519 matching studies

Sponsor Condition of Interest
Topical Chemoprevention of Skin Cancer Biomarkers
University of Alabama at Birmingham Non-melanoma Skin Cancer
This research study will test how well one topical medications work to prevent the development of non-melanoma skin cancers by reversing certain biomarkers in the skin. This study is also looking at the optimal dose of a medication in a small number of people. Biomarkers are... expand

This research study will test how well one topical medications work to prevent the development of non-melanoma skin cancers by reversing certain biomarkers in the skin. This study is also looking at the optimal dose of a medication in a small number of people. Biomarkers are molecules that are found in the body and inside of cells. Some biomarkers are associated with specific diseases such as skin cancer. In this study, one topical medication will be evaluated; diclofenac. Diclofenac and is approved by the Food and Drug Administration (FDA) for other uses. 24 patients will be enrolled in this study by University of Alabama at Birmingham.

Type: Interventional

Start Date: Feb 2016

open study

Clinical Effectiveness Of High Frequency Chest Wall Oscillation (HFCWO) In A Bronchiectasis Population
Electromed, Inc. Bronchiectasis
The primary objective is to compare the patient's baseline QoL prior to HFCWO use against the patient's QoL at various study timepoints over a one-year period of HFCWO use. expand

The primary objective is to compare the patient's baseline QoL prior to HFCWO use against the patient's QoL at various study timepoints over a one-year period of HFCWO use.

Type: Observational

Start Date: Feb 2020

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

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

Physical Therapy After Reverse Total Shoulder Arthroplasty
University of Alabama at Birmingham Orthopedic Disorder
A common operation for various shoulder conditions is a total shoulder arthroplasty (TSA). In cases with severe rotator cuff tears or other conditions, a variant of the procedure called a reverse total shoulder arthroplasty may be performed. It is unclear whether or not patients... expand

A common operation for various shoulder conditions is a total shoulder arthroplasty (TSA). In cases with severe rotator cuff tears or other conditions, a variant of the procedure called a reverse total shoulder arthroplasty may be performed. It is unclear whether or not patients require formal physical therapy (as opposed to no physical therapy with recommended avoided movements) after reverse TSA. Orthopaedic surgeons have varying opinions on the postoperative rehabilitation protocol for reverse TSA, with some surgeons not prescribing any physical therapy. The purpose of this study is to randomize patients into two groups: one that sees a physical therapist after their reverse TSA, and one that is provided with actions not to perform and are allowed to self-rehabilitate.

Type: Interventional

Start Date: Feb 2019

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

ENRICH: Early MiNimally-invasive Removal of IntraCerebral Hemorrhage (ICH)
Nico Corporation Intracerebral Hemorrhage Cerebral Hemorrhage Intracerebral Haemorrhage
This is a multicenter, randomized, adaptive clinical trial comparing standard medical management to early (<24 hours) surgical hematoma evacuation using minimally invasive parafascicular surgery (MIPS) in the treatment of acute spontaneous supratentorial intracerebral hemorrhage.... expand

This is a multicenter, randomized, adaptive clinical trial comparing standard medical management to early (<24 hours) surgical hematoma evacuation using minimally invasive parafascicular surgery (MIPS) in the treatment of acute spontaneous supratentorial intracerebral hemorrhage.

Type: Interventional

Start Date: Dec 2016

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

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

Impact of Physical Activity and Diet on Symptom Experience in People Living With HIV
Case Western Reserve University HIV/AIDS
We will conduct a four-year, observational study of 850 participants to measure physical activity and diet, once a year for three years. All participants will also complete the standard Centers for AIDS Research (CFAR) Network of Integrated Clinical Systems (CNICS) patient-reported... expand

We will conduct a four-year, observational study of 850 participants to measure physical activity and diet, once a year for three years. All participants will also complete the standard Centers for AIDS Research (CFAR) Network of Integrated Clinical Systems (CNICS) patient-reported outcomes (PRO) and clinical assessment procedures. An enhanced PRO assessment (consisting measures of physical activity, diet intake and anthropomorphic factors) will be included after the routine patient clinic visit at four CNICS sites: Case Western Reserve University, University of Alabama at Birmingham, University of Washington, and Fenway Health.

Type: Observational

Start Date: Jan 2019

open study

RAD 1601: EDGE Radiosurgery for Intractable Essential Tremor and Tremor-Dominant Parkinson's Disease
University of Alabama at Birmingham Essential Tremor Parkinson Disease
To determine the efficacy of frameless Virtual Cone Radiosurgical Thalamotomy for medically refractory tremor resulting from either Essential Tremor or Tremor-Dominant Parkinson's Disease with the Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS) in patients who are not candidates... expand

To determine the efficacy of frameless Virtual Cone Radiosurgical Thalamotomy for medically refractory tremor resulting from either Essential Tremor or Tremor-Dominant Parkinson's Disease with the Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS) in patients who are not candidates for deep brain stimulation (DBS).

Type: Interventional

Start Date: Dec 2017

open study

VX-770 for the Treatment of Chronic Bronchitis
University of Alabama at Birmingham Chronic Bronchitis
This research study will test how well a new drug affects bronchiectasis or chronic bronchitis. The new drug, Ivacaftor (KALYDECO), is a drug that has recently been approved by the U.S. Food and Drug Administration (FDA) for patients with a lung disease called Cystic Fibrosis... expand

This research study will test how well a new drug affects bronchiectasis or chronic bronchitis. The new drug, Ivacaftor (KALYDECO), is a drug that has recently been approved by the U.S. Food and Drug Administration (FDA) for patients with a lung disease called Cystic Fibrosis (CF). It has not been approved for use in patients with bronchiectasis or chronic bronchitis.

Type: Interventional

Start Date: Jan 2020

open study

Enhancing Shared Decision-Making in Breast Cancer
University of Alabama at Birmingham Shared Decision Making
The objective of this trial is to conduct a two-arm, randomized controlled trial (RCT) of SDM Treatment Plans (TPs) delivered at the time of decision-making compared to standard oncology care (delayed delivery of standard-of-care TPs) to determine impact on SDM. The intervention... expand

The objective of this trial is to conduct a two-arm, randomized controlled trial (RCT) of SDM Treatment Plans (TPs) delivered at the time of decision-making compared to standard oncology care (delayed delivery of standard-of-care TPs) to determine impact on SDM. The intervention will be piloted in a RCT with 140 early stage breast cancer (EBC) and 140 metastatic breast cancer (MBC) patients to assess impact. Subjects will be enrolled across two sites. Our primary outcome will be the increase in percentage of patients reporting a perception of shared decision-making. Aim.1: The primary outcome will be to evaluate the impact of the SDM intervention on the percentage of patients perceiving shared or greater role in decision-making. Aim 2: To evaluate the impact of the SDM intervention on provider outcomes including the percentage of providers perceiving SDM with the patient, number of treatment options offered to patients, the proportion of times that clinical trials are offered to patients, the use of NCCN guideline-based treatment, and self-report of treatment plan use. Aim 3: Secondary fidelity and provider outcomes from audio recording will include whether providers elicit: any patient preferences during treatment planning, preferences related to physical side effects or efficacy, or preferences related to other aspects of the patient experience. We will also assess whether providers use the TP in the decision-making discussion and whether providers discuss or offer clinical trials to the patient.

Type: Interventional

Start Date: Dec 2018

open study

A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study...
Minneamrita Therapeutics LLC Advanced Cancer Gastric Cancer Breast Cancer Pancreatic Cancer Prostate Cancer Metastatic
A Phase I, Multicenter, Open-label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Minnelideā„¢Capsules given daily for 21 days followed by 7 days off schedule in patients with Advanced Solid Tumors expand

A Phase I, Multicenter, Open-label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Minnelideā„¢Capsules given daily for 21 days followed by 7 days off schedule in patients with Advanced Solid Tumors

Type: Interventional

Start Date: Oct 2017

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

Effects of Individual Intervention for Men in Focused Deterrence Program
University of Alabama at Birmingham Violence
This project will implement and evaluate a community-based intervention to improve individual outcomes in violence-related injuries and homicide. Young African American men participating in a focused deterrence program (the Birmingham Violence Reduction Initiative, BVRI) will be... expand

This project will implement and evaluate a community-based intervention to improve individual outcomes in violence-related injuries and homicide. Young African American men participating in a focused deterrence program (the Birmingham Violence Reduction Initiative, BVRI) will be randomized to receive an additional individual intervention based on the cognitive-behavioral Reasoning and Rehabilitation program.

Type: Interventional

Start Date: Mar 2018

open study

Impact of CCR5 Blockade in HIV+ Kidney Transplant Recipients
National Institute of Allergy and Infectious Diseases (NIAID) HIV Infections Kidney Diseases
Maraviroc (MVC) is a type of HIV medicine called a CCR5 inhibitor. This study will evaluate the safety and tolerability of MVC in HIV-infected adults receiving a kidney transplant. expand

Maraviroc (MVC) is a type of HIV medicine called a CCR5 inhibitor. This study will evaluate the safety and tolerability of MVC in HIV-infected adults receiving a kidney transplant.

Type: Interventional

Start Date: Jan 2017

open study

A Study Investigating the Efficacy, Safety, and PK Profile of ANB020 Administered to Adult Subjects With...
AnaptysBio, Inc. Atopic Dermatitis
This study is designed to evaluate the efficacy, safety, and pharmacokinetic (PK) profiles of multiple doses of ANB020 in subjects with atopic dermatitis (AD). expand

This study is designed to evaluate the efficacy, safety, and pharmacokinetic (PK) profiles of multiple doses of ANB020 in subjects with atopic dermatitis (AD).

Type: Interventional

Start Date: May 2018

open study

American Hepato-Pancreato-Biliary Association (AHPBA) Pancreatic Irreversible Electroporation (IRE) Registry
University of Louisville Pancreatic Cancer
The purpose of this study is to create a registry to provide insight into treatment selection and treatment outcome of pancreatic IRE in order to develop an evidence base such that physicians can provide the best possible care to patients with pancreatic cancer requiring surgical... expand

The purpose of this study is to create a registry to provide insight into treatment selection and treatment outcome of pancreatic IRE in order to develop an evidence base such that physicians can provide the best possible care to patients with pancreatic cancer requiring surgical interventions. The investigators seek a better understanding of the uses of ablation in the treatment of unresectable soft tissue pancreatic tumors and the limitations, concerns and complications that earlier users have.

Type: Observational [Patient Registry]

Start Date: Jan 2016

open study