This is a study to test whether a widely-used drug, hydroxychloroquine, might slow the progression of lupus like features in individuals who are at high risk for developing systemic lupus erythematosus. This will be measured by the accumulation of clinical and laboratory features of lupus. The study will randomize subjects to the active drug, hydroxychloroquine, or placebo, with an equal chance of receiving either treatment. The study treatment lasts approximately 2 years with visits approximately every 3 months.

Visits occur every 3 months for 2 years, Vitals signs and blood draws will occur at every visit.

Briefly, the purpose of this study is to use a self-management approach (combining education and exercise) to help older breast cancer survivors manage joint pain, a common side effect of aromatase inhibitors (AIs), a medication used to reduce hormones that might increase risk of recurrence and mortality following primary cancer treatment. We believe that reducing joint pain might help survivors take their medication longer and thus improve survival outcomes, compared to standard care.

Attend 4 in person visits, blood will be drawn at each visit.Complete physical function tests and surveys.Wear accelerometer for 7 days following each visit.Randomly selected participants will attend group exercise sessions twice a week for eight weeks via video call and record exercise activities between visits.

$160

This study continues our exploration into the mechanisms underlying the control of blood flow. During the experiments, we noninvasively measure skin blood flow (SkBF) and forearm blood flow (FBF) with a FLPI and venous occlusion plethysmography (VOP), respectively. The FLPI uses a low energy laser to measure SkBF. VOP uses blood pressure cuffs on the upper arm and wrist, and an elastic strain gauge encircling the forearm between the cuffs to measure the change in forearm-circumference over time from which we calculate FBF. For each experiment, we collect SkBF and FBF data for a 20-minute baseline, expose the skin of the forearms to negative pressure and then collect SkBF and FBF data for an additional 30-90 minutes. Each subject participates in 2 experiments that differ only in the protocol for the application of negative pressure (i.e. continuous, pulse).

A randomized placebo-controlled study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus

There is up to 15 visits over the course of 54 weeks. Lab samples will be collected, medication will be administered.

amount varies based on visits completed

This is a device study that will determine how much exoskeleton parameters need to change for the user to notice a difference. The parameters that will change affect how the exoskeleton responds when walking.

In a single visit, participants will walk in an ankle exoskeleton with changing forces and responsiveness. Participants will be asked if they notice a difference between different combinations of force and responsiveness.

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The original Childhood Arthritis & Rheumatology Research Alliance (CARRA) Registry was first established in 2010 to advance alliance infrastructure,facilitate expanded clinical and translational pediatric research, and transform the culture of pediatric rheumatology toward universal participation in research. Continuation of the CARRA Registry as described in the protocol attached to this IRB submission will support data collection onpatients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis for future CARRA studies. In particular, this observational registry will be used to answer pressingquestions about therapeutics used to treat pediatric rheumatic diseases, including examining safety questions. The Duke Clinical Research Institute (DCRI) is serving as the CARRA Clinicaland Data Coordinating Center (CDCC) for this protocol.

In addition to allowing the researchers to collect data on you from your medical record, we will ask you and your parents/caregivers to complete a short survey that takes about 15 minutes to completeThe research team will follow up every 6 months by reviewing your medical record and asking you and your parents/caregivers to complete a short survey that takes about 15 minutes to complete.If you agree to take part, you will be in the study for 10 or more years.

This is a multi center clinical trial to test the efficacy of N-acetylcysteine for treatment of patients with active systemic lupus Erythematosus. Healthy control subjects who do not receive treatment are also recruited to serve as controls for the laboratory assays.

This is a clinical trial to be carried out in patients who have systemic lupus erythematosus. Participants will be asked to attend seven study visits over a period of 13 months. After an initial period where it will be determined that the patient can tolerate the medication, N-acetyl cysteine, then there will be a three-month double blind phase where the participant receives either the active treatment or a placebo. At each visit the participant will be asked to complete several questionnaires and blood and urine samples will be obtained. Healthy control individuals will be also enrolled for blood samples only; not for any treatment intervention.

$20 per visit completed

We plan to conduct a qualitative study exploring perspectives of physical therapists and people with disability regarding physical activity promotion

This trial will address the safety of withdrawing hydroxychloroquine (HCQ) in patients with systemic lupus erythematous who are 60 years of age or older. In this older population the benefits of HCQ are expected to decrease since disease activity decreases with advancing age. The study will test whether HCQ can be safely discontinued in stable/quiescent patients.

Participants will be in this study for about 1 year, during which time they will come to 7 visits in the research clinic. The first visit will take up to 2 hours and will include blood and urine sampling and completion of self-assessment questionnaires. Subsequent visits will take up to 1 hour. Participants will be randomized to receive either the active drug hydroxychloroquine or placebo. The treatment will be blinded to both the participant and the investigator. Diaries will be requested in which the participant keeps track of dosing of the study medication.

The purpose of this study is to learn more about the daily experiences of people with back pain and their spouse/partner. Participants and their spouse/partner will be interviewed by video using a tablet computer every 6 months for 2 years and will be asked to complete daily surveys twice a day for 30 days using the provided tablet computer. The daily surveys will take about 5 to 10 minutes to complete. Questions for the interviews and daily surveys focus on physical symptoms, feelings, activities, and interactions.

Video interviews using a tablet computer every 6 months for 2 years. Complete daily surveys twice a day for 30 days using a tablet computer.

295.00

Treatment of Systemic Lupus with mycophenolate mofetil alone or with voclosporin

There will be 16 visit over a years time, physical exam, blood work, ECG, questionnaires

This experimental study will investigate foot joint function during walking and running and/or hopping and performing heel raises. Participants will walk and run and/or complete heel raises with mass added to their body and will walk and run and/or hop with a plastic wedge secured to the underside of their toes.

Participants will walk and run and/or complete heel raises with mass added to their body and will walk and run and/or hop with a plastic wedge secured to the underside of their toes.

The purpose of this study is to see if neck and shoulder function and pain are better after SLN biopsy surgery compared to the usual approach and to see if SLN biopsy surgery is as good as the usual approach in extending your time without cancer. SLN biopsy surgery is potentially less invasive compared to the usual approach, but it requires a radioactive imaging agent to see the lymph nodes and it could also cause side effects. These side effects are described in the risks section below. Your study doctor will choose the appropriate imaging agent, Lymphoseek or sulfur colloid, for use in your surgery.This study will help the study doctors find out if this different approach is better than the usual approach at improving neck and shoulder function. To decide if it is better, in the first part of the study, doctors will be looking to see if shoulder and neck function and quality of life are better after SLN biopsy surgery compared to the END surgery.

We are asking you to take part in a research study. This study has public funding from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH) in the United States Department of Health and Human Services. We do research studies to try to answer questions about how to prevent, diagnose, and treat diseases like cancer. We are asking you to take part in this research study because you have early-stage oral cavity cancer and are having neck dissection surgery.

This is a 48-week, two arm study that incorporates digital tools for assessing motor function in amyotrophic lateral sclerosis (ALS) and healthy controls.During the study, neck- and wrist-worn “activity sensors” (PAMSys, BioSensics, Newton, MA) will be worn by subjects while performing tasks of daily living. Subjects will also complete a motor, speech, and handwriting assessment during site visits. They will complete a digital home assessments of speech, handwriting, and pattern tracing tasks throughout the study, and report any falls which occur on the study tablet. We will explore whether sensor-based functional changes are sensitive to self-reported changes over the length of the study.

During the study, neck- and wrist-worn “activity sensors” (PAMSys, BioSensics, Newton, MA) will be worn by subjects while performing tasks of daily living. Subjects will also complete a motor, speech, and handwriting assessment during site visits. They will complete a digital home assessments of speech, handwriting, and pattern tracing tasks throughout the study, and report any falls which occur on the study tablet.Subjects will be required to visit the study site around the time of 5 consecutive standard ALS clinic appointments.The research study will last approximately 48 weeks.

$240

A randomized placebo-controlled study to evaluate the efficacy and safety of VIB4920 in study participants with active lupus nephritis

Patients come for in-person visits at the Penn State Hershey main hospital location. There will be blood draws, physical exams, and questionnaires spread out across 60 weeks.

The purpose of this study is to investigate why some individuals who have a few findings of autoimmunity eventually develop a condition such as systemic lupus erythematosus (SLE). In addition to stored biosamples from the SMILE clinical trial, new samples will be collected from persons with findings such as lab tests that are suggestive of lupus with an emphasis on recruitment of individuals ofnon-European ancestry, who were under-represented in the previous clinical trial.

Participants in this study will answer questions about their health and have a short physical exam performed on them. They will provide a blood and urine sample. These procedures will be repeated every twelve months for three years (a total of four times). Both routine and experimental tests will be performed on the blood and urine samples. Genetic studies will be done to help understand the risk of developing lupus.

People with narrowed blood vessels in their legs can only walk a short distance before needing to sit down due to pain in their calf muscles. Most of these patients do not follow their heart doctor's advice to walk at home because it hurts. A therapy that does not involve painful walking would be ideal for these patients to begin to treat their disease so they can eventually walk with less discomfort. We will ask patients with peripheral artery disease (PAD) to place both feet into inflatable ankle splints 30 minutes a day for 4 weeks to passively stretch their calf muscles. Before and after this 4-week program, we will measure the health and size of their leg blood vessels, the length, and function of their calf muscles and tendons, and how long they can walk without pain. We will also closely track their joint and foot movements and calf muscle oxygen levels while they walk down a hallway. People with and without risk factors for heart disease are also eligible for this study to compare differences in vascular and muscular health to patients with PAD. Volunteers without a PAD diagnosis or poor leg circulation will not undergo the 4-week stretch and no-stretch interventions.

Peripheral artery disease (PAD) and poor leg circulation patients:-4 visits to University Park Clinical Research Center ~3 hours per visit-1 blood draw-Wear a calf muscle stretching device for 30-min a day, 5 days a week, for 4 weeks and 4 weeks of no stretching-Several muscle and vascular ultrasound measurements-Walking performance tests on and off the treadmill-Wear a smartwatch to monitor physical activity during each 4-week stretch or no stretch interventionParticipants with and without risk factors for heart disease:-2 visits to University Park Clinical Research Center within the same week lasting ~3 hours per visit-Not diagnosed with PAD or poor leg circulation-1 blood draw-Several muscle and vascular ultrasound measurements-Walking performance tests on and off the treadmill

PAD participants can receive up to $450 in compensation. Participants with and without heart disease risk factors (non-PAD participants) will receive $50 for their participation.