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Study of Treatment for HPV16+ ASC-US or LSIL
University of Alabama at Birmingham
ASC-US
LSIL
Phase I clinical trial to assess safety of pNGVL4aCRTE6E7L2 DNA and TA-CIN protein
vaccinations, and to seek the appropriate dose of the pNGVL4aCRTE6E7L2 DNA vaccine expand
Phase I clinical trial to assess safety of pNGVL4aCRTE6E7L2 DNA and TA-CIN protein vaccinations, and to seek the appropriate dose of the pNGVL4aCRTE6E7L2 DNA vaccine Type: Interventional Start Date: Jul 2023 |
Endogenous Oxalate Synthesis in Idiopathic Calcium Oxalate Kidney Stone Disease
University of Alabama at Birmingham
Kidney Stones
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 production of oxalate by the body, which would
lead to increased urinary excretion of oxalate.
The study will recruit adult patients with a history of calcium oxalate kidney1 expand
The goal of this clinical trial study is to test if patients with idiopathic calcium oxalate kidney stones have an increased production of oxalate by the body, 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 amounts of oxalate for 5 days ingest a soluble form of glycolate and vitamin C collect urine, blood, stool during the dietary and oral dosing portions of the study and also collect breath sample during the oral glycolate test Type: Interventional Start Date: May 2025 |
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 sto1 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 are1 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 |
ProAgio in Pancreatic Ductal Adenocarcinoma (PDAC)
ProDa BioTech, LLC
Pancreatic Ductal Carcinoma
This is an open-label Phase I/Ib dose-escalation, dose-expansion clinical trial of the
safety, pharmacokinetics and clinical activity of ProAgio combined with gemcitabine and
nab paclitaxel (G-nP) in previously untreated subjects with metastatic pancreatic ductal
adenocarcinoma (PDAC) expand
This is an open-label Phase I/Ib dose-escalation, dose-expansion clinical trial of the safety, pharmacokinetics and clinical activity of ProAgio combined with gemcitabine and nab paclitaxel (G-nP) in previously untreated subjects with metastatic pancreatic ductal adenocarcinoma (PDAC) Type: Interventional Start Date: Sep 2023 |
Does Fluorescence With or Without Indocyanine Green Improve Parathyroid Identification and Preserva1
University of Alabama at Birmingham
Parathyroid Dysfunction
Adenoma
The aim of this study is to determine if fluorescence with or without indocyanine green
can facilitate safe and accurate thyroid and parathyroid surgery. expand
The aim of this study is to determine if fluorescence with or without indocyanine green can facilitate safe and accurate thyroid and parathyroid surgery. Type: Interventional Start Date: Apr 2024 |
Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for1
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 ab1 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 sens1 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-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 |
A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic1
Sanofi
Lung Transplant Rejection
This double-blind, randomized, placebo-controlled, multinational, multicenter,
parallel-group, Phase 3, 2-arm, study will investigate the efficacy and safety of
belumosudil compared with placebo, both administered on top of azithromycin and
standard-of-care regimen of immunosuppression in male or f1 expand
This double-blind, randomized, placebo-controlled, multinational, multicenter, parallel-group, Phase 3, 2-arm, study will investigate the efficacy and safety of belumosudil compared with placebo, both administered on top of azithromycin and standard-of-care regimen of immunosuppression in male or female participants at least 1 year after bilateral lung transplant, who are at least 18 years of age and who have evidence of progressive CLAD despite azithromycin therapy. Study details include: The study duration will be up to 31 weeks for participants not entering the open-label extension (OLE) period and up to 57 weeks for participants entering the OLE period but not the long-term OLE. The treatment duration will be up to 26 weeks for participants not entering the OLE period and up to 52 weeks for participants entering the OLE period but not the long-term OLE. The number of visits will be up to 10 visits for participants not entering the OLE period and up to 16 visits for participants entering the OLE period but not the long-term OLE. For participants who enter the long-term OLE, treatment and study participation will continue with visits every 12 weeks per protocol specifications. Type: Interventional Start Date: Oct 2023 |
Long-term, Open-label Study of SAR447537 (INBRX-101) in Adults With Alpha-1 Antitrypsin Deficiency1
Sanofi
Alpha 1-Antitrypsin Deficiency
Emphysema
Phase 2 open label extension study to evaluate SAR447537 (INBRX-101) in adults with AATD
emphysema expand
Phase 2 open label extension study to evaluate SAR447537 (INBRX-101) in adults with AATD emphysema Type: Interventional Start Date: Jun 2024 |
Tovorafenib for Treatment of Craniopharyngioma in Children and Young Adults
Sabine Mueller, MD, PhD
Craniopharyngioma, Child
Craniopharyngioma
Recurrent Craniopharyngioma
The current study assesses the tolerability and efficacy of monotherapy with
pan-RAF-kinase (Tovorafenib) inhibition for the treatment of children and young adults
with craniopharyngioma. expand
The current study assesses the tolerability and efficacy of monotherapy with pan-RAF-kinase (Tovorafenib) inhibition for the treatment of children and young adults with craniopharyngioma. Type: Interventional Start Date: Sep 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 |
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 bl1 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 |
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 firs1 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 |
Video Telehealth Pulmonary Rehabilitation to Reduce Hospital Readmission in Chronic Obstructive Pul1
University of Alabama at Birmingham
Chronic Obstructive Pulmonary Disease
The purpose of this study is to compare the efficacy and safety of a real time video
telehealth pulmonary rehabilitation intervention with standard of care in patients
hospitalized for an exacerbation of chronic obstructive pulmonary disease (COPD) to
determine the impact on hospital readmissions a1 expand
The purpose of this study is to compare the efficacy and safety of a real time video telehealth pulmonary rehabilitation intervention with standard of care in patients hospitalized for an exacerbation of chronic obstructive pulmonary disease (COPD) to determine the impact on hospital readmissions and respiratory morbidity, and to investigate the cost-effectiveness of the intervention. Type: Interventional Start Date: Jun 2022 |
Parkinson's Foundation PD GENEration Genetic Registry
Parkinson's Foundation
Parkinson's Disease
Development of a central repository for PD-related genomic data for future research. expand
Development of a central repository for PD-related genomic data for future research. Type: Observational [Patient Registry] Start Date: Dec 2020 |
Telemedicine for Unhealthy Alcohol Use in Persons Living With HIV Using CETA
University of Alabama at Birmingham
Hiv
Alcohol Problem
This study is designed to examine the efficacy of a brief intervention plus a
cognitive-behavioral intervention compared to brief intervention alone to address
unhealthy alcohol use and comorbid mental health symptoms to improve HIV outcomes among
people living with HIV in Alabama. expand
This study is designed to examine the efficacy of a brief intervention plus a cognitive-behavioral intervention compared to brief intervention alone to address unhealthy alcohol use and comorbid mental health symptoms to improve HIV outcomes among people living with HIV in Alabama. Type: Interventional Start Date: May 2023 |
Improving Scientific Rigor of Renal Clinical Endpoints for Sickle Cell Anemia
University of Alabama at Birmingham
Sickle Cell Disease
Renal Disease
Glomerular Disease
The investigators will attempt to develop a more accurate equation to estimate eGFR in
pediatric and adult sickle cell patients expand
The investigators will attempt to develop a more accurate equation to estimate eGFR in pediatric and adult sickle cell patients Type: Observational Start Date: May 2021 |
Monitoring HER2+ Breast Cancer Neoadjuvant Treatment With Advanced PET/MRI
University of Alabama at Birmingham
HER2-positive Breast Cancer
The purpose of the study is to see if using an investigational drug called [18F]FMISO
with PET/MRI imaging can help monitor and predict the effect of trastuzumab (Herceptin)
on chemotherapy in patients diagnosed with advanced HER2 positive breast cancer. This
study is for imaging purposes only and1 expand
The purpose of the study is to see if using an investigational drug called [18F]FMISO with PET/MRI imaging can help monitor and predict the effect of trastuzumab (Herceptin) on chemotherapy in patients diagnosed with advanced HER2 positive breast cancer. This study is for imaging purposes only and is not a treatment study. The results of this study will not change a patient's clinical treatment plan but it may help physicians and researchers better understand how best to treat patients with breast cancer in the future. Type: Interventional Start Date: Mar 2022 |
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Ri1
NRG Oncology
Ovarian Carcinoma
This clinical trial evaluates how well two surgical procedures (bilateral salpingectomy
and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for
individuals with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal
of fallopian tubes, and bilateral salp1 expand
This clinical trial evaluates how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for individuals with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal of fallopian tubes, and bilateral salpingo-oophorectomy involves the surgical removal of both the fallopian tubes and ovaries. This study may help doctors determine if the two surgical procedures are nearly the same for ovarian cancer risk reduction for women with BRCA1 mutations. Type: Interventional Start Date: Sep 2020 |
Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy1
National Cancer Institute (NCI)
Bladder Flat Urothelial Carcinoma In Situ
Non-Muscle Invasive Bladder Urothelial Carcinoma
Stage 0a Bladder Cancer AJCC v8
Stage 0is Bladder Cancer AJCC v8
Stage I Bladder Cancer AJCC v8
This phase II trial studies the effect of adding pembrolizumab to gemcitabine in treating
patients with non-muscle invasive bladder cancer whose cancer does not respond to
Bacillus Calmette-Guerin (BCG) treatment. Chemotherapy drugs, such as gemcitabine, work
in different ways to stop the growth of1 expand
This phase II trial studies the effect of adding pembrolizumab to gemcitabine in treating patients with non-muscle invasive bladder cancer whose cancer does not respond to Bacillus Calmette-Guerin (BCG) treatment. Chemotherapy drugs, such as gemcitabine, 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. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the patient's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding pembrolizumab to gemcitabine may delay the return of BCG-unresponsive bladder cancer for longer period compared to gemcitabine alone. Type: Interventional Start Date: Mar 2020 |
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 in both non-obese and o1 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 |
Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lym1
Juno Therapeutics, a Subsidiary of Celgene
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Small Lymphocytic
This is a Phase 1/2, open-label, multicenter study to determine the efficacy and safety
of JCAR017 in adult subjects with relapsed or refractory CLL or SLL. The study will
include a Phase 1 part to determine the recommended dose of JCAR017 monotherapy in
subjects with relapsed or refractory CLL or1 expand
This is a Phase 1/2, open-label, multicenter study to determine the efficacy and safety of JCAR017 in adult subjects with relapsed or refractory CLL or SLL. The study will include a Phase 1 part to determine the recommended dose of JCAR017 monotherapy in subjects with relapsed or refractory CLL or SLL, followed by a Phase 2 part to further assess the efficacy and safety of JCAR017 monotherapy treatment at the recommended dose. A separate Phase 1 cohort will assess the combination of JCAR017 and concurrent ibrutinib. Another separate Phase 1 cohort will assess the combination of JCAR017 and concurrent venetoclax. In all subjects, the safety, efficacy, and pharmacokinetics (PK) of JCAR017 will be evaluated. Type: Interventional Start Date: Nov 2017 |
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Se1
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 |
Assessment of Metformin for Restoration of Immune Homeostasis in HIV+ and HIV- Individuals With a H1
University of Alabama at Birmingham
Systemic Inflammation
Immune Dysregulation
Injection Drug Use
HIV
This randomized clinical trial (RCT) evaluates whether metformin can reduce systemic
inflammation and improve immune function in individuals with a history of injection drug
use, with or without HIV. Participants will receive metformin or placebo and undergo
immune system assessments, including vac1 expand
This randomized clinical trial (RCT) evaluates whether metformin can reduce systemic inflammation and improve immune function in individuals with a history of injection drug use, with or without HIV. Participants will receive metformin or placebo and undergo immune system assessments, including vaccine response evaluations. Type: Interventional Start Date: Apr 2025 |
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