18 month trial of elagolix and combined oral contraceptives for women with moderate to severe endometriosis related pain

Subjects will have a screening period of approximately 45 days. If eligible, there will be a 3 month double blind placebo controlled treatment period followed by an open label period of 15 months where all subjects will receive the study medication. Total treatment period is 18 months followed by a one month follow up.Onsite visits are once a month during screening and up until Month 3 when onsite visits will be every 3 months through Month 18.Tests include blood draws at each onsite visit, one ultrasound, an EKG, and 4 DXA scans.

$1475.00

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.

The goal of the proposed project is to identify biosignatures that predict resilience or vulnerability to the transition from acute to chronic pain in a cohort of patients recovering from an acute musculoskeletal trauma.

There is one in person visit that will include a 30-min MRI scan, sensory testing, and blood draw. Two follow-up surveys will be sent to the participants at 3- and 6-months following their injury.

$200

We wish to investigate the role of a specific gene in visceral pain sensation and perception. This gene, Nav1.8 has a known change present in 10% of the population which may affect the way we feel inflammatory pain in the gut. This is an important symptom in inflammatory bowel disease (IBD). Some patients feel high levels of pain we would like to control, other patients feel little to no pain in the presence of very active disease, which can lead to dangerously under-treated disease. In this study, we will use healthy volunteers as well as IBD patients, and test their sensitivity using rectal balloon dilation.Research subjects will be asked to fast, skipping solid foods and opaque liquids for 6 hours before the testing. Usually this means skipping 1 meal. At the beginning of the study visit. they will use an over the counter enema to clear their rectum of any stool. Healthy control subjects that have never had a colonoscopy before and all IBD patients will undergo a very brief proctoscopy to either verify rectal health or check for any IBD disease activity. Healthy controls that have had a prior colonoscopy within the last 5 years will skip that prior step. Then a trained physician on the research team will insert a thin, lubricated tube into the rectum, which will be inflated to specific pressures. Most of these tests will be designed to measure any change in sensation, then the need to use the toilet, followed by urgent need or discomfort, and lastly the lower threshold of pain. Test subjects will be able to stop testing at any time, should they become too uncomfortable. The testing takes between 1 and 1 and a half hours, and volunteers are compensated $200 for their time.

To simulate abdominal pain, we use a thin tube placed in the rectum that inflates a small balloon to very precise and safe pressures. Our bodies interpret these pressures (in ascending order) as the need to go to the bathroom; first just a little, then with increasing urgency and eventually discomfort and pain. During these experiments, we only measure the lower threshold of pain, and stop immediately when you tell us to stop. We have significant experience using this approach and we have found it consistently informative while causing the least amount of discomfort possible. The whole thing takes about an hour and we’re paying volunteers $200 for participating. We'll ask that you skip a meal before the study visit, and perform an over-the-counter enema at the start of the visit.

$200

We will conduct a pilot study to test feasibility of an innovative light device and blue-light glasses for promoting better sleep and a novel, smart water bottle for proper hydration. We will also examine women’s sleep and hydration behaviors in relation to their perceptions of pain, and obtain feedback from the participants on the overall patient intervention content to reduce prescription opioid use and promote behavioral pain management strategies after delivery.

Currently recruiting pregnant women who are in their 2nd or 3rd trimester.Attend a pre-session (in person OR remote) to explain the use of the water bottle, lighting devices, activity monitors, and weight scaleUse the devices for 22 days and complete surveys in your own homeAttend a post-session (in person OR remote) to return devices and participate an interview about the last 22 days

$100

We are looking to conduct a study looking at the effects of cannabidiol (CBD) in patients with endometriosis. We believe that CBD will improve both pain and quality of life. The study will last a total of 12 weeks and involve several onsite visits in addition to daily pain assessments.

There will be five in person visitsblood will be drawn at all of these visits

$175

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

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

Amyotrophic lateral sclerosis (ALS) leads to respiratory failure due to chronic hypoventilation. The gold standard for measuring hypoventilationrequires an arterial blood gas, which is impractical in the outpatient setting due to invasiveness, pain, and need for specialized equipment. Recently, the Penn State Health Hershey ALS Clinic has implemented transcutaneous CO2 (TCO2) monitoring as standard of care clinical assessment. The overall goals of this study are to gather critical preliminary data for stakeholder-driven refinement of a TCO2 monitoring protocol within a busy ALS clinic and identify how TCO2 may enhance our understanding of standard respiratory measurements.

Participants will complete a survey related to their experience having their CO2 reading performed in the ALS Clinic.

$20 will be paid for every survey completed, for a maximum possible payment of $80 per person.

To determine if the drug Amiloride will reduce exercise related muscle pain and improve exercise tolerance in healthy volunteers.

In each visit, you will be asked to perform foot exercise with, and without a blood pressure cuff inflated on your leg. You will also be asked to take pills prior to visit 2 and 3. One of these pills will be a drug called amiloride (10mg), which was traditionally used to lower blood pressure. The other pill will be a placebo (no active medication). During each visit, we will collect the following measurements:•We will collect a nerve recording from the leg not performing exercise, which will require a small needle-like electrode to be inserted behind your knee, just under the skin (a procedure called microneurography).•We will collect blood pressure from cuffs placed on your finger and upper arm.•We will collect blood lactate by sticking your finger with a small pin-prick (similar to taking a blood sugar measurement).•We will place to light-sensing device over the skin of your leg(s) to measure the oxygen level in your muscle.•We will hold a doppler ultrasound probe over your hip/leg region to measure blood flow.•We will use sticky-gel electrodes to measure heart rate and muscle activity.

You will receive $25 per hour for your participation in this research study

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.

The purpose of this study is see if Transcutaneous Electrical Nerve Stimulator (TENS) units help decrease endometriosis flare pain. Participants will complete surveys, record pain, medication use and bleeding in an online diary during endometriosis flare ups for 3 months without using the TENS unit. After the first 3 month period of time, a TENS unit will be given to participants to wear and again, record pain, medication use and bleeding in the online diary during endometriosis flare ups for and additional 3 months while using the TENS unit.

There will be one in person enrollment visit, involving being consented and completion of 2 surveys. The first 3 months, the "baseline period" will include filling out pain scores online on days of endometriosis flare without TENS unit use. The next 3 months, the "treatment period" will include filling out pain scores online on days of endometriosis flare with TENS unit. At end of study completion of 2 surveys.

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

To examine women’s self-reported pregnancy hydration behaviors, especially during a global pandemic. This study will also examine other lifestyle behaviors (e.g., weight gain, exercise, eating behaviors, sleep, pain management). It is hypothesized that hydration behaviors will decrease due to lifestyle changes related to the pandemic. Secondary outcomes will also be influenced by hydration behaviors and pandemic lifestyle changes.

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.

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.

This study is being done to find out how whether sleep duration is associated with pain responses and if a sleep intervention predicts a higher tolerance and a higher threshold for pain. This is a 21-day study. Participants will be asked to wear sleep-monitoring watches. Pressure pain and cold pain will be measured at study visits.

There will be four in-person visits. Height, weight, and blood pressure will be measured during each study visit. Participants will also be asked to complete surveys during each study visit.Pain will be measured during visits 2-4. Blood will be drawn during visits 2-4. Retinal images will be captured during visits 2-4. A Trail making test (a test for executive functioning) will be administered during visit 2-4. Participants will also be asked to provide screen shots of their phone screen use at visits 2-4.

$150

Women with endometriosis have more thromboxane being produced in their platelets. Thromboxane affects blood vessels, making them constrict, and sensory nerves, making them more sensitive. This study will determine if women with endometriosis are negatively effected by the excess thromboxane.

There will be three in-person visits: one screening and two experimental visits. Participants will take aspirin before one visit and a placebo before the other then will undergo brief tests of nerve sensitivity and a blood draw.

$150

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.

A 16 week double blind treatment period to investigate the safety and effectiveness of 3 doses of the study drug vs placebo for endometriosis related pain.

There will be 8 onsite visits and 2 phone visits, blood will be drawn at the onsite visitsThere is an ediary that must be completed every dayStudy exams include a TVU ultrasound, ECG, vital signs, urine pregnancy tests and blood work

$1477.00

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.

This is a survey and interview study recruiting patients with sickle cell disease (SCD). Participants will answer questionnaires and complete a remote interview about health care experiences, pain, and discrimination. Natural language processing of interview transcripts will be used to quantify linguistic features indicative of subjective associations between individual experiences of racial discrimination and sickle cell pain.

Participants will be asked to fill out questionnaires and answer questions during an interview.

$50