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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 Remove...
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). Immunotherapy... 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... 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 |
Study of Kidney Tumors in Younger Patients
Children's Oncology Group
Adult Cystic Nephroma
Anaplastic Kidney Wilms Tumor
Angiolipoma
Cellular Congenital Mesoblastic Nephroma
Classic Congenital Mesoblastic Nephroma
This research trial studies kidney tumors in younger patients. Collecting and storing
samples of tumor tissue, blood, and urine from patients with cancer to study in the
laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid
(DNA) and identify biomarkers related to... expand
This research trial studies kidney tumors in younger patients. Collecting and storing samples of tumor tissue, blood, and urine from patients with cancer to study in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer. Type: Observational Start Date: Feb 2006 |
Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel,...
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
Localized 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
Ultrahigh (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer.
Immunotherapy with monoclonal antibodies,... 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 Ultrahigh (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 Ultrahigh 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 |
Testing Sacituzumab Govitecan Therapy in Patients With HER2-Negative Breast Cancer and Brain Metastases
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 is... 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 |
A Study of PT217 in Patients With Neuroendocrine Carcinomas Expressing DLL3 (the SKYBRIDGE Study)
Phanes Therapeutics
Small Cell Lung Cancer (SCLC)
Large Cell Neuroendocrine Cancer (LCNEC)
Neuroendocrine Prostate Cancer (NEPC)
Gastroenteropancreatic Neuroendocrine Carcinoma (GEP-NEC)
PT217 is a bispecific antibody (bsAb) against human DLL3 (huDLL3) and human CD47
(huCD47). This is a first-in-human, Phase 1/2, open-label, dose-escalation and expansion
study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics,
and preliminary efficacy of PT217 in subjects... expand
PT217 is a bispecific antibody (bsAb) against human DLL3 (huDLL3) and human CD47 (huCD47). This is a first-in-human, Phase 1/2, open-label, dose-escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PT217 in subjects with neuroendocrine carcinomas. Patients with the following tumor types will be eligible for screening: small cell lung cancer (SCLC), large cell neuroendocrine carcinoma of the lung (LCNEC), and extrapulmonary neuroendocrine carcinoma (EP-NEC), including but not limited to neuroendocrine prostate cancer (NEPC) and gastroentero-pancreatic neuroendocrine carcinoma (GEP-NEC). Patients must have progressed after standard therapy (platinum-based chemotherapy) or standard therapy has proven to be ineffective, intolerable or is considered inappropriate. Type: Interventional Start Date: Sep 2023 |
Financial Toxicity and Quality of Life in Patients With TGCT
The University of Texas Health Science Center at San Antonio
Testicular Neoplasm
This is a cross-sectional, observational study employing validated questionnaires to
investigate financial toxicity in subjects with testicular germ cell tumors (TGCT). As
background, TGCTs are the most common malignancies among men from age 15-35. Treatment is
highly curative, but often consists... expand
This is a cross-sectional, observational study employing validated questionnaires to investigate financial toxicity in subjects with testicular germ cell tumors (TGCT). As background, TGCTs are the most common malignancies among men from age 15-35. Treatment is highly curative, but often consists of intensive multi-cycle chemotherapy with significant potential for physical toxicity. The treatment course itself is disruptive and long term physical and mental health consequences can increase risk for financial toxicity. Thus, we aim to study financial toxicity in both patients with TGCT actively receiving treatment and in TGCT survivors. There will be two separate cohorts: Cohort 1 will consist of subjects with recently diagnosed TGCT who will undergo multi-agent, multi-cycle chemotherapy and Cohort 2 will consist of subjects who have completed chemotherapy and are long-term survivors. Type: Observational Start Date: Mar 2023 |
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 |
Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal...
National Cancer Institute (NCI)
Primary Mediastinal Large B-Cell Lymphoma
This phase III trial compares the effects of nivolumab with chemo-immunotherapy versus
chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal
B-cell lymphoma (PMBCL). Immunotherapy with monoclonal antibodies, such as nivolumab, may
help the body's immune system attack... expand
This phase III trial compares the effects of nivolumab with chemo-immunotherapy versus chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal B-cell lymphoma (PMBCL). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Treatment for PMBCL involves chemotherapy combined with an immunotherapy called rituximab. Chemotherapy drugs 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. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving nivolumab with chemo-immunotherapy may help treat patients with PMBCL. Type: Interventional Start Date: Oct 2021 |
Blood Flow Restriction Training in Individuals Awaiting Total Knee Replacement
The University of Texas Health Science Center at San Antonio
Knee Osteoarthritis
The aim is to demonstrate that preoperative exercises (prehabilitation) using blood-flow
restriction training (BFRT) is safe, well tolerated, improves muscle function, decreases
functional limitation, and increases physical activity in older adults awaiting total
knee replacement (TKR). expand
The aim is to demonstrate that preoperative exercises (prehabilitation) using blood-flow restriction training (BFRT) is safe, well tolerated, improves muscle function, decreases functional limitation, and increases physical activity in older adults awaiting total knee replacement (TKR). Type: Interventional Start Date: Sep 2022 |
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 dependent... 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 |
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 |
Radiation Oncology Patient Medical Physics Intervention Study
The University of Texas Health Science Center at San Antonio
Anxiety
Patient Satisfaction
Radiation Therapy
This investigation is designed to be a two-arm, non-randomized prospective phase 2 study
evaluating the impact of medical physicist patient intervention on the anxiety level and
patient satisfaction of patients undergoing a course of radiation therapy. The goal is to
demonstrate that these interventions... expand
This investigation is designed to be a two-arm, non-randomized prospective phase 2 study evaluating the impact of medical physicist patient intervention on the anxiety level and patient satisfaction of patients undergoing a course of radiation therapy. The goal is to demonstrate that these interventions will have a significantly positive impact on the overall well-being of the oncology patients. Type: Interventional Start Date: Mar 2020 |
ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD)
Mayo Clinic
Frontotemporal Lobar Degeneration (FTLD)
Progressive Supranuclear Palsy (PSP)
Corticobasal Degeneration (CBD)
Behavioral Variant Frontotemporal Dementia (bvFTD)
Semantic Variant Primary Progressive Aphasia (svPPA)
ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD) represents the
formalized integration of ARTFL (U54 NS092089; funded through 2019) and LEFFTDS (U01
AG045390; funded through 2019) as a single North American research consortium to study
FTLD for 2019 and beyond. expand
ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD) represents the formalized integration of ARTFL (U54 NS092089; funded through 2019) and LEFFTDS (U01 AG045390; funded through 2019) as a single North American research consortium to study FTLD for 2019 and beyond. Type: Observational Start Date: Mar 2020 |
Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment...
NRG Oncology
Prostate Adenocarcinoma
This phase III trial uses the Decipher risk score to guide intensification (for higher
Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment to
better match therapies to an individual patient's cancer aggressiveness. The Decipher
risk score evaluates a prostate cancer... expand
This phase III trial uses the Decipher risk score to guide intensification (for higher Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment to better match therapies to an individual patient's cancer aggressiveness. The Decipher risk score evaluates a prostate cancer tumor for its potential for spreading. In patients with low risk scores, this trial compares radiation therapy alone to the usual treatment of radiation therapy and hormone therapy (androgen deprivation therapy). Radiation therapy uses high energy x-rays or particles to kill tumor cells and shrink tumors. Androgen deprivation therapy blocks the production or interferes with the action of male sex hormones such as testosterone, which plays a role in prostate cancer development. Giving radiation treatment alone may be the same as the usual approach in controlling the cancer and preventing it from spreading, while avoiding the side effects associated with hormonal therapy. In patients with higher Decipher gene risk, this trial compares the addition of darolutamide to usual treatment radiation therapy and hormone therapy, to usual treatment. Darolutamide blocks the actions of the androgens (e.g. testosterone) in the tumor cells and in the body. The addition of darolutamide to the usual treatment may better control the cancer and prevent it from spreading. Type: Interventional Start Date: Nov 2021 |
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... 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 |
Demineralized Bone Allograft Fibers Versus Particulate In Sinus Augmentation
The University of Texas Health Science Center at San Antonio
Bone Loss in Jaw
The purpose of this clinical trial is to assess if the addition of DFDBA fibers to DBBM
results in greater vital bone formation than the addition of DFDBA particles to DBBM.
The study team will examine the effects of the addition of DFDBA fibers to DBBM on vital
bone formation. Specifically, we... expand
The purpose of this clinical trial is to assess if the addition of DFDBA fibers to DBBM results in greater vital bone formation than the addition of DFDBA particles to DBBM. The study team will examine the effects of the addition of DFDBA fibers to DBBM on vital bone formation. Specifically, we will assess histologically the percent vital bone formation with each of the groups during implant placement, six months after the sinus augmentation procedure. We will also evaluate the radiographic volume achieved with both groups of materials. Type: Interventional Start Date: Sep 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 |
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 based... 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 |
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 vessels,... 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 |
Clinical Trial to Decrease Length of Stay in Infants With Neonatal Abstinence Syndrome With an Exclusive...
The University of Texas Health Science Center at San Antonio
Neonatal Abstinence Syndrome
A clinical trial to evaluate length of stay, growth velocity and clinical outcomes in
infants with neonatal abstinence syndrome receiving an exclusive human milk diet. Human
milk is defined as expressed human milk or donor milk and its derivatives, human
milk-based fortifier and human milk caloric... expand
A clinical trial to evaluate length of stay, growth velocity and clinical outcomes in infants with neonatal abstinence syndrome receiving an exclusive human milk diet. Human milk is defined as expressed human milk or donor milk and its derivatives, human milk-based fortifier and human milk caloric fortifier. Type: Interventional Start Date: Aug 2020 |
Effect of Tai Chi Exercise on Mechanical Joint Loading in Knee Osteoarthritis
Edward Via Virginia College of Osteopathic Medicine
Knee Osteoarthritis
This project is designed to identify the biomechanical mechanisms of Tai Chi (TC)
exercise and test a novel optimized TC intervention by modifying newly identified
mechanisms for those with knee osteoarthritis (OA) and to assess the changes in
mechanical load with the intervention. It combines unique... expand
This project is designed to identify the biomechanical mechanisms of Tai Chi (TC) exercise and test a novel optimized TC intervention by modifying newly identified mechanisms for those with knee osteoarthritis (OA) and to assess the changes in mechanical load with the intervention. It combines unique real time torque biofeedback approach, and uses external knee adduction moment (EKAM) as modulation target tailored to TC intervention in this population. The potential benefit from this project is to provide biomechanical insights of TC and this novel TC approach may produce meaningful changes of mechanical load in these patients who can learn and practice safely during this intervention. Type: Interventional Start Date: Aug 2018 |
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 that... 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 |
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