The study is examining the health effects of gestational diabetes mellitus (GDM) intervention and medically tailored meals within home visiting. A large study is proposed that will include nearly a thousand pregnant or recently pregnant adults with recent GDM and who are from different regions and backgrounds. Two treatment approaches are compared, and both are in home visiting. One treatment group is receiving enhanced lifestyle support for GDM along with meals, and the other is receiving just the enhanced lifestyle support. The study will examine whether these interventions help reduce diabetes and pre-diabetes through 12 months postpartum, as well as other health factors like weight and blood pressure.
Diabetes Mellitus· California Polytechnic State University-San Luis Obispo· San Luis Obispo, California · Chicago, Illinois +1 more
Diabetic Retinopathy (DR) is a common eye condition caused by diabetes, where high blood sugar levels damage the blood vessels in the back part of the eye (called the retina). Over time, this damage can lead to vision problems and even blindness if not treated. This study will assess surabgene lomparvovec (sura-vec) as a potential one-time gene therapy administered in the suprachoroidal space (SCS) for the treatment of diabetic retinopathy (DR) and prevention of vision-threatening events (VTEs) in participants with non-proliferative DR (NPDR) without center-involved diabetic macular edema (CI-DME).
This study will consist of 3 portions: a Phase 2b portion, a Phase 3 portion, and a bilateral treatment portion. Approximately 576 adult participants will be enrolled in the study across multiple sites in the United States and Puerto Rico.
In the Phase 2b and Phase 3 portions, participants will be randomized to different groups to receive sura-vec and prophylactic steroids or sham and artificial tears in their study eye. If assigned to sham, participants will be given an opportunity to cross over and receive treatment with sura-vec. In the bilateral treatment portion, participants will be enrolled to receive sura-vec and prophylactic steroids in both eyes. In all 3 portions, follow-up in the study will continue through 5 years following administration of sura-vec in each eye.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Diabetic Retinopathy· AbbVie· Phoenix, Arizona · Scottsdale, Arizona +1 more
This will be a multicenter registry-based study to evaluate safety and efficacy of GLP-1RA and SGLTi therapies in adjunct to insulin in adults with type 1 diabetes (T1D) over 1 year. This study will enroll participants who have been prescribed adjunct therapy as part of usual care.
Type 1 Diabetes· Indiana University· Newport Beach, California · Atlanta, Georgia +3 more
The goal of this study is to learn if treating insomnia with a therapy intervention in people with type 1 diabetes will help to better control sugar levels, sleep, and quality of life. The questions this study aims to answer include:
Will this intervention help the insomnia symptoms? Will obtaining better sleep aid in the control of diabetes through measures like sugar levels? Will the intervention help with quality of life factors like mood and fatigue?
Researchers will compare participants receiving the therapy intervention for sleep with those in the "healthy living" intervention to see if the outcomes are different based on the treatment.
Participants in the therapy intervention group will:
* meet virtually with a therapist for 8 sessions via Zoom. Once a week for the first 4 weeks and then every other week for the last 4 sessions.
Participants in the healthy living group will:
* receive weekly health education emails
* receive brief weekly calls from a coach to answer any questions
Participants, regardless of intervention, over the 12 week study period will:
* monitor their sleep for 2 weeks through a sleep-monitoring watch
* share their continuous glucose monitoring data throughout the study
* answer questionnaires prior to the intervention, halfway through the intervention and then after the intervention
* attend 3 in person office visits
Diabetes Mellitus Type 1· University of Illinois at Chicago· Chicago, Illinois· Ages 18–65
The overriding objective of DREAM is to conduct a prospective longitudinal (36 months) observational clinical study to investigate the incidence, etiology, and pathophysiology of diabetes mellitus (DM) following acute pancreatitis (AP).
Acute Pancreatitis· Milton S. Hershey Medical Center· Los Angeles, California · Stanford, California +2 more· Ages 18–75
The purpose of this study is to learn about the safety of islet transplantation when performed after kidney transplantation, which may provide more normal control of blood sugar without the need for insulin shots. Islets are special clusters of cells within the pancreas that produce insulin. These cells will be obtained from cadaver (non-living) donors and given to subjects by vein.
Diabetes Mellitus, Type 1· University of Chicago· Chicago, Illinois· Ages 18–68
The goal of this randomized crossover trial is to compare the differences in psychological and physiological effects of walking in two different outdoor environments (urban/suburban commercial environments vs. urban/suburban nature areas/preserves) in adults with prediabetes. The main questions it aims to answer are:
* Do psychological measures of stress, anxiety, and affect improve more in one type of outdoor environment over the other?
* Do physiological measures of stress improve more in one type of outdoor environment over the other?
As this is a crossover trial, participants will serve as their own controls. Researchers will compare both the psychological and physiological effects walking in the two types of outdoor environments.
Participants will:
* Walk 150-minutes per week for six weeks in each of the two outdoor conditions.
* Visit the clinic four times, including before and after each six-week walking period.
* Collect saliva samples immediately proceeding or following the four clinic visits.
* Return to their pre-study level of physical activity for a 5-week washout period between each of the two walking interventions.
PreDiabetes· University of Minnesota· Lake Forest, Illinois · Winfield, Illinois +1 more· Ages 25–64
The proposed research and training will allow Dr. Alana Biggers to obtain critical research skills and study a mindfulness meditation program designed to improve sleep and reduce stress in African-American adults with diabetes. If effective, this program may reduce the risk of cardiovascular disease among African-Americans with type 2 diabetes who are at high risk of cardiovascular disease.
Type 2 Diabetes· University of Illinois at Chicago· Chicago, Illinois· Ages 21–75
The investigators will test the hypothesis that culturally congruent coaching delivered via a technology application (Health360x) will improve the persistent disparities observed among women of color with lupus or lupus nephritis by addressing underlying psychosocial barriers to behavioral change.
Lupus Nephritis· Morehouse School of Medicine· Atlanta, Georgia
Hydroxychloroquine (HCQ) is a systemic lupus erythematosus (SLE) medication that has been very effective in reducing lupus disease activity and keeping patients stable with reduced symptoms. Despite a track record of safety with regard to infection compared to traditional immunosuppressive agents, the risk of HCQ retinal toxicity escalates with continued use. Evaluation using sensitive standard of care approaches suggests nearly a third of patients accrue retinal damage. Data are needed to accurately weigh the balance between accumulating ocular exposure of HCQ versus the risk of disease flare in a population that may have more inactive disease than younger patients. The purpose of this trial is to address the safety of withdrawal of HCQ in SLE patients \>=55 years old. The central hypothesis is that HCQ can be safely discontinued in stable/quiescent patients assessed by validated disease activity and flare instruments in the context of serologic, cytokine and transcriptomic profiling. Patients will be randomized to either the placebo or active arm and followed every 3 months for one year to assess disease activity and flares.
Systemic Lupus Erythematosus· NYU Langone Health· Atlanta, Georgia
This is a Phase IV, open-label, randomized trial to determine whether the combination of Belimumab (BEL) and Voclosporin (VCS), plus background therapy with Mycophenolate Mofetil (MMF), improves the proportion of patients with proliferative lupus nephritis achieving complete renal response (CRR) compared to proportion of patients achieving CRR from recent clinical trials. This protocol will additionally determine whether combination therapy using Belimumab (BEL) and Voclosporin (VCS) facilitates rapid discontinuation of MMF.
The purpose of this global, multicenter, Phase 3 study is to evaluate the efficacy and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic disease. Study details include:
Study Duration: Up to 35 weeks. Treatment Duration: 24 weeks. Visit Frequency: every 4 weeks, with the exception of the Week 2 televisit. Study Intervention Name: Enpatoran, Placebo.
Intervention Form: Film-coated tablet.
Systemic Lupus Erythematosus (SLE)· EMD Serono Research & Development Institute, Inc.· Atlanta, Georgia· Ages 18–75
Atrial Fibrillation (AF) is an abnormal heart rhythm. Because AF is often asymptomatic, it often remains undiagnosed in the early stages. Anticoagulant therapy greatly reduces the risks of stroke in patients diagnosed with AF. However, diagnosis of AF requires long-term ambulatory monitoring procedures that are burdensome and/or expensive.
Smart devices (such as Apple or Fitbit) use light sensors (called "photoplethysmography" or PPG) and motion sensors (called "accelerometers") to continuously record biometric data, including heart rhythm. Smart devices are already widely adopted.
This study seeks to validate an investigational machine-learning software (also called "algorithms") for the long-term monitoring and detection of abnormal cardiac rhythms using biometric data collected from consumer smart devices.
The research team aims to enroll 500 subjects who are being followed after a stroke event of uncertain cause at the Emory Stroke Center. Subjects will undergo standard long-term cardiac monitoring (ECG), using FDA-approved wearable devices fitted with skin electrodes or implantable continuous recorders, and backed by FDA-approved software for abnormal rhythm detection.
Patients will wear a study-provided consumer wrist device at home, for the 30 days of ECG monitoring, 23 hours a day. At the end of the 30 days, the device data will be uploaded to a secure cloud server and will be analyzed offline using proprietary software (called "algorithms") and artificial intelligence strategies. Detection of AF events using the investigational algorithms will be compared to the results from the standard monitoring to assess their reliability. Attention will be paid to recorded motion artifacts that can affect the quality and reliability of recorded signals.
The ultimate aim is to establish that smart devices can potentially be used for monitoring purposes when used with specialized algorithms. Smart devices could offer an affordable alternative to standard-of-care cardiac monitoring.
The goal of this clinical trial is to learn if the FARAFLEX™ Mapping and pulsed field ablation (PFA) System can safely and effectively treat symptomatic, drug-refractory Paroxysmal atrial fibrillation (PAF) and Persistent atrial fibrillation (PersAF). The main question it aims to answer is:
Is the FARAFLEX Mapping and PFA System a safe and effective treatment for patients?
Participants will undergo an ablation procedure using the FARAFLEX Mapping and PFA System.
Paroxysmal Atrial Fibrillation (PAF)· Boston Scientific Corporation· Jonesboro, Arkansas · Atlanta, Georgia +3 more
The purpose of this study is to evaluate long-term safety of subcutaneous guselkumab in pediatric participants with moderately to severely active ulcerative colitis, or moderately to severely active Crohn's disease, or juvenile psoriatic arthritis (jPsA).
Crohns Disease· Janssen Research & Development, LLC· Atlanta, Georgia
This study will evaluate exercise delivered through the Zesty Exercise System for Therapeutic Engagement (ZEST-E) for people with Parkinson's disease when sessions are monitored either in person or remotely. Participants will complete robot-guided exercise three times per week for three weeks. The study will assess feasibility, retention, safety, acceptability, and tolerability of remotely monitored ZEST-E and will measure changes in functional performance using the Standing Forward Reach test and the 30-Second Chair Stand test. These outcomes reflect range of motion and lower-body strength targeted by the exercise program.
This study is being done to answer the question: Do people with Parkinson's benefit from a new stepping therapy, and how do people with Parkinson's best learn new steps and rhythms set to music? Researchers will also compare individuals with Parkinson's Disease with people with Mild Cognitive Impairment, and with people with neither of these conditions.
The purpose of this study is to identify principles of human-music interactions to establish underlying guiding theories for application to music-based rehabilitation for older populations with neurodegenerative disease, leading to more refined and targeted music-based rhythmic movement therapies.
This study is being done to answer the question: How do people with Parkinson's disease, people with Mild Cognitive Impairment, and younger people process difficult topics in conversation? It will also explore themes related to dance, such as community building and justice, as perceived by persons with Parkinson's disease or Mild Cognitive Impairment, and younger individuals before and after the Adaptango performance process.
Veterans with mid to later stage Parkinson's disease (PD) may not be able to work out as hard as they need to, to prevent brain cell loss. Maybe they could work out longer and more frequently to make up for this during their good times and good weeks and then rest during the bad weeks. The investigators will compare how effective working out a lot one week per month with a break of three weeks is to continuously exercising weekly with no breaks in people with mid stage PD. The investigators will look at how fast participants walk per minute, whether they become more physically active, the biochemicals in their blood, and at how stiff their blood vessels are before and after the exercise.
Parkinson Disease· VA Office of Research and Development· Decatur, Georgia