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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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
Monitoring Symptoms to Help Young Women Take Hormone Therapy for Stage I-III Breast Cancer, ASPEN Study
SWOG Cancer Research Network
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Hormone Receptor-Positive Breast Carcinoma
This phase III trial compares the effect of active symptom monitoring and patient
education to patient education alone in helping young women with stage I-III breast
cancer stay on their hormone therapy medicines. The patient education tool contains
interactive weblinks which provide patients with... expand
This phase III trial compares the effect of active symptom monitoring and patient education to patient education alone in helping young women with stage I-III breast cancer stay on their hormone therapy medicines. The patient education tool contains interactive weblinks which provide patients with education material about breast cancer and side effects of therapy. Symptom monitoring is a weblink via email or text message with questions asking about symptoms. Hormone therapy for breast cancer can cause side effects, and may cause some women to stop treatment early. Asking about symptoms more often may help women keep taking hormone therapy medicines. Type: Interventional Start Date: Mar 2023 |
Melanoma Margins Trial-II: 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous...
Melanoma and Skin Cancer Trials Limited
Cutaneous Melanoma, Stage II
Patients with a primary invasive melanoma are recommended to undergo excision of the
primary lesion with a wide margin. There is evidence that less radical margins of
excision may be just as safe. This is a randomised controlled trial of 1 cm versus 2 cm
margin of excision of the primary lesion for... expand
Patients with a primary invasive melanoma are recommended to undergo excision of the primary lesion with a wide margin. There is evidence that less radical margins of excision may be just as safe. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of the primary lesion for adult patients with stage II primary invasive cutaneous melanomas (AJCC 8th edition) to determine differences in disease-free survival. A reduction in margins is expected to improve patient quality of life. Type: Interventional Start Date: Dec 2019 |
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