538 matching studies

Sponsor Condition of Interest
Immunotherapy Before and After Surgery for Treatment of Recurrent or Progressive High Grade Glioma1
Sabine Mueller, MD, PhD Glioblastoma Malignant Glioma Recurrent Glioblastoma Recurrent Malignant Glioma Recurrent Grade III Glioma
This phase I trial studies the side effects of nivolumab before and after surgery in treating children and young adults with high grade glioma that has come back (recurrent) or is increasing in scope or severity (progressive). Immunotherapy with monoclonal antibodies, such as nivolumab, may help th1 expand

This phase I trial studies the side effects of nivolumab before and after surgery in treating children and young adults with high grade glioma that has come back (recurrent) or is increasing in scope or severity (progressive). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Type: Interventional

Start Date: Oct 2020

open study

The Effects of Virtual Reality Greenspace on Stress Among Adults With Mobility Impairments
University of Alabama at Birmingham Mobility Impairments
The purpose of this project is to examine the effects of virtual reality greenspace exposure on physiological and affective acute stress responses among adults with mobility impairments. expand

The purpose of this project is to examine the effects of virtual reality greenspace exposure on physiological and affective acute stress responses among adults with mobility impairments.

Type: Interventional

Start Date: Apr 2025

open study

Weight Inclusive and Adaptive Strategies to Enhance Cardiometabolic Health in Black Adults
University of Alabama at Birmingham Obesity Prehypertension Hypertension PreDiabetes Type 2 Diabetes
The proposed 6-month pilot Sequential Multiple Assignment Randomize Trial (SMART) has two aims. The first and primary aim is to determine the feasibility of conducting a full-scale SMART to compare weight-focused (i.e., weight loss) and weight-neutral (i.e., weight loss is not an explicit goal) ada1 expand

The proposed 6-month pilot Sequential Multiple Assignment Randomize Trial (SMART) has two aims. The first and primary aim is to determine the feasibility of conducting a full-scale SMART to compare weight-focused (i.e., weight loss) and weight-neutral (i.e., weight loss is not an explicit goal) adaptive biobehavioral interventions for improving cardiometabolic health in Black adults with overweight or obesity (BMI ≥27 kg/m2) plus at least one weight-related cardiometabolic condition (high blood pressure, prediabetes or diabetes, and/or high cholesterol). Biobehavioral interventions are treatment strategies that combine lifestyle-based behavioral interventions such as eating a healthy diet and exercise with medications. In this study, participants will be randomly assigned to receive either weight-focused or weight-neutral health coaching for 7 weeks. At week 8, participants will be identified as either "responders" or "nonresponders" to the initial interventions. The threshold for response in the weight-focused condition is greater than or equal to 3% weight loss. The threshold for response in the weight-neutral condition is engaging in greater than or equal to 150 minutes of moderate physical activity for the 7 days prior to the week 8 study visit. Responders to the initial interventions will continue with health coaching on a biweekly basis for weeks 9-26 of the intervention. Nonresponders will be re-randomized to either intensify the lifestyle-based intervention by receiving a membership to the YMCA and enrolling in group fitness classes or augmenting the health coaching with enhanced medical management in partnership with their established primary care provider. The second aim is to use clinical data from the pilot SMART to estimate treatment effects and the between-person variability in these effects. Because this is a pilot study, these estimates will not be used to make comparisons or draw conclusions on the comparative effectiveness of intervention conditions. Rather, these data will be used to generate preliminary effect sizes that can be used to estimate the sample size required for a full-scale trial. Clinical trial feasibility data will be collected on an ongoing basis throughout the study and clinical data will be collected prior to initiating the intervention (baseline) and at week 8 (response visit) and week 26 (post-intervention visit).

Type: Interventional

Start Date: Oct 2024

open study

African Americans (AA) Communities Speak
University of Alabama at Birmingham Healthy Aging Health Knowledge, Attitudes, Practice Social Responsibility Care Eliciting Behavior Racism, Systemic
African Americans are less likely to receive quality end-of-life (EoL) care. Addressing disparities in EoL care will need efforts to support a better understanding of African American patients' EoL cultural values and preferences for EoL communication and the impact of historical and ongoing care d1 expand

African Americans are less likely to receive quality end-of-life (EoL) care. Addressing disparities in EoL care will need efforts to support a better understanding of African American patients' EoL cultural values and preferences for EoL communication and the impact of historical and ongoing care delivery inequities in healthcare settings. Our proposed "Caring for Older African Americans" training program is designed to empower clinicians to improve goal-concordant EoL care delivery by using community-developed storytelling videos to create empathy with experiences of racism in EoL care, guidelines for culturally concordant EoL care delivery, and an implicit bias recognition and management training to mitigate bias in goals of care communication.

Type: Interventional

Start Date: Feb 2025

open study

PRE-I-SPY Phase I/Ib Oncology Platform Program
QuantumLeap Healthcare Collaborative HER2-positive Breast Cancer Metastatic Cancer Metastatic Breast Cancer Metastatic HER2-positive Metastatic Breast Cancer
I-SPY Phase I/Ib (I-SPY-P1) is an open-label, multisite platform study designed to evaluate single agents or combinations in a metastatic treatment setting that may be relevant for breast cancer patients with the overall goal of moving promising drug regimens into the I-SPY 2 SMART Design Trial (NC1 expand

I-SPY Phase I/Ib (I-SPY-P1) is an open-label, multisite platform study designed to evaluate single agents or combinations in a metastatic treatment setting that may be relevant for breast cancer patients with the overall goal of moving promising drug regimens into the I-SPY 2 SMART Design Trial (NCT01042379) and/or other oncology-based trials in a timely manner.

Type: Interventional

Start Date: Feb 2023

open study

Pulsed Lavage in Implant-Based Breast Reconstruction
University of Alabama at Birmingham Breast Reconstruction
To determine if there is any benefit to using pulsed lavage to wash out the mastectomy pocket during breast reconstruction. Primary outcomes will include post-op complications including surgical site infection (SSI), hematoma, seroma, and implant failure. expand

To determine if there is any benefit to using pulsed lavage to wash out the mastectomy pocket during breast reconstruction. Primary outcomes will include post-op complications including surgical site infection (SSI), hematoma, seroma, and implant failure.

Type: Interventional

Start Date: Mar 2024

open study

A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other So1
Arcus Biosciences, Inc. Clear Cell Renal Cell Carcinoma Solid Tumors
The purpose of this study is to evaluate the safety and tolerability of: - casdatifan when taken alone in participants with advanced solid tumor malignancies and clear cell renal cell carcinoma (ccRCC) during the dose escalation stage; and - casdatifan monotherapy and casdatifan in com1 expand

The purpose of this study is to evaluate the safety and tolerability of: - casdatifan when taken alone in participants with advanced solid tumor malignancies and clear cell renal cell carcinoma (ccRCC) during the dose escalation stage; and - casdatifan monotherapy and casdatifan in combination with cabozantinib or zimberelimab in participants with ccRCC in the dose expansion stage

Type: Interventional

Start Date: Oct 2022

open study

Constraint-Induced Movement Therapy for Adults Post-Stroke With Mild Upper Extremity Impairment
University of Alabama at Birmingham CVA (Cerebrovascular Accident) Stroke Upper Extremity Paresis
Constraint-Induced Therapy (CI Therapy) is a behavioral approach to neurorehabilitation and consists of multi-components that have been applied in a systematic method to improve the use of the limb or function addressed in the intensive treatment. CI Therapy for the more-affected upper extremity (U1 expand

Constraint-Induced Therapy (CI Therapy) is a behavioral approach to neurorehabilitation and consists of multi-components that have been applied in a systematic method to improve the use of the limb or function addressed in the intensive treatment. CI Therapy for the more-affected upper extremity (UE) post-stroke is administered in daily treatment sessions over consecutive weekdays. Sessions include motor training with repeated, timed trials using a technique called shaping, a set of behavioral strategies known as the Transfer Package (TP) to improve the use of the more-affected hand in the life situation, and strategies to remind participants to use the more-affected UE including restraint. Robust improvements in the amount and qualify of use have been realized with stroke participants from mild-to-severe UE impairment.

Type: Interventional

Start Date: Dec 2022

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 questionnaire, Lu1 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

Implementation pRogram to Improve Screening and Management for CKD in Diabetes (IRIS-CKD) (Program1
Duke University Chronic Kidney Disease(CKD) Type 2 DM Type 2 Diabetes Mellitus (T2DM)
IRIS-CKD is a two-program implementation study to improve guideline-recommended screening and treatment of chronic kidney disease (CKD) in individuals with type 2 diabetes (T2D) in the United States. expand

IRIS-CKD is a two-program implementation study to improve guideline-recommended screening and treatment of chronic kidney disease (CKD) in individuals with type 2 diabetes (T2D) in the United States.

Type: Interventional

Start Date: Oct 2025

open study

Acceptance and Commitment Therapy for Religious OCD
University of Alabama at Birmingham Obsessive-Compulsive Disorder (OCD)
The purpose of the study is to examine the effects and feasibility of a specific form of psychotherapy, acceptance and commitment therapy (ACT), on religiously oriented obsessive and compulsive disorder (OCD). expand

The purpose of the study is to examine the effects and feasibility of a specific form of psychotherapy, acceptance and commitment therapy (ACT), on religiously oriented obsessive and compulsive disorder (OCD).

Type: Interventional

Start Date: Jul 2025

open study

Stimulation-Induced Changes in Fronto-Limbic Network
University of Alabama at Birmingham Epilepsy Mental Disorders
The purpose of this research is to better understand how emotion processing unfolds in the brain using stereoelectroencephalography (sEEG) and direct brain stimulation. This study will use standard behavioral emotion processing tasks combined with neural recording and direct brain stimulation to as1 expand

The purpose of this research is to better understand how emotion processing unfolds in the brain using stereoelectroencephalography (sEEG) and direct brain stimulation. This study will use standard behavioral emotion processing tasks combined with neural recording and direct brain stimulation to assess different aspects of emotion processing. Stimulation pulses during pre and post-test periods will assess the effects of stimulation before and after conditioning, the results of which will be combined with results from the activity of each electrode during the emotion tasks to inform us of the nature of emotion processing in the brain and allow us to devise brain modulation protocols in the future.

Type: Interventional

Start Date: Mar 2023

open study

Comparing Cooling and/or Compression Approaches of Limbs for Prevention of Chemotherapy-Induced Per1
SWOG Cancer Research Network Malignant Solid Neoplasm
This phase III trial compares the effect of 3 study approaches in preventing chemotherapy-induced peripheral neuropathy: 1) cryocompression, 2) continuous compression, and 3) low cyclic compression. Taxane chemotherapy drugs, such as paclitaxel or docetaxel, can cause a nerve disorder called periph1 expand

This phase III trial compares the effect of 3 study approaches in preventing chemotherapy-induced peripheral neuropathy: 1) cryocompression, 2) continuous compression, and 3) low cyclic compression. Taxane chemotherapy drugs, such as paclitaxel or docetaxel, can cause a nerve disorder called peripheral neuropathy, which can cause numbness, tingling, or pain in the arms and legs. The 3 study approaches will use a device, called the Paxman Limb Cryocompression System, made of wraps that cool and/or compress the arms and legs. This study may help researchers determine if any of the study approaches are able to prevent taxane chemotherapy from causing peripheral neuropathy.

Type: Interventional

Start Date: Jun 2023

open study

Trial of Vision Therapy for Intermittent Exotropia
Southern California College of Optometry at Marshall B. Ketchum University Intermittent Exotropia
The main objective of this randomized trial comparing vision therapy to observation is to determine the short-term effectiveness of vision therapy on distance intermittent exotropia control. The results will help determine whether to proceed to a full-scale, long-term randomized trial. expand

The main objective of this randomized trial comparing vision therapy to observation is to determine the short-term effectiveness of vision therapy on distance intermittent exotropia control. The results will help determine whether to proceed to a full-scale, long-term randomized trial.

Type: Interventional

Start Date: Oct 2021

open study

DeciPHer-ILD: A Real-world Patient Registry in Group 3 Pulmonary Hypertension Associated With Inter1
United Therapeutics Pulmonary Hypertension Due to Lung Diseases and Hypoxia Pulmonary Hypertension Interstitial Lung Disease
This is a prospective, non-interventional, multicenter, registry of patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). expand

This is a prospective, non-interventional, multicenter, registry of patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD).

Type: Observational

Start Date: Jan 2025

open study

Newly Diagnosed Stage III/IV Ovarian Cancer, Neoadjuvant Carbo/taxol/pembro, Maintenance Olaparib/p1
University of Alabama at Birmingham Ovarian Cancer
this is a trial evaluating three chemotherapy agents in patients with newly diagnosed ovarian cancer patients that are Stage III or Stage IV prior to surgery to remove the tumor. After surgery there will be additional chemotherapy given. expand

this is a trial evaluating three chemotherapy agents in patients with newly diagnosed ovarian cancer patients that are Stage III or Stage IV prior to surgery to remove the tumor. After surgery there will be additional chemotherapy given.

Type: Interventional

Start Date: Feb 2025

open study

Bodewell Products for the Treatment of Atopic Dermatitis
University of Alabama at Birmingham Atopic Dermatitis
This study aims to examine the safety and efficacy of topical application of the Bodewell eczema products expand

This study aims to examine the safety and efficacy of topical application of the Bodewell eczema products

Type: Interventional

Start Date: Nov 2023

open study

Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy
Dennis M. McNamara, MD, MS Peripartum Cardiomyopathy, Postpartum
The study will enroll 200 women newly diagnosed with peripartum cardiomyopathy within 5 months postpartum in a randomized placebo controlled trial of bromocriptine therapy to evaluate its impact on myocardial recovery and clinical outcomes. Given that bromocriptine prevents breastfeeding, an additi1 expand

The study will enroll 200 women newly diagnosed with peripartum cardiomyopathy within 5 months postpartum in a randomized placebo controlled trial of bromocriptine therapy to evaluate its impact on myocardial recovery and clinical outcomes. Given that bromocriptine prevents breastfeeding, an additional 50 women with peripartum cardiomyopathy excluded from the trial due to a desire to continue breastfeeding but meeting all other entry criteria will be followed in an observational cohort.

Type: Interventional

Start Date: Jul 2022

open study

Office-Based Superior Laryngeal Nerve Block for Treatment of Neurogenic Cough
University of Alabama at Birmingham Cough
The purpose of this study is to evaluate if office-based injection of a local anesthetic/steroid combination at the area of one superior laryngeal nerve can decrease cough frequency and alleviate symptoms of chronic cough in patients with neurogenic cough. expand

The purpose of this study is to evaluate if office-based injection of a local anesthetic/steroid combination at the area of one superior laryngeal nerve can decrease cough frequency and alleviate symptoms of chronic cough in patients with neurogenic cough.

Type: Observational

Start Date: Jan 2022

open study

Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cess1
University of Alabama at Birmingham Tobacco Dependence
Smoking remains the single most preventable cause of morbidity and mortality in the United States, accounting for approximately half a million deaths every year. The current study will investigate the efficacy and mechanisms of change of a novel smoking cessation intervention. The current study wil1 expand

Smoking remains the single most preventable cause of morbidity and mortality in the United States, accounting for approximately half a million deaths every year. The current study will investigate the efficacy and mechanisms of change of a novel smoking cessation intervention. The current study will thus provide essential information regarding a treatment that has the potential to enhance the efficacy of existing smoking cessation interventions, thereby having a beneficial impact on the public health of the United States.

Type: Interventional

Start Date: Aug 2019

open study

Generic Database of Very Low Birth Weight Infants
NICHD Neonatal Research Network Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature
The Generic Database (GDB) is a registry of very low birth weight infants born alive in NICHD Neonatal Research Network (NRN) centers. The GDB collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. The information collected is not speci1 expand

The Generic Database (GDB) is a registry of very low birth weight infants born alive in NICHD Neonatal Research Network (NRN) centers. The GDB collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. The information collected is not specific to a disease or treatment (i.e., it is "generic"). Data are analyzed to find associations and trends between baseline information, treatments, and infant outcome, and to develop future NRN trials.

Type: Observational

Start Date: Apr 1987

open study

Multi-Center Molecular Diagnosis and Host Response of Respiratory Viral Infections in Pediatric Tra1
Arkansas Children's Hospital Research Institute Hematopoietic Cell Transplant Solid Organ Transplant Respiratory Viral Infection
The participants are being asked to take part in this clinical trial, a type of research study, because the participants are scheduled to receive or have recently received a hematopoietic cell transplant (HCT) or a solid organ transplant (SOT). Primary Objective To determine if pre-transplant scr1 expand

The participants are being asked to take part in this clinical trial, a type of research study, because the participants are scheduled to receive or have recently received a hematopoietic cell transplant (HCT) or a solid organ transplant (SOT). Primary Objective To determine if pre-transplant screening for respiratory viral load predicts RVI within 1- year post-transplant among survivors. Secondary Objectives: - To develop and validate a classifier based on pre-transplant immunological profile predictive of developing an acute respiratory viral infection (aRVI), with RSV/PIV3/HMPV/SARS-CoV-2 through one-year post-transplant among survivors. - To develop and validate a classifier based on Day +100 post-transplant immunological profiles predictive of developing an acute respiratory viral infection (aRVI),with RSV/PIV3/HMPV/SARS-CoV-2 through one-year post-transplant among survivors .

Type: Observational

Start Date: Dec 2022

open study

myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD Patients in the Home
Temple University COPD
Parallel-group, prospective, randomized, controlled phase III trial of home High flow Nasal Therapy (HFNT) via myAirvo 3 plus usual COPD medical care vs. usual COPD medical care, for at least 1 year and up to two years in 642 GOLD Grade D, Stages II-IV patients with moderate to very severe COPD at1 expand

Parallel-group, prospective, randomized, controlled phase III trial of home High flow Nasal Therapy (HFNT) via myAirvo 3 plus usual COPD medical care vs. usual COPD medical care, for at least 1 year and up to two years in 642 GOLD Grade D, Stages II-IV patients with moderate to very severe COPD at risk for moderate and severe exacerbations with a prior history of severe exacerbation requiring hospitalization within the past 6 weeks.

Type: Interventional

Start Date: Feb 2022

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 mucociliary clearance (1 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

Study to Evaluate Biological & Clinical Effects of Significantly Corrected CFTR Function in Infants1
Sonya Heltshe Cystic Fibrosis
This is a two-part, multi-center, prospective longitudinal, exploratory study of highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators and their impact on children with cystic fibrosis (CF). expand

This is a two-part, multi-center, prospective longitudinal, exploratory study of highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators and their impact on children with cystic fibrosis (CF).

Type: Observational

Start Date: Nov 2020

open study