451 matching studies

Sponsor Condition of Interest
Vascular Effects of Mineralocorticoid Receptor Antagonism in Kidney Disease
University of Alabama at Birmingham Chronic Kidney Disease Albuminuria
Vascular endothelial dysfunction increases cardiovascular (CV) risk and contributes to the progression of chronic kidney disease (CKD). Mineralocorticoid receptor (MR) antagonists have been shown to improve endothelial function, as well as decrease CV mortality and proteinuria.... expand

Vascular endothelial dysfunction increases cardiovascular (CV) risk and contributes to the progression of chronic kidney disease (CKD). Mineralocorticoid receptor (MR) antagonists have been shown to improve endothelial function, as well as decrease CV mortality and proteinuria. The specific biochemical pathways that produce these pharmacological effects for MR antagonists, however, are poorly understood. This study investigates the effect of MR antagonism on endothelial function in patients with moderate (stage III) CKD using a randomized, controlled trial. Three specific aims are proposed: Aim 1: To determine if spironolactone improves endothelial function as compared to amiloride in patients with stage III CKD; Aim 2: To determine if oxidative stress is associated with changes in endothelial function by spironolactone compared to amiloride in patients with stage III CKD; and Aim 3: To determine if endothelial dysfunction contributes to albuminuria in patients with stage III CKD. The clinical relevance is to improve understanding of the mechanisms of kidney function decline in CKD in order to develop interventions to delay or prevent dialysis, which would translate into alleviating patient suffering, caregiver burden, and health care costs.

Type: Interventional

Start Date: Mar 2015

open study

Efficacy of Ketamine Infusion Compared With Traditional Anti-epileptic Agents in Refractory Status Epilepticus
University of Alabama at Birmingham Refractory Epilepsy
The study will investigate the efficacy of the N-methyl-D-aspartate receptor antagonist ketamine as a first line agent in refractory status epilepticus versus traditional general anesthetic agents used for burst suppression that target the gamma-aminobutyric acid adrenergic receptors.... expand

The study will investigate the efficacy of the N-methyl-D-aspartate receptor antagonist ketamine as a first line agent in refractory status epilepticus versus traditional general anesthetic agents used for burst suppression that target the gamma-aminobutyric acid adrenergic receptors.

Type: Interventional

Start Date: May 2017

open study

Mid and Standard Frequency Ventilation in Infants With Respiratory Distress Syndrome
University of Alabama at Birmingham Ventilator-Induced Lung Injury Respiratory Distress Syndrome Bronchopulmonary Dysplasia Preterm Infant
The purpose of this study is to determine, in preterm infants less than 37 weeks gestation with respiratory distress who are ventilated in the first 48 hours after birth, if mid frequency ventilation strategy using ventilator rate of ≥ 60 to ≤ 150 per minute compared with standard... expand

The purpose of this study is to determine, in preterm infants less than 37 weeks gestation with respiratory distress who are ventilated in the first 48 hours after birth, if mid frequency ventilation strategy using ventilator rate of ≥ 60 to ≤ 150 per minute compared with standard frequency ventilation strategy using ventilator rates of ≥ 20 to < 60 per minute will increase the number of alive ventilator-free days after randomization and reduce the risk of ventilator induced lung injury.

Type: Interventional

Start Date: Aug 2017

open study

Remote Ischemic Conditioning Using the autoRIC
CellAegis US, Inc. Ischemia-Reperfusion Injury
The purpose of the study is to evaluate the hypothesis that patients receiving remote ischemic conditioning using the autoRIC device show statistically significant reduction in the prevalence of ischemia-reperfusion injury to the myocardium as compared to patients in the autoRIC... expand

The purpose of the study is to evaluate the hypothesis that patients receiving remote ischemic conditioning using the autoRIC device show statistically significant reduction in the prevalence of ischemia-reperfusion injury to the myocardium as compared to patients in the autoRIC Sham device arm (within 12-24 hours post non-emergent PCI with stent implantation).

Type: Interventional

Start Date: Jan 2018

open study

Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Malignant Salivary...
Radiation Therapy Oncology Group Head and Neck Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation... expand

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective when given together with chemotherapy or alone after surgery in treating salivary gland tumors. PURPOSE: This randomized phase II/III trial is studying radiation therapy with or without chemotherapy to see how well it works in treating patients with high-risk malignant salivary gland tumors that have been removed by surgery.

Type: Interventional

Start Date: Jan 2011

open study

Effect of Increased Enteral Protein on Body Composition of Preterm Infants
University of Alabama at Birmingham Premature Infant
The study hypothesis is that, in human milk-fed extremely preterm infants, higher protein intake compared to usual protein intake reduces percent body fat (%BF) at 3 months of age. expand

The study hypothesis is that, in human milk-fed extremely preterm infants, higher protein intake compared to usual protein intake reduces percent body fat (%BF) at 3 months of age.

Type: Interventional

Start Date: Aug 2018

open study

Treatment of Proteinuria Due to Treatment Resistant or Treatment Intolerant Idiopathic FSGS
Mallinckrodt Idiopathic Focal Segmental Glomerulosclerosis
Multicenter, multiple dose study to examine the effect of H.P. Acthar® Gel (repository corticotropin injection) in adult subjects with idiopathic focal segmental glomerulosclerosis (FSGS) who have failed to achieve remission with, or who are intolerant of, 1 or more previous... expand

Multicenter, multiple dose study to examine the effect of H.P. Acthar® Gel (repository corticotropin injection) in adult subjects with idiopathic focal segmental glomerulosclerosis (FSGS) who have failed to achieve remission with, or who are intolerant of, 1 or more previous immunosuppressive therapies.

Type: Interventional

Start Date: May 2016

open study

Peripheral Vision Training Study
University of Alabama at Birmingham Visual Impairment Cognitive Change
This study will train participants (young people and older adults) to do a visual task, and will assess whether this results in changes in behavioral assessments. In some participants, we will be also testing whether MRI measures (cortical thickness, functional connectivity)... expand

This study will train participants (young people and older adults) to do a visual task, and will assess whether this results in changes in behavioral assessments. In some participants, we will be also testing whether MRI measures (cortical thickness, functional connectivity) change with training.

Type: Interventional

Start Date: May 2017

open study

Prospective Study to Evaluate Outcomes From Trans-oral Base of Tongue Resection for Obstructive Sleep...
University of Alabama at Birmingham Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)
This is a prospective observational study that will collect outcome data for patients who choose to undergo transoral tongue base operations for Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)as part of their standard of care treatment. This is a data collection study only... expand

This is a prospective observational study that will collect outcome data for patients who choose to undergo transoral tongue base operations for Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)as part of their standard of care treatment. This is a data collection study only and does not provide for evaluations or treatment of OSAHS.

Type: Observational

Start Date: Mar 2010

open study

Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III-IVA Squamous Cell Carcinoma...
ECOG-ACRIN Cancer Research Group Head and Neck Squamous Cell Carcinoma Hypopharyngeal Squamous Cell Carcinoma Laryngeal Squamous Cell Carcinoma Laryngeal Squamous Cell Carcinoma, Spindle Cell Variant Lip and Oral Cavity Squamous Cell Carcinoma
This phase II trial studies how well radiation therapy with or without cisplatin works in treating patients with stage III-IVA squamous cell carcinoma of the head and neck who have undergone surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.... expand

This phase II trial studies how well radiation therapy with or without cisplatin works in treating patients with stage III-IVA squamous cell carcinoma of the head and neck who have undergone surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, 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. It is not yet known if radiation therapy is more effective with or without cisplatin in treating patients with squamous cell carcinoma of the head and neck.

Type: Interventional

Start Date: Mar 2016

open study

Gan & Lee Insulin Glargine Target Type (1) Evaluating Research
Gan and Lee Pharmaceuticals, USA Diabetes Mellitus, Type 1
Primary Objective: - To demonstrate equivalence of Gan & Lee Insulin Glargine Injection and Lantus® in terms of immunogenicity Secondary Objective: - Immunogenicity: To evaluate the percentage of subjects with negative anti-insulin antibodies (AIA)... expand

Primary Objective: - To demonstrate equivalence of Gan & Lee Insulin Glargine Injection and Lantus® in terms of immunogenicity Secondary Objective: - Immunogenicity: To evaluate the percentage of subjects with negative anti-insulin antibodies (AIA) at baseline who develop confirmed positive AIA up to Week 26

Type: Interventional

Start Date: Oct 2017

open study

Comparing Inflammatory Markers in Patients With and Without Depression With Chronic Periodontitis
University of Alabama at Birmingham Chronic Periodontitis Depression
This study will evaluate whether use of antidepressants can reduce gingival inflammation in patients with periodontal (gum) disease. expand

This study will evaluate whether use of antidepressants can reduce gingival inflammation in patients with periodontal (gum) disease.

Type: Interventional

Start Date: Jul 2018

open study

Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions...
W.L.Gore & Associates Aortic Aneurysm, Thoracic Aorta; Lesion
The objective of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta. expand

The objective of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta.

Type: Interventional

Start Date: Aug 2016

open study

A Prospective Observational Study of Biopredictors of Bronchial Thermoplasty Response in Patients With...
Washington University School of Medicine Asthma
Clinical response, as defined by improvement in asthma quality of life, to bronchial thermoplasty in patients with severe refractory asthma can be predicted through the use of clinical, physiologic, biologic and imaging markers. expand

Clinical response, as defined by improvement in asthma quality of life, to bronchial thermoplasty in patients with severe refractory asthma can be predicted through the use of clinical, physiologic, biologic and imaging markers.

Type: Observational

Start Date: Aug 2010

open study

Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions...
W.L.Gore & Associates Aortic Aneurysm, Thoracic Aorta, Lesion
The objective of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta. expand

The objective of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta.

Type: Interventional

Start Date: Aug 2016

open study

Phase I Trial of PACE for Metastatic Prostate Cancer
University of Alabama at Birmingham Metastatic Prostate Cancer
This trial is being conducted to determine the feasibility and recommended dose of the combination of four drugs (prednisone, abiraterone, cabazitaxel and enzalutamide (PACE) as first-line therapy for metastatic castration-resistant prostate cancer (mCRPC). expand

This trial is being conducted to determine the feasibility and recommended dose of the combination of four drugs (prednisone, abiraterone, cabazitaxel and enzalutamide (PACE) as first-line therapy for metastatic castration-resistant prostate cancer (mCRPC).

Type: Interventional

Start Date: Jul 2018

open study

Folfirinox or Gemcitabine-Nab Paclitaxel Followed by Stereotactic Body Radiotherapy for Locally Advanced...
University of Alabama at Birmingham Locally Advanced Pancreatic Cancer Borderline Pancreatic Inoperable Cancer Pancreatic Cancer
This study will implement a new treatment regimen for patients with advanced and inoperable pancreatic cancer using chemotherapy combinations of Folfirinox or gemcitabine-nab paclitaxel (abraxane) followed by a short course of high dose radiation called Stereotactic Body Radiation... expand

This study will implement a new treatment regimen for patients with advanced and inoperable pancreatic cancer using chemotherapy combinations of Folfirinox or gemcitabine-nab paclitaxel (abraxane) followed by a short course of high dose radiation called Stereotactic Body Radiation Therapy (SBRT). While the chemotherapy is standard of care, the strategy of adding SBRT has not been investigated. An increase in the percentage of patients who can proceed to have surgery to remove their disease is anticipated with this approach.

Type: Interventional

Start Date: Dec 2016

open study

ACES - ACE Inhibitors Combined With Exercise for Seniors With Hypertension
University of Alabama at Birmingham Hypertension Aging Sedentary Lifestyle
The purpose of this project is to conduct a randomized, controlled trial (RCT) to determine if choice of antihypertensive medication influences changes in functional status and other cardiovascular risk factors among older persons with hypertension when combined with physical... expand

The purpose of this project is to conduct a randomized, controlled trial (RCT) to determine if choice of antihypertensive medication influences changes in functional status and other cardiovascular risk factors among older persons with hypertension when combined with physical exercise.

Type: Interventional

Start Date: May 2018

open study

Outpatient Foley For Starting Induction of Labor at Term in Nulliparous Women
University of Alabama at Birmingham Pregnancy Related
The investigators are performing a randomized controlled trial investigating starting cervical ripening in the outpatient setting with a mechanical method, the transcervical Foley catheter. The objective of the study is to determine if outpatient compared to inpatient cervical... expand

The investigators are performing a randomized controlled trial investigating starting cervical ripening in the outpatient setting with a mechanical method, the transcervical Foley catheter. The objective of the study is to determine if outpatient compared to inpatient cervical ripening with a transcervical Foley catheter in nulliparous women undergoing induction shortens the time spent in labor and delivery (from the time of admission to the time of delivery).

Type: Interventional

Start Date: May 2018

open study

Brain Stimulation and Rehabilitation for Adults With Chronic, Severe Arm Motor Impairment After Stroke
University of Alabama at Birmingham Stroke Hemiplegia Hemiparesis
This pilot study will examine a combination therapy for adults with chronic, severe motor impairment of an arm after stroke. The intervention will combine brain stimulation with physical rehabilitation of the arm on the side of the body more-affected by stroke. expand

This pilot study will examine a combination therapy for adults with chronic, severe motor impairment of an arm after stroke. The intervention will combine brain stimulation with physical rehabilitation of the arm on the side of the body more-affected by stroke.

Type: Interventional

Start Date: Jun 2018

open study

Nitrite Infusion in Islet Cell Transplantation
University of Alabama at Birmingham Diabetes
This study seeks to investigate the effects of administering nitrite to pancreatic islet cells that have been removed from a patient for autotransplantation. expand

This study seeks to investigate the effects of administering nitrite to pancreatic islet cells that have been removed from a patient for autotransplantation.

Type: Interventional

Start Date: May 2017

open study

Race, Natriuretic Peptides and Physiological Perturbations
University of Alabama at Birmingham Healthy Pre Hypertension
The purpose of the study is to understand the origins of differential response to beta-blockers in African-Americans and may provide insight regarding racial differences in cardiovascular risk. expand

The purpose of the study is to understand the origins of differential response to beta-blockers in African-Americans and may provide insight regarding racial differences in cardiovascular risk.

Type: Interventional

Start Date: Apr 2017

open study

Study Evaluating the Safety and Efficacy of JCARH125 in Subjects With Relapsed and/or Refractory Multiple...
Juno Therapeutics, Inc. Multiple Myeloma
This is an open-label, multicenter, Phase 1/2 study to determine the safety and efficacy of JCARH125, a CAR T-cell product that targets B-cell maturation antigen (BCMA), in adult subjects with relapsed and/or refractory multiple myeloma. The study will include a Phase 1 part... expand

This is an open-label, multicenter, Phase 1/2 study to determine the safety and efficacy of JCARH125, a CAR T-cell product that targets B-cell maturation antigen (BCMA), in adult subjects with relapsed and/or refractory multiple myeloma. The study will include a Phase 1 part to determine the recommended dose of JCARH125 in subjects with relapsed and/or refractory multiple myeloma, followed by a Phase 2 part to further evaluate the safety and efficacy of JCARH125 at the recommended dose.

Type: Interventional

Start Date: Feb 2018

open study

Psilocybin-facilitated Treatment for Cocaine Use
University of Alabama at Birmingham Cocaine-Related Disorders
The primary purpose of this study is to evaluate the feasibility and estimate the efficacy of psilocybin-facilitated treatment for cocaine use. We also will monitor the impact of psilocybin-facilitated treatment on the use of other drugs and outcomes relevant to cocaine involvement... expand

The primary purpose of this study is to evaluate the feasibility and estimate the efficacy of psilocybin-facilitated treatment for cocaine use. We also will monitor the impact of psilocybin-facilitated treatment on the use of other drugs and outcomes relevant to cocaine involvement (e.g., criminal involvement). MRI assessment is a unique aspect of this study. As a potential biological mechanism of psilocybin's effect includes changes in default mode network functional connectivity (Carhart-Harris et al., 2012), we will determine if psilocybin's therapeutic effects are mediated by such changes. Moreover, as Glx (a brain metabolite that reflects glutamate) abnormalities have been shown to play a role in cocaine addiction, we will determine if psilocybin impacts Glx in the anterior cingulate cortex and hippocampus.

Type: Interventional

Start Date: May 2015

open study

Harvoni Treatment Porphyria Cutanea Tarda
Wake Forest University Health Sciences Porphyria Cutanea Tarda Hepatitis C
In the medical literature there case reports that Harvoni improves symptoms in patients with PCT. However, this has never been systematically tested. Therefore, the purpose of this study is to assess whether Harvoni alone is an effective therapy of active PCT in patients with... expand

In the medical literature there case reports that Harvoni improves symptoms in patients with PCT. However, this has never been systematically tested. Therefore, the purpose of this study is to assess whether Harvoni alone is an effective therapy of active PCT in patients with Chronic Hepatitis C.

Type: Interventional

Start Date: Aug 2017

open study