449 matching studies

Sponsor Condition of Interest
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

A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole...
Pfizer Breast Cancer
This is a multicenter, open label, Phase 1b study in patients with mBC. This study will have a dose escalation to identify the maximum tolerated dose (MTD) of the combination of gedatolisib plus palbociclib/fulvestrant and gedatolisib plus palbociclib/letrozole and expansion... expand

This is a multicenter, open label, Phase 1b study in patients with mBC. This study will have a dose escalation to identify the maximum tolerated dose (MTD) of the combination of gedatolisib plus palbociclib/fulvestrant and gedatolisib plus palbociclib/letrozole and expansion to estimate the objective response rate (OR) of the combination of gedatolisib plus palbociclib/letrozole or palbociclib/fulvestrant.

Type: Interventional

Start Date: Jun 2016

open study

Early Integrated Telehealth Versus In-Person Palliative Care for Patients With Lung Cancer
Massachusetts General Hospital Lung Cancer
This research study is evaluating ways to provide palliative care to patients who have recently been diagnosed with lung cancer and their families. expand

This research study is evaluating ways to provide palliative care to patients who have recently been diagnosed with lung cancer and their families.

Type: Interventional

Start Date: Jun 2018

open study

Microtubule-Targeted Agent BAL101553 and Radiation Therapy in Treating Patients With Newly Diagnosed...
Basilea Pharmaceutica Glioblastoma MGMT-Unmethylated Glioblastoma
This phase I trial studies the side effects and best dose of microtubule-targeted agent BAL101553 when given together with radiation therapy in treating patients with newly diagnosed glioblastoma. Drugs used in chemotherapy, such as microtubule-targeted agent BAL101553, work... expand

This phase I trial studies the side effects and best dose of microtubule-targeted agent BAL101553 when given together with radiation therapy in treating patients with newly diagnosed glioblastoma. Drugs used in chemotherapy, such as microtubule-targeted agent BAL101553, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving microtubule-targeted agent BAL101553 and radiation therapy may work better in treating patients with glioblastoma.

Type: Interventional

Start Date: Jun 2017

open study

Neuroimaging Biomarker for Seizures
Providence VA Medical Center Seizure Disorder Seizure Disorder, Post Traumatic Traumatic Brain Injury Non-Epileptic Seizure Conversion Disorder
This multi-site study will examine patients with epilepsy (ES) following head injury [i.e., posttraumatic epilepsy (PTE)] and posttraumatic psychogenic Non-epileptic seizures (PNES) and will compare them to patients with traumatic brain injury (TBI) who do not have seizures using... expand

This multi-site study will examine patients with epilepsy (ES) following head injury [i.e., posttraumatic epilepsy (PTE)] and posttraumatic psychogenic Non-epileptic seizures (PNES) and will compare them to patients with traumatic brain injury (TBI) who do not have seizures using functional neuroimaging.

Type: Interventional

Start Date: Sep 2017

open study

To Compare Two Commonly Used Soft Tissue Grafting Techniques to Achieve Coronal Flap Advancement and...
University of Alabama at Birmingham Gingival Recession
This study will compare two incision designs to allow for coronal gingival/mucosal flap advancement and tissue augmentation with acellular dermal matrix (ADM) graft around teeth with gingival recession and a lack of adequate keratinized gingiva. To the investigators knowledge,... expand

This study will compare two incision designs to allow for coronal gingival/mucosal flap advancement and tissue augmentation with acellular dermal matrix (ADM) graft around teeth with gingival recession and a lack of adequate keratinized gingiva. To the investigators knowledge, these two techniques have not been compared for differences in clinical (amount of root coverage, tissue thickness, and esthetics) and patient-centered outcomes (pain, swelling, change in daily activities) in a controlled study.

Type: Interventional

Start Date: Apr 2019

open study

Advancing Research and Treatment for Frontotemporal Lobar Degeneration (ARTFL)
University of California, San Francisco FTLD Progressive Supranuclear Palsy (PSP) Frontotemporal Dementia (FTD) Corticobasal Degeneration (CBD) PPA Syndrome
Frontotemporal Lobar Degeneration (FTLD) is the neuropathological term for a collection of rare neurodegenerative diseases that correspond to four main overlapping clinical syndromes: frontotemporal dementia (FTD), primary progressive aphasia (PPA), corticobasal degeneration... expand

Frontotemporal Lobar Degeneration (FTLD) is the neuropathological term for a collection of rare neurodegenerative diseases that correspond to four main overlapping clinical syndromes: frontotemporal dementia (FTD), primary progressive aphasia (PPA), corticobasal degeneration syndrome (CBS) and progressive supranuclear palsy syndrome (PSPS). The goal of this study is to build a FTLD clinical research consortium to support the development of FTLD therapies for new clinical trials. The consortium, referred to as Advancing Research and Treatment for Frontotemporal Lobar Degeneration (ARTFL), will be headquartered at UCSF and will partner with six patient advocacy groups to manage the consortium. Participants will be evaluated at 14 clinical sites throughout North America and a genetics core will genotype all individuals for FTLD associated genes.

Type: Observational

Start Date: Sep 2014

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

Implementing the Decision-Aid for Lupus (IDEAL Strategy)
University of Alabama at Birmingham Systemic Lupus Erythematosus
The study will attempt to put into practice a shared decision making (SDM) strategy, using an individualized, computerized decision- aid (DA) for Systemic lupus erythematosus (SLE). expand

The study will attempt to put into practice a shared decision making (SDM) strategy, using an individualized, computerized decision- aid (DA) for Systemic lupus erythematosus (SLE).

Type: Observational

Start Date: Dec 2018

open study

Skeletal Health in Bariatric Surgery Patients
University of Alabama at Birmingham Bariatric Surgery Osteoporosis Fractures, Bone Roux En-Y Gastric Bypass Sleeve Gastrectomy
The investigators propose a prospective cohort trial that will help to understand the impact of Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) in pre- and post-menopausal female bariatric patients. expand

The investigators propose a prospective cohort trial that will help to understand the impact of Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) in pre- and post-menopausal female bariatric patients.

Type: Observational

Start Date: Mar 2018

open study

Extension Study of Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to...
ACADIA Pharmaceuticals Inc. Adjunctive Treatment of Major Depressive Disorder
To assess the safety and tolerability of long-term pimavanserin treatment in subjects with major depressive disorder and inadequate response to antidepressant treatment. expand

To assess the safety and tolerability of long-term pimavanserin treatment in subjects with major depressive disorder and inadequate response to antidepressant treatment.

Type: Interventional

Start Date: Jun 2019

open study

Project BIPAMS: Behavioral Intervention for Physical Activity in Multiple Sclerosis
University of Alabama at Birmingham Multiple Sclerosis
This randomized controlled trial will examine the effect of a 6-month behavioral intervention, based on social cognitive theory and delivered through the Internet, for increasing physical activity and secondarily improving mobility, cognition, symptoms and quality of life in... expand

This randomized controlled trial will examine the effect of a 6-month behavioral intervention, based on social cognitive theory and delivered through the Internet, for increasing physical activity and secondarily improving mobility, cognition, symptoms and quality of life in persons with MS. The investigators hypothesize that individuals who receive the 6-month behavioral intervention will demonstrate an increase in physical activity behavior that will last throughout a 6-month follow up compared with participants in the control condition. The investigators further hypothesize that individuals in the behavioral intervention will demonstrate better walking mobility and cognitive function, reduced fatigue, depression, anxiety, and pain, and improved quality of life compared to the control condition. The investigators hypothesize that the behavioral intervention will increase physical activity through positive changes in self-efficacy, outcome expectations, goal setting, and impediments as social-cognitive determinants.

Type: Interventional

Start Date: Mar 2018

open study

Influence of Obesity on Endogenous Oxalate Synthesis
University of Alabama at Birmingham Kidney Stone
There is increasing evidence that obesity is associated with increased urinary oxalate excretion, an important risk factor for calcium oxalate stone formation. By the administration of a controlled low oxalate diet the investigators will estimate endogenous oxalate synthesis... expand

There is increasing evidence that obesity is associated with increased urinary oxalate excretion, an important risk factor for calcium oxalate stone formation. By the administration of a controlled low oxalate diet the investigators will estimate endogenous oxalate synthesis in both non-obese and obese non-kidney-stone forming adults. This study seeks to thusly increase the understanding of the relationships between obesity and endogenous oxalate synthesis to serve as a platform to develop novel therapies for stone prevention.

Type: Interventional

Start Date: May 2019

open study

Diastolic Dysfunction and Pauci-inflammatory Acute Exacerbations of COPD
University of Alabama at Birmingham Chronic Obstructive Pulmonary Disease Diastolic Dysfunction
This is a prospective study to determine the relationships between pauci-inflammatory exacerbations and diastolic dysfunction, and their implications in hospitalized patients with acute exacerbations of COPD. To assess changes within subjects from stable to acute phase, a number... expand

This is a prospective study to determine the relationships between pauci-inflammatory exacerbations and diastolic dysfunction, and their implications in hospitalized patients with acute exacerbations of COPD. To assess changes within subjects from stable to acute phase, a number of comparisons will be made in subjects enrolled during acute exacerbation with similar measurements made in the stable phase after recovery from exacerbation after at least 35 days from index hospitalization or prior exacerbation.

Type: Observational

Start Date: Nov 2013

open study

Improving Thinking in Everyday Life: Pilot Study A
University of Alabama at Birmingham Cognitive Impairment
This is a pilot study at the University of Alabama at Birmingham. The purpose of this initial study is to test how effective a new therapy is for improving participants ability to think, particularly how rapidly they process information that they receive from their senses, e.g.,... expand

This is a pilot study at the University of Alabama at Birmingham. The purpose of this initial study is to test how effective a new therapy is for improving participants ability to think, particularly how rapidly they process information that they receive from their senses, e.g., sight, hearing,… . The study will also test whether the new therapy improves how often and how well they are able to carry out tasks that rely on thinking in their daily life. The therapy will combine a computer game that ask participants to identify targets on the screen as rapidly as possible with a set of psychological techniques that will help to apply the improvements that are made in how rapidly participants process information as a result of the game to carrying out tasks that rely on thinking in your daily life.

Type: Interventional

Start Date: Mar 2019

open study

Regulation of Inflammatory Genes in Psoriasis
University of Alabama at Birmingham Psoriasis Inflammation
Psoriasis is a chronic and recurrent skin disorder characterized by marked inflammatory changes in the skin. An extensive cytokine network including generated by activated dendritic cells and T cells mediates the formation of psoriatic lesions. These immune-response parameters... expand

Psoriasis is a chronic and recurrent skin disorder characterized by marked inflammatory changes in the skin. An extensive cytokine network including generated by activated dendritic cells and T cells mediates the formation of psoriatic lesions. These immune-response parameters can be used as markers in the severity and management of the disease after further in-depth studies.

Type: Observational

Start Date: Apr 2014

open study

Preventing Sickle Cell Kidney Disease
University of Alabama at Birmingham Anemia, Sickle Cell Sickle Cell Disease Kidney Disease Hypertension Proteinuria
Untreated hypertension and renal injury are risk factors for increased morbidity and mortality in sickle cell disease, yet early markers of progressive disease have not been identified and therapies to prevent the development of adverse cardiovascular outcomes have not been defined.... expand

Untreated hypertension and renal injury are risk factors for increased morbidity and mortality in sickle cell disease, yet early markers of progressive disease have not been identified and therapies to prevent the development of adverse cardiovascular outcomes have not been defined. Circadian blood pressure, as defined by 24 hour blood pressure monitoring, is more accurate than clinic blood pressure in defining secondary hypertension and abnormal nocturnal blood pressured dipping and nocturnal hypertension have been linked to progressive renal disease in other diseases. Methodology/Aims: A randomized feasibility trial of losartan will be conducted among adolescent HbSS and SB0 thalassemia patients (11-19 years) with abnormal nocturnal blood pressure dipping. During this six month feasibility trial, two dosing strategies of losartan (titrated to keep clinic BP <95th percentile vs. <75th percentile) will be analyzed for safety and effect on restoring normal circadian blood pressure. A prospective cohort study among HbSS and SB0 thalassemia patients (6-19 years) will also be conducted to evaluate the incidence of hypertension and role of monitoring potential biomarkers of kidney injury and hypertension. Cohort participants will undergo annual evaluations of hypertension(24 hour blood pressure monitoring for participants ≥ 11yrs, clinic BP in all participants) and markers of kidney injury/hypertension. Expected Results: At the completion of the feasibility trial, vital background information will be obtained to design a definitive multicenter trial of hypertension in sickle cell disease. At the completion of the cohort study, the incidence of pediatric hypertension will be identified and the role for monitoring blood and urine biomarkers will be better understood. As therapy for patients with renal failure is dismal, it is imperative that SCD patients at risk are identified early and that therapeutic trials are conducted that prevent progression.

Type: Interventional

Start Date: Apr 2015

open study

Ultrasound Assessment of Volume in Patients on Continuous Dialysis
University of Alabama at Birmingham Volume Overload Kidney Failure Respiratory Failure
Renal failure and resuscitation measures in critically ill patients can result in fluid overload. Fluid overload in renal failure patients can cause harmful effects like pulmonary edema, anasarca and congestive cardiac failure exacerbations among other complications. These have... expand

Renal failure and resuscitation measures in critically ill patients can result in fluid overload. Fluid overload in renal failure patients can cause harmful effects like pulmonary edema, anasarca and congestive cardiac failure exacerbations among other complications. These have been associated with increased time on the ventilator, increased length of stay in the ICU, and higher overall mortality for patients requiring dialysis in the ICU. The current standard of care for adjusting fluid removal rates in patients on continuous renal replacement therapy relies on clinical judgement. Clinicians take into account factors like the patient's condition, vasopressor requirements, kidney function, total intake and outputs, vital signs, and physical examination findings when making daily changes to fluid removal rates on dialysis machines. Such assessment is highly subjective and can be imprecise/inaccurate leading to hypotension and hemodynamic instability in a critically ill patient. Use of conventional ultrasound by physicians to assess volume status using compressibility of the inferior vena cava has been shown to be a reliable predictor of volume status and can help guide therapy. Such use makes bedside volume assessment a non-invasive, rapid, repeatable point of care tool that can provide objective data to guide fluid removal determine velocity of fluid removal and help identify patients at risk of hypotension and hemodynamic instability during the process of fluid removal. Apart from rare possible local allergic reactions to ultrasound jelly and transient local discomfort, the disadvantages are minimal. Ultrasonography has been considered a safe imaging modality. This protocol will measure inferior vena cava compressibility using the General Electric VScan with Dual Probe, which has FDA approval for abdominal and vascular imaging in humans.

Type: Interventional

Start Date: Jun 2016

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

UAB Alzheimer's Disease Center Core Cohort - Imaging Substudy
University of Alabama at Birmingham Alzheimer Disease
The primary objective of this study is to measure the concentration and the regional brain distribution of pathologic amyloid deposition using the PET tracer [C-11]PiB in participants in the UAB Alzheimer's Disease Center cohort. Assessment of interactions between race and vascular... expand

The primary objective of this study is to measure the concentration and the regional brain distribution of pathologic amyloid deposition using the PET tracer [C-11]PiB in participants in the UAB Alzheimer's Disease Center cohort. Assessment of interactions between race and vascular risk factors, brain amyloid levels measured with [C-11]PiB-PET, and cognitive status will be the primary outcome of this imaging study.

Type: Interventional

Start Date: Apr 2018

open study

Ivacaftor for Acquired CFTR Dysfunction in Chronic Rhinosinusitis
University of Alabama at Birmingham Chronic Rhinosinusitis (Diagnosis)
The purpose of this pilot study is to explore wither ivacaftor in refractory CRS patients will demonstrate safety and tolerability; restore CFTR-mediated Cl- secretions as measured by EDSPD testing; produce detectable improvements in validated measures of CRS including the SNOT-22... expand

The purpose of this pilot study is to explore wither ivacaftor in refractory CRS patients will demonstrate safety and tolerability; restore CFTR-mediated Cl- secretions as measured by EDSPD testing; produce detectable improvements in validated measures of CRS including the SNOT-22 questionnaire, Lund-MacKay CT scan grading, and Lund-Kennedy endoscopic scores; and provide beneficial effects on readily measured markers of sinonasal inflammation and infection (IP-10, IL-8, and Pseudomonas CFUs).

Type: Interventional

Start Date: May 2019

open study

Inspire® Post-Approval Study / Protocol Number 2014-001
Inspire Medical Systems, Inc. Obstructive Sleep Apnea
The purpose of this study is to obtain additional long-term safety and efficacy data on the use of Inspire therapy. expand

The purpose of this study is to obtain additional long-term safety and efficacy data on the use of Inspire therapy.

Type: Interventional

Start Date: May 2015

open study

FET-PET/MRI for Surgical Assessment of Pediatric Brain Tumors
University of Alabama at Birmingham Pediatric Brain Tumors
The primary objectives of this study are: 1. Determine the percentage of patients whose surgical plan would change with FET-PET/MRI compared to MRI alone. 2. Determine the percentage of patients who have residual tumor after surgery detected with FET-PET/MRI.... expand

The primary objectives of this study are: 1. Determine the percentage of patients whose surgical plan would change with FET-PET/MRI compared to MRI alone. 2. Determine the percentage of patients who have residual tumor after surgery detected with FET-PET/MRI. A secondary objective of this study is: 1) Perform preliminary correlations between the pre- and post-surgical metabolic tumor volumes measured with FET-PET/MRI to progression free survival.

Type: Interventional

Start Date: Apr 2018

open study

Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy
Calliditas Therapeutics AB Primary IgA Nephropathy
The overall aim of the study is to evaluate the efficacy, safety, and tolerability of Nefecon 16 mg per day in the treatment of patients with primary IgAN (Immunoglobulin A nephropathy) at risk of progressing to end-stage renal disease (ESRD), despite maximum tolerated treatment... expand

The overall aim of the study is to evaluate the efficacy, safety, and tolerability of Nefecon 16 mg per day in the treatment of patients with primary IgAN (Immunoglobulin A nephropathy) at risk of progressing to end-stage renal disease (ESRD), despite maximum tolerated treatment with renin-angiotensin system (RAS) blockade using angiotensin converting enzyme inhibitors (ACEIs) or angiotensin II type I receptor blockers (ARBs).

Type: Interventional

Start Date: Sep 2018

open study

Ivacaftor for Acquired CFTR Dysfunction in Chronic Rhinosinusitis (EDSPD Protocol)
University of Alabama at Birmingham CRS
The purpose of this study is to establish the novel endoscopically-directed sinus potential difference (EDSPD) assay as an endpoint for therapy of sinus disease. expand

The purpose of this study is to establish the novel endoscopically-directed sinus potential difference (EDSPD) assay as an endpoint for therapy of sinus disease.

Type: Observational

Start Date: May 2017

open study