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NCT05634252
The proposed study is a Multiphase Optimization Strategy (MOST) that uses factorial experiments to evaluate individual and combined effects of intervention components to improve intervention efficiency. The study team anticipates enrolling a total of 528 undergraduate students (\>18 years) into the trial to identify intervention approaches that eliminate sunburn, and secondarily to motivate sun protection and discourage tanning. The study team will test personalized risk components: 1) UV Photo, 2) Action Plan, and 3) MC1R Testing. A full factorial experiment will be conducted to test which of the proposed components or their combinations eliminate sunburn over one year. The study team will also examine effects of the intervention on secondary outcomes. Study assessments will be completed at 4 time points: baseline, 1-month post-intervention, 4-months post-intervention, and 15-months post-intervention.
NCT05937724
The current body of research fails to acknowledge or understand what type of care children are giving to their siblings, yet it appears to be a common practice in many cultures. To address this gap, we propose to examine the role and activities children provide to siblings with a chronic illness or disability. Additionally, we seek to better understand what preparation, training, or support (either formal or informal) are provided to siblings who are actively engaged in the caregiving process. We will further examine indicators for quality of relationship between the two siblings and examine themes and associations. We will accomplish this through a mixed-methods design with the four following aims: Aim 1: Describe the role and activities of children (ages 7 to 17) while providing care for a sibling with a chronic illness or disability. Through a descriptive qualitative inquiry, we will ascertain details and experiences on caregiving from the perspective of the parent and the sibling (separately) regarding the care the sibling provides to the child with a chronic illness. Themes of connection, friendship, direct medical and physical care (such as feeding) will be explored. Open ended questions which support the aim will be asked indirectly and directly, such as, "What does your day look like when you are getting ready to go somewhere" verses "Can you describe how you help your sibling each day." Aim 2: Investigate ways in which children are educated, trained, or supported in their caregiving role. Both qualitative information and quantitative data will be gathered as guided by Aim 1. For example, if a sibling indicates they provide feeding support, they will be asked questions such as, "How did you learn or know how to help feed them?" Informants will also be asked questions regarding how often and how long they spend caring for their sibling using a Likert-type scale. Aim 3: Explore quality indicators of sibling relationship from the caregiving perspective. Parents (main caregiver) will be asked to complete a demographic survey and the sibling inventory of behavior survey, a psychometrically validated tool to measure indicators of the sibling relationship. Qualitative data from aims 1 and 2 and quantitative data from aim 2 will be used to understand how specific themes may positively or negatively be associated with a positive sibling relationship, as a positive sibling relationship serves as a protective factor for sibling outcomes10. Aim 4: Determine to what extent the quantitative data about parental-perceived sibling relationships converge with or diverge from the qualitative data about care provided by the sibling. For the mixed-methods data analysis, a joint display will be created to show a side-by-side comparison of the quantitative, qualitative, and integrated findings. Points of concordance, discordance, and expansion will provide rich insights into caregiving provided by siblings.
NCT03152058
This treatment trial evaluates the addition of an anti-tumor necrosis factor-alpha drug, certolizumab, to usual treatment (a heparin agent and low-dose aspirin) in pregnant women with antiphospholipid syndrome (APS) and repeatedly positive tests for lupus anticoagulant (LAC) to determine if this regimen will improve pregnancy outcomes. All enrolled patients will receive certolizumab, and pregnancy outcomes will be compared to those of women with APS and repeatedly positive tests for LAC enrolled in a previous study by the investigators.
NCT04366440
The overall objective of this study is to identify the best strategy to eliminate unnecessary antibiotic use after surgery in pediatric surgical procedures considered low-risk for an SSI. Based on literature and our preliminary data suggesting surgeons will not fully accept standardized order sets based on current guidelines, the investigators hypothesize that order set modification combined with ASP facilitation will outperform standard order set modification alone in de-implementing unnecessary postoperative antibiotic use.
NCT02612311
This study evaluates the combination of ublituximab, a novel monoclonal antibody, and TGR-1202, a novel PI3K delta inhibitor compared to obinutuzumab and chlorambucil, and compared to ublituximab or TGR-1202 alone in Chronic Lymphocytic Leukemia (CLL) participants.
NCT03465904
The main objective of this study is to have Phase III evidences of the efficacy of the Cefaly® Abortive Program device used at home for 2 hours to treat a migraine attack. This randomized, double-blind, sham-controlled trial will study the abortive treatment of migraine using the Cefaly® Abortive Program device.
NCT01889238
The purpose of this study is to determine if enzalutamide is safe and effective in the treatment of patients with advanced breast cancer that express the androgen receptor but do not express the estrogen or progesterone receptor and are not Her2 amplified.
NCT03640481
This is a Phase 2, randomized, multicenter study to evaluate the efficacy and safety of KD025 in subjects with Chronic Graft Versus Host Disease (cGVHD) after at least 2 prior lines of systemic therapy
NCT03001128
The purpose of this study is to collect information about what happens when people pause, or temporarily stop taking, ART, and to collect blood samples from these people at frequent intervals. We will also study the safety of pausing ART under close observation.
NCT01032070
This is a phase 2 study to evaluate the efficacy of single-agent erlotinib versus oral etoposide in patients with recurrent or refractory pediatric ependymoma.
NCT05161078
To date, little knowledge exists related to the use of hemodialysis (HD) in infants and has been limited to mainly single center studies. The CARPEDIEM (CArdio-Renal PEdiatric Dialysis Emergency Machine) device, which can be used to provide hemodialysis in infants, has been launched in the United States. This study/registry is designed to obtain data on critically ill infants who require HD using the CARPEDIEM device to understand the indications for initiation, best practice in prescribing and performing treatment, expected treatment course, and outcomes of a dedicated infant continuous renal replacement therapy (CRRT) machine.
NCT00634049
The purpose of this study is to investigate the efficacy and safety of isavuconazole in the treatment of renally impaired participants with invasive fungal infections caused by Aspergillus and participants with invasive fungal disease caused by rare fungi.
NCT06598449
Dravet syndrome is a genetic epilepsy associated with pathogenic variants in SCN1A that codes for Nav1.1, a protein necessary for sodium channels. Children with Dravet syndrome classically present in the first year of life with prolonged seizures, often hemiclonic and in the setting of fever or temperature changes such as getting in or out of bath water. Many anti-seizure medications are sodium channel blockers and exacerbate seizures in this patient population. This creates some limitations in medication choices for this patient population. Recently fenfluramine was approved for use in Dravet syndrome for people 2 years and older. Randomized studies demonstrated a 74.9% reduction of convulsive motor seizures compared to 19.2% in the placebo group. Additionally, 16% of children treated with fenfluramine were seizure free. Fenfluramine is likely to be as effective in children under the age of 2 years. The current study has proposed a treatment protocol to allow access to fenfluramine for children under 24 months of age.
NCT04020185
Open-label, dose escalation (Phase I) and dose expansion (Phase IIA) study of patients receiving intra-tumoral IMSA101 alone or in combination with an immune checkpoint inhibitor (ICI) (Phase I and II)
NCT05130970
This is a prospective, phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of garadacimab in subjects with idiopathic pulmonary fibrosis (IPF).
NCT05000931
The CochlearTM Osia®2 System was cleared by the Food and Drug Administration November 15, 2019 (K191921) for individuals aged 12 years and older who present with conductive or mixed hearing loss (up to 55 dB HL) or single-sided-deafness (SSD).Published and unpublished data suggest significant pre to postoperative benefit and minimal risk in both children and adults who have received the Osia system. Thus the objective of this study is to examine the safety and effectiveness of the Cochlear Osia 2 system in a group of pediatric subjects aged 5 to 11 years who suffer from conductive or mixed hearing loss (up to 55 dB HL), or single-sided-deafness (SSD) with the intent of expanding the indications for use.
NCT03817424
The purpose of this study is to evaluate the safety and tolerability of escalating, multiple subcutaneous (SC) doses of VIB7734 in participants with Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis.
NCT05109091
This study will assess the safety and efficacy of ATH434 in participants with Multiple System Atrophy
NCT01027936
To collect three dimensional retinal measurements of the optic disc and the macula lutea on healthy normal subjects using the 3D OCT-1000 Mark II for the purpose of developing a normative database that is stratified by age.
NCT03922204
This is an open-label, non-randomized, Phase 1 study to determine the safety, tolerability, and preliminary efficacy of MCLA-145 in adult patients with advanced metastatic solid tumors or B-cell lymphomas. The study will be conducted in 2 parts.