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Head Positioning After Retina Detachment Repair
University of Kansas Medical Center
Retina; Detachment, Rhegmatogenous
This study aims to determine if one day post-operative prone head positioning can be as
good as seven days post-operative prone head positioning in patients with retinal
detachments with inferior retinal breaks after pars that pars plana vitrectomy (PPV)
using perfluoropropane (C3F8) gas as a tamponade.... expand
This study aims to determine if one day post-operative prone head positioning can be as good as seven days post-operative prone head positioning in patients with retinal detachments with inferior retinal breaks after pars that pars plana vitrectomy (PPV) using perfluoropropane (C3F8) gas as a tamponade. The investigator will conduct a single arm phase II study using a Simon's two-stage design Type: Interventional Start Date: Apr 2019 |
Clinical Procedures to Support Research in ALS
University of Miami
Amyotrophic Lateral Sclerosis
ALS-Frontotemporal Dementia
Primary Lateral Sclerosis
Progressive Muscular Atrophy
The purpose of the Clinical Procedures To Support Research (CAPTURE) study is to utilize
information collected in the medical record to learn more about a disease called
amyotrophic lateral sclerosis (ALS) and related disorders. expand
The purpose of the Clinical Procedures To Support Research (CAPTURE) study is to utilize information collected in the medical record to learn more about a disease called amyotrophic lateral sclerosis (ALS) and related disorders. Type: Observational Start Date: Feb 2018 |
To Develop a Walking Exercise Program for Non-ambulatory Stroke Survivors
University of Kansas Medical Center
Stroke
Walking, Difficulty
Cardiovascular Injury
The goal of this clinical trial is to test a gait (walking) training program in
non-ambulatory (unable to walk) chronic stroke survivors. The main question it aims to
answer is:
• Will gait training improve the cardiovascular system in non-ambulatory chronic stroke
survivors better than a sitting... expand
The goal of this clinical trial is to test a gait (walking) training program in non-ambulatory (unable to walk) chronic stroke survivors. The main question it aims to answer is: • Will gait training improve the cardiovascular system in non-ambulatory chronic stroke survivors better than a sitting leg cycling exercise? Participants will walk on a treadmill with a partial body-weight support system and the gait training device. Researchers will compare with a leg-cycling exercise to see if there are significant differences in resting heart rate, systolic blood pressure (SBP), and A1c levels in the blood. Type: Interventional Start Date: Feb 2024 |
A Study of NT-112 in HLA-C*08:02-Positive Adult Subjects with Unresectable, Advanced, And/ or Metastatic...
Neogene Therapeutics, Inc.
Non-small Cell Lung Cancer
Colorectal Carcinoma
Pancreatic Ductal Adenocarcinoma
Endometrial Cancer
Solid Tumor, Adult
Phase I Study of NT-112, an autologous T-cell therapy product genetically engineered to
express an HLA-C*08:02-restricted T cell receptor (TCR), targeting KRAS G12D mutant solid
tumors. expand
Phase I Study of NT-112, an autologous T-cell therapy product genetically engineered to express an HLA-C*08:02-restricted T cell receptor (TCR), targeting KRAS G12D mutant solid tumors. Type: Interventional Start Date: Feb 2024 |
Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation
Eledon Pharmaceuticals
Kidney Transplant Rejection
This study will evaluate the safety and efficacy of AT-1501 compared with tacrolimus in
patients undergoing kidney transplantation. expand
This study will evaluate the safety and efficacy of AT-1501 compared with tacrolimus in patients undergoing kidney transplantation. Type: Interventional Start Date: Aug 2023 |
Safety, Tolerability and Efficacy of AntiBKV as Treatment of BKV Infection in Kidney Transplant Recipients
Memo Therapeutics AG
BK Viremia; BKV DNAemia
The purpose of this study is to evaluate the safety, tolerability, and efficacy of
AntiBKV in reducing BKV DNAemia and progression to biopsy-confirmed BKVAN in kidney
transplant recipients. This study has an operationally seamless phase II/III design. The
phase II part will evaluate the safety of... expand
The purpose of this study is to evaluate the safety, tolerability, and efficacy of AntiBKV in reducing BKV DNAemia and progression to biopsy-confirmed BKVAN in kidney transplant recipients. This study has an operationally seamless phase II/III design. The phase II part will evaluate the safety of AntiBKV in kidney transplant recipients and establish antiviral proof of concept. The phase II part includes a dose-comparison part to generate additional PK and PD data of AntiBKV. The phase III part will assess the efficacy of AntiBKV in kidney transplant recipients. For both the phase II and phase III parts, participants will be randomized to receive either four doses of AntiBKV or four doses of placebo (every four weeks). In phase II, 60 participants will be first randomized (1:1) to receive either four doses of 1,000 mg of AntiBKV or placebo. In an additional dose-comparison extension, another 30 participants will be enrolled and randomized (1:1:1) to receive either four doses of 1,000 mg AntiBKV, four doses of 500 mg AntiBKV, or placebo. Based on a Day 141 analysis after phase II the sample size for the phase III part of the trial will be defined. Both the phase II and phase III parts will follow identical study assessments and schedules for participants. Eligible participants will receive an intravenous infusion of the investigational medicinal product (IMP) that will be administered four times at a four-week interval. For the first ten participants enrolled in the study, the infusion time will be at least 60 minutes. Provided there are no safety concerns observed with the first ten participants the duration of subsequent infusions will be at least 30 minutes. After administration of the final dose, participants will return as out participants for periodic safety, BKV DNAemia, and PK follow-up assessments until the end of the trial visits, 26 weeks post last IMP application. Regular kidney biopsies will be performed at baseline (prior to infusion) and on Day 141 (8 weeks after full dosing). An additional biopsy will be taken on Day 267 (optional) and if clinically indicated. Type: Interventional Start Date: Apr 2023 |
ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1
Abivax S.A.
Ulcerative Colitis
This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and
safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission in subjects with
moderately to severely active ulcerative colitis who have inadequate response, no
response, a loss of response, or an intolerance... expand
This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies [corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies [biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors]. Type: Interventional Start Date: Oct 2022 |
US Pilot Study of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus
CereVasc Inc
Hydrocephalus, Normal Pressure
Hydrocephalus
The eShunt® System is a minimally invasive method of treating communicating
hydrocephalus. The eShunt System includes a proprietary eShunt Delivery System and the
eShunt Implant, a permanent implant deployed in a minimally invasive,
neuro-interventional procedure. The eShunt System is intended to... expand
The eShunt® System is a minimally invasive method of treating communicating hydrocephalus. The eShunt System includes a proprietary eShunt Delivery System and the eShunt Implant, a permanent implant deployed in a minimally invasive, neuro-interventional procedure. The eShunt System is intended to shunt cerebrospinal fluid from the intracranial subarachnoid space to the venous system for the treatment of patients with normal pressure hydrocephalus, reducing disability due to symptoms including one or more of gait disturbance, cognitive dysfunction and urinary incontinence. Type: Interventional Start Date: Apr 2022 |
Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple...
Novartis Pharmaceuticals
Relapsing Multiple Sclerosis
To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with
relapsing multiple sclerosis (RMS) expand
To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis (RMS) Type: Interventional Start Date: Dec 2021 |
A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer
Alliance Foundation Trials, LLC.
Endometrial Cancer
This is a Phase IB/II multi-cohort study designed to evaluate the efficacy and safety of
targeted agents with or without cancer immune checkpoint therapy with atezolizumab in
participant with recurrent and/or persistent endometrial cancer. The main protocol
provides a platform for genomic screening... expand
This is a Phase IB/II multi-cohort study designed to evaluate the efficacy and safety of targeted agents with or without cancer immune checkpoint therapy with atezolizumab in participant with recurrent and/or persistent endometrial cancer. The main protocol provides a platform for genomic screening with homogeneous basic eligibility criteria in order to direct study participants into biomarker-matched study cohorts consisting of testing targeted agents. Type: Interventional Start Date: Oct 2021 |
Study of Pyridostigmine With Ondansetron in Subjects With Anti-AchR Positive Myasthenia Gravis
DAS-MG, Inc
Myasthenia Gravis
This is a phase II, single center, randomized, double-blind, placebo-controlled, study in
patients with a diagnosis of anti-AchR antibody positive myasthenia gravis. expand
This is a phase II, single center, randomized, double-blind, placebo-controlled, study in patients with a diagnosis of anti-AchR antibody positive myasthenia gravis. Type: Interventional Start Date: Nov 2023 |
Targeting Inflammation With Losartan to Improve Response to Modulator Therapy in Cystic Fibrosis.
University of Kansas Medical Center
Cystic Fibrosis
The goal of this clinical trial is to test use of losartan in those with cystic fibrosis
(CF) on modulator therapy. The main question it aims to answer is if treatment with
losartan improves response of the CF transmembrane conductance regulator (CFTR) channel
to modulator therapy.
Participants... expand
The goal of this clinical trial is to test use of losartan in those with cystic fibrosis (CF) on modulator therapy. The main question it aims to answer is if treatment with losartan improves response of the CF transmembrane conductance regulator (CFTR) channel to modulator therapy. Participants will be asked take losartan or placebo for twelve weeks and will have changes in sweat chloride levels measured as a marker of CFTR function. Type: Interventional Start Date: Jun 2024 |
MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of...
National Cancer Institute (NCI)
Acute Myeloid Leukemia
Myelodysplastic Syndrome
This MyeloMATCH Master Screening and Reassessment Protocol (MSRP) evaluates the use of a
screening tool and specific laboratory tests to help improve participants' ability to
register to clinical trials throughout the course of their myeloid cancer (acute myeloid
leukemia or myelodysplastic syndrome)... expand
This MyeloMATCH Master Screening and Reassessment Protocol (MSRP) evaluates the use of a screening tool and specific laboratory tests to help improve participants' ability to register to clinical trials throughout the course of their myeloid cancer (acute myeloid leukemia or myelodysplastic syndrome) treatment. This study involves testing patients' bone marrow and blood for certain biomarkers. A biomarker (sometimes called a marker) is any molecule in the body that can be measured. Doctors look at markers to learn what is happening in the body. Knowing about certain markers can give doctors more information about what is driving the cancer and how to treat it. Testing patients' bone marrow and blood will show doctors if patients have markers that specific drugs can target. The marker testing in this study will let doctors know if they can match patients with a treatment study (myeloMATCH clinical trial) that tests treatment for the type of cancer they have or continue standard of care treatment with their doctor on the Tier Advancement Pathway (TAP). Type: Interventional Start Date: Jun 2024 |
DMCRN-02-001: Assessing Pediatric Endpoints in DM1
Virginia Commonwealth University
Congenital Myotonic Dystrophy
Childhood Myotonic Dystrophy
CDM
CHDM
The overall goal of the study is to establish valid clinical endpoint assessments for
children with congenital myotonic dystrophy type 1 and childhood myotonic dystrophy type
1, and develop biomarkers for the condition. expand
The overall goal of the study is to establish valid clinical endpoint assessments for children with congenital myotonic dystrophy type 1 and childhood myotonic dystrophy type 1, and develop biomarkers for the condition. Type: Observational Start Date: Aug 2022 |
Mitral Valve Screening Survey
Medstar Health Research Institute
Mitral Valve Disease
This study aims to examine the clinical profile/anatomical characteristics and natural
history of patients who subsequently fail screening for transcatheter mitral valve
intervention (TMVI). expand
This study aims to examine the clinical profile/anatomical characteristics and natural history of patients who subsequently fail screening for transcatheter mitral valve intervention (TMVI). Type: Observational [Patient Registry] Start Date: Aug 2021 |
Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic...
National Cancer Institute (NCI)
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
This phase III trial compares early treatment with venetoclax and obinutuzumab versus
delayed treatment with venetoclax and obinutuzumab in patients with newly diagnosed
high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma. Venetoclax is in a
class of medications called B-cell lymphoma-2... expand
This phase III trial compares early treatment with venetoclax and obinutuzumab versus delayed treatment with venetoclax and obinutuzumab in patients with newly diagnosed high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma. 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. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Starting treatment with the venetoclax and obinutuzumab early (before patients have symptoms) may have better outcomes for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma compared to starting treatment with the venetoclax and obinutuzumab after patients show symptoms. Type: Interventional Start Date: Mar 2021 |
Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE)
Johns Hopkins University
Chronic Obstructive Pulmonary Disease Severe
Chronic Bronchitis
A multi-center, randomized, 72-month, parallel- group, non-inferiority, phase III study
to compare the effectiveness of roflumilast (Daliresp, 500 mcg quaque die (QD) or
alternate regimen) therapy versus azithromycin (250 mg QD, 500 mg QD three times per
week, or alternate regimen) to prevent hospitalization... expand
A multi-center, randomized, 72-month, parallel- group, non-inferiority, phase III study to compare the effectiveness of roflumilast (Daliresp, 500 mcg quaque die (QD) or alternate regimen) therapy versus azithromycin (250 mg QD, 500 mg QD three times per week, or alternate regimen) to prevent hospitalization or death in a patients at high risk for COPD exacerbations. Type: Interventional Start Date: Feb 2020 |
A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
Center for International Blood and Marrow Transplant Research
Hematologic Malignancies
Inherited Disorders of Metabolism
Inherited Abnormalities of Platelets
Histiocytic Disorders
Acute Myelogenous Leukemia (AML or ANLL)
This study is an access and distribution protocol for unlicensed cryopreserved cord blood
units (CBUs) in pediatric and adult patients with hematologic malignancies and other
indications. expand
This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications. Type: Observational Start Date: Oct 2011 |
Guided Episodic Future Thinking to Increase Physical Activity Adherence and Promote Healthy Brain Aging
University of Kansas Medical Center
Exercise Training
Aging
The goal of this behavioral clinical trial is to learn how to increase physical activity
in mid-life adults. Specifically, can guided imagery that includes creating mental
pictures increase excitement about working out.
Participants will be asked to complete testing at the beginning of the study,... expand
The goal of this behavioral clinical trial is to learn how to increase physical activity in mid-life adults. Specifically, can guided imagery that includes creating mental pictures increase excitement about working out. Participants will be asked to complete testing at the beginning of the study, following 6-weeks of an in-person exercise program, and 6-weeks after finishing the exercise program. Testing will include an exercise test, MRI, questionnaires, computer tasks, and a blood draw. Type: Interventional Start Date: Feb 2024 |
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Myasthenia Gravis
University of Missouri-Columbia
Generalized Myasthenia Gravis
During this pilot study, the investigators will examine the effects of whole-body
electrical muscle stimulation exercise (WB-EMS Exercise) on neuromuscular junction (NMJ)
transmission and fatigability in adults with Generalized Myasthenia Gravis (gMG). The
investigators will also test whether a relationship... expand
During this pilot study, the investigators will examine the effects of whole-body electrical muscle stimulation exercise (WB-EMS Exercise) on neuromuscular junction (NMJ) transmission and fatigability in adults with Generalized Myasthenia Gravis (gMG). The investigators will also test whether a relationship exists between NMJ transmission dysfunction and fatigability in gMG, which has long been presumed but never directly assessed. Participants will undergo clinical and electrophysiologic testing before and after the WB-EMS Exercise intervention. The WB-EMS Exercise intervention will be delivered 2 times per week for 4 weeks. The hypotheses are (a) that the WB-EMS exercise will improve fatigability and NMJ transmission, and (b) that NMJ transmission dysfunction is related to fatigability. Type: Interventional Start Date: Jul 2023 |
A Study to Evaluate INCA033989 Administered in Participants With Myeloproliferative Neoplasms
Incyte Corporation
Myeloproliferative Neoplasms
This study is being conducted to evaluate the safety, tolerability, dose-limiting
toxicity (DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s)
for expansion (RDE) of INCA033989 administered in participants with myeloproliferative
neoplasms. expand
This study is being conducted to evaluate the safety, tolerability, dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) of INCA033989 administered in participants with myeloproliferative neoplasms. Type: Interventional Start Date: Dec 2023 |
SHARPEN - Parkinson's Disease Dementia
Scion NeuroStim
Parkinson Disease Dementia
The purpose of this single arm study is to evaluate the feasibility and safety of
treatments with a non-invasive neuromodulation device in adults diagnosed with
mild/moderate Parkinson's disease dementia (PDD). A non-invasive device is a device that
stays outside of the body and is not implanted and... expand
The purpose of this single arm study is to evaluate the feasibility and safety of treatments with a non-invasive neuromodulation device in adults diagnosed with mild/moderate Parkinson's disease dementia (PDD). A non-invasive device is a device that stays outside of the body and is not implanted and does not penetrate the skin. Neuromodulation means that the device stimulates activity in the brain. Type: Interventional Start Date: May 2024 |
Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma
TransThera Sciences (Nanjing), Inc.
Cholangiocarcinoma
This study is a Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate
the Efficacy and Safety of Oral Tinengotinib versus Physician's Choice in Subjects with
Fibroblast Growth Factor Receptor (FGFR)-altered, Chemotherapy- and FGFR
Inhibitor-Refractory/Relapsed Cholangiocarcinoma expand
This study is a Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib versus Physician's Choice in Subjects with Fibroblast Growth Factor Receptor (FGFR)-altered, Chemotherapy- and FGFR Inhibitor-Refractory/Relapsed Cholangiocarcinoma Type: Interventional Start Date: Dec 2023 |
Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell...
SWOG Cancer Research Network
Diffuse Large B-Cell Lymphoma
Grade 3b Follicular Lymphoma
Primary Mediastinal (Thymic) Large B-Cell Lymphoma
Recurrent Diffuse Large B-Cell Lymphoma
Refractory Diffuse Large B-Cell Lymphoma
This phase II trial tests whether mosunetuzumab and/or polatuzumab vedotin helps benefit
patients who have received chemotherapy (fludarabine and cyclophosphamide) followed by
chimeric antigen receptor (CAR) T-cell therapy (tisagenlecleucel, axicabtagene
ciloleucel, or lisocabtagene maraleucel) for... expand
This phase II trial tests whether mosunetuzumab and/or polatuzumab vedotin helps benefit patients who have received chemotherapy (fludarabine and cyclophosphamide) followed by chimeric antigen receptor (CAR) T-cell therapy (tisagenlecleucel, axicabtagene ciloleucel, or lisocabtagene maraleucel) for diffuse large B-cell lymphoma that has come back (recurrent) or that does not respond to treatment (refractory) or grade IIIb follicular lymphoma. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Polatuzumab vedotin is a monoclonal antibody, called polatuzumab, linked to a drug called vedotin. Polatuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, and delivers vedotin to kill them. Chemotherapy drugs, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving mosunetuzumab and/or polatuzumab vedotin after chemotherapy and CAR T-cell therapy may be more effective at controlling or shrinking the cancer than not giving them. Type: Interventional Start Date: Jun 2023 |
A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced...
Sanofi
Solid Tumor
This is a Phase 1/2, open label, multiple cohort study to assess the safety and
preliminary efficacy of SAR445877 as a monotherapy or in combination with other
anticancer therapies for participants aged at least 18 years with advanced unresectable
or metastatic solid tumors.
The study will include... expand
This is a Phase 1/2, open label, multiple cohort study to assess the safety and preliminary efficacy of SAR445877 as a monotherapy or in combination with other anticancer therapies for participants aged at least 18 years with advanced unresectable or metastatic solid tumors. The study will include 2 parts: A dose escalation Part 1: for finding the therapeutic dose(s) of SAR445877 in a monotherapy given every 2 weeks (Q2W) or weekly (QW) and in combination with other anticancer therapies when applicable. A multicohort dose expansion/dose optimization Part 2: for the assessment of safety and preliminary efficacy of SAR445877 in monotherapy and in combination with cetuximab: 2 recommended doses for expansion/optimization of SAR445877 identified from dose escalation part 1 will be tested in different indications in monotherapy and in combination with other anticancer therapies as applicable. Approximately 285 participants will be enrolled to the study intervention: approximately 75 participants in part 1 and up to 210 participants in expansion/dose optimization part (part 2). Type: Interventional Start Date: Nov 2022 |
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