 2025 |
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A Phase 1 Study of AJ1-11095 in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera M1
Ajax Therapeutics, Inc.
Primary Myelofibrosis
Post-Essential Thrombocythemia Myelofibrosis
Post-Polycythemia Vera Myelofibrosis
PMF
PPV-MF
AJX-101 is a first-in-human (FIH), phase 1, non-randomized, multi-center, open-label
clinical trial designed to investigate the safety, tolerability, pharmacokinetics (PK),
clinical activity and changes in biomarkers of an orally administered type II JAK2
inhibitor, AJ1-11095, in subjects with prim1 expand
AJX-101 is a first-in-human (FIH), phase 1, non-randomized, multi-center, open-label clinical trial designed to investigate the safety, tolerability, pharmacokinetics (PK), clinical activity and changes in biomarkers of an orally administered type II JAK2 inhibitor, AJ1-11095, in subjects with primary or secondary myelofibrosis previously treated with at least one type I JAK2 inhibitor. Type: Interventional Start Date: Oct 2024 |
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Study of Arlocabtagene Autoleucel (BMS-986393) a GPRC5D-directed CAR T Cell Therapy in Adult Partic1
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Multiple Myeloma
The purpose of this study is to evaluate the effectiveness and safety of Arlocabtagene
Autoleucel (BMS-986393) in participants with relapsed or refractory multiple myeloma. expand
The purpose of this study is to evaluate the effectiveness and safety of Arlocabtagene Autoleucel (BMS-986393) in participants with relapsed or refractory multiple myeloma. Type: Interventional Start Date: Mar 2024 |
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COOL-IT-PRO: Cryoablation of Breast Cancer in Non-surgical Patients
Washington University School of Medicine
Breast Cancer
Cancer of the Breast
This is a subject registry study of patients who undergo cryoablation for their breast
cancer after being determined not to be surgical candidates. Data collected as part of
this registry will be used to assess the safety of percutaneous ultrasound-guided
cryoablation in this population as well as1 expand
This is a subject registry study of patients who undergo cryoablation for their breast cancer after being determined not to be surgical candidates. Data collected as part of this registry will be used to assess the safety of percutaneous ultrasound-guided cryoablation in this population as well as provide long-term follow-up of subjects who received cryoablation. Type: Observational [Patient Registry] Start Date: Jul 2023 |
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Alzheimer"s Imaging Biomarkers in Obesity
Cyrus A Raji
Alzheimer Disease
Obesity
Metabolic Disease
High body fat at midlife, as evidenced by overweight or obese body mass index (BMI), is
increasingly understood as a risk factor for Alzheimer's disease. However, the underlying
processes and mechanisms that may underlie this risk remains unknown. With this project,
the Investigator proposes to cre1 expand
High body fat at midlife, as evidenced by overweight or obese body mass index (BMI), is increasingly understood as a risk factor for Alzheimer's disease. However, the underlying processes and mechanisms that may underlie this risk remains unknown. With this project, the Investigator proposes to create a new cohort of cognitively normal 120 midlife individuals, age 40-60 years. The investigator and research staff will characterize the participant's overweight or obese status using metabolic tests including, an oral glucose tolerance test, fasting plasma insulin, fasting plasma glucose, and hemoglobin A1c measurements. This testing will generate categories of metabolically abnormal overweight and obese (MAOO), metabolically normal overweight and obese (MNOO), and metabolically normal lean participants (MNLP). Research staff will evaluate differences between these groups on neuroimaging with the newer classification framework of Alzheimer's biomarkers with amyloid (A), tau (T), and neurodegeneration (N), or ATN. Neurodegeneration will be assessed by atrophy on brain MRI as reflected by regional volumes on Freesurfer. Staff will also evaluate MR neuroimaging markers for neuroinflammation using a newer method called diffusion basis spectrum imaging (DBSI), developed at the Mallinckrodt Institute of Radiology at Washington University in St. Louis in collaboration with The Charles F. and Joanne Knight Alzheimer's Disease Research Center (Knight ADRC). Type: Observational Start Date: Oct 2021 |
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Neoepitope-based Personalized DNA Vaccine Approach in Pediatric Patients With Recurrent Central Ner1
Washington University School of Medicine
Pediatric Recurrent Central Nervous System Tumors
The purpose of this research study is to learn about the safety and feasibility of giving
a personalized DNA vaccine to people with central nervous system tumors that have
returned or have been resistant to treatment. expand
The purpose of this research study is to learn about the safety and feasibility of giving a personalized DNA vaccine to people with central nervous system tumors that have returned or have been resistant to treatment. Type: Interventional Start Date: Oct 2024 |
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Reduced Intensity Conditioning and Familial HLA-Mismatched BMT for Non-Malignant Disorders
Washington University School of Medicine
Severe Sickle Cell Disease
Bone Marrow Failure Syndromes
Metabolic Disorders
Immunologic Disorders
Hemoglobinopathies
This study is designed to estimate the efficacy and toxicity of familial HLA mismatched
bone marrow transplants in patients with non-malignant disease who are less than 21 years
of age and could benefit from the procedure. expand
This study is designed to estimate the efficacy and toxicity of familial HLA mismatched bone marrow transplants in patients with non-malignant disease who are less than 21 years of age and could benefit from the procedure. Type: Interventional Start Date: Mar 2017 |
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HCRN Core Data Project: Characterizing Patient Populations in the Hydrocephalus Clinical Research N1
University of Utah
Pediatric Hydrocephalus
The Hydrocephalus Clinical Research Network (HCRN) has been established by philanthropic
funding to conduct multi-institutional research (clinical trials and observational
studies) on pediatric hydrocephalus. In addition to philanthropic funding, the HCRN has
also received an NIH NINDS Challenge Gr1 expand
The Hydrocephalus Clinical Research Network (HCRN) has been established by philanthropic funding to conduct multi-institutional research (clinical trials and observational studies) on pediatric hydrocephalus. In addition to philanthropic funding, the HCRN has also received an NIH NINDS Challenge Grant to support the network infrastructure which allows for the conduct of this and other network studies. The HCRN consists of multiple Clinical Centers and the Data Coordinating Center (DCC). The HCRN Core Data Project will obtain data about all neurosurgical hydrocephalus events from the network Clinical Centers, and create a database to be used by HCRN investigators. The ongoing maintenance of the Core Data Project serves two main purposes: 1) it will help investigators understand the variability, progression, and current treatment practices for hydrocephalus in children, with an ultimate goal of better guiding and assessing therapeutic intervention and providing recommendations on patient care and, 2) it will provide pilot and descriptive data necessary for hypothesis generation and study design (i.e. preliminary power analyses, recruitment projections) for studies under development by the HCRN. This multi-institutional database will be maintained throughout the lifetime of the HCRN, and may be useful for tracking trends in pediatric hydrocephalus over time. The Core Data Project will be an invaluable resource to the HCRN and will help stimulate new research protocols, identify potential need for future expansion of the network to incorporate additional patient populations, and provide a descriptive understanding of children with hydrocephalus cared for within the network. Type: Observational Start Date: Apr 2008 |
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Feasibility of HPV Self-Collection Kits for Cervical Cancer Screening
Washington University School of Medicine
Cervical Cancer
HPV Infection
This study is testing and implementing an equity-focused, community-based intervention
that improves women's access to cervical cancer screening and adherence to follow up
after an abnormal result. The study's objective is to assess and compare the feasibility
of different methods of distributing a1 expand
This study is testing and implementing an equity-focused, community-based intervention that improves women's access to cervical cancer screening and adherence to follow up after an abnormal result. The study's objective is to assess and compare the feasibility of different methods of distributing at-home HPV testing kits for cervical cancer screening among individuals who are under-screened. Type: Interventional Start Date: Apr 2026 |
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5-Fluorouracil Response and Optimization STudy (The FROST Trial)
Washington University School of Medicine
Squamous Cell Carcinoma of Head and Neck
Metastatic Squamous Cell Carcinoma
Recurrent Squamous Cell Carcinoma of the Head and Neck
This randomized phase II trial will characterize the efficacy, adverse event (AE)
profile, and safety of two regimens of 5-FU given as 2L+ treatment to patients with
RM-HNSCC. Eligible patients for this trial will have previously received platinum and
PD-1 inhibitor therapy. The experimental regime1 expand
This randomized phase II trial will characterize the efficacy, adverse event (AE) profile, and safety of two regimens of 5-FU given as 2L+ treatment to patients with RM-HNSCC. Eligible patients for this trial will have previously received platinum and PD-1 inhibitor therapy. The experimental regimen (Arm 1) will comprise the two days every two weeks (2D-Q2W) regimen of 5-FU. The standard regimen (Arm 2) will consist of the four days every three weeks (4D-Q3W) regimen of 5-FU. The primary hypotheses is that each regimen of 5-FU will result in an ORR of 10% of greater assessed by RECIST v1.1 criteria. The study will also describe treatment-related AEs assessed by CTCAE v5.0, dose interruptions, discontinuations, and modifications in each regimen. Type: Interventional Start Date: Apr 2026 |
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Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head1
National Cancer Institute (NCI)
Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Locally Recurrent Head and Neck Squamous Cell Carcinoma
Locally Recurrent Hypopharyngeal Squamous Cell Carcinoma
Locally Recurrent Laryngeal Squamous Cell Carcinoma
This phase II trial tests the addition of chemotherapy, with carboplatin and paclitaxel,
or chemo-immunotherapy, with carboplatin, paclitaxel and cemiplimab to standard salvage
surgery followed by post operative radiation therapy and cisplatin for high risk
patients, for the treatment of patients w1 expand
This phase II trial tests the addition of chemotherapy, with carboplatin and paclitaxel, or chemo-immunotherapy, with carboplatin, paclitaxel and cemiplimab to standard salvage surgery followed by post operative radiation therapy and cisplatin for high risk patients, for the treatment of patients with PD-L1 positive head and neck squamous cell carcinoma that has come back and spread to nearby tissue or lymph nodes after a period of improvement (locally recurrent) or is persistent. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Salvage surgery is surgery that takes place to remove tumor tissue after a failure of other treatment. High risk patients also receive radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Adding chemotherapy or chemo-immunotherapy to standard salvage surgery may kill more tumor cells than salvage surgery alone in patients with PD-L1 positive locally recurrent or persistent head and neck squamous cell carcinoma. Type: Interventional Start Date: Apr 2026 |
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Testing Immunotherapy With or Without Stereotactic Body Radiation Therapy in Patients With Advanced1
NRG Oncology
Advanced Hepatocellular Carcinoma
Stage III Hepatocellular Carcinoma AJCC v8
Stage IV Hepatocellular Carcinoma AJCC v8
This phase III trial compares the effect of immunotherapy (IO) with stereotactic body
radiation therapy (SBRT) to IO alone in treating patients with liver cancer
(hepatocellular cancer) that may have spread from where it first started to nearby
tissue, lymph nodes, or distant parts of the body (adv1 expand
This phase III trial compares the effect of immunotherapy (IO) with stereotactic body radiation therapy (SBRT) to IO alone in treating patients with liver cancer (hepatocellular cancer) that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). The usual approach is treatment with IO-based drug combinations, such as atezolizumab and bevacizumab, durvalumab and tremelimumab, or ipilimumab and nivolumab. IO with monoclonal antibodies, such as durvalumab, tremelimumab, atezolizumab, nivolumab and ipilimumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor cells. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Giving IO with SBRT may be more effective than IO alone in helping patients with advanced hepatocellular cancer live longer. Type: Interventional Start Date: Feb 2026 |
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Descartes-08 for Children, Adolescents, and Young Adults With Autoimmune Disorders
Cartesian Therapeutics
Childhood-onset Systemic Lupus Erythematous
ANCA-Associated Vasculitis (AAV)
Juvenile Myasthenia Gravis
Juvenile Dermatomyositis
Safety, tolerability and efficacy of Descarte-08 in children, adolescents and young
adults with childhood-onset systemic lupus erythematosus, ANCA-associated vasculitis,
juvenile myasthenia gravis, and juvenile dermatomyositis expand
Safety, tolerability and efficacy of Descarte-08 in children, adolescents and young adults with childhood-onset systemic lupus erythematosus, ANCA-associated vasculitis, juvenile myasthenia gravis, and juvenile dermatomyositis Type: Interventional Start Date: Jan 2026 |
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Embryonal Tumor With Multilayered Rosettes
University of California, San Francisco
Embryonal Tumor With Multilayered Rosettes
Embryonal Tumor With Multilayered Rosettes, Nos
This is an open-label, comprehensive, iterative investigation of evaluating the use of
induction chemotherapy, high-dose chemotherapy, and focal radiation therapy in children
with newly diagnosed Embryonal Tumor With Multilayered Rosettes (ETMR). expand
This is an open-label, comprehensive, iterative investigation of evaluating the use of induction chemotherapy, high-dose chemotherapy, and focal radiation therapy in children with newly diagnosed Embryonal Tumor With Multilayered Rosettes (ETMR). Type: Interventional Start Date: Mar 2025 |
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A Study of TAK-411 in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Takeda
Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
CIDP is an autoimmune disease. This means that the body's germ fighting (immune) system
attacks itself. In CIDP, the immune system attacks the protective covering around the
nerves called myelin. Over time, these nerves lose their ability to send signals to the
muscles in the body. This leads to mu1 expand
CIDP is an autoimmune disease. This means that the body's germ fighting (immune) system attacks itself. In CIDP, the immune system attacks the protective covering around the nerves called myelin. Over time, these nerves lose their ability to send signals to the muscles in the body. This leads to muscle weakness and loss of sensation in arms and legs among other symptoms. Participants with CIDP can be treated with a protein called immunoglobulin (or IG). TAK-411 is a special type of immune globulin G (hsIgG) that has been chemically changed. It is made from IG that comes from human plasma. This study will test if TAK-411 can decrease inflammation and improve symptoms of CIDP. The main aim of this study is to check how TAK-411 affects the physical functioning of adults with CIDP when compared with results of the placebo group of a historical trial. Participants may be treated with TAK-411 for up to 1 year (51 weeks) and will be followed up for 3 weeks after last dose. During the study, participants may visit their study clinic up to approximately 21 times. Type: Interventional Start Date: May 2025 |