The purpose of this study is to learn more about late-onset epilepsy of unknown etiology (LOEU), which is defined as an onset of seizure activity in late life (age 60 or above) without a clear neurological cause. That is, many older adults will experience seizures due to neurological conditions such as stroke, brain injury, tumor, or infection. However, other individuals will also develop seizures with no identified cause.

Participation entails a single study visit lasting 2-3 hours including a fasting blood draw, completion of standardized cognitive testing, and several questionnaires. The goals of the study include to examine blood markers that can help us to better understand the condition including dementia risk, and how these markers may impact the clinical presentation of the condition. No interventions/treatments are included with this study.

The primary aim is to construct individualized treatment rule (ITR) models that predict optimal medication selection for deprescribing to maximize potential benefits and reduce harms to patients. To address this aim, we will collect retrospective EHR data for individuals over age 65 from three participating sites (Duke, Vanderbilt, and Medical University of South Carolina) and link this with medication dispensing and insurance claims data from the Centers for Medicare and Medicaid Services(CMS). We will apply causal inference methodology and supervised and unsupervised machine learning algorithms to predict both the benefits (reduced falls, cognitive disorders, hospitalizations) and potential
harms (adverse drug withdrawal events) of medication discontinuation. These predictions will be specific to individual patients and various central nervous system (CNS)-acting medication classes. The resulting machine learning models will be integrated into ITR models which will, in turn, support clinical practice by
recommending the medication class most likely to provide benefits, factoring in individual patient characteristics.

The purpose of this research is to assess the emotional impact on mothers of children with mitochondrial disease (MD). This study plans to compare survey responses between mothers of children with MD caused by mitochondrial DNA (mtDNA) variants, which are exclusively maternally inherited, and nuclear DNA variants (nDNA), which can be inherited from either parent or new in the individual (de novo). This survey also plans to assess the impact on future reproductive decisions due to the fact that reliable preimplantation genetic testing (PGT) for mtDNA variants is lacking and the transmission of mtDNA variants from mother to child is hard to predict.

This study involves research. You are being asked to participate in this research study to have your temperature taken. The purpose of the study is to collect data to test a temperature measurement module that is part of medical study device that measure's human body temperature.

Children spend more time than ever using screens — increasingly on portable digital media devices like tablets and smartphones, but our understanding about how these devices impact health is lagging. This project proposes to uncover how patterns of digital media use are formed and maintained and examine how those patterns predict mental health and cardiovascular health risk over time. The novel forms of media measurement used in this project – including passive mobile sampling, ecological momentary assessment and accelerometry – will allow us to uncover the unique and complex ways in which digital media impacts health behaviors.

The Alpha-1 Foundation Therapeutic Development Network (TDN) aims to make it easier to design and carry out clinical trials that enhance the treatment of patients with Alpha-1 Antitrypsin Deficiency (AATD). To achieve this, the TDN will establish a network of clinical trial centers that have enough patients to gather a comprehensive database of clinical and genetic information. This data will be crucial in determining the criteria for including or excluding participants in the trials and in recruiting suitable subjects.

Specifically, this study will enroll participants by in person or remote consent who will allow collection of medical records to be entered into an Alpha-1 TDN database. Participants will then be invited to future clinical trials.

This is an observational non-medication study. The purpose of this study is to understand the immune system in people who are at risk for developing systemic lupus erythematosus ("lupus" or "SLE"). The investigators hope to develop better ways to predict who will get lupus and possibly come up with ideas for new treatments that can prevent or treat the disease.

Participants will be asked to complete 4 annual study visits and monthly telephone contacts with the study team over the course of 3 years. Visits will include a physical exam, collection of blood and urine, and the completion of some surveys/questionnaires about your health and wellbeing. The monthly phone calls will be a brief contact to check on any changes in your health and should take no longer than 15 minutes to complete.

Compensation is available for participation.

Cannabis is the most commonly used illicit substance among pregnant and postpartum women, with the postpartum period being a common time for relapse to cannabis. Currently there are no interventions for preventing return to cannabis use during this vulnerable time. The goal of this research is to better understand risk factors such as stress, craving, anxiety, mood, sleep, and hormone levels that may contribute to return to cannabis use during the postpartum period in order to help develop targeted prevention and treatment interventions in the future.

The study will compare the effectiveness of endoscopic surveillance and endoscopic eradication therapy (EET) for the management of Barrett's esophagus (BE) and low-grade dysplasia (LGD).

This project is an extension of the CDC-funded FORWARD (Fragile X Online Registry With Accessible Research Database) study. From its inception in 2010, the goal of the FORWARD study has been to characterize the natural history of fragile X syndrome (FXS). This current extension project is known as FORWARD-MARCH (Multiple Assessments for Research CHaracterization) because it will include multiple assessments to characterize behavioral, adaptive, and cognitive function in greater depth and thereby further improve understanding of the natural history of FXS. FORWARD-MARCH continues the mission of FORWARD to better understand the natural history of FXS in order to improve the lives of children and adolescents with FXS and the lives of their families. FORWARD-MARCH will also better define trajectories of development in FXS that will be useful in understanding the long-term effects of an intervention relative to the natural history of FXS.

FORWARD-MARCH builds upon the foundation of the FORWARD study. The FORWARD study included 24 participating FXS specialty clinics throughout the US that are members of the FXCRC (Fragile X Clinical & Research Consortium). The FORWARD study worked closely with the Centers for Disease Control and Prevention (CDC), the National Fragile X Foundation (NFXF), and other stakeholders in the FXS community. FORWARD-MARCH will also involve a contractor, Chickasaw Nation Industries (CNI), funded through a contract with the CDC. CNI will assist in data collection and management.

Between September 2022 and August 2026, FORWARD-MARCH expects to enroll at least 600 individuals with fragile X syndrome who were born between 2003-2017. The majority of these individuals will already be FORWARD study participants, enabling researchers to conduct longitudinal analyses incorporating previously collected data. Cognitive, behavioral, and adaptive function will be assessed using parent or caregiver-completed surveys and in-person clinical assessments. After completion of data collection, deidentified data will be securely maintained at CDC and will be an important long-term resource for analyses of the natural history of FXS.

Previous phases of the FORWARD study, conducted between 2012 and 2022, have received IRB review and approval by the institutions of each participating clinic. These previous phases of the study did not require review by a CDC IRB, as CDC had no participant contact and did not have access to personal identifying information (PII). The extension of the FORWARD study covered in this protocol (FORWARD-MARCH, 2022-2026) will continue to be reviewed and approved by the institutions of each participating clinic conducting data collection. However, review and approval are also being sought from the CDC IRB because PII will be maintained on CDC servers and because CDC's contractor, CNI, will regularly have access to PII and interact directly with study participants. A reliance agreement allowing CNI to rely on CDC's IRB is being developed and will be executed before data collection is begun. To clarify which aspects of the protocol involve CDC and CNI staff (rather than just clinic staff), sections 3,4 and 5 of this protocol document each end with a subsection that specifically focuses on the role of CDC and CNI staff.