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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 Epidermal... 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 |
The Pediatric Acute Leukemia (PedAL) Screening Trial - A Study to Test Bone Marrow and Blood in Children...
LLS PedAL Initiative, 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 information... 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 |
A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT
Children's Oncology Group
Central Nervous System Nongerminomatous Germ Cell Tumor
Choriocarcinoma
Embryonal Carcinoma
Immature Teratoma
Malignant Teratoma
This phase II trial studies the best approach to combine chemotherapy and radiation
therapy (RT) based on the patient's response to induction chemotherapy in patients with
non-germinomatous germ cell tumors (NGGCT) that have not spread to other parts of the
brain or body (localized). This study has... expand
This phase II trial studies the best approach to combine chemotherapy and radiation therapy (RT) based on the patient's response to induction chemotherapy in patients with non-germinomatous germ cell tumors (NGGCT) that have not spread to other parts of the brain or body (localized). This study has 2 goals: 1) optimizing radiation for patients who respond well to induction chemotherapy to diminish spinal cord relapses, 2) utilizing higher dose chemotherapy followed by conventional RT in patients who did not respond to induction chemotherapy. Chemotherapy drugs, such as carboplatin, etoposide, ifosfamide, and thiotepa, 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. Radiation therapy uses high energy x-rays or high-energy protons to kill tumor cells and shrink tumors. Studies have shown that patients with newly-diagnosed localized NGGCT, whose disease responds well to chemotherapy before receiving radiation therapy, are more likely to be free of the disease for a longer time than are patients for whom the chemotherapy does not efficiently eliminate or reduce the size of the tumor. The purpose of this study is to see how well the tumors respond to induction chemotherapy to decide what treatment to give next. Some patients will be given RT to the spine and a portion of the brain. Others will be given high dose chemotherapy and a stem cell transplant before RT to the whole brain and spine. Giving treatment based on the response to induction chemotherapy may lower the side effects of radiation in some patients and adjust the therapy to a more efficient one for other patients with localized NGGCT. Type: Interventional Start Date: Jul 2021 |
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 |
A Study to Learn More About the Health of Persons With Down Syndrome After Treatment for Acute Leukemia
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. By... 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: Jun 2023 |
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 |
Inotuzumab Ozogamicin in Treating Younger Patients With B-Lymphoblastic Lymphoma or Relapsed or Refractory...
Children's Oncology Group
Recurrent B Acute Lymphoblastic Leukemia
Recurrent B Lymphoblastic Lymphoma
Refractory B Acute Lymphoblastic Leukemia
Refractory B Lymphoblastic Lymphoma
This phase II trial studies how well inotuzumab ozogamicin works in treating younger
patients with B-lymphoblastic lymphoma or CD22 positive B acute lymphoblastic leukemia
that has come back (relapsed) or does not respond to treatment (refractory). Inotuzumab
ozogamicin is a monoclonal antibody, called... expand
This phase II trial studies how well inotuzumab ozogamicin works in treating younger patients with B-lymphoblastic lymphoma or CD22 positive B acute lymphoblastic leukemia that has come back (relapsed) or does not respond to treatment (refractory). Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers ozogamicin to kill them. Type: Interventional Start Date: Jun 2017 |
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 |
Nutritional Optimization and Bone Health Management for Older Adults Undergoing Hip Fracture Surgery
The University of Texas Health Science Center at San Antonio
Hip Fractures
The overall objective of this pilot study is to test a comprehensive nutritional
intervention in elderly patients diagnosed with hip fracture, which the study team
believe will reduce functional decline, morbidity and mortality. expand
The overall objective of this pilot study is to test a comprehensive nutritional intervention in elderly patients diagnosed with hip fracture, which the study team believe will reduce functional decline, morbidity and mortality. Type: Interventional Start Date: Sep 2023 |
Study of Tecovirimat for Human Mpox Virus
National Institute of Allergy and Infectious Diseases (NIAID)
MPOX
A5418 is a randomized, placebo-controlled, double-blind study to establish the efficacy
of tecovirimat for the treatment of people with laboratory-confirmed or presumptive HMPXV
disease. expand
A5418 is a randomized, placebo-controlled, double-blind study to establish the efficacy of tecovirimat for the treatment of people with laboratory-confirmed or presumptive HMPXV disease. Type: Interventional Start Date: Sep 2022 |
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 |
A Study to See if Memantine Protects the Brain During Radiation Therapy Treatment for Primary Central...
Children's Oncology Group
Central Nervous System Carcinoma
This phase III trial compares memantine to usual treatment in treating patients with
primary central nervous system tumors. Memantine may block receptors (parts of nerve
cells) in the brain known to contribute to a decline in cognitive function. Giving
memantine may make a difference in cognitive... expand
This phase III trial compares memantine to usual treatment in treating patients with primary central nervous system tumors. Memantine may block receptors (parts of nerve cells) in the brain known to contribute to a decline in cognitive function. Giving memantine may make a difference in cognitive function (attention, memory, or other thought processes) in children and adolescents receiving brain radiation therapy to treat a primary central nervous system tumors. Type: Interventional Start Date: May 2022 |
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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