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Phosphatidylethanol and Other Ethanol Consumption Markers
The University of Texas Health Science Center at San Antonio
Healthy Volunteer
Alcohol Consumption
This study is intended to help the investigators understand how a biomarker found in the
blood may be used to better identify the quantity and different patterns of alcohol use.
The investigators hope that the results of this study will help identify the uses of
alcohol-use markers in the blood in1 expand
This study is intended to help the investigators understand how a biomarker found in the blood may be used to better identify the quantity and different patterns of alcohol use. The investigators hope that the results of this study will help identify the uses of alcohol-use markers in the blood in future alcohol prevention and treatment programs. It is hoped that the information learned from this study will benefit other people in the future. The study participants will come into the lab and will (1) consume alcohol in the lab designed to produce a peak blood alcohol concentration of 0.06% and have blood collected over 6 hours followed by abstinence for 10 days to give a small blood sample 4 times and (2) to give a small amount of blood 5 times within 28 days (naturalistic drinking) and provide answers about alcohol use. Type: Interventional Start Date: Jan 2025 |
Mirragen Diabetic Foot Ulcer Study
The University of Texas Health Science Center at San Antonio
Diabetic Foot Ulcer
Osteomyelitis Chronic
This study is being done to collect data from treatment of patients who have diabetes
with non-healing foot wounds and are being treated with a resorbable and biocompatible
borate-based bioactive glass fiber matrix. A borate-based bioactive glass fiber matrix is
used to cover the ulcer for wound ma1 expand
This study is being done to collect data from treatment of patients who have diabetes with non-healing foot wounds and are being treated with a resorbable and biocompatible borate-based bioactive glass fiber matrix. A borate-based bioactive glass fiber matrix is used to cover the ulcer for wound management. The primary objective of this study is to evaluate the safety and efficacy of the borate-based bioactive glass fiber matrix in the treatment of diabetic foot ulcers in a real-world setting. The secondary objective is to evaluate the clinical and financial benefits in terms of quality of healing, pain, and treatment cost. Type: Observational Start Date: Sep 2024 |
Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxe1
National Cancer Institute (NCI)
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
HER2-Negative Breast Carcinoma
Hormone Receptor-Positive Breast Carcinoma
This phase III trial compares the addition of an immunotherapy drug (durvalumab) to usual
chemotherapy versus usual chemotherapy alone in treating patients with MammaPrint High 2
Risk (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer.
Immunotherapy with monoclonal antibodies1 expand
This phase III trial compares the addition of an immunotherapy drug (durvalumab) to usual chemotherapy versus usual chemotherapy alone in treating patients with MammaPrint High 2 Risk (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as paclitaxel, doxorubicin, and cyclophosphamide 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. There is some evidence from previous clinical trials that people who have a MammaPrint High 2 Risk result may be more likely to respond to chemotherapy and immunotherapy. Adding durvalumab to usual chemotherapy may be able to prevent the cancer from returning for patients with MP2 stage II-III hormone receptor positive, HER2 negative breast cancer. Type: Interventional Start Date: Nov 2023 |
The Pediatric Acute Leukemia (PedAL) Screening Trial - A Study to Test Bone Marrow and Blood in Chi1
PedAL BCU, LLC
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Acute Myeloid Leukemia Post Cytotoxic Therapy
Juvenile Myelomonocytic Leukemia
Mixed Phenotype Acute Leukemia
This study aims to use clinical and biological characteristics of acute leukemias to
screen for patient eligibility for available pediatric leukemia sub-trials. Testing bone
marrow and blood from patients with leukemia that has come back after treatment or is
difficult to treat may provide informat1 expand
This study aims to use clinical and biological characteristics of acute leukemias to screen for patient eligibility for available pediatric leukemia sub-trials. Testing bone marrow and blood from patients with leukemia that has come back after treatment or is difficult to treat may provide information about the patient's leukemia that is important when deciding how to best treat it, and may help doctors find better ways to diagnose and treat leukemia in children, adolescents, and young adults. Type: Interventional Start Date: Apr 2022 |
Trial of Encapsulated Rapamycin (eRapa) for Bladder Cancer Prevention
Robert Svatek
Non-muscle Invasive Bladder Cancer
eRapa (encapsulated rapamycin) will be investigated for secondary prevention in patients
with diagnosed non-muscle invasive bladder cancer (NMIBC) through a phase II double-blind
randomized controlled trial of long-term (one year) prevention with eRapa versus placebo.
The primary hypothesis is that1 expand
eRapa (encapsulated rapamycin) will be investigated for secondary prevention in patients with diagnosed non-muscle invasive bladder cancer (NMIBC) through a phase II double-blind randomized controlled trial of long-term (one year) prevention with eRapa versus placebo. The primary hypothesis is that eRapa decreases the risk of cancer relapse for patients with NMIBC. Secondary hypotheses are that eRapa can improve certain immune parameters and improve cognition and physical function without adversely affecting patient-reported outcomes and quality of life. Type: Interventional Start Date: Jan 2021 |
A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients W1
Children's Oncology Group
Acute Myeloid Leukemia
This phase III trial compares standard chemotherapy to therapy with liposome-encapsulated
daunorubicin-cytarabine (CPX-351) and/or gilteritinib for patients with newly diagnosed
acute myeloid leukemia with or without FLT3 mutations. Drugs used in chemotherapy, such
as daunorubicin, cytarabine, and1 expand
This phase III trial compares standard chemotherapy to therapy with liposome-encapsulated daunorubicin-cytarabine (CPX-351) and/or gilteritinib for patients with newly diagnosed acute myeloid leukemia with or without FLT3 mutations. Drugs used in chemotherapy, such as daunorubicin, cytarabine, and gemtuzumab ozogamicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. CPX-351 is made up of daunorubicin and cytarabine and is made in a way that makes the drugs stay in the bone marrow longer and could be less likely to cause heart problems than traditional anthracycline drugs, a common class of chemotherapy drug. Some acute myeloid leukemia patients have an abnormality in the structure of a gene called FLT3. Genes are pieces of DNA (molecules that carry instructions for development, functioning, growth and reproduction) inside each cell that tell the cell what to do and when to grow and divide. FLT3 plays an important role in the normal making of blood cells. This gene can have permanent changes that cause it to function abnormally by making cancer cells grow. Gilteritinib may block the abnormal function of the FLT3 gene that makes cancer cells grow. The overall goals of this study are, 1) to compare the effects, good and/or bad, of CPX-351 with daunorubicin and cytarabine on people with newly diagnosed AML to find out which is better, 2) to study the effects, good and/or bad, of adding gilteritinib to AML therapy for patients with high amounts of FLT3/ITD or other FLT3 mutations and 3) to study changes in heart function during and after treatment for AML. Giving CPX-351 and/or gilteritinib with standard chemotherapy may work better in treating patients with acute myeloid leukemia compared to standard chemotherapy alone. Type: Interventional Start Date: Jul 2020 |
A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement o1
MediWound Ltd
Venous Leg Ulcer (VLU)
The main objective of this study is:
To assess the efficacy and safety of EscharEx (EX-03 5% formulation) compared to placebo
control,in debridement and wound bed preparation of Venous Leg Ulcers (VLU). expand
The main objective of this study is: To assess the efficacy and safety of EscharEx (EX-03 5% formulation) compared to placebo control,in debridement and wound bed preparation of Venous Leg Ulcers (VLU). Type: Interventional Start Date: Apr 2025 |
KIOS Mobile App Evaluation
The University of Texas Health Science Center at San Antonio
Opioid Use Disorder
Evaluation of a mobile medical app (KIOS) vs. treatment as usual for the treatment of
opioid use disorder (OUD). expand
Evaluation of a mobile medical app (KIOS) vs. treatment as usual for the treatment of opioid use disorder (OUD). Type: Interventional Start Date: May 2024 |
A Study to Learn More About the Health of Persons With Down Syndrome After Treatment for Acute Leuk1
Children's Oncology Group
B Acute Lymphoblastic Leukemia Associated With Down Syndrome
Down Syndrome
Myeloid Leukemia Associated With Down Syndrome
This study attempts to learn more about the health of persons with Down syndrome after
treatment for acute leukemia. Children with Down syndrome are at increased risk for side
effects during treatment for acute leukemia, but it is unclear of their risk for
long-term effects of cancer treatment. By1 expand
This study attempts to learn more about the health of persons with Down syndrome after treatment for acute leukemia. Children with Down syndrome are at increased risk for side effects during treatment for acute leukemia, but it is unclear of their risk for long-term effects of cancer treatment. By learning more about the factors that may contribute to chronic health conditions and long-term effects after treatment for leukemia in persons with Down syndrome, clinical practice guidelines for survivorship care can be developed to help improve their quality-of-life. Type: Observational Start Date: Nov 2023 |
Molecular and Epidemiological Risk Factors in the Development of Gastric Cancer
The University of Texas Health Science Center at San Antonio
Gastric Cancer
This protocol is a single-institution feasibility study to identify the molecular and
epidemiological risk factors in the development of gastric cancer in high-risk
predominantly Hispanic South Texas population. The study is broken down into two main
parts: 1) To identify molecular differences in g1 expand
This protocol is a single-institution feasibility study to identify the molecular and epidemiological risk factors in the development of gastric cancer in high-risk predominantly Hispanic South Texas population. The study is broken down into two main parts: 1) To identify molecular differences in gastric adenocarcinoma (GAC) between Non-Hispanics and Hispanics, stratified by age, and in benign, pre-malignant, and malignant gastric lesions; and 2) To identify environmental and clinicopathological factors in Hispanics associated with specific molecular changes linked to the development of GAC. Type: Observational Start Date: Jan 2021 |
A Phase 1 Study of LNCB74 in Advanced Solid Tumors
NextCure, Inc.
Ovarian Cancer
Breast Cancer
Endometrial Cancer
Biliary Tract Cancer
Non-Small Cell Lung Cancer
This is an open-label, phase 1, dose escalation and dose expansion study to determine
safety and tolerability, and to determine the maximum tolerated dose and / or recommended
phase 2 dose of LNCB74 in participants with advanced solid tumors. expand
This is an open-label, phase 1, dose escalation and dose expansion study to determine safety and tolerability, and to determine the maximum tolerated dose and / or recommended phase 2 dose of LNCB74 in participants with advanced solid tumors. Type: Interventional Start Date: Jan 2025 |
Comparative Effectiveness of Two Initial Combination Therapies in Patients With Recent Onset Diabet1
The University of Texas Health Science Center at San Antonio
Type 2 Diabetes (Adult Onset)
The primary purpose of this study is to evaluate the efficacy, durability, and mechanism
of HbA1c reduction produced by the combination of pioglitazone plus tirzepatide compared
to metformin plus sitagliptin in patients with recently diagnosed type 2 diabetes
mellitus. expand
The primary purpose of this study is to evaluate the efficacy, durability, and mechanism of HbA1c reduction produced by the combination of pioglitazone plus tirzepatide compared to metformin plus sitagliptin in patients with recently diagnosed type 2 diabetes mellitus. Type: Interventional Start Date: Nov 2024 |
Acute and Chronic Effects of Oral Ketones in Subjects With HFrEF and Diabetes
The University of Texas Health Science Center at San Antonio
Type 2 Diabetes
Heart Failure, Reduced Ejection Fraction
This study will provide insight into whether cardiac function changes with oral Ketone
Esters (KE) administered to patients with Type 2 Diabetes Mellitus (T2DM) and Heart
failure with reduced ejection fraction (HFrEF). Plasma ketones are avidly extracted by
cardiac muscle and their uptake is not de1 expand
This study will provide insight into whether cardiac function changes with oral Ketone Esters (KE) administered to patients with Type 2 Diabetes Mellitus (T2DM) and Heart failure with reduced ejection fraction (HFrEF). Plasma ketones are avidly extracted by cardiac muscle and their uptake is not dependent upon insulin or influenced by insulin resistance. Type: Interventional Start Date: Jan 2024 |
Study of Tremelimumab and Durvalumab (MEDI4736) (T300+D) in Advanced Hepatocellular Carcinomas with1
The University of Texas Health Science Center at San Antonio
Hepatocellular Carcinoma
Cirrhosis, Liver
This is a single-arm, phase II study of patients with advanced liver cancer or
hepatocellular carcinoma (HCC) who are eligible for first-line treatment with T300+D. The
invesitgators hypothesize that T300+D will be safe and tolerated in CP-B patients with
HCC. HCC mostly affects disadvantaged popul1 expand
This is a single-arm, phase II study of patients with advanced liver cancer or hepatocellular carcinoma (HCC) who are eligible for first-line treatment with T300+D. The invesitgators hypothesize that T300+D will be safe and tolerated in CP-B patients with HCC. HCC mostly affects disadvantaged populations with higher rates among racial/ethnic minorities, who are often not included in clinical trials (i.e., Hispanics, Blacks, underserved, low socioeconomic status) and present with more severe disease. Given there is not much data in the US patient cohort, this study provides a chance to gain that knowledge. Type: Interventional Start Date: Dec 2024 |
Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH)
Johns Hopkins University
Intracerebral Hemorrhage
This first-in-patient phase 2a pilot study will assess the safety and tolerability of
MW01-6-189WH (hereafter called MW189) in patients with Intracerebral Hemorrhage (ICH). expand
This first-in-patient phase 2a pilot study will assess the safety and tolerability of MW01-6-189WH (hereafter called MW189) in patients with Intracerebral Hemorrhage (ICH). Type: Interventional Start Date: Oct 2022 |
Stroke Thrombectomy and Aneurysm Registry
Medical University of South Carolina
Stroke
Thromboses, Intracranial
Aneurysm, Brain
This international multi-center registry is used to collect existing information and
outcomes for patients undergoing an operation for treatment of injuries to the brain
including the blockage of blood flow to an area of the brain, an abnormal ballooning of
an artery, abnormal tangling of blood ves1 expand
This international multi-center registry is used to collect existing information and outcomes for patients undergoing an operation for treatment of injuries to the brain including the blockage of blood flow to an area of the brain, an abnormal ballooning of an artery, abnormal tangling of blood vessels, abnormal formation of blood vessels, tearing of vein, and bleeding in the brain. This information is used to help predict outcomes that undergo an operation for treatment of the above-listed brain injuries. Additionally, the information is used to compare techniques and devices' effects on technical and clinical outcomes. Type: Observational [Patient Registry] Start Date: Sep 2019 |
Brain Oxygen Optimization in Severe TBI, Phase 3
University of Michigan
Brain Injuries, Traumatic
BOOST3 is a randomized clinical trial to determine the comparative effectiveness of two
strategies for monitoring and treating patients with traumatic brain injury (TBI) in the
intensive care unit (ICU). The study will determine the safety and efficacy of a strategy
guided by treatment goals based1 expand
BOOST3 is a randomized clinical trial to determine the comparative effectiveness of two strategies for monitoring and treating patients with traumatic brain injury (TBI) in the intensive care unit (ICU). The study will determine the safety and efficacy of a strategy guided by treatment goals based on both intracranial pressure (ICP) and brain tissue oxygen (PbtO2) as compared to a strategy guided by treatment goals based on ICP monitoring alone. Both of these alternative strategies are used in standard care. It is unknown if one is more effective than the other. In both strategies the monitoring and goals help doctors adjust treatments including the kinds and doses of medications and the amount of intravenous fluids given, ventilator (breathing machine) settings, need for blood transfusions, and other medical care. The results of this study will help doctors discover if one of these methods is more safe and effective. Type: Interventional Start Date: Aug 2019 |
Quantifying Hepatic Mitochondrial Fluxes in Humans
The University of Texas Health Science Center at San Antonio
Non-Alcoholic Fatty Liver Disease
Type 2 Diabetes
Mitochondrial Metabolism Disorders
In this study the investigators will quantitate hepatic mitochondrial fluxes in T2D
patients with NAFL and NASH before and after 16-weeks treatment with the insulin
sensitizer pioglitazone expand
In this study the investigators will quantitate hepatic mitochondrial fluxes in T2D patients with NAFL and NASH before and after 16-weeks treatment with the insulin sensitizer pioglitazone Type: Interventional Start Date: Nov 2022 |
Avexitide for Treatment of Post-Bariatric Hypoglycemia
Amylyx Pharmaceuticals Inc.
Post Bariatric Hypoglycemia
AVX-001 (LUCIDITY) is a Phase 3 study to evaluate avexitide compared to placebo in
participants with post bariatric hypoglycemia (PBH) related to Roux-en-Y gastric bypass
(RYGB). The study will assess avexitide compared to placebo for safety and efficacy,
measured by reduction of hypoglycemic event1 expand
AVX-001 (LUCIDITY) is a Phase 3 study to evaluate avexitide compared to placebo in participants with post bariatric hypoglycemia (PBH) related to Roux-en-Y gastric bypass (RYGB). The study will assess avexitide compared to placebo for safety and efficacy, measured by reduction of hypoglycemic events. The study includes a Screening period with a Run-in period (of up to 6- and 3-weeks, respectively); a randomized, double-blind, placebo-controlled study treatment period of 16 weeks; and a two-part open-label extension (OLE) period with a duration of approximately 32 weeks. Type: Interventional Start Date: Apr 2025 |
Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)
Merck Sharp & Dohme LLC
Essential Thrombocythemia
The purpose of this study is to evaluate the efficacy and safety of bomedemstat compared
with hydroxyurea in cytoreductive therapy naïve essential thrombocythemia (ET)
participants for whom cytoreductive therapy is indicated. Its primary objective is to
compare bomedemstat to hydroxyurea with respe1 expand
The purpose of this study is to evaluate the efficacy and safety of bomedemstat compared with hydroxyurea in cytoreductive therapy naïve essential thrombocythemia (ET) participants for whom cytoreductive therapy is indicated. Its primary objective is to compare bomedemstat to hydroxyurea with respect to durable clinicohematologic response (DCHR). The primary hypothesis is that bomedemstat is superior to hydroxyurea with respect to DCHR. Type: Interventional Start Date: Jul 2024 |
Bionic Pancreas in CFRD
Jaeb Center for Health Research
Cystic Fibrosis-related Diabetes
This multi-center randomized controlled trial (RCT) will compare efficacy and safety
endpoints using the insulin-only configuration of the iLet Bionic Pancreas System (BP)
versus a control group using their usual care insulin delivery method and continuous
glucose monitoring (CGM) during a 13-week1 expand
This multi-center randomized controlled trial (RCT) will compare efficacy and safety endpoints using the insulin-only configuration of the iLet Bionic Pancreas System (BP) versus a control group using their usual care insulin delivery method and continuous glucose monitoring (CGM) during a 13-week study period in individuals ≥14 years old with cystic fibrosis-related diabetes (CFRD). After 13 weeks, participants will continue in a 13-week Extension Phase in which the BP group will continue to use the BP system and the Usual Care group will initiate use of the BP system. Type: Interventional Start Date: Sep 2024 |
A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis1
Boehringer Ingelheim
Idiopathic Pulmonary Fibrosis
Progressive Pulmonary Fibrosis
This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive
pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a
previous study with a medicine called nerandomilast or BI 1015550.
The goal of this study is to find out how well people with1 expand
This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a previous study with a medicine called nerandomilast or BI 1015550. The goal of this study is to find out how well people with pulmonary fibrosis tolerate long- term treatment with nerandomilast. The study also tests whether nerandomilast improves lung function and prolongs the time until symptoms get worse, participants need to go to the hospital, or die. Every participant takes nerandomilast as tablets for up to 1 year and 10 months. The participants may also continue their regular treatment for pulmonary fibrosis during the study. Participants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. Participants also regularly do lung function tests. Type: Interventional Start Date: May 2024 |
A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumoma1
National Cancer Institute (NCI)
B Acute Lymphoblastic Leukemia
This pilot trial assesses the effect of the combination of blinatumomab with dasatinib or
imatinib and standard chemotherapy for treating patients with Philadelphia chromosome
positive (Ph+) or ABL-class Philadelphia chromosome-like (Ph-like) B-Cell acute
lymphoblastic leukemia (B-ALL). Blinatumoma1 expand
This pilot trial assesses the effect of the combination of blinatumomab with dasatinib or imatinib and standard chemotherapy for treating patients with Philadelphia chromosome positive (Ph+) or ABL-class Philadelphia chromosome-like (Ph-like) B-Cell acute lymphoblastic leukemia (B-ALL). Blinatumomab is a bispecific antibody that binds to two different proteins-one on the surface of cancer cells and one on the surface of cells in the immune system. An antibody is a protein made by the immune system to help fight infections and other harmful processes/cells/molecules. Blinatumomab may bind to the cancer cell and a T cell (which plays a key role in the immune system's fighting response) at the same time. Blinatumomab may strengthen the immune system's ability to fight cancer cells by activating the body's own immune cells to destroy the tumor. Dasatinib and imatinib are in a class of medications called tyrosine kinase inhibitors. They work by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Giving blinatumomab and dasatinib or imatinib in combination with standard chemotherapy may work better in treating patients with Ph+ or Ph-like ABL-class B-ALL than dasatinib or imatinib with chemotherapy. Type: Interventional Start Date: May 2025 |
A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezo1
Celgene
Relapsed or Refractory Multiple Myeloma
The purpose of this study is to compare the efficacy and safety of mezigdomide
(CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and
dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM)
who received between 1 to 3 prior lines of the1 expand
The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure. Type: Interventional Start Date: Sep 2022 |
Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis
University of Florida
Intracranial Arteriosclerosis
Stroke
The primary goal of the trial is to determine if the experimental arms (rivaroxaban or
ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of
ischemic stroke, intracerebral hemorrhage, or vascular death. expand
The primary goal of the trial is to determine if the experimental arms (rivaroxaban or ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of ischemic stroke, intracerebral hemorrhage, or vascular death. Type: Interventional Start Date: Aug 2022 |
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