74 Clinical Trials for Various Conditions
The study participant is being asked to be in a research study called LEGACY, because you were treated for high-risk neuroblastoma (HR-NBL). Primary Objective To determine the feasibility of conducting comprehensive evaluations, leveraging the established SJLIFE (St. Jude Lifetime Cohort Study) study infrastructure, in survivors of HR-NBL (high-risk neuroblastoma) who are greater than 2 years from completion of contemporary therapy and were previously treated at SJCRH (St. Jude Children's Research Hospital). Exploratory Objectives * To describe the health outcomes of survivors of HR-NBL previously treated at SJCRH with contemporary era therapy who are greater than 2 years from completion of therapy. * To describe the relationship between patient outcomes and social determinants of health (SDOH) in survivors of HR-NBL previously treated at SJCRH with contemporary era therapy who are greater than 2 years from completion of therapy.
Sickle Cell Disease is one of the most common genetic diseases in the United States, occurring in approximately 1 in 400 births. Approximately 100,000 individuals are diagnosed with SCD in the United States. Mortality for children with SCD has decreased substantially over the past 4 decades, with \>99% of those born in high resource settings, including the United States, France, and England, now surviving to 18 years of age. However, the life expectancy of adults with SCD is severely shortened. Dysfunction of the heart, lung, and kidney is directly associated with decreased life expectancy. With the variety of curative therapies that are now available for SCD, long-term health outcomes studies are time-sensitive. As of now, efforts to determine long-term health outcomes following curative therapies for SCD have been limited. Though curative therapies initially should provide a cure for symptoms of SCD, there is the risk of late health outcomes to consider. Defining health outcomes following curative therapy is essential to improve personalized decision-making when considering curative versus disease-modifying therapeutic options. The primary goal of this study is to determine whether curative therapies for individuals with SCD will result in improved or worsening heart, lung, and kidney damage when compared to individuals with SCD receiving standard therapy. The investigators will also explore whether certain genes are associated with a good or bad outcome after curative therapy for SCD.
The purpose of this study is to test the feasibility of a novel, Health Information Technology behavior change tool in a single clinic setting. The PREVENT tool is the first electronic health record (EHR)-compatible tool that both tailors evidence-based behavior change strategies and incorporates community-level data specific to each patient into routine care. The central hypothesis is that PREVENT will improve patient's attitudes towards behavior change recommendations, increase adherence to recommended behavior change and improve cardiovascular health. Fifty adolescents will be randomized to intervention or wait-list, routine care control to assess the preliminary effectiveness of PREVENT. Qualitative and quantitative methods will be used among patients, parents and providers to examine barriers to current and future implementation of the PREVENT tool to inform adoption and maintenance.
This trial studies how well manual therapy works in treating fibrosis-related late effect dysphagia in head and neck cancer survivors. Manual therapy is the use of massage and stretching exercises to increase blood flow and muscle movement in the neck, throat, jaw, and mouth, which may help to improve swallowing ability and range of motion in participants who have had treatment for head and neck cancer.
CAROLE seeks to evaluate the relationship between chest Radiation Therapy and coronary artery disease. The purpose of CAROLE is to check the heart health of women who received breast cancer treatments in the past and protect them from future heart disease.
The goal of this study is to learn about the cognitive and behavioral functioning of children being treated for cancer.
Children with brain tumors who have had radiation therapy are at risk for problems with attention, memory, and problem solving. Such problems may cause difficulty in school and daily life. Memantine, the drug being used for this study, is not yet approved for use in children by the U.S. Food and Drug Administration. However, studies have shown some improvements in memory for patients with dementia, Attention Deficit Hyperactivity Disorder, and autism. Scientists have also used this medication for adult cancer patients receiving radiation therapy with results showing less cognitive declines over time compared to patients taking a placebo (inactive pill). These studies have also shown few side effects. This is a pilot/feasibility study and the first known study involving children with a cancer diagnosis or brain tumor. PRIMARY OBJECTIVES: * To estimate the participation rate in a study of memantine used as a neuro-protective agent in children undergoing radiotherapy for localized brain tumors (low grade glioma, craniopharyngioma, ependymoma, or germ cell tumor) * To estimate the rate of memantine medication adherence * To estimate the rate of completion of cognitive assessments SECONDARY OBJECTIVES: * To estimate the effect size of change in neurobehavioral outcomes (cognitive, social, quality of life, neurologic) associated with memantine * To evaluate the frequency and nature of memantine side effects as measured by the Systematic Assessment for Treatment Emergent Events (SAFTEE)
This research trial studies late effects after treatment in patients with previously diagnosed high-risk neuroblastoma. Studying late effects after treatment may help to decide which treatments for high-risk neuroblastoma are better tolerated with less side effects over time.
Through improved early detection and treatment, the number of long term breast cancer survivors continues to increase. There are now 2.8 million breast cancer survivors in the U.S. Florida alone adds over 9,000 women to the survivorship pool each year. Most receive radiation treatment (RT) of the affected breast and chest wall to reduce risk of recurrence. Even with advanced radiation techniques for dose conformality to minimize exposure of the highly sensitive lung, 14% of breast cancer patients treated with radiation develop clinical pulmonary toxicity, with 4% overall experiencing high grade clinical toxicity. Early diagnosis and intervention to mitigate lung radiation toxicity is increasingly important for the long term care of these survivors. The investigators' goal is to better identify breast cancer patients at high risk for experiencing severe pulmonary toxicity requiring medical intervention, provide a means to identify toxicity early on, and tailor treatment and/or early intervention on a per-patient basis.
This is a prospective non-therapeutic study, assessing the long-term toxicity of pediatric HCT for hematologic malignancies. This study is a collaboration between the Pediatric Blood and Marrow Transplant Consortium (PBMTC), the Center for International Blood and Marrow Transplant Research (CIBMTR), the National Marrow Transplant Program (NMDP) and the Resource for Clinical Investigation in Blood and Marrow Transplantation (RCI-BMT) of the CIBMTR. The study will enroll pediatric patients who undergo myeloablative HCT for hematologic malignancies at PBMTC sites.
Background: - More children with cancer are surviving into adulthood. Some side effects from treatment go away quickly. But some problems may not go away or may only show up months or years later. These problems are called late effects. Late effects can cause difficulties in cognitive functions, such as attention and memory. Physical activity has been found to improve the attention and memory skills of children with Attention Deficit Hyperactivity Disorder (ADHD). Researchers want to see if physical activity can help with these cognitive problems in children with brain tumors. Objectives: - To see if physical activity can improve cognitive functions in children who had radiation therapy for a brain tumor. Eligibility: - Children ages 8 17 who had radiation for a brain tumor at least 2 years ago. They must have access to a computer. Design: * Participants will be screened with height, weight, and medical history. They will answer questions about daily physical activities. Their heart will be checked. * Participants will go to the clinic for 2 days. They will have a fitness exam and tests about attention, memory, and concentration. They will have blood taken and answer questions. Parents will also answer questions. * Participants will be put into 2 groups. For the first 12 weeks, the intervention group will follow a physical activity program. The control group will do their usual physical activities. * For the second 12 weeks, the control group will follow the physical activity program. The intervention group will continue the activities on their own. All groups will track their physical activity with an activity monitor and computer. * Participants will have a follow-up visit at the clinic after each session. They will repeat some of the tests listed above. * The study lasts 24 weeks plus the two follow-up visits. Participants can keep their activity monitor.
The purpose of this study is to establish a registry of survivors of cancer, tumor, or a related illness.
Periconceptional folic acid supplements of 400 (Micro) daily prevent neural tube defects (NTD) in offspring. Some data suggest that periconceptional folic acid supplements, folate levels during pregnancy, and/or certain variants in the gene that encodes methylenetetrahydrofolate reductase (MTHFR), a key enzyme that catalyzes synthesis of 5-methyltetrahydrofolate \[the primary methyl donor in most metabolic pathways involving methylation including DNA methylation\] from 5,10 methylenetetrahydrofolate may be associated with reduced risks of certain adverse events during the prenatal period, birth weight and certain serious diseases in offspring, while other studies have raised concerns about increased risks of specific serious disorders. Only one study has examined late health effects in mothers that might be associated with use of periconceptional folic acid supplements. We propose to study potential health benefits and adverse effects of periconceptional folic acid supplements in a 15-year follow-up of offspring and mothers. In the offspring, we will evaluate whether periconceptional folic acid supplements reduced risk of external congenital birth defects and childhood acute lymphoblastic leukemia, and whether risks are reduced or increased for other pediatric disorders linked with periconceptional folic acid supplements including asthma, pervasive developmental disorders and autism, diabetes, obesity and blood pressure. In the mothers, we will assess cardiovascular diseases and associated risk factors, breast and colorectal cancers and precursor conditions, and other cancers. We will also conduct exploratory assessment of other serious diseases in mothers. To increase the limited data on the morbidity and survival of children born with a major birth defect, particularly in low- or middle-income countries, we plan to assess morbidity and mortality outcomes in children identified with neural tube defects as part of our follow-up. The women and children who participated in the joint China-U.S. Community Intervention Program (CIP) trial (N=243,779 women treated or not treated with folic acid in the periconceptional period and their offspring) represent unique cohorts whose periconceptional exposure to folic acid is well documented. We propose to follow a sample of 22,000 CIP mothers and their offspring (currently 14 to 17 years of age), to ascertain vital status, medical history, and lifestyle habits. The study will clarify whether there are differences with respect to growth, physical development during the puberty period, selected serious morbidity and mortality in offspring and risks of serious health outcomes and mortality in mothers associated with periconceptional folic acid supplements. Data from this study will inform us about cohort participation rate, cost, and effective approaches for future follow-up of the full cohort. The current protocol focuses on a pilot study (Pilot Study # 1) in which we will carry out two specific aims in 500 families. We will test and evaluate the most effective approaches to trace the mothers who enrolled in the CIP in 1993-1995 in CIP counties, fathers, and children. If the child is not living with the biological mother, we will trace the caretaker or next of kin with whom the child is living. We will also conduct in-person interviews, obtain anthropometric and blood pressure measurements and determine cohort participation rate in a sample of 500 CIP families from two of the 21 CIP project counties to obtain health information, medical history, and vital status. We will attempt to enroll in the pilot study 500 mothers/caretakers and 500 offspring, and 500 fathers (Total N=1500). Excluded from the Pilot Study #1 at this time are the families in which the mother or the child is deceased. We will seek permission from the IRB to enroll these families at a later date.
This two-part research study will compare childhood cancer survivors receiving specialized follow-up care in the REACH for Survivorship clinic to patients receiving routine follow-up care.
Children treated for a brain tumor (BT) or acute lymphoblastic leukemia (ALL) show elevated rates of working memory impairment. Working memory (WM) is the ability to hold and manipulate information online; for example, when an individual mentally rehearses a phone number in order to dial it without writing it down. A computer-based working memory intervention has been successful in children diagnosed with ADHD and stroke survivors. Individuals participating in the intervention showed improvements on working memory measures as well as more complex problem solving skills. Neuroimaging (brain scans) conducted before and after training showed changes in brain activation suggestive of underlying changes in brain systems that support working memory. This study investigates the effectiveness of this computer-based working memory intervention for childhood cancer survivors.
The purpose of this study is to collect information from medical records to see what effects proton beam radiation has on cancer and analyze possible side effects.
In this research study, we are looking to study the side effects from the use of proton radiation in treating people with low-grade gliomas that are recommended radiation treatment. We expect response of the tumors to be the same with proton radiation as compared to standard 3D conformal radiation therapy, but also expect less side effects from radiation.
The purpose of the study is to evaluate the effectiveness and safety of atomoxetine in enhancing attention and concentration among childhood survivors of cancer.
The Late Effects Study is being conducted in order to answer scientific questions and to serve as a resource for Wilms tumor patients and their families. Patients must have been enrolled on the NWTS-5 protocol in order to be eligible for this study.
BACKGROUND * This protocol acknowledges that it is in the interest of the NIH and ROB, as well as our participants, to continue to follow those who have been treated with radiotherapy at ROB and are not otherwise eligible for current active research protocols. * It also provides a mechanism for the correlation and interpretation of disparate data for research into the long term side effects and outcomes for a variety of disease entities and treatments, such as combined modality treatment, MoAb, PDT, radiation modifiers, intraoperative radiotherapy, etc. OBJECTIVE -The primary objective of this protocol is to assess the late effects of treatment and the natural history of disease through collection of data from any standard procedures performed as part of follow up care on participants previously treated with radiotherapy. ELIGIBILITY -Participants who received radiation therapy. DESIGN * This is a natural history protocol in which long-term follow up data will be collected from participants who received radiation therapy. * It will be made clear to participants in the consent form, that data collected during their follow-up may be used anonymously for publications concerning the natural history of disease processes and long-term effects of treatment.
This study will examine late effects of treatment for sarcoma (bone and soft tissue cancers) in children. Survival of patients with these diseases has improved over the years, but long-term adverse effects of treatment have also been noted. Patients previously treated for sarcoma in the NCI's Pediatric Oncology Branch who are in their first remission from sarcoma after completion of therapy and who have had no further cancer treatment (chemotherapy, radiation therapy, cancer related surgery or immunotherapy) for at least 24 months may be eligible for this 3- to 4-day study. It will review the incidence and extent of the following late effects of therapy. * Heart problems-The chemotherapy drug doxorubicin can cause acute and late injuries to the heart muscle. Patients will undergo magnetic resonance imaging (MRI) of the heart to look for changes and compare the findings with information obtained by standard echocardiogram (ultrasound test of the heart) and by MUGA (nuclear medicine scan of the heart). * Gonadal dysfunction-The chemotherapy drug cyclophosphamide may affect sex hormone production, leading to infertility, early menopause or brittle bones. Low sex hormone levels may also increase the risk for heart attack, obesity or fracture. Patients will have blood tests to measure hormone levels as well as mineral levels, lipid levels and blood cell counts. They will also have a DEXA scan to measure bone mineral density and a CT scan of the abdomen to evaluate the distribution of fatty tissue in the abdomen. Males will be offered a semen analysis as part of the fertility evaluation. * Psychosocial problems- Cancer diagnosis and treatment pose a major life stress that can lead to problems with personal relationships, jobs, insurance, education, health care, and personal and professional goal setting. Some patients may become depressed or develop a psychiatric illness. Patients will fill out a questionnaire about their treatment, recovery, and aspects of their current life and will meet with a psychologist and psychiatrist. * Changes in bodily function and capabilities-Patients who undergo surgery and radiation to treat sarcoma treatment may experience muscle, bone and joint changes. Patients will be interviewed about their performance of daily activities, physical limitations, and changes in skill levels. They will do a series of exercises and will have measurements of strength, mobility and physical skills, focusing on the parts of the body that were affected by the sarcoma and subsequent local therapy. * Exposure to viruses-A number of patients received blood transfusions as part of their cancer treatment. Some transfusions were given before HIV screening became available. Patients will be tested for this virus as well as the hepatitis virus and HTLV-1 (human T-cell leukemia virus-1), for which there are also small transfusion-associated risks. * Kidney function-The chemotherapy drug ifosfamide may affect kidney function. Patients will provide a urine specimen for kidney function tests. * Immune function-Chemotherapy affects the function of infection-fighting immune cells called T-lymphocytes. A blood sample will be drawn for studies of the time involved in recovering full immune function.
Non-Hodgkin's lymphoma has been studied in the Pediatric Branch for at least 20 years, during which time a number of different treatment protocols have been used. Approximately 110 patients have apparently been cured of their lymphoma. The present protocol has no therapeutic component, but is designed to document the late effects that may have been encountered by our patients, either as a consequence of the disease or its treatment. In essence, patients who consent to participate will be asked a series of questions pertaining to the quality of their life and possible medical problems that they may be encountering. In addition, they will receive a complete physical examination and undergo non-invasive investigations designed to identify the presence of unsuspected late effects. Investigators in the Eye Clinic, Dental Clinic, Audiology, Cardiology and Endocrinology departments will participate in the protocol. As a part of the study, blood samples will be obtained to investigate the possibility that predisposing genetic factors may be identifiable in the patients normal cells (e.g., p53 mutations, evidence of DNA instability). If such abnormalities are detected, blood samples from family members will also be examined to determine whether the defect was inherited.
This is a single-blinded randomized control trial aiming to explore the use of immersive virtual reality (VR) training in conjunction with real-life tasks therapy in 75 first time stroke patients with upper limb weakness.
This investigation is a prospective, open-label pharmacokinetic study of daptomycin prophylaxis in patients undergoing coronary artery bypass graft surgery without valvular replacement.
A Non-Therapeutic Study that aims to establish a cohort of GCT survivors to understand short term and long-term adverse effects of treatment and to conduct molecular analyses to improve risk stratification.
There is evidence that survivors of childhood cancer have a high prevalence of poor sleep, including symptoms of insomnia. Insomnia is highly comorbid and has been associated with impaired cognitive performance, a range of psychiatric disorders, cardiovascular disease, and reduced quality of life. However, we still lack knowledge about the direct impact of available internet-based insomnia treatment programs for survivors of childhood cancer experiencing insomnia, in addition to how improving insomnia symptoms impacts neurocognitive function and late health morbidities in this population. Therefore, in this study, we will utilize the resources available in the Childhood Cancer Survivor Study (CCSS) to use an accepted, established, efficacious internet-delivered CBTi insomnia treatment program and evaluate the efficacy of this program in adult survivors of childhood cancer. Positive results from this study and our use of an internet-based intervention are likely generalizable and be scalable to the large and geographically diverse population of childhood cancer survivors with chronic health conditions. Primary Objective To examine the efficacy of an eHealth intervention for improving symptoms of insomnia among adult survivors of childhood cancer. Secondary Objectives To examine the impact of an eHealth intervention for insomnia on the clinical severity of insomnia symptoms in adult survivors of childhood cancer. To determine whether treatment of insomnia symptoms will improve neurocognitive function in adult survivors of childhood cancer with both insomnia and neurocognitive impairment. To explore the mediating effects of improved neurocognitive function, emotional distress, and cardiovascular health on the association between insomnia symptoms and quality of life.
This study will measure efficacy of early in-patient exercise as an adjunct to current Standard of Care (SOC) for 96 patients in a multi-centre trial. The secondary purpose is to assess the efficacy of a personalized, structured, and quantifiable exercise program (MP10) carried out soon after admission until hospital discharge (including during the BICU stay and time on ventilation).
The aim of this study is to evaluate the prophylactic effects of Ranolazine on new onset atrial fibrillation in post-operative coronary artery bypass graft and valve surgery patient population at Staten Island University hospital.
This study is being done to learn more about the short-term and long-term side effects of CAR-T cell therapy. Specifically, researchers want to know how often patients get infections, have delays in recovering blood cell counts and/or have damage to the nervous system.
Children and adolescents treated for a brain tumor often experience fatigue and cognitive symptoms, such as slowed information processing and inattention. These symptoms may cause difficulty carrying out daily activities at home and at school. There are few well-researched, non-pharmacological interventions aimed at improving symptoms of fatigue and by extension cognitive symptoms. Systematic bright light exposure has been shown to improve symptoms of fatigue in adult survivors of cancer and children treated for some forms of cancer. This is a pilot/feasibility study and the first known study in children treated for a brain tumor. Findings from this study will be used to help plan a larger study to examine the effectiveness of this intervention and mechanisms of action. PRIMARY OBJECTIVE: 1. To evaluate feasibility and adherence in a study of systematic bright light exposure used to improve fatigue and cognitive efficiency in survivors of pediatric brain tumor, including rates of enrollment, adherence, and acceptability. SECONDARY OBJECTIVES: 2. To estimate the effect size of change in fatigue associated with bright light exposure. 3. To estimate the effect size of change in cognitive efficiency associated with bright light exposure.