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Vestibular Balance Therapy Intervention for Children
University of Alabama at Birmingham
Vestibulocochlear Nerve Diseases
Vestibular Disorder
Bilateral Vestibular Loss
The goal of this within groups clinical trial is to determine the feasibility of a
home-based vestibular balance therapy program for children with vestibular hypofunction.
The main questions to be answered are: 1) what is the intervention's feasibility and 2)
what is the intervention's preliminary... expand
The goal of this within groups clinical trial is to determine the feasibility of a home-based vestibular balance therapy program for children with vestibular hypofunction. The main questions to be answered are: 1) what is the intervention's feasibility and 2) what is the intervention's preliminary impact on function? Participants will receive a comprehensive battery of vestibular function and balance tests, then an 8-week home-based intervention to be done 5 times/week with weekly checks from the physical therapist. Data will be used to design a larger clinical trial with a comparison group. Type: Interventional Start Date: Mar 2023 |
18F-rhPSMA-7.3 PET/MRI in Prostate Cancer Active Surveillance: A Pilot Study
University of Alabama at Birmingham
Prostate Cancer
The purpose of this study is to investigate the usefulness of PET/MRI with an
investigational radioactive drug, 18F-rhPSMA-7.3, and MRI contrast in evaluating patients
with prostate cancer eligible for active surveillance. This study is for imaging purposes
only and is not a treatment study. expand
The purpose of this study is to investigate the usefulness of PET/MRI with an investigational radioactive drug, 18F-rhPSMA-7.3, and MRI contrast in evaluating patients with prostate cancer eligible for active surveillance. This study is for imaging purposes only and is not a treatment study. Type: Interventional Start Date: Apr 2025 |
Study of Tecovirimat for Human Mpox Virus
National Institute of Allergy and Infectious Diseases (NIAID)
MPOX
A5418 is a randomized, placebo-controlled, double-blind study to establish the efficacy
of tecovirimat for the treatment of people with laboratory-confirmed or presumptive HMPXV
disease. expand
A5418 is a randomized, placebo-controlled, double-blind study to establish the efficacy of tecovirimat for the treatment of people with laboratory-confirmed or presumptive HMPXV disease. Type: Interventional Start Date: Sep 2022 |
Constraint-Induced Movement Therapy Plus Sensory Components After Stroke
University of Alabama at Birmingham
CVA (Cerebrovascular Accident)
Stroke
Upper Extremity Paresis
Constraint-Induced Movement Therapy or CI Therapy is a form of treatment that
systematically employs the application of selected behavioral techniques delivered in
intensive treatment over consecutive day with the following strategies utilized:
behavioral strategies are implemented to improve the... expand
Constraint-Induced Movement Therapy or CI Therapy is a form of treatment that systematically employs the application of selected behavioral techniques delivered in intensive treatment over consecutive day with the following strategies utilized: behavioral strategies are implemented to improve the use of the more- affected limb in life situation called a Transfer Package (TP), motor training using a technique called shaping to make progress in successive approximations, repetitive, task oriented training, and strategies to encourage or constrain participants to use the more-affected extremity including restraint of the less-affected arm in the upper extremity (UE) protocol. Numerous studies examining the application of CI therapy with UE rehabilitation after stroke have demonstrated strong evidence for improving the amount of use and the quality of the more-affected UE functional use in the participant's daily life situation. CI Therapy studies with adults, to date, have explored intensive treatment for participants with a range from mild-to-severe motor impairment following stroke with noted motor deficits and limited use of the more-affected arm and hand in everyday activities. Each CI Therapy protocol was designed for the level of impairment demonstrated by participants recruited for the study. However, often following stroke, patients not only have motor deficits but somatosensory impairments as well. The somatosensory issues have not, as yet, been systematically measured and trained in CI Therapy protocols with adults and represent an understudied area of stroke recovery. We hypothesize that participants with mild-to-severe motor impairment and UE functional use deficits can benefit from CI therapy protocols that include somatosensory measurement and training components substituted for portions of motor training without loss in outcome measure gains. Further, we hypothesize that adults can improve somatosensory outcomes as a result of a combined CI therapy plus somatosensory component protocol. Type: Interventional Start Date: Mar 2023 |
Sensory Filtering in the Human Basal Ganglia as a Mechanism of Parkinson's Disease
University of Alabama at Birmingham
Parkinson Disease
The investigators are investigating the brain activity associated with sensory
information in movement disorders in order to improve treatment of these symptoms beyond
what is currently available. expand
The investigators are investigating the brain activity associated with sensory information in movement disorders in order to improve treatment of these symptoms beyond what is currently available. Type: Observational Start Date: Jun 2022 |
Embolization of the Splenic Artery After Trauma
Andrew J. Gunn
High-grade Splenic Injuries
Our aim is to conduct a multi-center, Bayesian, randomized clinical trial to evaluate the
primary technical success of coils and vascular plugs for proximal splenic artery
embolization in the setting of high-grade splenic trauma. The investigator has previously
demonstrated the feasibility of such... expand
Our aim is to conduct a multi-center, Bayesian, randomized clinical trial to evaluate the primary technical success of coils and vascular plugs for proximal splenic artery embolization in the setting of high-grade splenic trauma. The investigator has previously demonstrated the feasibility of such a study in a single center pilot trial. Type: Interventional Start Date: May 2022 |
TTVR Early Feasibility Study
Medtronic Cardiovascular
Tricuspid Regurgitation
The objective of this early feasibility study is to gain early clinical insight into the
performance of the Intrepid transcatheter tricuspid valve replacement (TTVR) system
intended for transfemoral access to deliver a self-expanding bioprosthetic valve within
the tricuspid valve. expand
The objective of this early feasibility study is to gain early clinical insight into the performance of the Intrepid transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve. Type: Interventional Start Date: Oct 2020 |
Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or...
National Cancer Institute (NCI)
Stage IB Lung Non-Small Cell Carcinoma AJCC v7
Stage II Lung Non-Small Cell Cancer AJCC v7
Stage IIA Lung Cancer AJCC v8
Stage IIB Lung Cancer AJCC v8
Stage IIIA Lung Cancer AJCC v8
This ALCHEMIST trial studies genetic testing in screening patients with stage IB-IIIA
non-small cell lung cancer that has been or will be removed by surgery. Studying the
genes in a patient's tumor cells may help doctors select the best treatment for patients
that have certain genetic changes. expand
This ALCHEMIST trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain genetic changes. Type: Interventional Start Date: Sep 2014 |
Maternal Newborn Health Registry
NICHD Global Network for Women's and Children's Health
Pregnancy Outcome Trends in Low-resource Geographic Areas
The primary purpose of this population-based study is to quantify and understand the
trends in pregnancy outcomes in defined low-resource geographic areas over time, in order
to provide population-based data on stillbirths, neonatal and maternal mortality. expand
The primary purpose of this population-based study is to quantify and understand the trends in pregnancy outcomes in defined low-resource geographic areas over time, in order to provide population-based data on stillbirths, neonatal and maternal mortality. Type: Observational Start Date: May 2008 |
BeFit Toolbox Collaboration: Building Empowerment Through Fitness
University of Alabama at Birmingham
Low-Income Population
Women's Health
This project will identify the causative behavioral factors in low-income African
American women leading to sedentarism, a major source of morbidity in HABD communities.
Working with our partner, WUCN, we will engage with women in HABD housing to develop and
(later) deliver a physical activity education... expand
This project will identify the causative behavioral factors in low-income African American women leading to sedentarism, a major source of morbidity in HABD communities. Working with our partner, WUCN, we will engage with women in HABD housing to develop and (later) deliver a physical activity education program (BeFit) customized for this population. Type: Interventional Start Date: Mar 2024 |
A Multi-site Feasibility Clinical Trial of Retraining and Control Therapy (ReACT), a Mind and Body Treatment...
University of Alabama at Birmingham
Functional Seizures
Convulsion, Non-Epileptic
The purpose of this study is to assess the feasibility of conducting a future fully
powered multi-site efficacy Randomized Controlled Trial (RCT) comparing two treatments
for pediatric functional seizures (FS). In this study, 11-18-year-olds diagnosed with FS
will be randomized to 12 sessions of Retraining... expand
The purpose of this study is to assess the feasibility of conducting a future fully powered multi-site efficacy Randomized Controlled Trial (RCT) comparing two treatments for pediatric functional seizures (FS). In this study, 11-18-year-olds diagnosed with FS will be randomized to 12 sessions of Retraining and Control Therapy (ReACT) or Competent Adulthood Transition with Cognitive Behavioral, Humanistic, and Interpersonal Training (CATCH-IT) at 3 sites: University of Alabama at Birmingham, Yale School of Medicine/Yale New Haven Children's Hospital and Baylor College of Medicine/Texas Children's Hospital. Feasibility of recruitment will be measured by the percentage of planned participant enrollment target obtained at each site and overall during the 18 months of planned enrollment. Acceptability will be assessed using the Acceptability Questionnaire. Participant retention will be measured by the percent of enrolled participants that complete the 2-month follow-up visit at each site and overall. For treatment fidelity assessment, 20% of each therapist's sessions will be randomly chosen and assessed for fidelity. Patient adherence will be measured in two ways: 1) the percent of ReACT or CATCH-IT sessions completed at each site and overall and 2) for ReACT, the percent of times participants report using the treatment plan during FS episodes (measured by FS diary) and for CATCH-IT, the number of times parents and children spend using CATCH-IT each week (measured by the CATCH-IT platform). These data will be used to support a future fully-powered multi-site RCT assessing the efficacy of ReACT for pediatric FS. Type: Interventional Start Date: Mar 2024 |
A Phase 3 Study to Evaluate the Effect of Resmetirom on Clinical Outcomes in Patients With Well-compensated...
Madrigal Pharmaceuticals, Inc.
NASH
Cirrhosis, Liver
This study will determine the effect of oral 80 mg resmetirom administered once daily on
participants with well-compensated non-alcoholic steatohepatitis (NASH) cirrhosis by
measuring the time to experiencing a Composite Clinical Outcome event. expand
This study will determine the effect of oral 80 mg resmetirom administered once daily on participants with well-compensated non-alcoholic steatohepatitis (NASH) cirrhosis by measuring the time to experiencing a Composite Clinical Outcome event. Type: Interventional Start Date: Aug 2022 |
Testing the Addition of Stereotactic Radiation Therapy With Immune Therapy for the Treatment of Patients...
NRG Oncology
Metastatic Renal Cell Carcinoma
Stage III Renal Cell Cancer AJCC v8
Stage IV Renal Cell Cancer AJCC v8
Unresectable Renal Cell Carcinoma
This phase II trial tests whether the addition of radiation to the primary tumor,
typically given with stereotactic ablative radiation therapy (SABR), in combination with
standard of care immunotherapy improves outcomes in patients with renal cell cancer that
is not recommended for surgery and has... expand
This phase II trial tests whether the addition of radiation to the primary tumor, typically given with stereotactic ablative radiation therapy (SABR), in combination with standard of care immunotherapy improves outcomes in patients with renal cell cancer that is not recommended for surgery and has spread to other places in the body (metastatic). Radiation therapy uses high energy photons to kill tumor cells and shrink tumors. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses of radiation over a shorter period and cause less damage to normal tissue. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, avelumab, and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Axitinib, cabozantinib, and lenvatinib are in a class of medications called antiangiogenic agents. They work by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving SABR in combination with standard of care immunotherapy may help shrink or stabilize the cancer in patients with renal cell cancer. Type: Interventional Start Date: Jun 2022 |
Nurse Coach-Led Early Palliative Care for Older Adults With COPD and Their Care Partners: The Project...
University of Alabama at Birmingham
COPD
Chronic obstructive pulmonary disease (COPD) is the third leading cause of death in older
Americans. COPD increases in frequency with age, and older adults with COPD often have
significant unmet geriatrics-palliative care needs that results in reduced quality of
life, high healthcare utilization,... expand
Chronic obstructive pulmonary disease (COPD) is the third leading cause of death in older Americans. COPD increases in frequency with age, and older adults with COPD often have significant unmet geriatrics-palliative care needs that results in reduced quality of life, high healthcare utilization, and care at the end of life that does not align with the values and wishes of patients and their care partners. Older adults with COPD could benefit from proactive geriatrics-palliative care before the end of life. However, no geriatrics-palliative care interventions have been systematically developed and tested in community-dwelling older adults with COPD and their care partners. As the number of older adults with COPD increases to levels unmatched by current palliative care workforce trends, innovative strategies are desperately needed to improve the delivery of geriatrics-palliative care in COPD before the end of life. Project EPIC (Empowering People to Independence in COPD) is a multiphase study to refine and pilot test the EPIC telephonic nurse coaching intervention in older adults with COPD and their care partners. EPIC is informed by the ENABLE (Educate, Nurture, Advise Before Life Ends) early palliative care intervention that improved quality of life and mood for patients with advanced cancer and has been iteratively refined over decades and rigorous randomized controlled trial testing. In the intervention, palliative care-trained nurse coaches deliver the Charting Your Course Curriculum over the phone to patients (six sessions) and their care partners (four sessions), with activities and monthly telephone follow-up following a manualized curriculum. We conducted a formative evaluation in a diverse and multidisciplinary group of stakeholders to refine ENABLE for patients with COPD and pilot tested the potential feasibility of the refined intervention, EPIC, in patients and their care partners. The current study summatively evaluates EPIC through a hybrid effectiveness-implementation pilot randomized controlled trial in dyads of community-dwelling older adults with moderate to very severe COPD and their care partners randomized to usual COPD care (control) versus usual COPD care + EPIC (intervention). The primary outcomes are trial and intervention feasibility and acceptability. Secondary geriatrics-palliative care outcomes include Life-Space mobility, quality of life, cognitive impairment, functional status, healthcare utilization, palliative care uptake, and care partner burden. Type: Interventional Start Date: May 2022 |
I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients
QuantumLeap Healthcare Collaborative
COVID-19
The goal of this project is to rapidly screen promising agents, in the setting of an
adaptive platform trial, for treatment of critically ill COVID-19 patients. In this phase
2 platform design, agents will be identified with a signal suggesting a big impact on
reducing mortality and the need for,... expand
The goal of this project is to rapidly screen promising agents, in the setting of an adaptive platform trial, for treatment of critically ill COVID-19 patients. In this phase 2 platform design, agents will be identified with a signal suggesting a big impact on reducing mortality and the need for, as well as duration, of mechanical ventilation. Type: Interventional Start Date: Jul 2020 |
NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness
Endospan Ltd.
Aortic Dissection
Aortic Aneurysm
Intramural Hematoma
Penetrating Aortic Ulcer
Prospective, non-randomized, multi-center clinical investigation of the NEXUS™ Aortic
Arch Stent Graft System (NEXUSTM) for the treatment of thoracic aortic lesions involving
the aortic arch with a proximal landing zone, native or previously implanted surgical
graft, in the ascending aorta and with... expand
Prospective, non-randomized, multi-center clinical investigation of the NEXUS™ Aortic Arch Stent Graft System (NEXUSTM) for the treatment of thoracic aortic lesions involving the aortic arch with a proximal landing zone, native or previously implanted surgical graft, in the ascending aorta and with a brachiocephalic trunk native landing zone. Type: Interventional Start Date: Oct 2020 |
ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD)
Mayo Clinic
Frontotemporal Lobar Degeneration (FTLD)
Progressive Supranuclear Palsy (PSP)
Corticobasal Degeneration (CBD)
Behavioral Variant Frontotemporal Dementia (bvFTD)
Semantic Variant Primary Progressive Aphasia (svPPA)
ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD) represents the
formalized integration of ARTFL (U54 NS092089; funded through 2019) and LEFFTDS (U01
AG045390; funded through 2019) as a single North American research consortium to study
FTLD for 2019 and beyond. expand
ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD) represents the formalized integration of ARTFL (U54 NS092089; funded through 2019) and LEFFTDS (U01 AG045390; funded through 2019) as a single North American research consortium to study FTLD for 2019 and beyond. Type: Observational Start Date: Mar 2020 |
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 |
A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients
United Therapeutics
PAH
Pulmonary Hypertension
Pulmonary Arterial Hypertension
Hypertension
Connective Tissue Diseases
Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of
ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or
PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1
PAH. expand
Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH. Type: Interventional Start Date: Aug 2018 |
Regulation of Inflammatory Genes in Psoriasis
University of Alabama at Birmingham
Psoriasis
Inflammation
Psoriasis is a chronic and recurrent skin disorder characterized by marked inflammatory
changes in the skin. An extensive cytokine network including generated by activated
dendritic cells and T cells mediates the formation of psoriatic lesions. These
immune-response parameters can be used as markers... expand
Psoriasis is a chronic and recurrent skin disorder characterized by marked inflammatory changes in the skin. An extensive cytokine network including generated by activated dendritic cells and T cells mediates the formation of psoriatic lesions. These immune-response parameters can be used as markers in the severity and management of the disease after further in-depth studies. Type: Observational Start Date: Apr 2014 |
AB-101 in Combination With B-Cell Depleting mAb in Patients Who Failed Treatment for Class III or IV...
Artiva Biotherapeutics, Inc.
Lupus Nephritis - WHO Class III
Lupus Nephritis - WHO Class IV
Refractory Systemic Lupus Erythematosus
AB-101 (also known as AlloNK) is an off-the shelf, allogeneic cell product made of
"natural killer" cells, also called NK cells. White blood cells are part of the immune
system and NK cells are a type of white blood cell that is known to enhance the effect of
monoclonal antibody therapies.
This... expand
AB-101 (also known as AlloNK) is an off-the shelf, allogeneic cell product made of "natural killer" cells, also called NK cells. White blood cells are part of the immune system and NK cells are a type of white blood cell that is known to enhance the effect of monoclonal antibody therapies. This clinical trial will enroll adult patients with lupus nephritis Class III or IV either with or without the presence of Class V who relapsed or did not respond to previous standard of care treatment approaches, or other forms of refractory systemic lupus erythematosus. The primary objective is to assess the safety, tolerability and preliminary activity of AB-101 plus a B-cell depleting mAb (e.g., rituximab, obinutuzumab) after cyclophosphamide and fludarabine in adult subjects with relapsed/refractory lupus nephritis Class III or IV, with or without the presence of Class V, or other forms of refractory systemic lupus erythematosus. Patients will be assigned to receive either AB-101 alone as monotherapy or in combination with a B-cell depleting mAb (e.g., rituximab, obinutuzumab). All patients will receive at least 1 treatment cycle of AB-101, followed by scheduled assessments of overall health and response status. Patients may receive up to 2 cycles of treatment spaced 24 weeks apart. Type: Interventional Start Date: Apr 2024 |
Study of TTI-101 in Participants With Idiopathic Pulmonary Fibrosis
Tvardi Therapeutics, Incorporated
Idiopathic Pulmonary Fibrosis
The primary objective of this study is to evaluate the safety and tolerability of oral
daily administration of TTI-101 over a 12-week treatment duration in participants with
idiopathic pulmonary fibrosis (IPF). expand
The primary objective of this study is to evaluate the safety and tolerability of oral daily administration of TTI-101 over a 12-week treatment duration in participants with idiopathic pulmonary fibrosis (IPF). Type: Interventional Start Date: May 2023 |
Trauma Resuscitation With Low-Titer Group O Whole Blood or Products
University of Alabama at Birmingham
Wounds and Injuries
Shock, Hemorrhagic
The goal of this clinical trial is to compare the effectiveness of unseparated whole
blood (referred to as Low-Titer Group O Whole Blood) and the separate components of whole
blood (including red cells, plasma, platelets, and cryoprecipitate) in critically injured
patients who require large-volume... expand
The goal of this clinical trial is to compare the effectiveness of unseparated whole blood (referred to as Low-Titer Group O Whole Blood) and the separate components of whole blood (including red cells, plasma, platelets, and cryoprecipitate) in critically injured patients who require large-volume blood transfusions. Type: Interventional Start Date: Jul 2023 |
A Study of ANV419 Alone or in Combination With Approved Treatment in Patients With Cutaneous Melanoma...
Anaveon AG
Melanoma (Skin)
Cutaneous Melanoma
Adult Disease
Advanced Solid Tumor
Metastatic Melanoma
The purpose of this study is to evaluate the efficacy and safety of ANV419 monotherapy or
the combination of ANV419 with anti-PD1 antibody or with anti-CTLA4 antibody in adult
participants with advanced (unresectable or metastatic) cutaneous melanoma. expand
The purpose of this study is to evaluate the efficacy and safety of ANV419 monotherapy or the combination of ANV419 with anti-PD1 antibody or with anti-CTLA4 antibody in adult participants with advanced (unresectable or metastatic) cutaneous melanoma. Type: Interventional Start Date: Dec 2022 |
Factors in Learning And Plasticity: Macular Degeneration
University of Alabama at Birmingham
Central Visual Impairment
Macular Degeneration
A greater understanding of plasticity after central vision loss can inform new therapies
for treating low vision and has the potential to benefit millions of individuals
suffering from low vision. The treatment of low vision is particularly relevant to the
mission of the NEI to support research on... expand
A greater understanding of plasticity after central vision loss can inform new therapies for treating low vision and has the potential to benefit millions of individuals suffering from low vision. The treatment of low vision is particularly relevant to the mission of the NEI to support research on visual disorders, mechanisms of visual function, and preservation of sight. The comparison of different training and outcome factors is in line with the NIMH RDOC framework and studies in an aging population are consistent with the mission of the NIA. Type: Interventional Start Date: Nov 2022 |
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