470 matching studies

Sponsor Condition of Interest
Natural History Study of SCID Disorders
National Institute of Allergy and Infectious Diseases (NIAID) Severe Combined Immunodeficiency (SCID) Leaky SCID Omenn Syndrome Reticular Dysgenesis ADA SCID
This study is a prospective evaluation of children with Severe Combined Immune Deficiency (SCID) who are treated under a variety of protocols used by participating institutions. In order to determine the patient, recipient and transplant-related variables that are most important... expand

This study is a prospective evaluation of children with Severe Combined Immune Deficiency (SCID) who are treated under a variety of protocols used by participating institutions. In order to determine the patient, recipient and transplant-related variables that are most important in determining outcome, study investigators will uniformly collect pre-, post- and peri-transplant (or other treatment) information on all children enrolled into this study. Children will be divided into three strata: - Stratum A: Typical SCID with virtual absence of autologous T cells and poor T cell function - Stratum B: Atypical SCID (leaky SCID, Omenn syndrome and reticular dysgenesis with limited T cell diversity or number and reduced function), and - Stratum C: ADA deficient SCID and XSCID patients receiving alternative therapy including PEG-ADA ERT or gene therapy. Each Group/Cohort Stratum will be analyzed separately.

Type: Observational

Start Date: Sep 2010

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

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

Personalized Theratyping Trial
University of Alabama at Birmingham Cystic Fibrosis
The purpose of this study is to explore the use of off-label CFTR modulators that may affect CFTR function in patients with CFTR mutations that are not currently approved for these drugs. expand

The purpose of this study is to explore the use of off-label CFTR modulators that may affect CFTR function in patients with CFTR mutations that are not currently approved for these drugs.

Type: Interventional

Start Date: Aug 2019

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

Effect of Preoperative Mobility Device Training on Postoperative Fall Incidence
University of Alabama at Birmingham Injury; Muscle, Ankle, and Foot, Multiple
The purpose of this study is to determine whether preoperative mobility device training is beneficial in reducing incidence of postoperative falls in patients undergoing elective foot and ankle surgery requiring a postoperative period of no weight-bearing. expand

The purpose of this study is to determine whether preoperative mobility device training is beneficial in reducing incidence of postoperative falls in patients undergoing elective foot and ankle surgery requiring a postoperative period of no weight-bearing.

Type: Interventional

Start Date: Sep 2019

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

Investigation of Microbiomes of Postmenopausal Women Looking for Outcomes and Response to Estrogen Therapy
University of Alabama at Birmingham Female Urogenital Diseases Vaginal Atrophy Postmenopausal Atrophic Vaginitis Genitourinary Disease Postmenopausal Symptoms
In this proposed pilot study, 16S ribosomal RNA (rRNA) gene sequencing will be used in the analysis of bacterial communities (microbiomes) in postmenopausal women with vulvovaginal atrophy (VVA) before and after eight weeks of vaginal estrogen use. The investigators plan to characterize... expand

In this proposed pilot study, 16S ribosomal RNA (rRNA) gene sequencing will be used in the analysis of bacterial communities (microbiomes) in postmenopausal women with vulvovaginal atrophy (VVA) before and after eight weeks of vaginal estrogen use. The investigators plan to characterize the composition and dynamics of the microbiomes of the vagina, bladder, and rectum for quantitative and qualitative changes in the distribution of operational taxonomic units (OTUs) before and after eight weeks of local vaginal estrogen therapy. Although the vagina, bladder, and gut microbiomes have been increasingly independently studied, less is known about the interactions of the bacterial communities among the three environments as well as the dynamic relationship with menopausal status and vaginal estrogen therapy and the investigators seek to elucidate these relationships further.

Type: Interventional

Start Date: Aug 2019

open study

Standard or Comprehensive Radiation Therapy in Treating Patients With Early-Stage Breast Cancer Previously...
NSABP Foundation Inc Stage IB Breast Cancer Stage II Breast Cancer
This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation... expand

This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer

Type: Interventional

Start Date: Aug 2013

open study

Study of ProTmune for Allogeneic HCT in Adult Patients With Hematologic Malignancies
Fate Therapeutics Hematologic Malignancies Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndromes Chronic Myelogenous Leukemia
This study is a Phase 1, Non-randomized, Open-label/Phase 2 Randomized, Blinded Study of ProTmune (ex vivo programmed mobilized peripheral blood cells) Versus Non-programmed mobilized peripheral blood cells for Allogeneic Hematopoietic Cell Transplantation (HCT) in Adult Subjects... expand

This study is a Phase 1, Non-randomized, Open-label/Phase 2 Randomized, Blinded Study of ProTmune (ex vivo programmed mobilized peripheral blood cells) Versus Non-programmed mobilized peripheral blood cells for Allogeneic Hematopoietic Cell Transplantation (HCT) in Adult Subjects Aged 18 years and older with Hematologic Malignancies. A maximum of 80 total eligible subjects will be enrolled and treated in the trial at approximately 15-20 centers in the US.

Type: Interventional

Start Date: Jun 2016

open study

Palbociclib in Real World Practice
Pfizer Advanced Breast Cancer Metastatic Breast Cancer
This Non-Interventional Study will describe and analyze the clinical use of palbociclib in routine clinical practice in the treatment of advanced breast cancer. expand

This Non-Interventional Study will describe and analyze the clinical use of palbociclib in routine clinical practice in the treatment of advanced breast cancer.

Type: Observational

Start Date: Jan 2017

open study

Diet and Exercise After Pancreatic Cancer
University of Alabama at Birmingham Pancreatic Cancer
Determine feasibility of a randomized controlled trial (RCT) in pancreatic cancer patients comparing the effects of diet alone vs. diet+exercise on functional and clinical outcomes. expand

Determine feasibility of a randomized controlled trial (RCT) in pancreatic cancer patients comparing the effects of diet alone vs. diet+exercise on functional and clinical outcomes.

Type: Interventional

Start Date: Aug 2017

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

Denosumab In Addition To Intense Urate-Lowering Therapy for Bone Erosions
University of Alabama at Birmingham Gout
Bone erosions are a common manifestation and feature of structural damage in severe/chronic tophaceous gout. Management of this destructive and often debilitating gout complication has focused exclusively on urate-lowering therapy (ULT) to reduce frequency of gout attacks, but... expand

Bone erosions are a common manifestation and feature of structural damage in severe/chronic tophaceous gout. Management of this destructive and often debilitating gout complication has focused exclusively on urate-lowering therapy (ULT) to reduce frequency of gout attacks, but little attention has been given to prevention or reversal of gout related bone erosions and other structural damage to bone caused by gout. Since there is no known effective treatment to attenuate or improve structural damage caused by gout, we propose a pilot, controlled, proof-of-concept study in which denosumab, an FDA approved medication for the treatment of bone loss, will be added to standard ULT in 20 patients with erosive gout.

Type: Interventional

Start Date: Feb 2017

open study

Nasal Potential Difference (NPD) Protocol in Chronic Rhinosinusitis
University of Alabama at Birmingham Rhinosinusitis
The purpose of this study is to determine if acquired (partial) Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) deficiency contributes substantially to the pathogenic mechanisms underlying Chronic Rhinosinusitis (CRS), creating a localized environment that impairs... expand

The purpose of this study is to determine if acquired (partial) Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) deficiency contributes substantially to the pathogenic mechanisms underlying Chronic Rhinosinusitis (CRS), creating a localized environment that impairs mucociliary clearance (MCC).

Type: Observational

Start Date: Jan 2015

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

QPI-1002 Phase 3 for Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for AKI...
Quark Pharmaceuticals Cardiac Surgery
This trial is designed to evaluate QPI-1002 versus placebo for the prevention of Major Adverse Kidney Events (MAKE) in subjects at high risk for acute kidney injury following cardiac surgery. Half of the participants will receive QPI-1002 while the other half will receive placebo.... expand

This trial is designed to evaluate QPI-1002 versus placebo for the prevention of Major Adverse Kidney Events (MAKE) in subjects at high risk for acute kidney injury following cardiac surgery. Half of the participants will receive QPI-1002 while the other half will receive placebo.

Type: Interventional

Start Date: May 2018

open study

Treatment of Chronic Antibody-mediated Rejection in Kidney Transplant With Acthar
University of Maryland, Baltimore Transplant Glomerulopathy
This is an open label safety and feasibility trial using Acthar® in addition to the investigators center-specific standard therapy, which could include increase in maintenance immunosuppression, high dose IVIG (2 g/Kg), and/or Rituximab, in patients with CAMR. expand

This is an open label safety and feasibility trial using Acthar® in addition to the investigators center-specific standard therapy, which could include increase in maintenance immunosuppression, high dose IVIG (2 g/Kg), and/or Rituximab, in patients with CAMR.

Type: Interventional

Start Date: Aug 2016

open study

DCM Precision Medicine Study
Ray Hershberger Idiopathic Dilated Cardiomyopathy
The aims of the DCM Precision Medicine Study are to test the hypothesis that DCM has substantial genetic basis and to evaluate the effectiveness of a family communication intervention in improving the uptake and impact of family member clinical screening. expand

The aims of the DCM Precision Medicine Study are to test the hypothesis that DCM has substantial genetic basis and to evaluate the effectiveness of a family communication intervention in improving the uptake and impact of family member clinical screening.

Type: Interventional

Start Date: Jun 2016

open study

Non-Surgical Treatment for Rotator-Cuff Tears Using Platelet-Rich-Plasma
University of Alabama at Birmingham Partial Tear of Rotator Cuff Tendinopathy of Rotator Cuff
The goal of this project is to identify an effective and conservative approach to treating partial thickness rotator cuff tears (PTRCT) that otherwise would end with a surgical correction needed. expand

The goal of this project is to identify an effective and conservative approach to treating partial thickness rotator cuff tears (PTRCT) that otherwise would end with a surgical correction needed.

Type: Interventional

Start Date: Jul 2014

open study

Obesity and Endogenous Oxalate Synthesis
University of Alabama at Birmingham Obesity Kidney Stone
The goal of this proposal is to determine the contribution and significance of obesity to urinary oxalate excretion and thus calcium oxalate kidney stone disease. Successful completion of the study will provide insight into the link between obesity and kidney stone disease and... expand

The goal of this proposal is to determine the contribution and significance of obesity to urinary oxalate excretion and thus calcium oxalate kidney stone disease. Successful completion of the study will provide insight into the link between obesity and kidney stone disease and should identify future strategies to treat this disease.

Type: Interventional

Start Date: Jan 2013

open study

Smart Telehealth Exercise Intervention to Reduce COPD Readmissions
University of Alabama at Birmingham Chronic Obstructive Pulmonary Disease
This is a prospective randomized controlled study to test the hypothesis that neuromuscular electrical stimulation (NMES) and remote pulmonary rehabilitation at home offered via a smart technology, called Smart TeleHealth, results in a reduction of systemic inflammation, via... expand

This is a prospective randomized controlled study to test the hypothesis that neuromuscular electrical stimulation (NMES) and remote pulmonary rehabilitation at home offered via a smart technology, called Smart TeleHealth, results in a reduction of systemic inflammation, via reduction of skeletal muscle tissue inflammation, and thereby improves functional capacity, and thus, reduces the rate of readmissions following hospitalization for acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD). This study will enroll up to 40 participants at UAB, about 30 will get Smart Telehealth and NMES, and 10 will get usual care.

Type: Interventional

Start Date: Jul 2016

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

P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation
CeraPedics, Inc Degenerative Disc Disease
The aim of this trial is to evaluate if P-15L bone graft (investigational device) is not inferior in effectiveness and safety to local autologous bone (and allograft where necessary) as an extender (control device) when applied in instrumented transforaminal lumbar interbody... expand

The aim of this trial is to evaluate if P-15L bone graft (investigational device) is not inferior in effectiveness and safety to local autologous bone (and allograft where necessary) as an extender (control device) when applied in instrumented transforaminal lumbar interbody fusion (TLIF) in subjects with degenerative disc disease (DDD). In addition to the general overall objective, a sub-group analysis will be performed on the high-risk subject population (tobacco use, obesity, diabetes), as previous studies have shown negative effects of smoking, obesity and diabetes on fusion and bone healing, increased peri/postoperative complications, and lower patient-reported outcome scores.

Type: Interventional

Start Date: Apr 2018

open study

Precision Event Monitoring for Patients With Heart Failure Using HeartLogic
Boston Scientific Corporation Heart Failure Defibrillators, Implantable Monitoring, Physiologic Cardiac Resynchronization Therapy Cardiovascular Disease
The goal of the PREEMPT-HF study is to collect device and clinical event data to evaluate extended applications of the HeartLogic Heart Failure Diagnostic (HeartLogic) in a broad spectrum of heart failure patients with an implantable cardioverter defibrillator or cardiac resynchronization... expand

The goal of the PREEMPT-HF study is to collect device and clinical event data to evaluate extended applications of the HeartLogic Heart Failure Diagnostic (HeartLogic) in a broad spectrum of heart failure patients with an implantable cardioverter defibrillator or cardiac resynchronization therapy defibrillator. There are no primary safety and/or efficacy endpoints for this study. Heart failure is a complex clinical syndrome with high morbidity, mortality, and economic burden. Chronic Heart Failure is persistent, gradually progressive, and punctuated by episodes of acute worsening leading to hospitalizations. Therefore, there remains an unmet clinical need to slow the progression of Heart Failure and prevent hospitalizations. HeartLogic, available in Boston Scientific cardiac resynchronization therapy devices and defibrillators, combines novel sensor parameters such as heart sounds and respiration with other measurements like thoracic impedance, heart rate, and activity into a HeartLogic Index for the early detection of worsening Heart Failure. However, there is limited data on the association of HeartLogic with the risk of Hear Failure readmissions and tachyarrhythmias, or for phenotyping the broad spectrum of Heart Failure patients.

Type: Observational

Start Date: Jun 2018

open study