516 matching studies

Sponsor Condition of Interest
Pain Relief for OsteoArthritis Through Combined Treatment (PROACT)
University of Florida Osteoarthritis of Knee
This mechanistic clinical trial proposes to test whether a five-day course of mindfulness meditation training (MMT) and tDCS, and their combination, can enhance pain modulatory balance and pain-related brain function, reduce clinical pain, among African Americans and non-Hispanic... expand

This mechanistic clinical trial proposes to test whether a five-day course of mindfulness meditation training (MMT) and tDCS, and their combination, can enhance pain modulatory balance and pain-related brain function, reduce clinical pain, among African Americans and non-Hispanic whites with knee osteoarthritis (OA). This approach will provide evidence that targeting stress and pain-related brain function will reduce OA-related pain and ethnic group differences therein.

Type: Interventional

Start Date: Mar 2020

open study

Late Permissive Hypercapnia for Intubated and Ventilated Preterm Infants
University of Alabama at Birmingham Premature Neonate
Preterm infants, less than 37 weeks gestation with respiratory distress syndrome, who remain ventilated between 7 and 14 days after birth will be randomized to a ventilator strategy of either a higher level of permissive hypercapnia or of a lower level of permissive hypercapnia... expand

Preterm infants, less than 37 weeks gestation with respiratory distress syndrome, who remain ventilated between 7 and 14 days after birth will be randomized to a ventilator strategy of either a higher level of permissive hypercapnia or of a lower level of permissive hypercapnia to determine if either strategy will increase the number of alive ventilator-free days in the 28 days after randomization.

Type: Interventional

Start Date: Dec 2015

open study

[68Ga]DOTATATE-PET/MRI in Hepatocellular Carcinoma
University of Alabama at Birmingham Hepatocellular Carcinoma
There is great need for new therapeutic options for patients with hepatocellular carcinoma (HCC). This proposal will assess the feasibility of a novel theranostic approach to HCC using [68Ga]DOTATATE, a recently approved positron emission tomography (PET) ligand for imaging... expand

There is great need for new therapeutic options for patients with hepatocellular carcinoma (HCC). This proposal will assess the feasibility of a novel theranostic approach to HCC using [68Ga]DOTATATE, a recently approved positron emission tomography (PET) ligand for imaging somatostatin receptor (SSTR) positive tumors. In this study, we will use [68Ga]DOTATATE to determine the percentage of HCCs that express adequate levels of SSTR for treatment with targeted radionuclide therapy (TRT) using the therapeutic SSTR ligand [177Lu]DOTATATE. This radionuclide therapy was FDA approved in January 2018 for treating neuroendocrine tumors (NETs) arising from the gastrointestinal tract, but its use in HCC has not yet been explored. In the long term, we envision using [68Ga]DOTATATE-PET to identify HCC patients with adequate SSTR expression for TRT using [177Lu]DOTATATE. Liver transplantation is the only curative therapy for HCC and is an option for a selected subset of HCC patients. For those who are not candidates for transplantation, locoregional therapies with limited efficacy are available such as percutaneous ablation, arterial chemoembolization, and Y-90 microsphere radionuclide therapies. There are few options for patients who progress or are not candidates for these therapies. The first line systemic therapy is sorafenib, a tyrosine kinase inhibitor. Sorafenib is often not well tolerated due to its side effects and there is need for additional systemic treatments. Multiple tissue-based studies demonstrate SSTR positivity in 20-50% of HCCs.[1-3] However, the fraction of HCCs have high enough levels of SSTR for [177Lu]DOTATATE therapy has not yet been assessed. This research plan is a critical prerequisite for determining the feasibility of this theranostic approach to treating HCC. If we obtain positive results, these data will be critical for designing a combined imaging and therapeutic study in HCC using DOTATATE.

Type: Interventional

Start Date: Jan 2019

open study

Gut Microbe Composition, Exercise, and Breast Breast Cancer Survivors
University of Alabama at Birmingham Breast Cancer Gut Microbiome Exercise Fatigue
The primary goal of this project is to determine the effects of exercise on the gut microbiome in breast cancer survivors and determine how these changes may relate to psychosocial symptoms such as fatigue. expand

The primary goal of this project is to determine the effects of exercise on the gut microbiome in breast cancer survivors and determine how these changes may relate to psychosocial symptoms such as fatigue.

Type: Interventional

Start Date: Jan 2020

open study

Panitumumab IRDye800 Optical Imaging Study
Eben Rosenthal Head and Neck Cancer
Phase I trial to evaluate the safety of escalating dose levels of conjugated panitumumab-IRDye800 in subjects with head and neck squamous cell carcinoma (HNSCC) that undergo surgery with curative intent. expand

Phase I trial to evaluate the safety of escalating dose levels of conjugated panitumumab-IRDye800 in subjects with head and neck squamous cell carcinoma (HNSCC) that undergo surgery with curative intent.

Type: Interventional

Start Date: Aug 2016

open study

Comparing NicoBloc to Nicotine Lozenges
University of Alabama at Birmingham Smoking Cessation Nicotine Dependence
To examine the feasibility, acceptability, and preliminary impact of using NicoBloc compared to nicotine lozenges expand

To examine the feasibility, acceptability, and preliminary impact of using NicoBloc compared to nicotine lozenges

Type: Interventional

Start Date: Mar 2019

open study

Acute Headache Treatment in Pregnancy: Occipital Nerve Block vs PO Acetaminophen With Caffeine
University of Alabama at Birmingham Headache Pregnancy Related Occipital Nerve Block
This is an open label randomized controlled trial evaluating response to bupivacaine occipital nerve block compared to Tylenol/Caffeine cocktail in treatment of pregnant patients seeking care of headache. expand

This is an open label randomized controlled trial evaluating response to bupivacaine occipital nerve block compared to Tylenol/Caffeine cocktail in treatment of pregnant patients seeking care of headache.

Type: Interventional

Start Date: Feb 2020

open study

Trikafta in Cystic Fibrosis Patients
Emory University Cystic Fibrosis
Cystic Fibrosis (CF) is a life threatening genetic disorder resulting from mutations found in the gene known as the cystic fibrosis transmembrane conductance regulator (CFTR). This clinical study will enroll 22 participants without the F508del mutation, carrying partial function... expand

Cystic Fibrosis (CF) is a life threatening genetic disorder resulting from mutations found in the gene known as the cystic fibrosis transmembrane conductance regulator (CFTR). This clinical study will enroll 22 participants without the F508del mutation, carrying partial function mutations not approved for Trikafta, and who are not expected to be approved for CFTR modulator treatment in the immediate future. Each participant will be given Trikafta for approximately four weeks. The study researchers will monitor clinical endpoints that include forced expiratory volume (FEV1), sweat chloride, and nasal potential difference. Additionally, the researchers will obtain skin biopsy material from each subject so that induced pluripotent stem (iPS) cells can be modified into airway cell monolayers and tested for response to Trikafta. In this way, the study will evaluate an emerging and readily accessible in vitro endpoint as a predictor of clinical response. This study will serve as a pilot/test case for other clinical protocols relevant to patients with rare CFTR variants who do not currently receive modulator therapies. It is hypothesized that a robust correlation will be established between in vitro Trikafta responsiveness of iPS cells and in vivo benefit (FEV1) to patients, and will provide a new tool for utilizing iPS to identify patient populations most suitable for cystic fibrosis modulator therapy.

Type: Interventional

Start Date: Sep 2019

open study

CHaractErizing CFTR Modulated Changes in Sweat Chloride and Their Association With Clinical Outcomes
Nicole Hamblett Cystic Fibrosis
This is a multicenter, cross-sectional, cohort study which will collect contemporary sweat chloride (SC) values from approximately 5000 Cystic Fibrosis (CF) patients prescribed and currently receiving commercially approved Cystic Fibrosis transmembrane conductance regulator... expand

This is a multicenter, cross-sectional, cohort study which will collect contemporary sweat chloride (SC) values from approximately 5000 Cystic Fibrosis (CF) patients prescribed and currently receiving commercially approved Cystic Fibrosis transmembrane conductance regulator (CFTR) modulator therapies.

Type: Observational

Start Date: Jan 2018

open study

Factors That Impact the Relationship Between Pulmonary Status and Susceptibility to Electronic Cigarette...
University of Alabama at Birmingham Electronic Cigarette Use Pulmonary Disease
The purpose of the study is to explores various psycho-social, physiological, cognitive, behavioral, and environmental factors that may affect the association between pulmonary status and Susceptibility to Electronic Cigarette Use expand

The purpose of the study is to explores various psycho-social, physiological, cognitive, behavioral, and environmental factors that may affect the association between pulmonary status and Susceptibility to Electronic Cigarette Use

Type: Observational

Start Date: Jan 2020

open study

Study of Intravenous ATYR1923 for Pulmonary Sarcoidosis
aTyr Pharma, Inc. Pulmonary Sarcoidosis
This randomized, double-blind, placebo-controlled, study will evaluate the safety, tolerability, immunogenicity, pharmacokinetic (PK), and preliminary efficacy of multiple ascending doses of IV ATYR1923 in patients with pulmonary sarcoidosis undergoing a protocol-guided oral... expand

This randomized, double-blind, placebo-controlled, study will evaluate the safety, tolerability, immunogenicity, pharmacokinetic (PK), and preliminary efficacy of multiple ascending doses of IV ATYR1923 in patients with pulmonary sarcoidosis undergoing a protocol-guided oral corticosteroid (OCS) tapering regimen.This study will consist of 3 staggered multiple dose cohorts. Each eligible participant will participate in only one cohort during the study. Within each cohort, 12 participants will be randomized 2:1 to ATYR1923 (N=8) or placebo (N=4).

Type: Interventional

Start Date: Jan 2019

open study

High Resolution Micro OCT Imaging
University of Alabama at Birmingham Cystic Fibrosis COPD PCD - Primary Ciliary Dyskinesia
The purpose of this study is to learn about using the imaging to make images of the lungs and nose with the long-term goal of the research leading to potential treatments and new therapies for patients with cystic fibrosis. expand

The purpose of this study is to learn about using the imaging to make images of the lungs and nose with the long-term goal of the research leading to potential treatments and new therapies for patients with cystic fibrosis.

Type: Observational

Start Date: Apr 2016

open study

The Inotrope Evaluation and Research Patient Registry
Coram Clinical Trials Heart Failure
The INTERPRET Inotrope Evaluation and Research Patient Registry is a longitudinal, observational study designed to look at the demographics and outcomes of heart failure patients on inotropic therapy administered in the home or infusion suite setting. The data gathered in... expand

The INTERPRET Inotrope Evaluation and Research Patient Registry is a longitudinal, observational study designed to look at the demographics and outcomes of heart failure patients on inotropic therapy administered in the home or infusion suite setting. The data gathered in this registry will provide information on how a patient's quality of life and symptoms change over time while on inotrope therapy, and help healthcare providers to have a better understanding of the benefits and risks associated with bridge-to-treatment and palliative care.

Type: Observational [Patient Registry]

Start Date: Aug 2014

open study

Pain Management in Head and Neck Surgery Patients
University of Alabama at Birmingham Pain Management
Our study aims to see if the addition of a scheduled non-opioid pain regimen will decrease the use and risk of opioid pain medications as well as improve pain control in head and neck surgery patients. Participants will be randomized to one of two pain regimens (opioid medication... expand

Our study aims to see if the addition of a scheduled non-opioid pain regimen will decrease the use and risk of opioid pain medications as well as improve pain control in head and neck surgery patients. Participants will be randomized to one of two pain regimens (opioid medication regimen vs combination regimen of opioid and non-opioid medications).

Type: Interventional

Start Date: Nov 2017

open study

Metabolic Health in Individuals With Spinal Cord Injury (SCI)
University of Alabama at Birmingham Spinal Cord Injuries Skeletal Muscle Atrophy Metabolic Disease
Individuals with spinal cord injury (SCI) live longer than before and live to an age where metabolic disorders become highly prevalent. Due to loss of mobility and severe skeletal muscle atrophy, obesity, glucose intolerance, and peripheral insulin resistance develop soon... expand

Individuals with spinal cord injury (SCI) live longer than before and live to an age where metabolic disorders become highly prevalent. Due to loss of mobility and severe skeletal muscle atrophy, obesity, glucose intolerance, and peripheral insulin resistance develop soon after the onset of SCI. These abnormalities are thought to contribute to the increased diabetes disease risk and accelerated aging process in the SCI population. As a result of these trends, overall burden of complications, economic impact and reduced quality of life are increasing. Until there are effective treatments for SCI, it is imperative to develop effective interventions to mitigate metabolic disorders that develop in individuals with SCI. The proposed research project examines the impact of early utilization of a novel neuromuscular electrical stimulation (NMES) program on skeletal muscle metabolism and overall metabolic health in individuals with sub-acute, complete SCI.

Type: Interventional

Start Date: Jan 2018

open study

Evaluation of the Efficacy and Mechanisms of a Novel Intervention for Chronic Pain Tailored to People...
University of Pittsburgh Chronic Pain
Due to its prevalence and impact on quality of life and overall health, the National Academy of Medicine has called chronic pain a "public health crisis." Therefore, this proposal is relevant to public health because it seeks to improve chronic pain treatment in accordance... expand

Due to its prevalence and impact on quality of life and overall health, the National Academy of Medicine has called chronic pain a "public health crisis." Therefore, this proposal is relevant to public health because it seeks to improve chronic pain treatment in accordance with the approach recommended by the Department of Health and Human Services National Pain Strategy: to develop and test Pain Self-Management interventions tailored to the needs of vulnerable populations, particularly people living with HIV (PLWH). Chronic pain is an important and understudied comorbidity among PLWH; therefore, this proposal is responsive to the NIH's HIV Research Priorities, which identify comorbidities as a high priority research topic.

Type: Interventional

Start Date: Aug 2019

open study

The EndRAD Trial: Eliminating Total Body Irradiation (TBI) for NGS-MRD Negative Children, Adolescents,...
Children's Hospital Los Angeles B-cell Acute Lymphoblastic Leukemia
This study will evaluate the use of non- TBI (total body irradiation) conditioning for B-ALL patients with low risk of relapse as defined by absence of NGS-MRD (next generation sequencing minimal residual disease) before receiving a hematopoietic cell transplant (HCT). Patients... expand

This study will evaluate the use of non- TBI (total body irradiation) conditioning for B-ALL patients with low risk of relapse as defined by absence of NGS-MRD (next generation sequencing minimal residual disease) before receiving a hematopoietic cell transplant (HCT). Patients diagnosed with B-ALL who are candidates for HCT will be screened by NGS-MRD on a test of bone marrow done before the HCT. Subjects who are pre-HCT NGS-MRD negative will be eligible to receive a non-TBI conditioning regimen as part of the treatment cohort of the study. Subjects who are pre-HCT NGS-MRD positive will be treated as per treating center standard and will be followed in an observational cohort (HCT center standard of care).

Type: Interventional

Start Date: Aug 2018

open study

Durvalumab and Tremelimumab in Treating Patients With Recurrent Stage IV Lung Cancer
Southwest Oncology Group Recurrent Squamous Cell Lung Carcinoma Stage IV Squamous Cell Lung Carcinoma AJCC v7
This phase II trial studies how well durvalumab and tremelimumab works in treating patients with stage IV lung cancer that has come back after previous treatment. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow... expand

This phase II trial studies how well durvalumab and tremelimumab works in treating patients with stage IV lung cancer that has come back after previous treatment. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow and spread.

Type: Interventional

Start Date: Oct 2017

open study

Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic...
Optinose US Inc. Chronic Sinusitis
This is a 24-week randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of intranasal administration of 186 and 372 μg twice daily (BID) of OPN-375 in subjects with chronic sinusitis (CS) without nasal polyps expand

This is a 24-week randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of intranasal administration of 186 and 372 μg twice daily (BID) of OPN-375 in subjects with chronic sinusitis (CS) without nasal polyps

Type: Interventional

Start Date: May 2019

open study

Postoperative Aspirin and Ankle Fracture Healing
University of Alabama at Birmingham Ankle Fractures
This study aims to identify if postoperative aspirin use leads to a delay in fracture healing. NSAIDs have long been avoided in the management of fractures, due to the belief that they may impair fracture healing. As aspirin is frequently prescribed for long-term management... expand

This study aims to identify if postoperative aspirin use leads to a delay in fracture healing. NSAIDs have long been avoided in the management of fractures, due to the belief that they may impair fracture healing. As aspirin is frequently prescribed for long-term management of various medical conditions, it is worth understanding if continuing to take aspirin during the process of fracture healing has a clinically significant effect on the rate of fracture healing.

Type: Interventional

Start Date: Jun 2019

open study

Efficacy of Opioid-limiting Pain Management Protocol in Men Undergoing Urethroplasty
University of Alabama at Birmingham Pain, Postoperative Urethral Stricture
The investigator's study aims to see if an enhanced recovery regimen of pain medications before and during surgery will decrease the use and risk of opioid pain medications as well as improve pain control in anterior urethroplasty patients. Participants will be randomized... expand

The investigator's study aims to see if an enhanced recovery regimen of pain medications before and during surgery will decrease the use and risk of opioid pain medications as well as improve pain control in anterior urethroplasty patients. Participants will be randomized to one of two pain regimens (enhanced recovery regimen vs standard regimen).

Type: Interventional

Start Date: Mar 2019

open study

Oxalobacter Formigenes Colonization and Urinary Oxalate Excretion
University of Alabama at Birmingham Calcium Oxalate Urolithiasis
The purpose of this research study is to assess the efficacy of ingesting a small amount of the harmless bacterium Oxalobacter formigenes in establishing residence in the guts of human subjects and to determine whether this influences the oxalate passed in urine of healthy... expand

The purpose of this research study is to assess the efficacy of ingesting a small amount of the harmless bacterium Oxalobacter formigenes in establishing residence in the guts of human subjects and to determine whether this influences the oxalate passed in urine of healthy volunteers.

Type: Interventional

Start Date: Apr 2018

open study

Exercise Training Effects on Cognition and Brain Function in Multiple Sclerosis: Project EXACT
University of Alabama at Birmingham Multiple Sclerosis Cognitive Impairment
Cognitive impairment is highly prevalent, poorly-managed, and disabling in persons with MS and exercise training might represent a promising approach to manage this symptom of the disease. The proposed study aims to examine the effects of 3-months of supervised, progressive... expand

Cognitive impairment is highly prevalent, poorly-managed, and disabling in persons with MS and exercise training might represent a promising approach to manage this symptom of the disease. The proposed study aims to examine the effects of 3-months of supervised, progressive (both intensity and duration) treadmill walking exercise training (designed based on pilot work and American College of Sports Medicine guidelines) compared with an active control condition (i.e., stretching-and-toning activities) on cognitive processing speed and functional MRI outcomes in 88 cognitively-impaired persons with MS. This study is critical for providing evidence supporting treadmill walking exercise training as a behavioral approach for managing slowed cognitive processing speed (i.e., the most common MS-related cognitive impairment) and improving brain health in persons with MS.

Type: Interventional

Start Date: Feb 2019

open study

YES! We Can PLAY: A Physical Activity and Nutrition After-School Program for 6th Graders
University of Alabama at Birmingham Child Obesity
YES! We can PLAY: A Physical Activity and Nutrition After-School Program for 6th Graders, is a collaborative partnership between the University of Alabama at Birmingham and the Birmingham City Schools District to decrease health disparities in obesity and obesity-related diseases... expand

YES! We can PLAY: A Physical Activity and Nutrition After-School Program for 6th Graders, is a collaborative partnership between the University of Alabama at Birmingham and the Birmingham City Schools District to decrease health disparities in obesity and obesity-related diseases by increasing physical activity levels and healthy eating behavior among Birmingham youth. Because physical activity levels often decline as students transition to middle school, the proposed program seeks to impact the sports readiness of students by providing opportunities for 6th graders to participate in 60 minutes of daily moderate to vigorous physical activity (MVPA). Beginning with 6 middle schools, we aim to expand to 11 schools by the end of this project. Through the daily after-school program in which children choose from a menu of sports programming that changes every 8 weeks, the proposed intervention will increase physical literacy of the students through education related to both physical activity and nutrition as well as social-emotional learning which will increase students' ability to integrate the information and activities of the program into their lives moving forward.

Type: Interventional

Start Date: Jan 2020

open study

Regional Block for Postoperative Free Flap Care
University of Alabama at Birmingham Pain Management
The purpose of this protocol is to evaluate the safety and efficacy of regional anesthesia for head and neck patients undergoing microvascular free flap reconstruction. expand

The purpose of this protocol is to evaluate the safety and efficacy of regional anesthesia for head and neck patients undergoing microvascular free flap reconstruction.

Type: Interventional

Start Date: Jan 2020

open study