451 matching studies

Sponsor Condition of Interest
Tornier Shoulder Outcomes Study to Examine Safety and Functional Outcomes in Shoulder Arthroplasty and...
Tornier, Inc. Shoulder Arthroplasty and Fracture Repair
The Tornier Shoulder Outcomes Study is designed to collect safety and efficacy data on designated commercially available Tornier Shoulder repair products. In addition, this study will provide performance data for use in education, marketing materials, peer-reviewed publications... expand

The Tornier Shoulder Outcomes Study is designed to collect safety and efficacy data on designated commercially available Tornier Shoulder repair products. In addition, this study will provide performance data for use in education, marketing materials, peer-reviewed publications and support research and development of future products.

Type: Observational [Patient Registry]

Start Date: Mar 2014

open study

Cognitive Training Intervention and Attitudes Towards Genetics
University of Alabama at Birmingham Cognitive Impairment Hematologic Neoplasms Hematopoietic Cell Transplant
A pilot study to evaluate feasibility of enrollment of patients in an intervention to improve neurocognitive function in hematopoietic cell transplantation (HCT) survivors using the cognitive training Lumosity program. In addition, patients' interest in receiving information... expand

A pilot study to evaluate feasibility of enrollment of patients in an intervention to improve neurocognitive function in hematopoietic cell transplantation (HCT) survivors using the cognitive training Lumosity program. In addition, patients' interest in receiving information regarding genetic risk of cognitive impairment post-HCT will be measured.

Type: Interventional

Start Date: Aug 2017

open study

Randomized Trial to Assess PO Versus IV Antibiotics
Major Extremity Trauma Research Consortium Wound Infection
The goal of this study is to evaluate the effect of treatment of post-op wound infection in long bones after fracture fixation or joint fusion and either: (Group 1) operative debridement and PO antibiotic treatment for 6 weeks; or (Group 2) operative debridement and IV antibiotics... expand

The goal of this study is to evaluate the effect of treatment of post-op wound infection in long bones after fracture fixation or joint fusion and either: (Group 1) operative debridement and PO antibiotic treatment for 6 weeks; or (Group 2) operative debridement and IV antibiotics for 6 weeks. Primary Hypothesis: The rate of treatment failure by one year in Group 1 will be non-inferior to the rate in Group 2. Treatment failure is defined as wound problems that require surgery >2 weeks after initial debridement, infection recurrence, infection with a new pathogen, joint erosion, implant failure, medical problems related to the treatment administration which necessitates a switch from one arm to the other.

Type: Interventional

Start Date: Dec 2013

open study

A Study for Testing Text Messaging and Newsletter as a Strategy for Interrupting Sedentary Behavior
University of Alabama at Birmingham Multiple Sclerosis
The study will examine the possibility of reducing sedentary behavior (SB) in African Americans with MS. SB consists of any waking activities that are done lying or sitting and do not demand significant physical effort (e.g., watching television, using the computer). SB is a... expand

The study will examine the possibility of reducing sedentary behavior (SB) in African Americans with MS. SB consists of any waking activities that are done lying or sitting and do not demand significant physical effort (e.g., watching television, using the computer). SB is a major public health issue because it is associated with mortality and higher probabilities of presenting with health conditions and morbidity. There is indication that SB is related to physical disability, which is the inability of performing daily activities independently. This outcome is of high concern for persons with MS, especially those from underserved groups, such as African Americans. Thus, reducing the amount of time that people with MS spend in SB is important, but it is hard to find ways of doing so in large groups of people with MS. One possibility is to use text-messages to inform people about the necessity and benefits of interrupting SB by standing up, walking, or doing another activity. Text-messages are an ideal way to prompt behavior change because almost everyone owns a cellphone/smartphone in today's world. Considering this potential, the investigators will be studying whether or not it is possible to have a small group of African Americans with MS spend less time in SB by sending informative text-messages prompting individuals to stand-up and move around. This study will be used to inform the development of a much larger study that will aim to reduce SB in a very large sample of persons with MS.

Type: Interventional

Start Date: Mar 2018

open study

Losartan and Inflammation in Cystic Fibrosis
University of Miami Cystic Fibrosis
The purpose of the study is to examine if a specific drug called losartan (Cozaar ®), generally used to treat high blood pressure and to protect kidneys from damage in patients suffering from Diabetes Mellitus, will have any effect on the nasal inflammation in patients with cystic... expand

The purpose of the study is to examine if a specific drug called losartan (Cozaar ®), generally used to treat high blood pressure and to protect kidneys from damage in patients suffering from Diabetes Mellitus, will have any effect on the nasal inflammation in patients with cystic fibrosis (CF). The study will be performed at the Pulmonary Division at the University of Miami, Cincinnati Children's Medical Hospital Center, University of Kansas Medical Center and University of Alabama-Birmingham.

Type: Interventional

Start Date: Nov 2017

open study

Belimumab Treatment of Emphysema Patients With Anti-GRP78 Autoantibodies
University of Alabama at Birmingham Chronic Obstructive Pulmonary Disease Emphysema
This is intended to be an initial "proof-of-concept" study to show feasibility, validate assays and approaches, and explore dosing and safety of belimumab in pulmonary emphysema patients who have clinically relevant (and quantifiable) autoimmune responses. The primary goal is... expand

This is intended to be an initial "proof-of-concept" study to show feasibility, validate assays and approaches, and explore dosing and safety of belimumab in pulmonary emphysema patients who have clinically relevant (and quantifiable) autoimmune responses. The primary goal is to determine effects of belimumab on levels of autoantibodies against glucose regulated protein 78 (GRP78) among patients with pulmonary emphysema attributable to cigarette smoking. The investigators hypothesize that belimumab treatment will safely reduce circulating levels of autoantibodies that are associated with emphysema, and comorbidities of this lung disease, including atherosclerosis.

Type: Interventional

Start Date: Aug 2018

open study

Dose Escalation of Dexamethasone to Increase Duration of Transversus Abdominal Plane Block Following...
University of Alabama at Birmingham Post Surgical Pain
The study aims to improve the care of the obstetric population after cesarean section and improve total patient satisfaction by improving post-surgical pain control with the use of dexamethasone in combination with bilateral TAP blocks. The investigators will utilize a dose-escalation... expand

The study aims to improve the care of the obstetric population after cesarean section and improve total patient satisfaction by improving post-surgical pain control with the use of dexamethasone in combination with bilateral TAP blocks. The investigators will utilize a dose-escalation of dexamethasone in the TAP block to observe its effects at specific small doses. It is the hope of the investigator that the studied technique would become utilized routinely for the obstetric population following cesarean section. The investigators hope to show that the addition of dexamethasone in bilateral TAP blocks will prolong the duration of the block in a dose-dependent fashion. The investigators hope to improve post-operative pain following cesarean section, increase duration of TAP block with use of dexamethasone, decrease overall pain scores in the first 24-48 hours, and decrease opioid requirements after cesarean section. The primary endpoint will be estimation of duration of TAP block, being assessed within 48 hours after surgery. Secondary endpoints will include pain scores both in PACU and on the floor, average pain scores, time until first opioid administration, total opioid consumption in first 48 hours, use of PONV medications, and overall patient satisfaction.

Type: Interventional

Start Date: Jul 2016

open study

Alcohol Research Consortium in HIV-Intervention Research Arm
University of Alabama at Birmingham HIV Positive Alcohol Use
Aim 1: Examine effects of algorithm-guided alcohol treatment on alcohol consumption and alcohol use Disorders (AUD) symptoms. Aim 2: Examine effects of algorithm-guided alcohol treatment on retention in HIV care and HIV-related outcomes. Aim 3: Examine effects of algorithm-guided... expand

Aim 1: Examine effects of algorithm-guided alcohol treatment on alcohol consumption and alcohol use Disorders (AUD) symptoms. Aim 2: Examine effects of algorithm-guided alcohol treatment on retention in HIV care and HIV-related outcomes. Aim 3: Examine effects of algorithm-guided alcohol treatment on comorbid conditions

Type: Interventional

Start Date: Nov 2017

open study

RETHINC: REdefining THerapy In Early COPD for the Pulmonary Trials Cooperative
University of Michigan COPD (Chronic Obstructive Pulmonary Disease)
The study hypothesis is that symptomatic current and former smokers with spirometric values within the normal range (post-bronchodilator FEV1/FVC≥0.70 and post-BD FVC ≥ 70% predicted will still derive symptomatic benefit from long-acting bronchodilator therapy even though they... expand

The study hypothesis is that symptomatic current and former smokers with spirometric values within the normal range (post-bronchodilator FEV1/FVC≥0.70 and post-BD FVC ≥ 70% predicted will still derive symptomatic benefit from long-acting bronchodilator therapy even though they are excluded from current GOLD guideline recommendations.

Type: Interventional

Start Date: Aug 2017

open study

Autoantibody Reduction for Acute Exacerbations of Idiopathic Pulmonary Fibrosis
University of Alabama at Birmingham Idiopathic Pulmonary Fibrosis, Acute Fatal Form
Acute exacerbations (AE) are a dreaded manifestation of idiopathic pulmonary fibrosis (IPF) that presents with rapidly worsening respiratory function over days to weeks. AE account for about 1/2 the deaths in IPF patients, and are refractory to all medical therapies attempted... expand

Acute exacerbations (AE) are a dreaded manifestation of idiopathic pulmonary fibrosis (IPF) that presents with rapidly worsening respiratory function over days to weeks. AE account for about 1/2 the deaths in IPF patients, and are refractory to all medical therapies attempted to date. Considerable preliminary data shows pathological B-cell abnormalities and autoantibodies are present in AE-IPF and associated with disease severity. The experimental therapy here (therapeutic plasma exchange plus rituximab plus intravenous immunoglobulin) is mechanistically targeted to ameliorate autoantibody-mediated pulmonary injury. Anecdotal pilot studies indicate these treatments have significant benefit for a disease syndrome that has, until now, been almost invariably inexorable. This clinical trial has the potential to profoundly affect current paradigms and treatment approaches to patients with AE-IPF.

Type: Interventional

Start Date: Sep 2018

open study

Voice and Swallowing Outcomes Following Revision Anterior Cervical Spine Surgery
University of Alabama at Birmingham Dysphagia Dysphonia
Evaluate voice and swallowing outcomes post operatively. expand

Evaluate voice and swallowing outcomes post operatively.

Type: Observational

Start Date: Oct 2009

open study

Glaucoma Management Optimism for African Americans Living With Glaucoma
University of Alabama at Birmingham Glaucoma
African Americans (AA) are at higher risk to develop and go blind from glaucoma than Caucasians. While glaucoma medications can help delay disease progression and possible blindness, problems with poor adherence have been documented for both racial groups, with a greater prevalence... expand

African Americans (AA) are at higher risk to develop and go blind from glaucoma than Caucasians. While glaucoma medications can help delay disease progression and possible blindness, problems with poor adherence have been documented for both racial groups, with a greater prevalence among AA. Of the very few interventions targeting glaucoma medication adherence studied to date, several methodological limitations persist. For example, few have been subjected to rigorous randomized clinical trial (RCT) designs, the intervention itself was designed and studied predominantly among Caucasians and thereby limiting generalizability, the effects on adherence have been short-term, most have been evaluated on small sample sizes, and/or the focus of the intervention was solely on providing patient education regarding eye disease and management. Needed in this important yet understudied area are culturally-relevant, health promotion-based approaches which are 1) targeted to high risk populations, 2) theoretically driven, 3) relevant to the beliefs, language, and values of underserved populations as well as challenges related to glaucoma medication adherence, 4) designed to promote preparation and readiness to engage in healthy behaviors, and 5) train patients in skills to use in order to more effectively problem-solve ongoing obstacles related to adherence. The investigators published a paper in the Journal of Glaucoma investigating determinants related to objective medication adherence as measured by an electronic dosing aid (DA). Findings revealed poorer rates of adherence among AA patients with glaucoma compared to Caucasian patients with glaucoma. Evidence for racial differences in adherence have also been increasingly documented in the glaucoma literature. In a follow-up study with focus groups of AA's with glaucoma that was published in Optometry and Vision Sciences, the goal was to identify the specific barriers and facilitators related to glaucoma medication adherence among this high-risk group. Several key themes emerged such as patient, provider, and socioeconomic factors, along with barriers in views of health, perceived harm from treatment, costs, avoidant coping styles, forgetfulness, and in eyedrop administration/scheduling. The investigators used these results along with guidance from a consumer advisory board consisting of AA patients with glaucoma in order to develop and pilot test the resulting culturally relevant, health promotion-based intervention. The pilot data demonstrated feasibility and favorable preliminary efficacy for the intervention to significantly improve medication adherence to further pursue in a clinical trial.

Type: Interventional

Start Date: Jul 2018

open study

NRT Sampling and Selection to Increase Medication Adherence
University of Alabama at Birmingham Smoking Cessation
To determine the preliminary impact on Nicotine Replacement Therapy (NRT)adherence and examine the underlying mechanisms of action associated with adherence. expand

To determine the preliminary impact on Nicotine Replacement Therapy (NRT)adherence and examine the underlying mechanisms of action associated with adherence.

Type: Interventional

Start Date: May 2018

open study

Speed of Processing Training for Cognitive Deficits After Delirium in Older Adults
University of Alabama at Birmingham Delirium Dementia
In this proposal, we will examine processing speed training (PST) as a potential intervention to reduce the risk of developing long-term cognitive impairment after a delirium episode. expand

In this proposal, we will examine processing speed training (PST) as a potential intervention to reduce the risk of developing long-term cognitive impairment after a delirium episode.

Type: Interventional

Start Date: Aug 2018

open study

Vaccine Therapy in Preventing Human Papillomavirus Infection in Younger Cancer Survivors
University of Alabama at Birmingham Cancer Survivor Prevention of Human Papillomavirus Infection
This trial will comprehensively evaluate the human papillomavirus (HPV) vaccine in cancer survivors between 9 and 26 years of age by (1) determining the prevalence of HPV vaccine initiation among young cancer survivors, and (2) determining the immune response to and safety/tolerability... expand

This trial will comprehensively evaluate the human papillomavirus (HPV) vaccine in cancer survivors between 9 and 26 years of age by (1) determining the prevalence of HPV vaccine initiation among young cancer survivors, and (2) determining the immune response to and safety/tolerability of the quadrivalent and nonavalent HPV vaccine in young cancer survivors.

Type: Interventional

Start Date: Jul 2012

open study

Fludarabine / Total Body Irradiation Regimen for ALLO HCT in Acute Lymphoblastic Leukemia
University of Alabama at Birmingham Adult Lymphoblastic Lymphoma
The goal of this research is to test if the conditioning regimen, fludarabine and total body irradiation (FluTBI), can lead to a safer and more effective stem cell transplant treatment regimen for ALL patients older than 40 years of age and/or younger patients with high risk... expand

The goal of this research is to test if the conditioning regimen, fludarabine and total body irradiation (FluTBI), can lead to a safer and more effective stem cell transplant treatment regimen for ALL patients older than 40 years of age and/or younger patients with high risk medical conditions. The primary objective is to establish the efficacy of allo HCT in older ALL patients using myeloablative FluTBI conditioning regimen. The investigators are also assessing the safety and toxicity of allo HCT in older ALL patients using myeloablative FluTBI conditioning regimen.

Type: Interventional

Start Date: Sep 2013

open study

Personalized CRT - MPP Post Approval Study
Medtronic Heart Failure
The purpose of this Post-Approval Study (PAS) is to evaluate the effectiveness of MPP to improve CRT response in the non-responder patient population when used in "real-world" clinical practice, following commercial release. This evaluation is based on the Clinical Composite... expand

The purpose of this Post-Approval Study (PAS) is to evaluate the effectiveness of MPP to improve CRT response in the non-responder patient population when used in "real-world" clinical practice, following commercial release. This evaluation is based on the Clinical Composite Score which summarizes the proportions and frequencies of CRT non-responder patients who are "improved", "unchanged" or "worsened" after receiving MPP therapy. Patients will be followed for the duration of the PAS. This study is required by FDA as a condition of approval of the MPP feature and is integrated within the Product Surveillance Registry (PSR).

Type: Observational [Patient Registry]

Start Date: Jul 2017

open study

Neoadjuvant Therapy Followed by Stereotactic Body Radiotherapy (SBRT) for Locally Advanced Pancreatic...
University of Alabama at Birmingham Pancreas Cancer
The purpose of this study is to evaluate a new treatment routine for patients with borderline resectable and unresectable pancreas cancers. expand

The purpose of this study is to evaluate a new treatment routine for patients with borderline resectable and unresectable pancreas cancers.

Type: Interventional

Start Date: Feb 2017

open study

Phase ll Study of Pirfenidone in Patients With RAILD (TRAIL1)
Ivan O. Rosas Rheumatoid Arthritis Interstitial Lung Disease
The purpose of this study is to to assess the safety and tolerability of pirfenidone 2403 mg/day for the treatment of RA-associated interstitial lung disease. expand

The purpose of this study is to to assess the safety and tolerability of pirfenidone 2403 mg/day for the treatment of RA-associated interstitial lung disease.

Type: Interventional

Start Date: Apr 2017

open study

Ibrutinib in Treating Patients With Refractory or Relapsed Lymphoma After Donor Stem Cell Transplant
Vanderbilt-Ingram Cancer Center Blastoid Variant Mantle Cell Lymphoma Recurrent Chronic Lymphocytic Leukemia Recurrent Follicular Lymphoma Recurrent Hodgkin Lymphoma Recurrent Mantle Cell Lymphoma
This phase II trial studies how well ibrutinib works in treating patients after a donor stem cell transplant for lymphoma that is not responding to treatment or has come back. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.... expand

This phase II trial studies how well ibrutinib works in treating patients after a donor stem cell transplant for lymphoma that is not responding to treatment or has come back. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Type: Interventional

Start Date: Sep 2016

open study

INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure
Brigham and Women's Hospital Heart Failure Myocardial Infarction
INVESTED will test the hypothesis that high dose trivalent influenza vaccine will reduce cardiopulmonary events to a greater extent than standard dose quadrivalent influenza vaccine in high-risk cardiovascular patients with a recent history of myocardial infarction or heart failure.... expand

INVESTED will test the hypothesis that high dose trivalent influenza vaccine will reduce cardiopulmonary events to a greater extent than standard dose quadrivalent influenza vaccine in high-risk cardiovascular patients with a recent history of myocardial infarction or heart failure. The trial will enroll 9300 participants over one Vanguard (pilot) season and three additional influenza seasons. The primary endpoint will be a composite of all-cause mortality or cardiopulmonary hospitalization.

Type: Interventional

Start Date: Aug 2016

open study

Music Therapy Versus Control for Total Knee Arthroplasty
University of Alabama at Birmingham Arthroplasty, Replacement, Knee
For millennia, people have listened to and enjoyed music for entertainment, as a distraction from daily troubles, and as a means to relax and relieve stress. It is no real surprise that the relaxing and stress-relieving effects of music have been shown in patients having surgery.... expand

For millennia, people have listened to and enjoyed music for entertainment, as a distraction from daily troubles, and as a means to relax and relieve stress. It is no real surprise that the relaxing and stress-relieving effects of music have been shown in patients having surgery. For patients having surgery with spinal anesthesia, music therapy during the operation decreases sedation requirements, anxiety and may improve patient satisfaction. Music therapy during surgery may also lead to a decreased stress response, as evidenced by more stable cortisol levels. Studies done previously have included patients undergoing various surgical procedures, however no studies have been done specifically for patients undergoing total knee arthroplasty. Because total knee arthroplasty is a common procedure usually done under spinal anesthesia at our institution, we would like to study the effects music therapy could have on our patient population.

Type: Interventional

Start Date: Oct 2018

open study

Lung-MAP: Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous...
Southwest Oncology Group Recurrent Squamous Cell Lung Carcinoma Stage IV Squamous Cell Lung Carcinoma AJCC v7
This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid ?Master Protocol? (S1400). The type of cancer trait... expand

This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid ?Master Protocol? (S1400). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes a ?non-match? sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of care also with the goal of approval.

Type: Interventional

Start Date: Jun 2014

open study

The Topic Trial - Study to Determine the Safety and Efficacy of Ivacaftor
University of Alabama at Birmingham Chronic Obstructive Pulmonary Disease Chronic Bronchitis
The study is a Phase 2 Study to establish the safety and efficacy of a drug called Ivacaftor (VX-770) in patients with chronic obstructive pulmonary disease (COPD), chronic bronchitis, and acquired CFTR dysfunction as detected by sweat chloride analysis. The design is a pilot,... expand

The study is a Phase 2 Study to establish the safety and efficacy of a drug called Ivacaftor (VX-770) in patients with chronic obstructive pulmonary disease (COPD), chronic bronchitis, and acquired CFTR dysfunction as detected by sweat chloride analysis. The design is a pilot, randomized (3:1, active:placebo), double-blind, placebo-controlled study. Approximately 40 subjects with COPD will be randomized.

Type: Interventional

Start Date: Mar 2017

open study

Determination of the Independent Effects of Beetroot Juice Components, Dietary Nitrate and Antioxidants,...
University of Alabama at Birmingham Metabolic Disease Obesity Exercise
The purpose of this study is to assess the effects of acute beetroot juice supplementation on exercise performance and cardiometabolic health in obese individuals with secondary cardiometabolic complications. Additionally, we will determine if the ergogenic health benefits of... expand

The purpose of this study is to assess the effects of acute beetroot juice supplementation on exercise performance and cardiometabolic health in obese individuals with secondary cardiometabolic complications. Additionally, we will determine if the ergogenic health benefits of beetroot juice is due to the nitric oxide compound within the product, the antioxidant compound within the product, or a combination of the two compounds.

Type: Interventional

Start Date: Aug 2018

open study