Clinical trials: sponsored by University of Alabama at Birmingham
Solid Tumor, Unspecified, Adult, Lymphoma
Granzyme B PET Imaging Drug as a Predictor of Immunotherapy Response to Checkpoint Inhibitors
First in Human Safety of [68Ga]-NOTA-hGZP PET Imaging in subjects with cancer undergoing treatment with a checkpoint inhibitor either as a monotherapy of in combination I-O therapy
- Trial name
- NCT04169321
- Testing
- Single Arm
- Where
- 3 sites in United States, Taiwan
- Volunteers
- 13 people
- Sponsor
- Cytosite Biopharma Inc.
COPD
Effect of Ensifentrine on Sputum Markers of Inflammation in COPD
This is a randomized, double-blind, placebo-controlled, two-period cross-over study of nebulized ensifentrine (3 mg) or placebo administered BID for two 8-week Treatment Periods.
- Trial name
- NCT05270525
- Testing
- Ensifentrine
- Where
- 3 sites in United States
- Volunteers
- 56 people
- Sponsor
- Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA
Acute Kidney Injury
Allogeneic HB-adMSCs vs Placebo for the Treatment of Acute Kidney Injury
This study aims to investigate, through the collection of valid scientific evidence necessary to determine safety and effectiveness, the potential use of Allogeneic Hope Biosciences Adipose-derived Mesenchymal Stem Cells…
- Trial name
- AKI (NCT06654193)
- Testing
- Allogeneic HB-adMSCs, Normal Saline
- Where
- 3 sites in United States
- Volunteers
- 70 people
- Sponsor
- Hope Biosciences LLC
Urolithiasis, Kidney Stone
A Retrospective, Multi-center Real-world Study of Steerable Ureteroscopic Renal Evacuation (SURE) Procedure With the CVAC® System
This is a retrospective, multi-center collaboration to assess real-world outcomes of a novel steerable aspiration system, the CVAC® System ("CVAC"), and flexible and navigable suction ureteral access sheath (FANS) for the…
- Conditions
- Urolithiasis, Kidney Stone, Kidney Stones
- Trial name
- REASON (NCT07225933)
- Testing
- CVAC® SYSTEM, FLEXIBLE AND NAVIGATIONAL URETERAL ACCESS SHEATH (FANS) IN FLEXIBLE URETEROSCOPY (FURS)
- Where
- United States
- Volunteers
- 3,000 people
- Sponsor
- Calyxo, Inc.
Pancreatic Ductal Adenocarcinoma (PDAC)
ProAgio in Pancreatic Ductal Adenocarcinoma (PDAC)
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, nab-paclitaxel (G-nP) or gemcitabine, nab-paclitaxel…
- Trial name
- NCT06182072
- Testing
- ProAgio Dose Levels (DL) 1,2,3,4, Gemcitabine, nab paclitaxel
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- ProDa BioTech, LLC
Prosthetic Joint Infection
Study to Evaluate Safety and Activity of TRL1068 in Prosthetic Joint Infections
TRL1068 is expected to eliminate the pathogen-protecting biofilm in the prosthetic joint and surrounding tissue, thus making these pathogens substantially more susceptible to established antibiotic treatment regimens.
- Trial name
- NCT04763759
- Testing
- TRL1068, a human monoclonal antibody
- Where
- 9 sites in United States
- Volunteers
- 15 people
- Sponsor
- Trellis Bioscience LLC
Mouth Diseases
Evaluation of Oral Potentially Malignant Disorders (OPMDs) with STRATICYTE™
The purpose of this study is to validate the ability of the STRATICYTE™ predictive model to predict the transformation of oral potentially malignant disorders (OPMDs) to oral squamous cell carcinoma (OSCC) in a retrospective…
- Trial name
- NCT05853783
- Testing
- STRATICYTE™ Test
- Where
- 5 sites in United States
- Volunteers
- 180 people
- Sponsor
- Proteocyte Diagnostics Inc.
Osteoporosis
Denosumab Safety Assessment in Multiple Observational Databases
This is a prospective open-cohort study with annual assessment and reporting of descriptive findings from 5 secondary data sources, US Medicare, Optum Research Database (formerly United HealthCare), Scandinavian national health…
- Trial name
- NCT02520362
- Testing
- denosumab, bisphosphonate
- Volunteers
- 517,991 people
- Sponsor
- Amgen
Child Safety Seat Harness Tension
Minnesota HealthSolutions Cellular Car Seat Study
The objective of the study is to evaluate an innovative child safety seat user engagement system (CCS system) designed to actively educate, instruct, and alarm caregivers with information associated with automatically-sensed…
- Trial name
- NCT05552027
- Testing
- CCS System- Prototype, CCS System- Control
- Where
- United States
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Minnesota HealthSolutions
Bronchiectasis
Clinical Effectiveness Of High Frequency Chest Wall Oscillation (HFCWO) In A Bronchiectasis Population
The primary objective is to compare the patient's baseline QoL prior to HFCWO use against the patient's QoL at various study timepoints over a one-year period of HFCWO use.
- Trial name
- HFCWO (NCT04271969)
- Testing
- SmartVest Airway Clearance System
- Where
- 4 sites in United States
- Volunteers
- 25 people
- Sponsor
- Electromed, Inc.
Breast Cancer, Chemotherapy-induced Peripheral Neuropathy
Risk Prediction of Taxane Chemotherapy-Induced Peripheral Neuropathy
This is an observational study to discover risk factors of chemotherapy-induced peripheral neuropathy (CIPN) in 350 patients with early stage breast cancer undergoing taxane-based chemotherapy at two main sites (University of…
- Conditions
- Breast Cancer, Chemotherapy-induced Peripheral Neuropathy, Aging
- Trial name
- SENSE (NCT04932031)
- Where
- 2 sites in United States
- Volunteers
- 123 people
- Sponsor
- Sapere Bio
Healthy Volunteers
Study to Evaluate the Safety and Dosimetry of [68Ga]-NOTA-hGZP (CSB-111) PET Imaging in Healthy Human Volunteers.
Phase one study to evaluate the safety and dosimetry of [68Ga]-NOTA-hGZP (CSB-111) PET Imaging in healthy human volunteers.
- Trial name
- NCT05285696
- Testing
- CSB-111
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Cytosite Biopharma Inc.
Stroke, Ischemic, Infarction, Middle Cerebral Artery
Testing of Identification Markers for Stroke
Stroke is the third leading cause of death and the first cause of physical disability and dementia worldwide. Ischemic stroke caused by large vessel occlusion (LVO) is responsible for the vast majority of deaths and disabilities.
- Conditions
- Stroke, Ischemic, Infarction, Middle Cerebral Artery, Infarction, Anterior Circulation, Brain
- Trial name
- TIME (NCT04292600)
- Testing
- POCKiT diagnostics' algorithm for LVO detection
- Where
- 3 sites in United States
- Volunteers
- 383 people
- Sponsor
- POCKiT diagnostics Ltd
Kidney Transplant Rejection
TruGraf and TRAC In Pediatrics Study
This is a pilot 3 center prospective study of pediatric renal kidney recipients undergoing protocol biopsies examining the performance of the TruGraf gene expression test in children and adolescents.
- Trial name
- TTIPS (NCT05335538)
- Testing
- Patients monitored with TruGraf and TRAC testing
- Where
- 3 sites in United States, Canada
- Volunteers
- 75 people
- Sponsor
- Transplant Genomics, Inc.
Stress Urinary Incontinence
Pelvic Floor Muscle Training With a Digital Therapeutic Device to Standard Exercises for Stress Urinary Incontinence
A virtual prospective randomized controlled study to evaluate the efficacy of using the leva® Pelvic Digital Health System (PDHS) to perform PFMT compared to a standard home exercise home program for the treatment of SUI/SMUI.
- Trial name
- NCT04508153
- Testing
- Leva Pelvic Digital Health System, Kegel exercises
- Where
- 3 sites in United States
- Volunteers
- 369 people
- Sponsor
- Renovia, Inc.
Ankle Arthritis, Foot Arthritis
The Use of a Dynamic Compression Intramedullary Nail for Tibiotalocalcaneal Arthrodesis
The purpose of this study is to determine the clinical efficacy of a novel sustained dynamic compression intramedullary nail for tibiotalocalcaneal (TTC) arthrodesis.
- Trial name
- NCT04784273
- Testing
- Tibiotalocalcaneal Arthrodesis, DynaNail
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- MedShape, Inc
Health Risk Behaviors
Sexually Active Adolescent Focused Education
SAAFE will be pilot tested in 2 geographically distinct areas (Washington, DC and Deep South) with 100 participants from each site to 1) primarily assess the efficacy of improved self-efficacy, knowledge about HIV/STIs and…
- Trial name
- SAAFE (NCT03646032)
- Testing
- SAAFE, Control
- Where
- 2 sites in United States
- Volunteers
- 178 people, healthy volunteers welcome
- Sponsor
- Benten Technologies, Inc.
Non Small Cell Lung Cancer
Study of TRC105 + Paclitaxel/Carboplatin and Bevacizumab in Patients With NSCLC
This is a single center, open-label, nonrandomized, phase 1b, dose-finding study of TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC.
- Trial name
- NCT03780010
- Testing
- TRC105
- Volunteers
- 15 people
- Sponsor
- Tracon Pharmaceuticals Inc.
HIV-1 Infection
A Safety and Immunogenicity Study of a Plasmid DNA Prime and MVA Boost Vaccine in HIV-1 Infected Adults on ART
GV-TH-01 is an open label Phase 1 study of 9 HIV-1 infected adults with suppressed viremia who started anti-retroviral therapy (ART) within 18 months of a negative HIV antibody test. This study has 3 phases.
- Trial name
- NCT01378156
- Testing
- JS7 plasmid DNA and MVA62B vaccine
- Where
- 3 sites in United States
- Volunteers
- 9 people
- Sponsor
- GeoVax, Inc.
Lung Cancer
Airway Epithelium Gene Expression: AEGIS IDE
The purpose of the research study is to develop a new, more sensitive, and less invasive test for diagnosing lung cancer at an earlier stage, when it can more easily be cured.
- Trial name
- AEGIS IDE (NCT00746759)
- Testing
- Biomarker (not used as an intervention)
- Where
- 21 sites in United States
- Volunteers
- 1,331 people
- Sponsor
- Allegro Diagnostics, Corp.