192 matching studies

Sponsor Condition of Interest
Hypofractionated vs. Conventional Regional Nodal Radiation Therapy for Patients With Invasive Breast...
M.D. Anderson Cancer Center Invasive Breast Carcinoma Stage I Breast Cancer AJCC v7 Stage IA Breast Cancer AJCC v7 Stage IB Breast Cancer AJCC v7 Stage II Breast Cancer AJCC v6 and v7
To compare how often cancer recurs (comes back) after 3 weeks of radiation compared to 5 weeks of radiation in patients who receive radiation therapy delivered to the lymph nodes near the breast. The side effects that can develop during or after radiation treatment, including how often arm swelling... expand

To compare how often cancer recurs (comes back) after 3 weeks of radiation compared to 5 weeks of radiation in patients who receive radiation therapy delivered to the lymph nodes near the breast. The side effects that can develop during or after radiation treatment, including how often arm swelling (edema) happens, will also be studied.

Type: Interventional

Start Date: Feb 2017

open study

Evaluating the Impact of Social and Genetic Factors on Outcomes in Adolescent and Young Adult Cancer...
ECOG-ACRIN Cancer Research Group Hodgkin Lymphoma Non-Hodgkin Lymphoma
This study examines the impact of social and genetic factors on outcomes in adolescent and young adult (AYA) cancer survivors of Hodgkin or non-Hodgkin lymphoma. Compared to both older adult and childhood cancer patients, AYAs with cancer experience different diagnoses and specific biological, clinical,... expand

This study examines the impact of social and genetic factors on outcomes in adolescent and young adult (AYA) cancer survivors of Hodgkin or non-Hodgkin lymphoma. Compared to both older adult and childhood cancer patients, AYAs with cancer experience different diagnoses and specific biological, clinical, psychological and social factors that affect their risks for post-treatment morbidity and premature death. Collecting samples of blood samples and health and treatment information from cancer survivors of Hodgkin or non-Hodgkin lymphoma may help doctors identify conditions that increase the likelihood of AYAs getting sick and dying after treatment of cancer and better understand how to address the needs of adolescent and young adult cancer survivors.

Type: Observational

Start Date: Oct 2023

open study

A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer
Aura Biosciences Non-muscle-invasive Bladder Cancer Muscle-Invasive Bladder Carcinoma
The main objectives of this study are to determine the feasibility and safety of AU-011 treatment of bladder cancer utilizing intratumoral injection with or without intramural injection and with or without laser application. expand

The main objectives of this study are to determine the feasibility and safety of AU-011 treatment of bladder cancer utilizing intratumoral injection with or without intramural injection and with or without laser application.

Type: Interventional

Start Date: Sep 2022

open study

An Open-Label Study of INV-1120 as a Single Agent and in Combination With Pembrolizumab in Adult Patients...
Shenzhen Ionova Life Sciences Co., Ltd. Cancer Solid Tumor, Adult Cancer Metastatic Solid Carcinoma Solid Tumor, Unspecified, Adult
Phase 1, open-label dose-escalation study to determine the MTD of INV-1120 and RP2D, and to assess the DLT of INV-1120 as a single agent or in the combination with pembrolizumab. The safety, tolerability, and PK of INV-1120 as a single agent or in the combination with pembrolizumab will be assessed... expand

Phase 1, open-label dose-escalation study to determine the MTD of INV-1120 and RP2D, and to assess the DLT of INV-1120 as a single agent or in the combination with pembrolizumab. The safety, tolerability, and PK of INV-1120 as a single agent or in the combination with pembrolizumab will be assessed in adult patients with advanced solid tumors.

Type: Interventional

Start Date: Jun 2020

open study

Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioma (ReSPECT)
Plus Therapeutics Glioma
This is a multi-center, sequential cohort, open-label, volume and dose escalation study of the safety, tolerability, and distribution of 186RNL given by convection enhanced delivery to patients with recurrent or progressive malignant glioma after standard surgical, radiation, and/or chemotherapy treatment.... expand

This is a multi-center, sequential cohort, open-label, volume and dose escalation study of the safety, tolerability, and distribution of 186RNL given by convection enhanced delivery to patients with recurrent or progressive malignant glioma after standard surgical, radiation, and/or chemotherapy treatment. The study uses a modified Fibonacci dose escalation, followed by an expansion at the maximum tolerated dose (MTD) to determine efficacy. The starting absorbed dose is 1mCi in a volume of 0.660mL.

Type: Interventional

Start Date: Jun 2015

open study

Study of LP-184 in Patients With Advanced Solid Tumors
Lantern Pharma Inc. Advanced Solid Tumor
The primary objective of this study is to evaluate the safety, tolerability, MTD and RP2D of LP-184 in patients with advanced solid tumors who have relapsed from or are refractory to standard therapy or for whom no standard therapy is available. The secondary objectives are to characterize the PK... expand

The primary objective of this study is to evaluate the safety, tolerability, MTD and RP2D of LP-184 in patients with advanced solid tumors who have relapsed from or are refractory to standard therapy or for whom no standard therapy is available. The secondary objectives are to characterize the PK of LP-184 and its metabolites in plasma and assess clinical activity of LP-184.

Type: Interventional

Start Date: Jun 2023

open study

Feasibility and Clinical Utility of Cell-free DNA (cfDNA) in Identifying Actionable Alterations and Minimal...
M.D. Anderson Cancer Center Lymphoma
To test the feasibility of collecting cell-free DNA (cfDNA) samples from DLBCL patients before and after treatment. cfDNA is DNA traveling in your blood outside of a cell and is easily collected from blood samples drawn using the vein puncture method. expand

To test the feasibility of collecting cell-free DNA (cfDNA) samples from DLBCL patients before and after treatment. cfDNA is DNA traveling in your blood outside of a cell and is easily collected from blood samples drawn using the vein puncture method.

Type: Interventional

Start Date: Feb 2023

open study

Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With...
Daiichi Sankyo Metastatic Non Small Cell Lung Cancer
This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab alone in participants with advanced or metastatic non-small cell lung cancer (NSCLC). expand

This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab alone in participants with advanced or metastatic non-small cell lung cancer (NSCLC).

Type: Interventional

Start Date: Mar 2022

open study

A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic...
National Cancer Institute (NCI) Anaplastic Astrocytoma Anaplastic Astrocytoma, Not Otherwise Specified Diffuse Intrinsic Pontine Glioma Diffuse Midline Glioma, H3 K27M-Mutant Glioblastoma
This phase I/II trial tests the safety, side effects, and best dose of selinexor given in combination with standard radiation therapy in treating children and young adults with newly diagnosed diffuse intrinsic pontine glioma (DIPG) or high-grade glioma (HGG) with a genetic change called H3 K27M mutation.... expand

This phase I/II trial tests the safety, side effects, and best dose of selinexor given in combination with standard radiation therapy in treating children and young adults with newly diagnosed diffuse intrinsic pontine glioma (DIPG) or high-grade glioma (HGG) with a genetic change called H3 K27M mutation. It also tests whether combination of selinexor and standard radiation therapy works to shrink tumors in this patient population. Glioma is a type of cancer that occurs in the brain or spine. Glioma is considered high risk (or high-grade) when it is growing and spreading quickly. The term, risk, refers to the chance of the cancer coming back after treatment. DIPG is a subtype of HGG that grows in the pons (a part of the brainstem that controls functions like breathing, swallowing, speaking, and eye movements). This trial has two parts. The only difference in treatment between the two parts is that some subjects treated in Part 1 may receive a different dose of selinexor than the subjects treated in Part 2. In Part 1 (also called the Dose-Finding Phase), investigators want to determine the dose of selinexor that can be given without causing side effects that are too severe. This dose is called the maximum tolerated dose (MTD). In Part 2 (also called the Efficacy Phase), investigators want to find out how effective the MTD of selinexor is against HGG or DIPG. Selinexor blocks a protein called CRM1, which may help keep cancer cells from growing and may kill them. It is a type of small molecule inhibitor called selective inhibitors of nuclear export (SINE). Radiation therapy uses high energy to kill tumor cells and shrink tumors. The combination of selinexor and radiation therapy may be effective in treating patients with newly-diagnosed DIPG and H3 K27M-Mutant HGG.

Type: Interventional

Start Date: May 2022

open study

Dapagliflozin Plus Pioglitazone in T1DM
The University of Texas Health Science Center at San Antonio Type 1 Diabetes Mellitus
Purpose: To examine the effect of addition of combination therapy with dapagliflozin plus pioglitazone to insulin on glucose control and plasma ketone concentration in patients with type 1 diabetes (T1DM) Research Design: 120 patients with type 1 diabetes who otherwise are healthy constitute the study... expand

Purpose: To examine the effect of addition of combination therapy with dapagliflozin plus pioglitazone to insulin on glucose control and plasma ketone concentration in patients with type 1 diabetes (T1DM) Research Design: 120 patients with type 1 diabetes who otherwise are healthy constitute the study population. After screening, eligible subjects will start 4 week run in. At week 4, subjects will receive dapagliflozin for 12 weeks. At week 16, subjects will be randomized to receive in a double blind fashion pioglitazone or placebo for 16 weeks. Methods: the following techniques will be employed in the present study: (1) mixed meal tolerance test; (2) indirect calorimetry; (3) continuous glucose monitoring. Clinical Relevance: the results of the present study will demonstrate that the addition of pioglitazone to SGLT2 inhibitor in T1DM patients produces greater reduction in the HbA1c without increasing risk of ketoacidosis and hypoglycemia.

Type: Interventional

Start Date: Aug 2019

open study

A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin...
National Cancer Institute (NCI) Lugano Classification Limited Stage Hodgkin Lymphoma AJCC v8
This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard treatment alone in improving survival in patients with stage I and II classical Hodgkin lymphoma. Brentuximab vedotin... expand

This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard treatment alone in improving survival in patients with stage I and II classical Hodgkin lymphoma. Brentuximab vedotin is in a class of medications called antibody-drug conjugates. It is made of a monoclonal antibody called brentuximab that is linked to a cytotoxic agent called vedotin. Brentuximab attaches to CD30 positive lymphoma cells in a targeted way and delivers vedotin to kill them. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as nivolumab, 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 doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, dacarbazine, and procarbazine hydrochloride 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. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Adding immunotherapy to the standard treatment of chemotherapy with or without radiation may increase survival and/or fewer short-term or long-term side effects in patients with classical Hodgkin lymphoma compared to the standard treatment alone.

Type: Interventional

Start Date: May 2023

open study

Affixus Natural Nail System Humeral Nail PMCF
Zimmer Biomet Humeral Fractures, Proximal Humeral Fractures
A commercially available product clinical study which aims to confirm the safety, performance and clinical benefits to the patient of the Affixus Natural Nail upper arm (humerus) bone nail system for both the implant itself and the instrumentation used during surgery. expand

A commercially available product clinical study which aims to confirm the safety, performance and clinical benefits to the patient of the Affixus Natural Nail upper arm (humerus) bone nail system for both the implant itself and the instrumentation used during surgery.

Type: Interventional

Start Date: Aug 2022

open study

Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy and Heart Failure After...
Children's Oncology Group Hodgkin Lymphoma in Remission Leukemia in Remission Lymphoblastic Lymphoma Osteosarcoma Recurrent Leukemia
This clinical trial studies the effects of dexrazoxane hydrochloride on biomarkers associated with cardiomyopathy and heart failure after cancer treatment. Studying samples of blood in the laboratory from patients receiving dexrazoxane hydrochloride may help doctors learn more about the effects of... expand

This clinical trial studies the effects of dexrazoxane hydrochloride on biomarkers associated with cardiomyopathy and heart failure after cancer treatment. Studying samples of blood in the laboratory from patients receiving dexrazoxane hydrochloride may help doctors learn more about the effects of dexrazoxane hydrochloride on cells. It may also help doctors understand how well patients respond to treatment.

Type: Observational

Start Date: Mar 2014

open study

Biomarkers in Tumor Tissue Samples From Patients With Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma
Children's Oncology Group Ganglioneuroblastoma Localized Resectable Neuroblastoma Localized Unresectable Neuroblastoma Regional Neuroblastoma Stage 4 Neuroblastoma
This research trial studies biomarkers in tumor tissue samples from patients with newly diagnosed neuroblastoma or ganglioneuroblastoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. expand

This research trial studies biomarkers in tumor tissue samples from patients with newly diagnosed neuroblastoma or ganglioneuroblastoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

Type: Observational

Start Date: Nov 2000

open study

Effects of Riboflavin in Mitigating Muscle Soreness in Ultra-marathon Athletes
Steven Moore Muscle Soreness
The aim of this project is to investigate the effects of riboflavin, also known as vitamin B2, on preventing delayed onset muscle soreness (DOMS) in ultramarathon athletes through a randomized placebo-controlled study. expand

The aim of this project is to investigate the effects of riboflavin, also known as vitamin B2, on preventing delayed onset muscle soreness (DOMS) in ultramarathon athletes through a randomized placebo-controlled study.

Type: Interventional

Start Date: Jun 2023

open study

Prostate Cancer IMAGing IN Early Detection (IMAGINED Trial)
The University of Texas Health Science Center at San Antonio Prostate Cancer
The researchers hope to learn if specific types of MRI software and techniques can help improve early prostate cancer detection at time of a MRI-guided prostate biopsy. expand

The researchers hope to learn if specific types of MRI software and techniques can help improve early prostate cancer detection at time of a MRI-guided prostate biopsy.

Type: Interventional

Start Date: Dec 2023

open study

Ketamine & Crisis Response Plan for Suicidal Ideation in the ED
The University of Texas Health Science Center at San Antonio Suicide
The goal of this randomized pilot trial is to assess the feasibility of administering a combination of 100mg intramuscular (IM) ketamine and Crisis Response Plan (a short psychosocial intervention) for patients with acute suicidality in the context of the Emergency Department setting. This study will... expand

The goal of this randomized pilot trial is to assess the feasibility of administering a combination of 100mg intramuscular (IM) ketamine and Crisis Response Plan (a short psychosocial intervention) for patients with acute suicidality in the context of the Emergency Department setting. This study will assess a combination of a pharmacologic intervention and a psychosocial one. The pharmacologic intervention is a one-time dose of 100mg ketamine delivered intramuscularly (IM) while the patient is in the ED. The psychosocial intervention under study is a brief, patient-centered therapy which takes, on average, 30 minutes to administer. Both interventions will be administered only once. The main questions this study aims to answer are: - Determine if 100mg of IM ketamine and Crisis Response Plan in combination results in greater short-term reductions in suicidal ideation in adult patients who report acutely elevated suicide risk during an ED visit. - Examine potential weight-based dose response differences in the reductions in suicidal ideation to determine if future treatment protocols with IM ketamine may benefit from weight-based dosing.

Type: Interventional

Start Date: Jan 2023

open study

Ketones, SGLT2, HFrEF
The University of Texas Health Science Center at San Antonio Type2diabetes Heart Failure With Reduced Ejection Fraction
The study team will examine the effects of elevated plasma ketone levels following initiation of SGLT2 inhibitor therapy in high-risk type 2 diabetes mellitus (T2DM) individuals with heart failure (HF) with reduced ejection fraction (HFrEF) providing an energy-rich fuel that is taken up with great... expand

The study team will examine the effects of elevated plasma ketone levels following initiation of SGLT2 inhibitor therapy in high-risk type 2 diabetes mellitus (T2DM) individuals with heart failure (HF) with reduced ejection fraction (HFrEF) providing an energy-rich fuel that is taken up with great avidity by the myocardium, to measure change in Left Ventricle diastolic and systolic function

Type: Interventional

Start Date: Jan 2024

open study

A Study to Investigate Efficacy and Safety of OG-6219 BID in 3 Dose Levels Compared with Placebo in Participants...
Organon and Co Endometriosis
The purpose of this global Phase 2 study is to determine the efficacy, safety, and tolerability of 3 dose levels of OG-6219 in pre-menopausal women between 18 and 49 years of age (inclusive), who have moderate to severe endometriosis-related pain. expand

The purpose of this global Phase 2 study is to determine the efficacy, safety, and tolerability of 3 dose levels of OG-6219 in pre-menopausal women between 18 and 49 years of age (inclusive), who have moderate to severe endometriosis-related pain.

Type: Interventional

Start Date: Oct 2022

open study

Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy
Dennis M. McNamara, MD, MS Peripartum Cardiomyopathy, Postpartum
The study will enroll 200 women newly diagnosed with peripartum cardiomyopathy within 5 months postpartum in a randomized placebo controlled trial of bromocriptine therapy to evaluate its impact on myocardial recovery and clinical outcomes. Given that bromocriptine prevents breastfeeding, an additional... expand

The study will enroll 200 women newly diagnosed with peripartum cardiomyopathy within 5 months postpartum in a randomized placebo controlled trial of bromocriptine therapy to evaluate its impact on myocardial recovery and clinical outcomes. Given that bromocriptine prevents breastfeeding, an additional 50 women with peripartum cardiomyopathy excluded from the trial due to a desire to continue breastfeeding but meeting all other entry criteria will be followed in an observational cohort.

Type: Interventional

Start Date: Jul 2022

open study

Effect of mTOR Inhibition & Other Metabolism Modulating Interventions on the Elderly [SubStudy Rapa &...
The University of Texas Health Science Center at San Antonio Aging
The ability to mount an effective immune response declines with age, leaving the elderly increasingly susceptible to infectious diseases and cancer. Rapamycin, an FDA approved drug to prevent transplant rejection, increases the lifespan and healthspan of mice and ameliorates age-related declines in... expand

The ability to mount an effective immune response declines with age, leaving the elderly increasingly susceptible to infectious diseases and cancer. Rapamycin, an FDA approved drug to prevent transplant rejection, increases the lifespan and healthspan of mice and ameliorates age-related declines in immune responsiveness, cancer survival, and cognition in laboratory animals. Investigators are conducting a translational trial to test whether rapamycin also improves life functions in humans focusing on elderly persons (aged 70-95). Substudy E will evaluate the Rapamycin and Cardiac Function.

Type: Interventional

Start Date: Feb 2022

open study

SGLT2 Inhibitors, Ketones, and Cardiovascular Benefit Research Plan
The University of Texas Health Science Center at San Antonio Type2 Diabetes Heart Failure With Preserved Ejection Fraction
The study team will examine the effects of SGLT2i (and SGLT2i-induced increases in plasma ketone concentrations) on skeletal muscle and cardiac ketone uptake, skeletal muscle bioenergetics, cardiopulmonary exercise capacity, and patient-reported functional outcomes. expand

The study team will examine the effects of SGLT2i (and SGLT2i-induced increases in plasma ketone concentrations) on skeletal muscle and cardiac ketone uptake, skeletal muscle bioenergetics, cardiopulmonary exercise capacity, and patient-reported functional outcomes.

Type: Interventional

Start Date: Jan 2021

open study

NICU Antibiotics and Outcomes Trial
Michael Morowitz Microbial Colonization Extreme Prematurity Early-Onset Neonatal Sepsis Late-Onset Neonatal Sepsis Necrotizing Enterocolitis of Newborn
The goal of the NANO trial is to study the longstanding clinical practice of empirically administering intravenous antibiotics to extremely low birthweight (ELBW) infants in the first days of life. In this 802-subject multicenter placebo-controlled randomized clinical trial, the hypothesis to be tested... expand

The goal of the NANO trial is to study the longstanding clinical practice of empirically administering intravenous antibiotics to extremely low birthweight (ELBW) infants in the first days of life. In this 802-subject multicenter placebo-controlled randomized clinical trial, the hypothesis to be tested is that the incidence of adverse outcomes is higher in babies receiving empiric antibiotics (EA) in the first week of life compared to babies receiving placebo. The study targets a population of ELBW infants in whom the clinical decision to use or not use EA is currently most challenging -- infants that are clinically stable that did not have a known exposure to intraamniotic infection and were not born preterm for maternal indications. The primary outcome is the composite outcome of late-onset sepsis (LOS), necrotizing enterocolitis (NEC), or death during the index hospitalization. Secondary safety outcomes will include total antibiotic days, days to full enteral feedings, and common morbidities in preterm infants that have previously been linked to EA, e.g. retinopathy of prematurity and bronchopulmonary dysplasia. Weight and length z-score, and head circumference, are standard measures to be collected weekly by clinical team per a standardized protocol.

Type: Interventional

Start Date: Aug 2020

open study

Neural Connectivity During Therapy for Adolescent PTSD
The University of Texas Health Science Center at San Antonio PTSD Adolescent Psychological Trauma
Posttraumatic stress disorder in adolescence impairs neurobiological networks underlying cognitive, social and emotional skills. Neuroimaging research that seeks to identify the neural mechanisms of treatments for PTSD could lead to novel treatments, but progress has been slow using current methods.... expand

Posttraumatic stress disorder in adolescence impairs neurobiological networks underlying cognitive, social and emotional skills. Neuroimaging research that seeks to identify the neural mechanisms of treatments for PTSD could lead to novel treatments, but progress has been slow using current methods. The proposed study uses an innovative approach to identify neural mechanisms of specific phases of trauma-focused therapy for youth with PTSD, allowing a new understanding of brain changes associated with the process of therapy.

Type: Interventional

Start Date: Nov 2022

open study

Ketones, Muscle Metabolism, and SGLT2 Inhibitors - Protocol 1
The University of Texas Health Science Center at San Antonio Heart Failure Type 2 Diabetes Mellitus
To examine the effect of an increase in plasma beta-hydroxy-butyrate (B-OH-B) levels, spanning the physiologic and pharmacologic range (+0.5, +2.0, and +5.0 mmol/L), on: (i) parameters of left ventricular (LV) systolic and diastolic function utilizing cardiac magnetic resonance imaging (MRI) and (ii)... expand

To examine the effect of an increase in plasma beta-hydroxy-butyrate (B-OH-B) levels, spanning the physiologic and pharmacologic range (+0.5, +2.0, and +5.0 mmol/L), on: (i) parameters of left ventricular (LV) systolic and diastolic function utilizing cardiac magnetic resonance imaging (MRI) and (ii) myocardial glucose uptake using positron emission tomography (PET) with 18F-fluoro-2-deoxy-D-glucose in type 2 diabetic patients with Class II-III New York Heart Association (NYHA).

Type: Interventional

Start Date: Jan 2019

open study