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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: Feb 2025 |
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
The University of Texas Health Science Center at San Antonio
End Stage Renal Disease
Fatigue
Fatigue is the most common symptom reported by end-stage kidney disease patients on
maintenance hemodialysis. Unfortunately, there currently is no medical management for
this overwhelming feeling of tiredness. As a result, patients continue to suffer with
poor quality of life and impaired daily act1 expand
Fatigue is the most common symptom reported by end-stage kidney disease patients on maintenance hemodialysis. Unfortunately, there currently is no medical management for this overwhelming feeling of tiredness. As a result, patients continue to suffer with poor quality of life and impaired daily activities. The purpose of this pilot trial is to find out if bupropion (a medicine commonly prescribed for stopping smoking, seasonal mood disorder, and depression) may help lessen fatigue in hemodialysis patients. In this study, hemodialysis participants will receive bupropion tablet orally three times a week during routine dialysis procedure for consecutive 8 weeks. Study participants will complete a battery of questionnaires to self-report fatigue, cognition, and quality of life. The study team will collect biological specimens. All these procedures will be performed at the dialysis clinic during routine dialysis procedure. Type: Interventional Start Date: Oct 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 |
Testing Cabozantinib With or Without Atezolizumab in Patients With Advanced Papillary Kidney Cancer1
National Cancer Institute (NCI)
Metastatic Papillary Renal Cell Carcinoma
Stage IV Renal Cell Cancer AJCC v8
This phase II trial compares the effect of atezolizumab in combination with usual
treatment with cabozantinib to cabozantinib alone in patients with papillary renal cell
carcinoma that has spread to other places in the body (metastatic). Papillary renal cell
carcinoma (PRCC) is a type of kidney can1 expand
This phase II trial compares the effect of atezolizumab in combination with usual treatment with cabozantinib to cabozantinib alone in patients with papillary renal cell carcinoma that has spread to other places in the body (metastatic). Papillary renal cell carcinoma (PRCC) is a type of kidney cancer that forms in the lining of the tiny tubes in the kidney that return filtered substances that the body needs back to the blood and remove extra fluid and waste as urine. Most papillary tumors look like long, thin finger-like growths under a microscope. It is also called papillary kidney cancer or PRCC. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Cabozantinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply and may also prevent the growth of new blood vessels that tumors need to grow. By these actions it may help slow or stop the spread of cancer cells. Combination therapy with atezolizumab and cabozantinib may shrink the cancer and allow a longer survival time in patients with metastatic renal cell carcinoma. Type: Interventional Start Date: Mar 2023 |
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 |
CD40 Agonist, Flt3 Ligand, and Chemotherapy in HER2 Negative Breast Cancer
University of Texas Southwestern Medical Center
HER2-negative Breast Cancer
Metastatic Breast Cancer
This research study is being done to find out if the immunotherapy drugs called CDX-301
and CDX-1140 in combination with the standard chemotherapy treatment pegylated liposomal
doxorubicin (PLD, Doxil) are safe and effective at controlling the cancer in patients
with metastatic triple Human Epiderm1 expand
This research study is being done to find out if the immunotherapy drugs called CDX-301 and CDX-1140 in combination with the standard chemotherapy treatment pegylated liposomal doxorubicin (PLD, Doxil) are safe and effective at controlling the cancer in patients with metastatic triple Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer, and to determine a safe dose and treatment schedule of the three drugs. This research study will also test how your immune system responds to these treatments alone and in combination. Type: Interventional Start Date: Apr 2022 |
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 |
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 |
Investigator-Initiated Study of Imipramine Hydrochloride and Lomustine in Recurrent Glioblastoma
The University of Texas Health Science Center at San Antonio
Glioblastoma
This study is designed as a single center, prospective, open label, single-arm
therapeutic trial with both surgical and non-surgical cohorts. expand
This study is designed as a single center, prospective, open label, single-arm therapeutic trial with both surgical and non-surgical cohorts. Type: Interventional Start Date: May 2022 |
Comparing the Outcome of Immunotherapy-Based Drug Combination Therapy With or Without Surgery to Re1
SWOG Cancer Research Network
Metastatic Clear Cell Renal Cell Carcinoma
Metastatic Renal Cell Carcinoma
Stage IV Renal Cell Cancer AJCC v8
This phase III trial compares the effect of adding surgery to a standard of care
immunotherapy-based drug combination versus a standard of care immunotherapy-based drug
combination alone in treating patients with kidney cancer that has spread to other places
in the body (metastatic). Immunotherapy1 expand
This phase III trial compares the effect of adding surgery to a standard of care immunotherapy-based drug combination versus a standard of care immunotherapy-based drug combination alone in treating patients with kidney cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, pembrolizumab, and avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Surgery to remove the kidney, called a nephrectomy, is also considered standard of care; however, doctors who treat kidney cancer do not agree on its benefits. It is not yet known if the addition of surgery to an immunotherapy-based drug combination works better than an immunotherapy-based drug combination alone in treating patients with kidney cancer. Type: Interventional Start Date: Mar 2021 |
Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)
The University of Texas Health Science Center at San Antonio
Diabetes Mellitus, Type 2
Impaired Glucose Tolerance (IGT)
Impaired Fasting Glucose (IFG)
HYPOTHESIS: Impaired glucose tolerance (IGT) and impaired fasting glucose (IFG) have
distinct pathophysiologic etiologies. Therefore, therapeutic interventions designed to
correct the specific underlying pathogenic abnormalities in IGT and IFG will be required
to optimally prevent the progressive b1 expand
HYPOTHESIS: Impaired glucose tolerance (IGT) and impaired fasting glucose (IFG) have distinct pathophysiologic etiologies. Therefore, therapeutic interventions designed to correct the specific underlying pathogenic abnormalities in IGT and IFG will be required to optimally prevent the progressive beta cell failure and development of overt type 2 diabetes. Type: Interventional Start Date: Jan 2014 |
Testing Sacituzumab Govitecan Therapy in Patients With HER2-Negative Breast Cancer and Brain Metast1
SWOG Cancer Research Network
Anatomic Stage IV Breast Cancer AJCC v8
Invasive Breast Carcinoma
Metastatic HER2 Negative Breast Carcinoma
Metastatic Malignant Neoplasm in the Brain
Prognostic Stage IV Breast Cancer AJCC v8
This phase II trial studies the effect of sacituzumab govitecan in treating patients with
HER2-negative breast cancer that has spread to the brain (brain metastases). Sacituzumab
govitecan is a monoclonal antibody, called sacituzumab, linked to a chemotherapy drug,
called govitecan. Sacituzumab is1 expand
This phase II trial studies the effect of sacituzumab govitecan in treating patients with HER2-negative breast cancer that has spread to the brain (brain metastases). Sacituzumab govitecan is a monoclonal antibody, called sacituzumab, linked to a chemotherapy drug, called govitecan. Sacituzumab is a form of targeted therapy because it attaches to specific molecules on the surface of cancer cells, known as Trop-2 receptors, and delivers govitecan to kill them. Giving sacituzumab govitecan may shrink the cancer in the brain and/or extend the time until the cancer gets worse. Type: Interventional Start Date: Jun 2021 |
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 |
Clinical Trial to Evaluate the Safety and Efficacy of DWN12088 in Patients With IPF
Daewoong Pharmaceutical Co. LTD.
Idiopathic Pulmonary Fibrosis
This is a randomized, double-blinded, placebo-controlled multicenter study to evaluate
the safety and efficacy of DWN12088 in patients with Idiopathic Pulmonary Fibrosis. expand
This is a randomized, double-blinded, placebo-controlled multicenter study to evaluate the safety and efficacy of DWN12088 in patients with Idiopathic Pulmonary Fibrosis. Type: Interventional Start Date: Jul 2022 |
Trial of Encapsulated Rapamycin (eRapa) for Bladder Cancer Prevention
Rapamycin Holdings, Inc. dba Emtora Biosciences
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 |
Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not B1
Gilead Sciences
HIV-1-infection
The goal of this clinical study is to learn more about the experimental drugs GS-1720 (an
oral, long-acting integrase strand transfer inhibitor (INSTI)) and GS-4182 (a prodrug of
Lenacapavir (LEN)); to compare the combination of GS-1720 and GS-4182 with the current
standard-of-care treatment bicteg1 expand
The goal of this clinical study is to learn more about the experimental drugs GS-1720 (an oral, long-acting integrase strand transfer inhibitor (INSTI)) and GS-4182 (a prodrug of Lenacapavir (LEN)); to compare the combination of GS-1720 and GS-4182 with the current standard-of-care treatment bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (Biktarvy), to see if the combination of GS-1720 and GS-4182 is safe and if it works for treating human immunodeficiency virus type 1 (HIV-1) infection in treatment-naive people with HIV-1 (PWH). This study has two phases: Phase 2 and Phase 3. The primary objectives of this study are: Phase 2: To evaluate the efficacy of oral weekly GS-1720 coadministered with GS-4182 versus continuing Biktarvy (BVY) in treatment-naive PWH at Week 24. Phase 3: To evaluate the efficacy of oral weekly GS-1720/GS-4182 fixed-dose combination (FDC) tablet regimen versus continuing BVY in treatment-naive PWH at Week 48. Type: Interventional Start Date: Oct 2024 |
A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)
Karuna Therapeutics
Alzheimer Disease
The purpose of this study is to evaluate the safety and efficacy of KarXT in adult
participants with mild to severe Alzheimer's Disease (AD) with moderate to severe
psychosis related to AD. expand
The purpose of this study is to evaluate the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD. Type: Interventional Start Date: Sep 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 |
Pasireotide s.c. in Patients With Post-Bariatric Hypoglycaemia
RECORDATI GROUP
Post-Bariatric Hypoglycemia
The Total duration of trial participation for each participant with post-bariatric
hypoglycemia will be a maximum of 59 weeks, with the following duration of trial periods
- 19 weeks for the Core Phase. It is composed of:
- a Screening period: a maximum of 3 weeks
- a Run-in p1 expand
The Total duration of trial participation for each participant with post-bariatric hypoglycemia will be a maximum of 59 weeks, with the following duration of trial periods - 19 weeks for the Core Phase. It is composed of: - a Screening period: a maximum of 3 weeks - a Run-in period (no treatment): 4 weeks - a Blinded Treatment Phase: 12 weeks - 36 weeks Extension Phase = an open-label Treatment period - 4 weeks for the safety follow-up period (without any treatment). Type: Interventional Start Date: Jan 2024 |
Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE): Shionogi Proteas1
University of Minnesota
COVID-19
Treatments are needed to improve outcomes among patients hospitalized for COVID-19,
including direct-acting antiviral (DAA) agents to mitigate the pathology driven by
ongoing viral replication. This trial will evaluate S-217622 (ensitrelvir), an
anti-SARS-CoV2 3C-like protease inhibitor (PI) develo1 expand
Treatments are needed to improve outcomes among patients hospitalized for COVID-19, including direct-acting antiviral (DAA) agents to mitigate the pathology driven by ongoing viral replication. This trial will evaluate S-217622 (ensitrelvir), an anti-SARS-CoV2 3C-like protease inhibitor (PI) developed by Shionogi &; Co. Ltd. The study design is a randomized, placebo-controlled, multi-center international clinical trial that will evaluate the clinical efficacy of ensitrelvir when given in addition to standard of care (SOC) for inpatients with COVID-19. The SOC will be determined by local established guidelines and may include additional DAA (e.g., remdesivir) and immunomodulatory treatment strategies. Certain SOC treatments will be pre-specified prior to randomization. Type: Interventional Start Date: Dec 2022 |
ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative1
Stemline Therapeutics, Inc.
Metastatic Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of elacestrant over the
course of 6 months in patients with estrogen receptor positive (ER+)/human epidermal
growth factor receptor-2 negative (HER2-) advanced/metastatic breast cancer who received
no prior cyclin-dependent kinase tar1 expand
The purpose of this study is to evaluate the efficacy and safety of elacestrant over the course of 6 months in patients with estrogen receptor positive (ER+)/human epidermal growth factor receptor-2 negative (HER2-) advanced/metastatic breast cancer who received no prior cyclin-dependent kinase targeting enzymes CDK4 and CDK6 inhibitor (CDK4/6i) in the metastatic setting. Type: Interventional Start Date: May 2023 |
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 |
Safety & Efficacy/Tolerability of Rhenium-186 NanoLiposomes (186RNL) for Patients Who Received a Pr1
Plus Therapeutics
Glioma
This is an open-label, multicenter, Phase 1 study to establish the safety and
efficacy/tolerability of a single dose of 186RNL by the intraventricular route (via
intraventricular catheter) for recurrence glioma in patients who received a prior
treatment of 186RNL. expand
This is an open-label, multicenter, Phase 1 study to establish the safety and efficacy/tolerability of a single dose of 186RNL by the intraventricular route (via intraventricular catheter) for recurrence glioma in patients who received a prior treatment of 186RNL. Type: Interventional Start Date: Dec 2024 |
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