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B Cell and Antibody Response to Seasonal Influenza Vaccines in Younger and Older Adults
University of Alabama at Birmingham
Influenza
This study will examine how various FDA-approved seasonal influenza vaccine types, used
in a manner consistent with their approved use, impact the characteristics of influenza
specific antibodies in humans, and how these responses differ based on age and prior
immunization history. expand
This study will examine how various FDA-approved seasonal influenza vaccine types, used in a manner consistent with their approved use, impact the characteristics of influenza specific antibodies in humans, and how these responses differ based on age and prior immunization history. Type: Interventional Start Date: Apr 2021 |
Real-world Experience of Catheter Ablation for the Treatment of Paroxysmal and Persistent Atrial Fibrillation
Heart Rhythm Clinical and Research Solutions, LLC
Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation
The primary purpose of this registry is to obtain real-world clinical experience of
Paroxysmal (PAF) and Persistent (PsAF) Atrial Fibrillation ablation radiofrequency (RF)
technologies. Data from the registry will be used to assess clinical outcomes, including
procedural efficiency, safety, and long-term,... expand
The primary purpose of this registry is to obtain real-world clinical experience of Paroxysmal (PAF) and Persistent (PsAF) Atrial Fibrillation ablation radiofrequency (RF) technologies. Data from the registry will be used to assess clinical outcomes, including procedural efficiency, safety, and long-term, effectiveness of catheter ablation with novel RF technologies in PAF and PsAF patients. Type: Observational [Patient Registry] Start Date: Jan 2018 |
Functional Consequences of T-bet Expression in Flu-specific Memory B Cells After Live Attenuated Influenza...
University of Alabama at Birmingham
Influenza, Human
As yet the investigators do not understand if there are biomarkers of immune protection
after the Flumist or Live Attenuated Flu Vaccine (LAIV). Here the investigators test the
hypothesis that the T-bet expressing fraction of flu-specific B cells after live
attenuated influenza vaccination also serves... expand
As yet the investigators do not understand if there are biomarkers of immune protection after the Flumist or Live Attenuated Flu Vaccine (LAIV). Here the investigators test the hypothesis that the T-bet expressing fraction of flu-specific B cells after live attenuated influenza vaccination also serves as an early biomarker of long-lived antibody responses after vaccination. In this study the investigators will be providing the LAIV to up to 10 healthy subjects and assaying their immune response and then providing the intramuscular influenza vaccination and testing to see if the immune protection after the LAIV also protects after the intramuscular influenza vaccination. Update: We have amended this protocol to study the antigen-specific B cell populations that circulate after LAIV or IIV prime and LAIV or IIV boost. Type: Interventional Start Date: Nov 2019 |
Sleep for Stroke Management and Recovery Trial
University of Michigan
Ischemic Stroke
Sleep Apnea
Sleep Apnea, Obstructive
Stroke
CPAP
The purpose of this study is to determine whether treatment of obstructive sleep apnea
(OSA) with positive airway pressure starting shortly after acute ischemic stroke (1)
reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after
the event, and (2) improves stroke outcomes... expand
The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke. Type: Interventional Start Date: May 2019 |
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe...
Medtronic Cardiovascular
Mitral Valve Regurgitation
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All
subjects enrolled with receive the study device. expand
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device. Type: Interventional Start Date: Oct 2017 |
The Nuestros Días ("Our Days") Study
University of Alabama at Birmingham
Caregiver Burden
Well-Being, Psychological
Stress, Psychological
Depression
Anxiety
The goal of this observational study is to understand how contextual, individual-level,
and cultural factors influence the daily and long-term well-being of caregivers of
relatives with memory problems or dementia. The study focuses on caregivers from the
Hispanic and Latino community. The main questions... expand
The goal of this observational study is to understand how contextual, individual-level, and cultural factors influence the daily and long-term well-being of caregivers of relatives with memory problems or dementia. The study focuses on caregivers from the Hispanic and Latino community. The main questions it aims to answer are: - What daily factors increase (i.e., risk factors) or decrease (i.e., protective factors) the daily odds of depression and anxiety symptoms reported by caregivers? - How do these symptoms vary over time? - Do variations in depression and anxiety symptoms predict distal health outcomes? Participants will: - Complete an online baseline survey to understand their caregiving situation. - Fill out daily surveys online for three weeks about their caregiving experiences and well-being. - Complete two follow-up surveys, along with daily surveys, six and twelve months after the baseline survey. All the study information and surveys can be completed in English or Spanish based on the participant's preference. Type: Observational Start Date: Mar 2023 |
Histiocytic Disorder Follow-up Study
University of Alabama at Birmingham
Histiocytosis
Langerhans Cell Histiocytosis
Erdheim-Chester Disease
Rosai Dorfman Disease
Xanthogranuloma
The purpose of the study is to describe the burden of chronic health conditions,
psychological dysfunction, chronic pain, healthcare utilization, worse health-related
quality of life, overall mortality, and cause-specific mortality among individuals with
histiocytic disorders expand
The purpose of the study is to describe the burden of chronic health conditions, psychological dysfunction, chronic pain, healthcare utilization, worse health-related quality of life, overall mortality, and cause-specific mortality among individuals with histiocytic disorders Type: Observational Start Date: Sep 2022 |
An Open-label, Study to Assess Safety, Efficacy and Cellular Kinetics of YTB323 in Severe, Refractory...
Novartis Pharmaceuticals
Systemic Lupus Erythematosus
Lupus Nephritis
The study is intended to assess safety, efficacy and cellular kinetics of YTB323
treatment in participants with severe refractory systemic lupus erythematosus. expand
The study is intended to assess safety, efficacy and cellular kinetics of YTB323 treatment in participants with severe refractory systemic lupus erythematosus. Type: Interventional Start Date: Feb 2023 |
A Clinical Study That Will Measure How Well SEP-363856 Works and How Safe It is in Adults with Generalized...
Otsuka Pharmaceutical Development & Commercialization, Inc.
Generalized Anxiety Disorder
A clinical study that will meaure how well SEP-363856 works and how safe it is in adults
with Generalized Anixety Disorder. This study will be accepting both male and female
subjects between the ages of 18 years and 65 years old. The study will be held in
Approximately 50 global study centers and... expand
A clinical study that will meaure how well SEP-363856 works and how safe it is in adults with Generalized Anixety Disorder. This study will be accepting both male and female subjects between the ages of 18 years and 65 years old. The study will be held in Approximately 50 global study centers and approximately 15 additional centers for a separate Japan population. Participation in the study can be up to approximately 12 weeks. Type: Interventional Start Date: Mar 2023 |
Palbociclib and Binimetinib in RAS-Mutant Cancers, A ComboMATCH Treatment Trial
National Cancer Institute (NCI)
Exocrine Pancreas Carcinoma
Malignant Solid Neoplasm
Ovarian Low Grade Serous Adenocarcinoma
Stage IV Ovarian Cancer AJCC v8
Stage IV Pancreatic Cancer AJCC v8
This phase II ComboMATCH treatment trial evaluates the effectiveness of palbociclib and
binimetinib in treating patients with RAS-mutated cancers. Palbociclib and binimetinib
are both in a class of medications called kinase inhibitors. They work by blocking the
action of abnormal proteins that signals... expand
This phase II ComboMATCH treatment trial evaluates the effectiveness of palbociclib and binimetinib in treating patients with RAS-mutated cancers. Palbociclib and binimetinib are both in a class of medications called kinase inhibitors. They work by blocking the action of abnormal proteins that signals cancer cells to multiply. This trial may help researchers understand if giving the combination of palbociclib and binimetinib can help improve the amount of time before the cancer grows in patients with patients with low grade serous ovarian cancer who have certain changes in the tumor DNA. This trial may also help researchers understand if giving the combination of palbociclib and binimetinib can help improve outcomes among patients with low grade serous ovarian cancer who have previously received a MEK inhibitor. For patients with other tumors, with the exception of lung cancer, colon cancer, melanoma and low grade serous ovarian cancers, this trial may help researchers understand if giving the combination of palbociclib and binimetinib can improve the clinical outcome of survival without progression in patients who have certain changes in their tumor's DNA. Type: Interventional Start Date: Dec 2023 |
BEACON: A Study Evaluating the Safety and Efficacy of BEAM-101 in Patients With Severe Sickle Cell Disease
Beam Therapeutics Inc.
Sickle Cell Disease
This is an open-label, single-arm, multicenter, Phase 1/2 study evaluating the safety and
efficacy of the administration of autologous base edited CD34+ HSPCs (BEAM-101) in
patients with severe SCD expand
This is an open-label, single-arm, multicenter, Phase 1/2 study evaluating the safety and efficacy of the administration of autologous base edited CD34+ HSPCs (BEAM-101) in patients with severe SCD Type: Interventional Start Date: Aug 2022 |
Mocravimod As Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT
Priothera SAS
Adult Acute Myeloid Leukemia
This is a multi-center, randomized, double-blinded, placebo controlled trial. expand
This is a multi-center, randomized, double-blinded, placebo controlled trial. Type: Interventional Start Date: Jun 2022 |
RNS System LGS Feasibility Study
NeuroPace
Epilepsy
Lennox Gastaut Syndrome
Lennox-Gastaut Syndrome, Intractable
Seizures
Seizures, Generalized
To generate preliminary safety and effectiveness data for brain-responsive
neurostimulation of thalamocortical networks as an adjunctive therapy in reducing the
frequency of generalized seizures in individuals 12 years of age or older with Lennox
Gastaut Syndrome (LGS) who are refractory to antiseizure... expand
To generate preliminary safety and effectiveness data for brain-responsive neurostimulation of thalamocortical networks as an adjunctive therapy in reducing the frequency of generalized seizures in individuals 12 years of age or older with Lennox Gastaut Syndrome (LGS) who are refractory to antiseizure medications. The intent is to determine the feasibility and the optimal design of a subsequent pivotal study in order to expand the indication for use for the RNS System as a treatment for patients with medically intractable LGS. Type: Interventional Start Date: Oct 2022 |
Intravenous Fluid Administration's Effect on Pediatric Lumbar Puncture
University of Alabama at Birmingham
Pediatric Lumbar Puncture
The purpose of this project is to determine if administration of normal saline
intravenous fluids prior to a lumbar puncture improves first time success of lumbar
puncture in infants less than 3 months of age. First time success of lumbar puncture
defined as cerebrospinal fluid obtained on the first... expand
The purpose of this project is to determine if administration of normal saline intravenous fluids prior to a lumbar puncture improves first time success of lumbar puncture in infants less than 3 months of age. First time success of lumbar puncture defined as cerebrospinal fluid obtained on the first attempt with less than 1000 red blood cells per mm3 in the fluid specimen. Type: Interventional Start Date: Nov 2022 |
Parathyroid Allotransplantation in Medically Refractory Hypoparathyroidism
University of Alabama at Birmingham
Hypoparathyroidism
Options for treatment of severe, refractory hypocalcemia are limited for the thousands of
patients in the United States who suffer from hypoparathyroidism. Parathyroid
allotransplantation is an emerging treatment that provides hope for these individuals.
Currently, this therapy has only been successfully... expand
Options for treatment of severe, refractory hypocalcemia are limited for the thousands of patients in the United States who suffer from hypoparathyroidism. Parathyroid allotransplantation is an emerging treatment that provides hope for these individuals. Currently, this therapy has only been successfully provided by a few centers in the world. In the UAB PATH trial, we propose to become one of the few centers worldwide to successfully achieve parathyroid allotransplantation in transplant-naïve patients. Type: Interventional Start Date: Jul 2025 |
Study of ONO-4685 in Patients With Relapsed or Refractory T Cell Lymphoma
Ono Pharmaceutical Co. Ltd
Relapsed or Refractory T Cell Lymphoma
This study will investigate the safety, tolerability, pharmacokinetics, and preliminary
efficacy of ONO-4685 in patients with relapsed or refractory T cell Lymphoma expand
This study will investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ONO-4685 in patients with relapsed or refractory T cell Lymphoma Type: Interventional Start Date: Dec 2021 |
Cycled Phototherapy
NICHD Neonatal Research Network
Hyper Bilirubinemia
Premature Infant
Cycled phototherapy (PT) is likely to increase survival over that with continuous PT
among extremely premature infants (< 750 g BW or <27 weeks GA). expand
Cycled phototherapy (PT) is likely to increase survival over that with continuous PT among extremely premature infants (< 750 g BW or <27 weeks GA). Type: Interventional Start Date: Jul 2020 |
Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients for Breast Cancer
ECOG-ACRIN Cancer Research Group
Breast Screening
This randomized phase III trial studies digital tomosynthesis mammography and digital
mammography in screening patients for breast cancer. Screening for breast cancer with
tomosynthesis mammography may be superior to digital mammography for breast cancer
screening and may help reduce the need for... expand
This randomized phase III trial studies digital tomosynthesis mammography and digital mammography in screening patients for breast cancer. Screening for breast cancer with tomosynthesis mammography may be superior to digital mammography for breast cancer screening and may help reduce the need for additional imaging or treatment. Type: Interventional Start Date: Sep 2017 |
A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
Center for International Blood and Marrow Transplant Research
Hematologic Malignancies
Inherited Disorders of Metabolism
Inherited Abnormalities of Platelets
Histiocytic Disorders
Acute Myelogenous Leukemia (AML or ANLL)
This study is an access and distribution protocol for unlicensed cryopreserved cord blood
units (CBUs) in pediatric and adult patients with hematologic malignancies and other
indications. expand
This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications. Type: Observational Start Date: Oct 2011 |
Gut Oxalate Absorption in Calcium Oxalate Stone Disease
University of Alabama at Birmingham
Kidney Stone
Kidney Calculi
Urolithiasis
Urolithiasis, Calcium Oxalate
Nephrolithiasis
The goal of this clinical trial study is to test if patients with idiopathic calcium
oxalate kidney stones have an increased absorption of dietary oxalate, which would lead
to increased urinary excretion of oxalate.
The study will recruit adult patients with a history of calcium oxalate kidney stones... expand
The goal of this clinical trial study is to test if patients with idiopathic calcium oxalate kidney stones have an increased absorption of dietary oxalate, which would lead to increased urinary excretion of oxalate. The study will recruit adult patients with a history of calcium oxalate kidney stones and healthy volunteers without kidney stones. Participants will - ingest fixed diets containing low and moderately high amounts of oxalate for 5 days at a time - ingest a soluble form of oxalate and sugar preparations to test gut permeability - collect urine, blood, stool and breath sample during the fixed diets and the soluble oxalate test Type: Interventional Start Date: Apr 2024 |
O. Formigenes Colonization in Calcium Oxalate Kidney Stone Disease
University of Alabama at Birmingham
Kidney Stone
Kidney Calculi
Urolithiasis
Urolithiasis, Calcium Oxalate
Nephrolithiasis
The goal of this trial is to test if colonization with the gut bacteria Oxalobacter
formigenes leads to a reduction in urinary oxalate excretion in patients with calcium
oxalate kidney stone disease.
The study will recruit adult participants with a history of calcium oxalate kidney stones
who are... expand
The goal of this trial is to test if colonization with the gut bacteria Oxalobacter formigenes leads to a reduction in urinary oxalate excretion in patients with calcium oxalate kidney stone disease. The study will recruit adult participants with a history of calcium oxalate kidney stones who are not colonized with Oxalobacter formigenes. Participants will - ingest fixed diets containing low and moderately high amounts of oxalate for 4 days at a time - collect urine, blood and stool samples during the fixed diets - ingest a preparation of live Oxalobacter formigenes to induce colonization with Oxalobacter formigenes Type: Interventional Start Date: Apr 2024 |
Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+...
National Cancer Institute (NCI)
Malignant Female Reproductive System Neoplasm
Malignant Solid Neoplasm
Recurrent Malignant Female Reproductive System Neoplasm
Recurrent Malignant Solid Neoplasm
This phase II ComboMATCH treatment trial compares the effect of neratinib to the
combination of neratinib and palbociclib in treating patients with HER2 positive solid
tumors. Neratinib and palbociclib are in a class of medications called kinase inhibitors.
They work by blocking the action of an abnormal... expand
This phase II ComboMATCH treatment trial compares the effect of neratinib to the combination of neratinib and palbociclib in treating patients with HER2 positive solid tumors. Neratinib and palbociclib are in a class of medications called kinase inhibitors. They work by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of tumor cells. Giving neratinib and palbociclib in combination may shrink or stabilize cancers that over-express a specific biomarker called HER2. Type: Interventional Start Date: May 2024 |
Long COVID Brain Fog: Cognitive Rehabilitation Trial
University of Alabama at Birmingham
Long COVID
Brain Fog
Cognitive Impairment
Cognitive Dysfunction
Post-Acute COVID-19 Syndrome
This study will compare two approaches to cognitive rehabilitation in adults with long
COVID with persistent, mild to moderate, cognitive impairment. One approach will feature
(A) web-based computer "games" that trains how quickly individuals process information
that they receive through their senses;... expand
This study will compare two approaches to cognitive rehabilitation in adults with long COVID with persistent, mild to moderate, cognitive impairment. One approach will feature (A) web-based computer "games" that trains how quickly individuals process information that they receive through their senses; (B) in-lab training on everyday activities with important cognitive components, (C) procedures designed to transfer improvements in cognition from the treatment setting to everyday life, and (D) a non-invasive form of vagus nerve stimulation (VNS), i.e., trans-auricular VNS (taVNS). Component B will include work-related tasks. This approach is termed Constraint-Induced Cognitive Therapy (CICT). The other approach will feature (A) web-based computer "games" that train reaction time and eye-hand coordination; (B) in-lab training on relaxation, healthy nutrition, and healthy sleep, (C) procedures designed to promote integration of these lifestyle changes into everyday life, and (D) taVNS. This approach is termed Brain Fitness Training (BFT). A subset of participants, who qualify for and and desire vocational rehabilitation (VR), will receive VR from the Alabama Department of Rehabilitation Services (ADRS) in addition to CICT or BFT. ADRS VR will include career counseling, prescription of on-the-job accommodations, and guidance on return-to-work. Those in the CICT + VR group will also receive on-the-job coaching from a peer mentor for a month after completing training. CICT, with or without VR, will involve 30 hours of training. Ten 3-hour in-lab, face-to-face, therapist-directed sessions will be scheduled. These sessions will feature one hour of gaming; the remainder will be committed to in-lab training on the target behaviors and the procedures designed to promote transfer of therapeutic gains to daily life and improving skills essential to work; the set of the latter procedures is termed the Transfer Package. ta-VNS will administered for 10 minutes before gaming and in-lab target behavior training. To accommodate the demands of participants' other activities, training sessions will be permitted to be scheduled as tightly as every weekday over 2 weeks or as loosely as every other weekday or so over 4 weeks. If a family caregiver is available, they will receive training on how to best support participants in their therapeutic program. After training ends, four follow-up phone calls will be scheduled approximately one-week apart with participants to promote integration of the skills gained during training into everyday life. BFT, with or without VR, will involve 30 hours of training following the same schedule as for CICT. Ten 3-hour in-lab, face-to-face, therapist-directed sessions will be scheduled. These sessions will feature one hour of gaming; the remainder will be committed to in-lab training on the target behaviors (healthy sleep, nutrition and relaxation habits) and the procedures designed to promote transfer of behavior change to daily life. ta-VNS will be administered for 10 minutes before gaming and in-lab target behavior training. If a family caregiver is available, they will receive training on how to best support participants in their therapeutic program. After training ends, four follow-up phone calls will be scheduled approximately one-week apart with participants to promote integration of the skills gained during training into everyday life. Participants will be randomly assigned to the interventions. Randomization will be stratified by whether participants qualify for and desire VR from ADRS or not. If yes, participants will be randomized in equal numbers to CICT + VR or BFT + VR. If no, participants will be randomized in equal numbers to CICT or BFT. Testing will happen one month before treatment, one day before treatment, one day afterwards, and 6- and 12-months afterwards. Outcomes measured will include cognitive processing speed, cognitive function on laboratory tests, and spontaneous performance of everyday activities with important cognitive components in daily life. Another important outcome measure will be whether or not participants were able to return back to work or had significant improvements in their work activities. Type: Interventional Start Date: Apr 2024 |
Testing the Use of the Combination of Selumetinib and Olaparib or Selumetinib Alone Targeted Treatment...
National Cancer Institute (NCI)
Recurrent Endometrial Carcinoma
Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Primary Peritoneal Carcinoma
This phase II ComboMATCH treatment trial compares selumetinib plus olaparib to
selumetinib alone in women with endometrial or ovarian (fallopian tube and primary
peritoneal) cancer that has come back (recurrent) or that remains despite treatment
(persistent) and harbors a mutation in the RAS pathway.... expand
This phase II ComboMATCH treatment trial compares selumetinib plus olaparib to selumetinib alone in women with endometrial or ovarian (fallopian tube and primary peritoneal) cancer that has come back (recurrent) or that remains despite treatment (persistent) and harbors a mutation in the RAS pathway. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. The addition of olaparib to selumetinib could increase the percentage of tumors that shrink as well as lengthen the time that the tumors remain stable (without progression) as compared to selumetinib alone. Type: Interventional Start Date: Apr 2023 |
Oxalate-Driven Host Responses in Kidney Stone Disease
University of Alabama at Birmingham
Kidney Stones
This study is looking to understand the role of oxalate on kidney stone development and
immunity. This study will enroll healthy participants and participants with calcium
oxalate kidney stones (CaOx KS). Participants will be in this study for about 3 weeks,
consume controlled diets, and provide blood... expand
This study is looking to understand the role of oxalate on kidney stone development and immunity. This study will enroll healthy participants and participants with calcium oxalate kidney stones (CaOx KS). Participants will be in this study for about 3 weeks, consume controlled diets, and provide blood and urine specimens. Type: Interventional Start Date: May 2023 |
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