202 Clinical Trials for Various Conditions
In this SBIR, ALTality, Inc. ("SpellBound") will assess the feasibility of a dual English/Spanish language augmented reality(AR)-enabled tool for assessing inpatient postoperative pain/nausea/vomiting in Hispanic/Latino children and adolescents with cancer in collaboration with bilingual Spanish-speaking anesthesiologists at the MD Anderson Cancer Center. If successful, the AR app will be an immediately implementable and commercially viable method of providing Hispanic/Latino pediatric cancer patients with limited English proficiency an adjunctive tool to overcome infrastructural barriers to receiving translation services in acute care settings that put them at higher risk of under and/or overtreatment of pain by prescription opioids and future prescription opioid dependency and misuse, at no cost to them or their families.
The overall purpose of this protocol is to identify subacute sepsis-associated cardiac disease in pediatric patients with cancer by CMR and evaluate the CMR findings during their follow-up. This will help inform heart failure management decision making. Evidence of dysfunction or elevated T2 values may inform adjustment of afterload reduction and beta blocker administration, and elevated ECV findings will suggest the need for increased surveillance for diastolic dysfunction. Primary Objectives: (Feasibility Phase) To determine the feasibility of cardiac MRI without anesthesia in the immediate post-sepsis period in children with cancer. CMR scanning will be completed within 10 days of presentation - this will allow us to ensure that possible hemodynamic or respiratory instability and renal dysfunction has resolved prior to transport to the MRI scanner during the most acute phase of illness. (Completion Phase) To estimate the frequency of subacute sepsis-associated cardiac disease, including myocardial inflammation and dysfunction, in the post-acute phase (within 10 days of presentation) of severe sepsis in children with cancer
This pilot study will be a prospective, single arm study to investigate the feasibility and acceptability of a brief, telehealth, cognitive compensatory training intervention for children with a history of pediatric cancer at the University of Michigan. Study aims to enroll 10 children with a history of treatment for pediatric cancer, along with their caregiver.
The goal of this study is to assess the feasibility of using a game-based tool for caregivers of pediatric oncology patients to increase caregiver knowledge about supportive care for oncology patients while simultaneously reducing caregiver anxiety.
Tto learn if playing an augmented reality game called SpellBound can reduce pain and the need for opioids in young patients following surgery.
To learn if playing an augmented reality game called SpellBound can reduce pain and the need for opioids in young patients scheduled for surgery.
This study is being conducted to learn more about the patient/family experience when opting to enroll in Phase I clinical trials and their quality of life (QOL) while receiving experimental therapy. Palliative care (PC) has the potential to be beneficial for these families and further studies are needed to determine the most effective way for integration of PC into the care of patients enrolled on experimental clinical trials. Primary Objective * To qualitatively assess the patient and family experience, their hopes and worries and associated distress while deciding to enroll on a Phase I clinical trial.
Influenza infection occurring during oncologic treatment or following hematopoietic cell transplantation (HCT) is associated with increased risk of morbidity in the form of lower respiratory tract infection (LRTI) and mortality relative to otherwise healthy patients. The study participants have been diagnosed with a hematological malignancy and are eligible to receive the current seasonal influenza (Flu) vaccine. Primary Objective * To determine the feasibility of opening a longitudinal prospective study of IIV immunogenicity in pediatric leukemia patients. * To describe the immunogenicity, as measured by the development of cell- and/or antibody-mediated influenza specific responses 3 to 5 weeks following vaccination, in a cohort of pediatric leukemia patients. Secondary Objectives * To describe whether an immune response, as measured by development of cell- and/or antibody-mediated influenza specific responses, is detectable 1-2 weeks following vaccination in a cohort of pediatric leukemia patients. * To describe the durability of immunogenicity by measuring cell - and antibody- mediated influenza specific responses at 6 months and 1 year following vaccination in a cohort of pediatric leukemia patients. Exploratory Objectives * To estimate the clinical effectiveness of influenza vaccine in this cohort by monitoring for the development of clinical diagnosis of influenza in the cohort of enrolled pediatric oncology patients. * To correlate results of immune cell frequency in blood, as measured by complete blood count with differential, with development of an immune response to IIV.
The purpose of this study is to see if there are physical and emotional benefits to participating in a structured exercise regimen for those who are ages 2-25, are newly diagnosed with a blood or solid tumor cancer, and are currently undergoing or will begin cancer treatment.
The use of weighted blankets has been studied in the adult population but there is a lack of evidence to determine their benefit among a pediatric population, specifically oncology pediatric patients. Pediatric oncology patients routinely experience anxiety during therapy and as cure rates increase, attention has progressively turned to treating psychosocial aspects of care.
This is a pilot study to evaluate the feasibility of SpellBound's AR (augmented reality)-enabled scavenger hunt use among 20 pediatric cancer patients undergoing surgery.
This is a randomized double-blind control trial evaluating the use Tranexamic acid (TXA) to decrease blood loss and transfusion requirements in pediatric and young adult cancer patients undergoing a limb salvage procedure that frequently requires perioperative or post-operative transfusions of blood products. Primary Objective * To evaluate the difference in intra-or post-operatively transfused blood volume (mL/kg) for patients undergoing limb salvage procedures of the distal femur or proximal tibia who are randomized to receive perioperative tranexamic acid (TXA) versus placebo. Secondary Objectives * To evaluate changes in platelets and in hemoglobin from pre-op to post-op level for patients randomized to receive perioperative TXA versus placebo. * To evaluate differences in post-operative daily surgical drain output for patients randomized to receive perioperative TXA versus placebo. * To evaluate changes in estimated blood loss (EBL) for patients randomized to receive perioperative TXA versus placebo. * To evaluate the association between the intra-or post-operatively transfused blood volume and estimated blood loss (EBL) for patients randomized to receive perioperative TXA and placebo, respectively. Exploratory Objectives * To evaluate differences in functional outcomes post-operatively for patients randomized to receive perioperative TXA versus placebo. * To explore if significant correlations are observed between parameters reported with rotational thromboelastometry (ROTEM®) and EBL and transfusion requirements in pediatric and young adult patients undergoing limb salvage procedure who are randomized to perioperative TXA versus placebo. * To evaluate differences in the prevalence and management of wound complications such as superficial or periprosthetic infections, wound dehiscence, contact dermatitis, post- operative hematomas, or any other clinically significant wound complication between patients randomized to receive perioperative TXA versus placebo.
This study is being done because researchers want to learn more about genes that control the immune response in the participant's lungs and blood when the participant have lung disease leading to respiratory failure. Primary Objective To evaluate the feasibility of performing single cell gene expression analyses on tracheal aspirates from immunocompromised pediatric patients with immune compromising conditions, including HCT recipients. Secondary Objectives * To assess whether cell composition and activation states in longitudinally obtained tracheal aspirate and blood samples are able to distinguish unique immunopathology for each of the early post-HCT lung diseases. * To assess whether cell composition and activation states in longitudinally obtained tracheal aspirate and blood samples are different between two immunodeficient patient populations (alloHCT vs non alloHCT) with lung disease and respiratory failure. * To test the hypothesis that allogeneic T cell responses are implicated in the pathogenesis of early post-HCT lung diseases. Exploratory Objectives To correlate immune cell signaling in the lower respiratory tract and blood of patients with early post-HCT lung diseases with the presence or absence of pathogenic microbes at each site. To explore HLA testing in Tracheal Aspirates in samples where enough cells are present.
This trial studies how well a parenting skills intervention works in improving medication adherence in pediatric cancer patients. The parenting skills intervention provides support and skills training to parents who administer medicine daily to their child and may improve the childs taking of medications correctly as prescribed by the doctor. Ultimately, this may improve treatment outcomes, among children who are experiencing an illness.
Chemotherapy places patients at an increased risk of infection. A medication called granulocyte colony-stimulating factor is given as a daily injection in order to help decrease the risk of infection. The purpose of this study is to determine the best time to begin granulocyte colony-stimulating factor while maintaining the same clinical benefits. The current study aims to fill these research gaps and address the general question: Can G-CSF safely be given 72 hours following the last day of chemotherapy without increasing the incidence of febrile neutropenia, the duration of neutropenia, or causing increased delays in the next course of chemotherapy.
It is possible to distinguish between pediatric oncology patients who are at high or low risk for serious infection during periods of fever and treatment related neutropenia based on clinical parameters. Patients with low risk can be safely treated as outpatients primarily using oral antibiotics. It is possible to improve methods of risk stratification through the addition of genomic and proteomic factors.
The purpose of this study is to better understand whether or not children with ALL can complete an exercise program during treatment and whether or not that program may impact peripheral neuropathy. Researchers will also study changes in the blood and body that may occur during the program by collecting samples of blood at various times during the study. Aim 1: Evaluate the feasibility and acceptability of EX as an intervention for VIPN in pediatric patients with ALL. Aim 2: Estimate preliminary effect sizes of the EX intervention.
This is a Phase IV clinical trial observing and evaluating the safety of proton therapy in children. Protocol therapy is not being done as part of this clinical trial. The radiation targeting, planning, prescribed dose, fractionation, schedule, and use of other forms of therapy will be done per other therapeutic protocols at St. Jude Children's Research Hospital (SJCRH) at the discretion of the treating physicians associated with those trials.
The human microbiome is composed of unique groups of microorganisms occupying distinct habitats distributed throughout the human body. The Human Microbiome Project recently evaluated the bacterial composition of the microbiome in 18 (for women) and 15 (for men) body sites. Much initial attention in the field of microbiome research has focused on the bacterial contribution to a "healthy" microbiome. However, it is clear that other microorganisms, including fungi and viruses, are also distributed throughout the human body and serve as functional components of the microbiome. The populations of microorganisms residing within the oral and nasal cavities make important contributions to human health and disease. These contributions may be especially important in immunosuppressed patients, including those patients receiving myelosuppressive chemotherapy or undergoing hematopoietic stem cell transplantation. In these patients, organisms typically considered as commensals can become pathogenic, either locally or systemically. This observational study is primarily undertaken to evaluate the oral and nasal microbiota and to define the population of fungal organisms residing within the oral and nasal cavities in pediatric oncology patients before and after receiving protocol-directed chemotherapy and associated supportive care.
The proposed project will examine feasibility and preliminary efficacy of a yoga intervention in the pediatric oncology unit at Connecticut Children's Medical Center (CCMC) and includes two parts: (1) a survey of children and parents regarding preferences (e.g., convenient days/times), experiences and expectations regarding yoga (including barriers and positive expectancies) and (2) an eight week clinical trial of a yoga intervention in 10 pairs of children and parents.
Toxicities related to pediatric cancer treatment can lead to significant illness, organ damage, treatment delays, increased health care cost, and decrease in quality of life. Such toxicities are largely due to tissue damage sustained by chemotherapy, and strategies designed to limit such cellular damage to normal tissues may reduce therapy-related morbidity and mortality. In addition to their in vitro and in vivo anti-cancer effects, naturally occurring soy isoflavones have anti-inflammatory and anti-oxidant properties, and have been shown to reduce side effects of therapy in adult oncology clinical trials. This study will examine the effect of genistein, the major isoflavone component in soybeans and the most extensively studied of the soy isoflavones, on short-term side effects of myelosuppressive chemotherapy in pediatric cancer patients. Subjects will be randomized to receive either: a) 30 mg genistein daily throughout chemotherapy Cycles 1 and 2 and placebo during chemotherapy Cycles 3 and 4; or b) placebo daily during chemotherapy Cycles 1 and 2 and 30 mg genistein daily during chemotherapy Cycles 3 and 4. Investigators hypothesize that subjects will have fewer short-term therapy-related side effects during cycles of chemotherapy given in conjunction with genistein supplementation than cycles given with placebo.
The development of next generation sequencing (NGS) techniques, including whole genome (WGS), exome (WES) and RNA sequencing has revolutionized the ability of investigators to query the molecular mechanisms underlying tumor formation. Through the Pediatric Cancer Genome Project (PCGP), investigators at St. Jude Children's Research Hospital (SJCRH) have successfully used NGS approaches to evaluate more than 1,000 pediatric cancers ranging from hematologic malignancies to central nervous system (CNS) and non-CNS solid tumors. From these and related studies, it has become clear that genomic approaches can accurately classify tumors into distinct pathologic and prognostic subtypes and detect alterations in cellular pathways that may serve as novel therapeutic targets. Collectively, these studies suggest that by characterizing the genomic make-up of individual tumors, investigators will be able to develop personalized and potentially more effective cancer treatments and/or preventive measures. This protocol was initially enacted to usher NGS approaches into routine clinical care. During the initial phase of the G4K protocol, 310 participants were recruited and enrolled onto the study. Tumor and/or germline sequencing was completed on all 310 patients, with 253 somatic reports generated (representing 96% of the 263 participants for whom tumor tissue was available and analyzed) and 301 germline reports generated (100% of the 301 participants who agreed to the receipt of germline results). Analyses of the study data are ongoing with plans to prepare initial manuscripts within the next several months. Due to the successful initial execution of the G4K protocol, clinical genomic sequencing of tumor and germline samples is now offered as part of standard clinical care for pediatric oncology patients at St. Jude. The G4K protocol has now been revised. With the revision, the study team will record, store and analyze germline and tumor genomic information. Through the collection of these data, we will examine how germline mutations in 150 cancer predisposition genes influence clinical presentation, tumor histology, tumor genomic findings, response to therapy and long-term outcomes. The overall goals of this research are to further define the prevalence, spectrum and heritability of germline variants in these genes and to decipher how germline mutations influence the phenotypes of an expanding array of cancer predisposition syndromes. These studies allow us to provide more accurate genetic counseling and management strategies to future children harboring mutations in these genes. This remains a non-therapeutic study. Investigators anticipate a sample size of approximately 2500 patients who will be recruited over the next 7 years.
Diarrhea is a common problem in the pediatric population. Children with cancer are especially at increased risk for gastrointestinal infection-related morbidity and mortality due to their ongoing immunosuppression. However, the epidemiology of diarrheal illnesses in immunocompromised children is poorly understood. In the past, many or most cases of gastroenteritis have gone undiagnosed, largely due to a lack of sensitive diagnostic tests and a presumption that a large proportion of cases are due to treatment, rather than infections. The availability of new diagnostic tests that detect many gastrointestinal pathogens simultaneously offers the first opportunity to gain a comprehensive picture of the causes of infectious diarrhea in children with cancer. Researchers at St. Jude Children's Research Hospital want to learn about the epidemiology of diarrheal diseases in pediatric oncology patients utilizing broadly multiplexed, automated PCR.
Fevers raise the concern for serious bacterial infections in pediatric oncology patients receiving chemotherapy. The gold standard for diagnosing bacteremia (bacterial infection of the blood) is a blood culture. However, bacterial growth may not occur for 48 hours or there can be a false negative result. Thus, the biomarker, procalcitonin, has been investigated for its predictive ability to identify bacteremia earlier than blood culture. We believe that procalcitonin can assist in differentiating bacteremia from non-bacteremia infections in febrile pediatric oncology patients. A reliable predictor of bacteremia infections in pediatric oncology patients should decrease hospitalizations for fever and unnecessary antibiotic treatment. In our study we will measure procalcitonin levels in pediatric oncology patients presenting with fever. We will measure procalcitonin at the time of admission which is part of our standard of care for febrile pediatric oncology admissions. For the purpose of our study, we will additionally measure procalcitonin levels at 12 hours and at 24 hours post admission. We will examine procalcitonin levels at these three timepoints to determine if elevated procalcitonin levels predict bacteremia in pediatric oncology patients with and without neutropenia.
This is a single-arm, open-label study to assess the safety and effectiveness of a single dose of oral propranolol in reducing18F-fluorodeoxyglucose (FDG) uptake in brown adipose tissue (BAT) in pediatric oncology patients. This study is designed to better understand if taking a single dose of an oral medication called propranolol can reduce the chance of brown fat showing up on a PET scan, and therefore make the scan more accurate and easy to interpret. All humans have some degree of normal brown fat (called brown adipose tissue), and this normal tissue can sometimes light up on a PET scan. That creates problems because it may be wrongly interpreted by the radiologist as tumor, or it may hide true areas of tumor underneath it. Participants will not be randomized and will receive a single dose of oral propranolol approximately 60 minutes prior to the injection of the FDG tracer. The dose of propranolol will be 20 mg for all participants.
This is a non-randomized prospective pilot study in a single academic center with historic controls. This study will compare Cardiac Magnetic Resonance Images (MRI) of patients who have undergone childhood cancer treatment that has cardio-toxic effects to historic controls. The ultimate goal of this study is to develop a safe and effective method for early diagnosis of heart problems in children who are receiving chemotherapy treatments that may be toxic to the heart.
Hematology-oncology patients may require frequent lumbar puncture for diagnosis, assessment and therapy. When LP is difficult, the patient may endure multiple attempts, prolonged anesthesia time, and with failure of LP may require fluoroscopy-guidance with associated radiation exposure. This investigation will evaluate lumbar punctures performed in the intraoperative setting by oncologists with ultrasound guidance performed by the anesthesiologist in the leukemic pediatric population. The investigators hypothesis is that anesthesiologist guided ultrasound assistance will decrease intraoperative time, number of attempts and need to have the procedure done with fluoroscopy minimizing radiation exposure.
Many children with cancer cannot participate regularly in school due to frequent hospitalizations for treatment or treatment related effects such as pain, nausea, and fatigue. Prior studies have shown that children with cancer desire to attend school while receiving therapy despite these challenges, and that they report psychological and psychosocial difficulties if unable to attend. While school attendance has been found to correlate with Health-Related Quality of Life (HRQoL), self-efficacy beliefs, and self-esteem, little is known about how children with cancer experience school attendance while receiving active cancer therapy. The purpose of this study will be to explore how 6-12 year old children with cancer perceive school attendance pre and post diagnosis during active therapy as measured at one-time point, 6 months (± 2months) into active therapy.
Background: - Palliative care, also known as comfort care, is intended to keep a patient comfortable by focusing on pain and symptom management to improve quality of life. Although palliative care has been demonstrated to be beneficial, it is underutilized in children who have been diagnosed with cancer, because current trends favor palliative care primarily at the end of life and in only a small number of patients. Children with cancer likely would benefit from the incorporation of palliative care from the time of diagnosis, but both doctors and families are often reluctant to include it for a variety of reasons. Researchers are interested in understanding these reasons to determine better ways to include palliative care as part of cancer treatment methods in children with cancer. Objectives: - To collect information on pediatric oncology patients and their parents attitudes towards palliative care, along with cancer treatment, from the time of diagnosis. Eligibility: * Children and adolescents between 10 and 17 years of age who have been diagnosed with cancer in the past year. * Parents of eligible children. Design: * Participants will complete a 30-minute survey about experiences with pain, symptom management, and focus on quality of life in the first month following cancer diagnosis. Child participants will be asked about their views on the importance of quality of life in the beginning of their illness, as well as their attitudes toward symptom-oriented care. Parent participants will be asked questions about their child s illness, which includes understanding, discussion, and impact of illness. * Treatment will not be provided as part of this protocol.
The purpose of this study is to evaluate for iron overload in pediatric oncology and transplant patients who have completed their treatment between one to ten years ago.