Physical Therapists Role in Promoting Physical Activity for People with Chronic Physical Disabilities
We plan to conduct a qualitative study exploring perspectives of physical therapists and people with disability regarding physical activity promotion
Fluent in english
Individual with a physical disability (eg. limb amputation, spinal cord injury, spinabifida, cerebralpalsy, arthritis, motor impairment)
Has participated in physical therapy in the last year
Does not speak fluent english
does not have a physical disability
Has not participated in physical activity in the last year
Study of Antimalarials in Incomplete Lupus Erythematosus (SMILE)
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.
Age 18 to 49 years, inclusive
Have never taken hydroxychloroquine
Diagnosis of systemic lupus erythematosus
Acute to Chronic Pain Signatures in Traumatic Injury
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.
Presence of acute traumatic blunt chest trauma with multiple (≥ 2) closed fractures of the ribs
Non-surgical treatment of rib fractures
Able and willing to provide informed consent
Must be able to read and communicate in English sufficiently to complete all study requirements
Open rib fractures
Single, isolated rib fractures
Presence of implanted ferromagnetic materials or devices
Visceral Pain Sensation and Nav1.8
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 of a known genotype for Nav1.8, 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. 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. Patients 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.
Had a colonoscopy in HMC health record within the past 6 months (UC or Crhon's) or 5 years (healthy control)
Healthy control: any diagnosed lower GI disease (such as IBS or active diverticulitis) or significant abdominal pain in the last 12 months.
Any peripheral neuropathy or neuromodulating/opioid medications
Any Autoimmune disease (except Crohn's disease or ulcerative colitis)
Smart Connected Water Bottle and Lighting Devices: A Pilot Study
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.
Attend a pre-session (in person OR remote) to explain the use of the water bottle and lighting devices Use the devices for 22 days and complete surveys in your own home Attend a post-session (in person OR remote) to return devices and participate an interview about the last 22 days
Reside around State College, PA
Diagnosed eating disorders/extreme dietary restrictions
Currently diagnosed with gestational diabetes
Currently diagnosed with pre-eclampsia
A Randomized Controlled Pilot Study of the Use of Cannabidiol in the Management of Endometriosis Pain
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 visits blood will be drawn at all of these visits
Diagnosed with endometriosis by surgical diagnosis with direct visualization and/or histopathologic confirmation of endometriosis
Women with chronic daily opioid use ( > 14 days / month)
Women that are currently using Cannabis based products
Non-English speaking or inability to read and understand English
Using Exercise to Relieve Arthralgia (Joint Pain) and Improve AI Adherence in Older Survivors (REJOIN): A Pilot Study
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.
Breast Cancer Survivor
Preparing to Start AI medication
Gross Cognitive Impairment
Recent Joint Surgery
Cardiac event/Stroke within last 6 months
Not willing to come to HMC for Exercise Sessions
A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN STUDY PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS
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
≥40kg and ≤160kg
diagnosis of Systemic lupus erythematosus (SLE)
history of chronic alcohol or drug abuse
known history of allergic reaction to the drug
A double-blind randomized placebo-controlled study on the analgesic properties of amiloride in exercise-induced skeletal muscle pain
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
between 21-40 years old
any race or ethnicity
high blood pressure
taking amiloride or similar medication
Couples' Daily Lives with Chronic Back Pain
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.
Experienced moderate or severe back pain for at least 3 months
Married or in a long-term relationship AND living with spouse or partner
Understanding Prenatal Hydration Behaviors
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.
Younger than 18
A Phase 3b Study to Evaluate the Safety and Efficacy of Elagolix in Combination with Combined Oral Contraceptives in Premenopausal Women with Documented Endometriosis and Associated Moderate to Severe Pain
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.
diagnosed with endometriosis with moderate to severe pain
regular menstrual cycles
willing to use non hormonal contraception throughout the study
osteoperosis or other chronic bone disease
other active chronic pain not related to endometriosis
history of hysterectomy or removal of both ovaries
current or former nicotine user if over age 33
Observational Study for Pediatric Rheumatic Diseases: The CARRA Registry
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 on patients 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 pressing questions 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 complete The 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.
Onset prior to age 19 years for all other rheumatic diseases
Willing to participate in a registry you will be followed during your treatment and have information about you disease and treatment collected.
A volunteer study to determine the anatomical distribution of injectate, the extent of sensory block, and the pharmacokinetics of ropivacaine following Erector Spinae Plane (ESP) blocks.
This study will recruit healthy volunteers to determine the effect of a peripheral nerve block. The participants will get an injection in their back muscle after an intravenous line is placed in their hand or arm. After the injection they will have two MRI done at 30 and 90 minute time intervals. A half tablespoon of blood also will be taken through the IV line already placed 6 times during the study period starting just before to Peripheral nerve block placement up to four hours post injections. They will be discharged from the study after half an hour of the last blood sample. During this whole process they will be monitored for their blood pressure, oxygen saturation and other effects related to the procedure.
The potential participant will have a screening visit at the Anesthesia clinic to discuss research, sign consent form and for screening blood work. Research day the potential participant will have a peripheral nerve block, 2 MRI's and 6 blood draws. Total time commitment: 1. one clinic visit 2. one full day of research 3. 2 follow up phone calls
Weight between 55kgs (~120lbs) and 100kgs (~220lbs)
Height 160cms (~5ft 3in) to 190cms (~6ft 3in)
History of previous major spinal, abdominal or thoracic surgery, 4. Congenital abnormalities of the spine, back, thorax or abdomen
History of major trauma to the thorax or abdomen; 6. Allergy to ropivacaine or other amide local anesthetics
The presence of any metallic implant in their body, 9. Allergy to Gadolinium radiological contrast agent
Any contraindication to magnetic resonance imaging as determined by completion of a standard questionnaire administered to all patients undergoing magnetic resonance imaging.
A Pre-Post Study of the Use of Transcutaneous Electrical Nerve Stimulation Unit in the Management of Endometriosis Pain
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.
Surgical diagnosis of endometriosis, visualized and/or pathology confirmed
Having monthly endometriosis pain flares on average
Has never used a TENS unit before for endometriosis pain flares
Must be greater than 12 weeks post-op for abdominal/pelvic surgery
Has a cardiac arrhythmia
Has open skin sores over area of TENS placement
Not planning to have surgery or hormonal medication changes during the study
Management Of Pain After Cesarean Trial
This is a double blinded, placebo-controlled randomized controlled trial to test the efficacy of a combination of acetaminophen and ibuprofen administered to patients on schedule compared to ibuprofen and placebo on the patient's reported pain score on the second post-operative day after Cesarean delivery. We will also record opiate consumption and pain scores throughout the hospitalization of participants, and will survey patients at one and two weeks after surgery regarding opiate consumption and quality of life.
Planned delivery via C-section
Pfannenstiel ("bikini line") skin incision
Able to read and speak English fluently
Unplanned surgery (hysterectomy, bowel/bladder repair, cystoscopy)
Allergy or contraindication to study medication
History of opioid or other substance use disorder either before or during pregnancy
History of kidney or liver disease
Site for Systemic Lupus Erythematosus Treatment with N-acetylcysteine
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
Age 18 years or older
On stable medications
Experiencing flare of disease
regular daily use of Tylenol (acetaminophen)
active chronic infections
current treatment with cyclophosphamide or rituximab
current use of anti-oxidants
A Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy
This study is for patients with active Systemic Lupus Erythematosus(SLE) to test the effect and safety of different doses of the experimental drug AMG 570. To see if AMG 570 is a treatment option for SLE patients who are not responding to current standard of care.
Pregnant or breastfeeding
Site for RANDOMIZED PHASE II/III TRIAL OF SENTINEL LYMPH NODE BIOPSY VERSUS ELECTIVE NECK DISSECTION FOR EARLY-STAGE ORAL CAVITY CANCER (NRG-HN006) (PSCI# 20-085)
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.
Age ≥ 18
Zubrod Performance Status 0-2 within 42 days prior to registration
Only English speaking patients (able to read and understand English) are eligible to participate as the mandatory patient reported NDII tool is only available in this language
For women of child bearing potential, negative serum or urine pregnancy test within 42 days prior to registration
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
Patient with severe, active co-morbidity that would preclude an elective or completion neck dissection
Incomplete resection of oral cavity lesion with a positive margin; however, an excision biopsy is permitted
Actively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte or immunomodulatory therapy.
A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy, and Safety Study in Prurigo Nodularis with Nalbuphine ER Tables for Pruritus Relief Through Itch Scratch Modulation (PRISM Study)
Prurigo Nodularis: Phase 2b/3 Subject and Investigator Blinded, 56 Week study. Oral medication taken twice daily, Males/Females 18 years and older with Prurigo Nodularis Prurigo Nodularis (PN) is a skin disease that causes hard, itchy lumps (nodules) to form on the skin. The itching (pruritus) can be intense, cause people to scratch themselves to the point of bleeding or pain. The goal of this study is to evaluate the change of itch with using Nalbuphine ER.
Willing to follow all study directions and attend appointments
Certain diagnosis associated with PN are not allowed, coordinator will discuss specifics
In Vivo Assessment of the Effect of Bench Press Exercise on Glenohumeral Cartilage Deformation
The goal of this project is to investigate the impact of high-load exercise, like the bench press with a large amount of weight as opposed to an exercise like the push-up, on the shoulder joint cartilage , tissue on the ends of our bones that cushion and protect them from damage, as well as assess how well qualitative assessments of personal pre- and post-exercise pain coordinate with cartilage structure. We predict that there will be a significant difference in pre- and post-exercise cartilage thickness.
The study involves one research visit where you will: lie on your back for 45 minutes while a study team member asks survey questions; have an MRI of your dominant shoulder that takes approximately 15-30 minutes; travel to the University Fitness Center on the Penn State Health Hershey's campus for the bench press exercise protocol; return for an MRI post-exercise on the same shoulder; complete a post-exercise questionnaire (approx. 30 minutes). Travel will be in your own vehicle. Total time about 6 hours.
Inability to undergo MRI
Inability to perform exercise protocol
Under the age of 18 or over the age of 35