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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 sitting1 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 |
ESPBs vs TAPs for Satisfactory Analgesia Following DIEP Surgery
University of Kansas Medical Center
Pain
Breast cancer is the second most common cancer diagnosed in American women . For patients
who have undergone surgical mastectomy, autologous breast reconstruction is an
alternative option to breast implants. Deep Inferior Epigastric Perforator (DIEP) flaps
are the gold standard for autologous breas1 expand
Breast cancer is the second most common cancer diagnosed in American women . For patients who have undergone surgical mastectomy, autologous breast reconstruction is an alternative option to breast implants. Deep Inferior Epigastric Perforator (DIEP) flaps are the gold standard for autologous breast reconstruction . Effective pain control following surgery is imperative and ultrasound-guided bilateral transversus abdominis plane blocks (TAPs) with the infiltration of local anesthetics, such a bupivacaine are a common regional technique of choice . A newer described technique, bilateral Erector Spinae Plane blocks (ESPBs) (which also are an infiltration of local anesthetic) present as an alternative approach for post-operative analgesia. ESPBs have been proven efficacious in reducing intra- and post-operative opioid requirements, lessening the need for rescue analgesics in other similar surgical procedures. The hypothesis is that preoperative bilateral ESPBs could provide equivalent pain control as a regional analgesic for patients undergoing DIEP flap surgery when compared to preoperative bilateral TAPs Type: Interventional Start Date: Nov 2023 |
BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
Orchestra BioMed, Inc
Hypertension
Hypertension, Systolic
Hypertension, Essential
A prospective, multinational, randomized, double-blind, clinical trial evaluating the
safety and effectiveness of a novel atrioventricular interval modulation (AVIM) algorithm
downloaded into a dual-chamber Medtronic Astra/Azure pacemaker. expand
A prospective, multinational, randomized, double-blind, clinical trial evaluating the safety and effectiveness of a novel atrioventricular interval modulation (AVIM) algorithm downloaded into a dual-chamber Medtronic Astra/Azure pacemaker. Type: Interventional Start Date: Dec 2023 |
Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction
Medtronic Cardiac Rhythm and Heart Failure
Heart Failure With Preserved Ejection Fraction
Concentric Hypertrophy
FIRE-HFpEF is a multi-center, prospective, randomized, single-blinded, clinical
feasibility study. This study will enroll up to 105 subjects with heart failure with
preserved ejection fraction in the United States. Data will be collected to evaluate
whether pacing therapies can lead to improvements1 expand
FIRE-HFpEF is a multi-center, prospective, randomized, single-blinded, clinical feasibility study. This study will enroll up to 105 subjects with heart failure with preserved ejection fraction in the United States. Data will be collected to evaluate whether pacing therapies can lead to improvements in exercise capacity and health status of subjects. Type: Interventional Start Date: Sep 2024 |
CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Sever1
Ionis Pharmaceuticals, Inc.
Severe Hypertriglyceridemia
The purpose of this study is to evaluate the safety and tolerability of olezarsen in
participants with SHTG. expand
The purpose of this study is to evaluate the safety and tolerability of olezarsen in participants with SHTG. Type: Interventional Start Date: Dec 2022 |
Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
Immunocore Ltd
Advanced Melanoma
The purpose of this study is to evaluate the efficacy and safety of tebentafusp-based
regimens, including tebentafusp monotherapy and in combination with anti-PD1 vs
investigator choice (including clinical trials of investigational agents, salvage therapy
per local standard of care [SoC], best supp1 expand
The purpose of this study is to evaluate the efficacy and safety of tebentafusp-based regimens, including tebentafusp monotherapy and in combination with anti-PD1 vs investigator choice (including clinical trials of investigational agents, salvage therapy per local standard of care [SoC], best supportive care [BSC] on protocol survivor follow up) in patients with advanced non-ocular melanoma. Type: Interventional Start Date: Dec 2022 |
A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal1
Janssen Research & Development, LLC
Carcinoma, Non-small-Cell Lung
The purpose of this study is to assess the anti-tumor activity and safety of amivantamab
which will be administered as a co-formulation with recombinant human hyaluronidase PH20
(rHuPH20) (subcutaneous co-formulation [SC-CF]) in combination treatment (all cohorts
except Cohort 4) and to characteriz1 expand
The purpose of this study is to assess the anti-tumor activity and safety of amivantamab which will be administered as a co-formulation with recombinant human hyaluronidase PH20 (rHuPH20) (subcutaneous co-formulation [SC-CF]) in combination treatment (all cohorts except Cohort 4) and to characterize the safety of amivantamab SC-CF (Cohort 4). Type: Interventional Start Date: Nov 2022 |
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 screening1 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 |
PPMI Clinical - Establishing a Deeply Phenotyped PD Cohort
Michael J. Fox Foundation for Parkinson's Research
Parkinson Disease
The Parkinson Progression Marker Initiative (PPMI) is a longitudinal, observational,
multi-center natural history study to assess progression of clinical features, digital
outcomes, and imaging, biologic and genetic markers of Parkinson's disease (PD)
progression in study participants with manifest1 expand
The Parkinson Progression Marker Initiative (PPMI) is a longitudinal, observational, multi-center natural history study to assess progression of clinical features, digital outcomes, and imaging, biologic and genetic markers of Parkinson's disease (PD) progression in study participants with manifest PD, prodromal PD, and healthy controls. The overall goal of PPMI is to identify markers of disease progression for use in clinical trials of therapies to reduce progression of PD disability. Type: Observational Start Date: Jul 2020 |
Pulmonary Hypertension Association Registry
Pulmonary Hypertension Association, Inc.
Pulmonary Arterial Hypertension
Chronic Thromboembolic Pulmonary Hypertension
Pulmonary Hypertension
The PHA Registry (PHAR) is a national study about people who have pulmonary arterial
hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). PHAR
collects information from people with PAH and CTEPH who are cared for in participating
PHA-accredited Pulmonary Hypertension Care C1 expand
The PHA Registry (PHAR) is a national study about people who have pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). PHAR collects information from people with PAH and CTEPH who are cared for in participating PHA-accredited Pulmonary Hypertension Care Centers throughout the U.S. PHAR will determine how people with PAH and CTEPH are evaluated, tested, and treated, and will observe how well these participants do. The goal is to see if people with PH are treated according to recommended guidelines, and to see if there are certain factors that can lead to better or worse outcomes. PHAR will include information about people with PAH and CTEPH in the U.S. who are seen at participating PHA-accredited PH Care Centers. PHAR contains data about patient care and outcomes. Specifically, data in the PHAR includes information on diagnosis; clinical status; socioeconomic status; diagnosis test results; body size; treatment information; interest in participating in clinical trials; family health and social history; and information about smoking, alcohol, or drug use. Participants are followed over time, and provide updates such as changes in therapy, how often participants need to go to the hospital, and survival. Such information may help healthcare providers provide better care. Type: Observational [Patient Registry] Start Date: Oct 2015 |
Cooking Skills to Improve Long-Term Weight Loss in Young Adults With Intellectual Disabilities
University of Kansas Medical Center
Intellectual Disability
Overweight and Obesity
The goal of this study is to see if adding hands-on cooking classes to a weight
management program (called Chef-ID) helps young adults with intellectual disabilities
lose more weight and keep it off compared to a standard weight loss program. The study
will last 24 months and include three phases:1 expand
The goal of this study is to see if adding hands-on cooking classes to a weight management program (called Chef-ID) helps young adults with intellectual disabilities lose more weight and keep it off compared to a standard weight loss program. The study will last 24 months and include three phases: 6 months of active support, 12 months of maintenance, and 6 months with no contact. The investigators will look at how much weight participants lose over the first 18 months. Changes in cooking skills, body fat, health markers (like blood pressure and cholesterol), daily living skills, and caregiver stress will be tracked. Finally, factors that might help or prevent weight loss, and how changes in weight and body fat are linked to overall health will be explored. This research will help inform on how to better support healthy lifestyles for people with intellectual disabilities. Type: Interventional Start Date: Jun 2025 |
Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the1
National Cancer Institute (NCI)
Non-Muscle Invasive Bladder Urothelial Carcinoma
Recurrent Non-Muscle Invasive Bladder Urothelial Carcinoma
Stage I Bladder Cancer AJCC v8
This phase II trial compares the use of pembrolizumab and radiation therapy to
chemotherapy with cisplatin, gemcitabine, 5-fluorouracil or mitomycin-C and radiation
therapy for the treatment of non-muscle invasive bladder cancer. Immunotherapy with
monoclonal antibodies, such as pembrolizumab, may1 expand
This phase II trial compares the use of pembrolizumab and radiation therapy to chemotherapy with cisplatin, gemcitabine, 5-fluorouracil or mitomycin-C and radiation therapy for the treatment of non-muscle invasive bladder cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as cisplatin, gemcitabine, 5-fluorouracil or mitomycin-C, 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 x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving pembrolizumab with radiation may kill more tumor cells than chemotherapy with radiation therapy in patients with non-muscle invasive bladder cancer. Type: Interventional Start Date: Jun 2025 |
A Clinical Trial to Learn About the Effects of VHB937 in People With Amyotrophic Lateral Sclerosis1
Novartis Pharmaceuticals
Amyotrophic Lateral Sclerosis (ALS)
This is a multicenter, randomized, double-blind, placebo-controlled, parallel group Phase
II study to evaluate the efficacy and safety of VHB937 in participants with early-stage
ALS (within 2 years of ALS symptoms onset). The study comprises a core double-blind (DB)
40-week treatment period followe1 expand
This is a multicenter, randomized, double-blind, placebo-controlled, parallel group Phase II study to evaluate the efficacy and safety of VHB937 in participants with early-stage ALS (within 2 years of ALS symptoms onset). The study comprises a core double-blind (DB) 40-week treatment period followed by an open label extension (OLE). Type: Interventional Start Date: Oct 2024 |
A Study of Mosliciguat in PH-ILD
Pulmovant, Inc.
Pulmonary Hypertension
Interstitial Lung Disease
Lung Diseases
Vascular Diseases
Cardiovascular Diseases
This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center clinical
study to evaluate the safety and efficacy of inhaled mosliciguat in participants with
pulmonary hypertension associated with interstitial lung disease (PH-ILD). expand
This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center clinical study to evaluate the safety and efficacy of inhaled mosliciguat in participants with pulmonary hypertension associated with interstitial lung disease (PH-ILD). Type: Interventional Start Date: Oct 2024 |
Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular L1
National Cancer Institute (NCI)
Classic Follicular Lymphoma
Follicular Lymphoma With Unusual Cytological Features
This phase III trial compares the effectiveness of rituximab to mosunetuzumab in treating
patients with follicular lymphoma with a low tumor burden. Rituximab is a monoclonal
antibody. It binds to a protein called CD20, which is found on B cells (a type of white
blood cell) and some types of cancer1 expand
This phase III trial compares the effectiveness of rituximab to mosunetuzumab in treating patients with follicular lymphoma with a low tumor burden. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. It is not yet known if giving rituximab or mosunetuzumab works better in treating patients with follicular lymphoma with a low tumor burden. Type: Interventional Start Date: Oct 2024 |
VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTL1
Replimune Inc.
Advanced Melanoma
This is a randomized, controlled, multicenter, open-label Phase 3 clinical study
comparing VO in combination with nivolumab versus Physician's Choice treatment for
patients with unresectable Stage IIIb-IV cutaneous melanoma whose disease progressed on
an anti PD-1 and an anti-CTLA-4 containing regi1 expand
This is a randomized, controlled, multicenter, open-label Phase 3 clinical study comparing VO in combination with nivolumab versus Physician's Choice treatment for patients with unresectable Stage IIIb-IV cutaneous melanoma whose disease progressed on an anti PD-1 and an anti-CTLA-4 containing regimen (administered either as a combination regimen or in sequence) or who are not candidates for treatment with an anti-CTLA-4 therapy. Type: Interventional Start Date: Jul 2024 |
ARTEMIS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With a H1
Novo Nordisk A/S
Cardiovascular Risk
Acute Myocardial Infarction (AMI)
The research study is being done to see if ziltivekimab can be used to treat people who
were admitted to hospital because of a heart attack. Ziltivekimab might reduce
development of heart disease, thereby preventing new heart attacks or strokes.
Participants will either get ziltivekimab (active med1 expand
The research study is being done to see if ziltivekimab can be used to treat people who were admitted to hospital because of a heart attack. Ziltivekimab might reduce development of heart disease, thereby preventing new heart attacks or strokes. Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body). Which treatment participants get is decided by chance. The chance of getting ziltivekimab or placebo is the same. The participant will need to inject the study medicine into a flat skin surface in there stomach, thigh, or upper arm once every month. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe. The study will last for about 2 years. Type: Interventional Start Date: Jun 2024 |
Testing the Addition of an Anti-cancer Drug, SNDX-5613, to the Standard Chemotherapy Treatment (Dau1
National Cancer Institute (NCI)
Acute Myeloid Leukemia With KMT2A Rearrangement
Acute Myeloid Leukemia With NPM1 Mutation
This phase Ib trial tests the safety, side effects, and best dose of SNDX-5613 when given
in combination with the standard chemotherapy treatment (daunorubicin and cytarabine) in
treating patients with newly diagnosed acute myeloid leukemia that has changes in the
NPM1 gene or MLL/KMT2A gene. SNDX-1 expand
This phase Ib trial tests the safety, side effects, and best dose of SNDX-5613 when given in combination with the standard chemotherapy treatment (daunorubicin and cytarabine) in treating patients with newly diagnosed acute myeloid leukemia that has changes in the NPM1 gene or MLL/KMT2A gene. SNDX-5613 blocks signals passed from one molecule to another inside cancer cells that are needed for cancer cell survival. Drugs used in chemotherapy, such as daunorubicin and cytarabine, 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. Adding SNDX-5613 to the standard chemotherapy treatment may be able to shrink or stabilize the cancer for longer than the standard chemotherapy treatment alone. Type: Interventional Start Date: Jun 2024 |
MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard1
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 syndrom1 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 |
A Study to Assess the Effects of ACI-24.060 in Alzheimer's Disease and in Down Syndrome (ABATE Stud1
AC Immune SA
Alzheimer's Disease
Prodromal Alzheimer's Disease
Amyloid Plaque
Beta-Amyloid
Alzheimer's Disease in Down Syndrome
The purpose of this study is to assess the safety, tolerability, immunogenicity and
pharmacodynamic effects of ACI-24.060 in subjects with prodromal Alzheimer's disease and
in non-demented adults with Down syndrome. expand
The purpose of this study is to assess the safety, tolerability, immunogenicity and pharmacodynamic effects of ACI-24.060 in subjects with prodromal Alzheimer's disease and in non-demented adults with Down syndrome. Type: Interventional Start Date: Jun 2022 |
DMCRN-02-001: Assessing Pediatric Endpoints in DM1
Virginia Commonwealth University
Congenital Myotonic Dystrophy
CDM
The overall goal of the study is to establish valid clinical endpoint assessments for
children with congenital 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 develop biomarkers for the condition. Type: Observational Start Date: Aug 2022 |
Pancreatic Cancer Early Detection Consortium
Arbor Research Collaborative for Health
Pancreas Cancer
Pancreas Cyst
Pancreatic Ductal Adenocarcinoma
Genetic Predisposition
The purpose of the Pancreatic Cancer Early Detection (PRECEDE) Consortium is to conduct
research on multiple aspects of early detection and prevention of pancreatic ductal
adenocarcinoma (PDAC) by establishing a multisite cohort of individuals with family
history of PDAC and/or individuals carrying1 expand
The purpose of the Pancreatic Cancer Early Detection (PRECEDE) Consortium is to conduct research on multiple aspects of early detection and prevention of pancreatic ductal adenocarcinoma (PDAC) by establishing a multisite cohort of individuals with family history of PDAC and/or individuals carrying pathogenic/likely pathogenic germline variants (PGVs) in genes linked to PDAC risk for longitudinal follow up. Type: Observational Start Date: Sep 2020 |
Study of Safety and Efficacy of Iberdomide (CC-220) and CC-99282 Combined With R-CHOP to Treat Lymp1
Celgene
Lymphoma, B-Cell
This is a Phase 1b study consisting of 2 parts: a dose escalation (Part 1) of CC-220 or
CC-99282 added to the standard R-CHOP-21 regimen for first-line treatment of a-BCL. The
dose escalation (Part 1) will consist of 2 parallel arms in combination with Rituximab,
Cyclophosphamide, Doxorubicin, Vinc1 expand
This is a Phase 1b study consisting of 2 parts: a dose escalation (Part 1) of CC-220 or CC-99282 added to the standard R-CHOP-21 regimen for first-line treatment of a-BCL. The dose escalation (Part 1) will consist of 2 parallel arms in combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP-21); CC-220 and R-CHOP-21 or CC-99282 and R-CHOP-21. Part 1 will be followed by a randomized dose expansion (Part 2) with CC-220 and/or CC-99282 at the Recommended Phase 2 Dose (RP2D) in combination with R-CHOP-21. A polatuzumab-R-CHP regimen in combination with CC-220 or CC-99282 will be explored with the addition of a new cohort only after the RP2D for the CC-220 and/or CC-99282 and R-CHOP-21 combination has been defined. Type: Interventional Start Date: Sep 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 hospi1 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 |
Estab Biomarkers and Clinical Endpoints in Myotonic Dystrophy Type 1 (END-DM1)
Virginia Commonwealth University
Myotonic Dystrophy 1
DM1
Building on previous work of the Myotonic Dystrophy Clinical Research Network (DMCRN),
the present study seeks to overcome insufficient data on natural history; lack of
reliable biomarkers; and incomplete characterization and limited biological understanding
of the phenotypic heterogeneity of Myoto1 expand
Building on previous work of the Myotonic Dystrophy Clinical Research Network (DMCRN), the present study seeks to overcome insufficient data on natural history; lack of reliable biomarkers; and incomplete characterization and limited biological understanding of the phenotypic heterogeneity of Myotonic Dystrophy 1 by examining strategies to improve the reliability by making further refinements in our sample collection and analysis procedures by developing strategies for managing patient heterogeneity going forward. Funding Source- FDA OOPD Type: Observational Start Date: Jan 2019 |
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