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A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) with Pembrolizumab (MK3475) in Combination with Transarterial Chemoembolization (TACE) Versus TACE in Participants with Incurable/Non-metastatic Hepatocellular Carcinoma (LEAP-012)

This is a study that will compare a study drug pembrolizumab plus a study drug lenvatinib in combination with the therapy called TACE (transarterial chemoembolization) which is a way to deliver chemotherapy locally through a procedure called embolization and how that works versus placebo (or no study medications) plus TACE and how it could lead to progression-free survival (PFS).

This is a study that will compare a study drug pembrolizumab plus a study drug lenvatinib in combination with the therapy called TACE (transarterial chemoembolization) which is a way to deliver chemotherapy locally through a procedure called embolization and how that works versus placebo (or no study medications) plus TACE and how it could lead to progression-free survival (PFS).

Yes
 

Nelson Yee
Irina Geier - at igeier@pennstatehealth.psu.edu or 717-531-8678
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04246177
STUDY00014964
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Inclusion Criteria:
Has a diagnosis of HCC confirmed by radiology, histology, or cytology
Has HCC localized to the liver without portal vein thrombosis, and not amenable to curative treatment such as resection, ablation, or liver transplant.
Has at least one measurable HCC lesion based on RECIST 1.1,
Has an ECOG performance score of 0 to 1
Has a predicted life expectancy of >3 months.

Exclusion Criteria:
Is currently a candidate for liver transplantation.
Has had esophageal or gastric variceal bleeding within the last 6 months.
Has clinically apparent ascites on physical examination that is not controlled with medication
Has had clinically diagnosed hepatic encephalopathy in the last 6 months unresponsive to therapy.
Has clinically significant hemoptysis from any source or tumor bleeding within 2 weeks prior
Cancer
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Hershey, PA ,

Effects of amiloride on walking ability in patients with peripheral artery disease

The purpose of the study is to determine the effects of amiloride on the blood pressure response to walking in PAD patients and healthy controls.

In each visit, you will be asked to walk on a treadmill. You will also be asked to take capsules prior to visit 2 and 3. The capsules for one visit will be a drug called amiloride (10mg, in 2 capsules with 5mg of amiloride in each capsule), which was traditionally used to lower blood pressure. The other capsules will be a placebo (no active medication). A blood sample will be drawn at each visit.

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

Yes
 

Jian Cui
Cheryl Blaha - at cblaha@pennstatehealth.psu.edu or 717-531-1605
Heart and Vascular Institute (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00018296
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Inclusion Criteria:
Men and women age 21- 85 years
Any race or ethnicity
Healthy: Free of acute medical conditions
PAD: Diagnosis of PAD, no pain at rest

Exclusion Criteria:
Pregnant or nursing women
Resting blood pressure of 150/100 or higher
Already taking amiloride
Recent heart attack or epilepsy
Peripheral neuropathy
Men's Health, Heart & Vascular, Women's Health
Not applicable
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Hershey, PA ,

Healthy Mom Zone: Control Systems Engineering for Optimizing a Prenatal Weight Gain Intervention Study 2.0

The proposed overall research aims to establish feasibility of delivering an individually-tailored, behavioral intervention to manage gestational weight gain [GWG] that adapts to the unique needs and challenges of overweight/obese pregnant women [OW/OB-PW] and will utilize control systems engineering to optimize this intervention; in other words, make this intervention manage GWG in OW/OB-PW as effectively and efficiently as possible.

You will be randomized into an intervention or attention control group from ~8 weeks gestation to ~37 weeks gestation with a BMI of 24-45 (>40 with physician consent).You will have 1 pre-intervention session that explains the study procedures and to get you ready for the study. Here you will also complete various measures of demographics, behavioral surveys, etc.Over the course of the study, you will weigh yourself each day, wear an activity monitor and complete various surveys. If you are randomized to the intervention group, you may have healthy eating demonstrations and/or physical activity sessions each week.You will have 1 post-intervention session where you will return your devices, complete a 30-60 minute interview and complete the last of the surveys.

$250

Yes
 

Danielle Downs
Abigail Pauley - at healthymomzone@psu.edu
Kinesiology (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
NCT05807594
STUDY00019075
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Inclusion Criteria:
Pregnant women
18-45 years old
8-18 gestational weeks
English speaking
BMI 24-45 (>40 with provider consent)

Exclusion Criteria:
Non-pregnant
Men
Younger than 18
Non-English speaking
BMI <24
Pregnancy & Infertility, Mental & Behavioral Health, Women's Health
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Altoona, PA ,
State College, PA ,

Music Appreciation of Pediatric and Adult Hearing Aid Users over Time

The purpose of this study is to survey hearing aid users over a 6 month time period to see if their music perception improves over time.

Study participants will complete surveys about their music experience four times: first at your initial clinic visit and then sent to your email at 1, 3, and 6 months following your visit. This survey will include questions about the participants experience with music as well as name, age, gender, and duration of hearing aid use.

Yes
 

Varun Patel
Caia Hypatia - at chypatia@pennstatehealth.psu.edu
Otolaryngology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
STUDY00023837
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Inclusion Criteria:
Acquired hearing loss
Hearing aid use

Exclusion Criteria:
Cochlear implant use
Auditory implants including bone anchored hearing aids
Poor compliance with the use of hearing aids
Age 12 years old or younger
Language & Linguistics
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Hershey, PA ,

Athletes' Experiences in Sport

In this study, we are interested in learning about how male athletes think about and understand the experience and expression of emotion in competitive sports.

Yes
 

Heather MacArthur
Heather MacArthur - at hjm158@psu.edu
Psychology (UNIVERSITY PARK)
 

Male
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00008052
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Inclusion Criteria:
Male
Competitive athlete
Penn State student
18+ years

Exclusion Criteria:
Female
Non-athlete
Non-student
Under 18 years
Education
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State College, PA ,

A data and biorepository for individuals with subjective cognitive decline (SCD), mild cognitive impairment (MCI), dementia, and other individuals at increased risk for dementia

This research is being done to help us better understand the risk factors and protective factors for cognitive decline in people who are at increased risk for dementia. The goal of the study is to establish a data and biorepository for people at increased risk for dementia.

Eligible patients for the study, in addition to routine clinic visits, may undergo a series of questionnaires and blood testing.

Yes
 

William Jens
psniclinresearch@pennstatehealth.psu.edu
Neurology (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00015640
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Inclusion Criteria:
Age 18 and older
Patient participants - Meet the criteria for subjective cognitive decline, mild cognitive impairment, dementia or at risk for any
Health controls - Normal age and education-adjusted performance on the Montreal Cognitive Assessment Test or another standardized cognitive screening test

Exclusion Criteria:
Age less than 18
Neurology
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Hershey, PA ,

Postmenopausal women and their endothelium: Is dietary nitrate supplementation protective?

Heart disease is the leading cause of death in the United States. The loss of estrogen from menopause puts women at a greater risk of developing heart disease. The purpose of this study is to determine the effects of drinking beetroot juice on measures of blood vessel health and blood pressure. Participants will drink beetroot juice and placebo juice each for one week followed by blood pressure measurements and ultrasound imaging of an artery in the upper arm. A sub-aim of this study is to investigate the effects of estrogen status on blood vessel function between pre- and post-menopausal women.

There are a total of 6 in-person visits to the Clinical Research Center. You will be asked to drink beetroot juice (2 oz) every day for 7 days. Participants will undergo vascular assessments, blood pressure measurements, and blood draws (11 in total for 6 visits).

$120

Yes
 

David Proctor
Jocelyn Delgado - at jmd956@psu.edu or 408-679-8390
Kinesiology (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
NCT03644472
STUDY00010017
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Inclusion Criteria:
Post-menopausal women (1-6 years since menopause preferred)
BMI <35
Blood pressure <130/80
LDL <170 mg/dL

Exclusion Criteria:
Individuals taking hormone therapy
Individuals with resting blood pressure > or = 130/80 mmHg
Users of any tobacco and/or nicotine products (smokers, chewing tobacco, nicotine-containing patches/gum, smokeless cigarettes)
Individuals with any overt cardiovascular, metabolic, hematologic, pulmonary, renal, musculoskeletal, and/or neurological disease(s)
Individuals with active cancer
Food & Nutrition, Heart & Vascular, Women's Health
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Altoona, PA ,
State College, PA ,

NRG-GI008 Colon Adjuvant Chemotherapy based on Evaluation of Residual Disease (CIRCULATE-US) (22-070)

To compare time to ctDNA (+ve) status in ctDNA (-ve) cohort following resection of stage III colon cancer treated with immediate vs delayed (based on serial ctDNA surveillance) chemotherapy. Time to positive event is defined as time from randomization to the first ctDNA positive result for the immediate arm (Arm 1) and to the 2nd ctDNA positive result for the delayed arm (Arm 2) to allow for the potential effect of delayed adjuvant chemotherapy. Patients recurred without a positive ctDNA result will be considered to have ctDNA positive status at the time of recurrence for both study arms.

We are asking you to take part in this research study because you have colon cancer that has been treated with surgery but has spread to some of your lymph nodes and is known as stage III colon cancer. Or, you have stage II or stage III colon cancer with a higher risk of cancer returning, your colon cancer has been treated with surgery, and you had ctDNA testing done and are ctDNA positive. Stage II colon cancer is an early stage colon cancer that has been treated with surgery but has not spread to your lymph nodes. ctDNA, or circulating tumor DNA, is DNA that has been released from tumor cells into your bloodstream. This DNA can be measured using a blood test.

Yes
 

Nelson Yee
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05174169
SITE00001215
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Inclusion Criteria:
patient must be ≥ 18 years old.
Hemoglobin must be ≥ 9 g/dL
HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months
The treating investigator must deem the patient a candidate for all potential agents used in this trial (5FU, LV, oxaliplatin and irinotecan)
The patient must have an ECOG performance status of 0 or 1

Exclusion Criteria:
Colon cancer histology other than adenocarcinoma
Tumor-related bowel perforation
Synchronous primary rectal and/ or colon cancers
Active seizure disorder uncontrolled by medication
Active or chronic infection requiring systemic therapy
Cancer
Not applicable
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Hershey, PA ,

How urban infrastructure fosters romantic relationships

The primary endpoint of this study is to identify the contributing factors in development of romantic relationships through an analysis of the real-life experiences of Penn state couples that we collect in our surveys. Our focus is to identify the spatial factors in different scales as they relate to two-person relationships. The results of this study informs architects, planners, and administrators of practical strategies to generate friendly spaces in college towns.

No
 

Sohrab Rahimi
sohrab rahimi - at sur216@psu.edu or 814-206-4341
Architecture (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00004696
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Inclusion Criteria:
Be in a romantic relationship
Live in State College area
Has visited at least 5 places with their romantic partner(s) in State College

Exclusion Criteria:
Have never lived in State College area
have never engaged in a romantic relationship
Education
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To stretch, not strain: Impact of passive stretching on calf muscle and gait mechanics in peripheral artery disease

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.

Yes
 

David Proctor
Jocelyn Delgado - at proctorlab@psu.edu
Kinesiology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT06041880
STUDY00022960
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Inclusion Criteria:
Patients (40-85 years) diagnosed with peripheral artery disease or poor leg circulation
Participants (40-85 years) with or without risk factors for heart disease (high blood pressure, blood sugar, cholesterol, etc.) and not diagnosed with PAD
Ability to walk on or off a treadmill at 1 mile per hour
Men and women who are not pregnant or nursing

Exclusion Criteria:
Cannot walk on a treadmill at a slow pace
Heart attack within the past 6 months or unstable angina
Severe lung disease, rheumatoid arthritis, degenerative joint disease, critical limb ischemia
Major surgery or lower extremity revascularization surgery within the past 6 months
Recent serious ankle, Achilles tendon, or foot injuries
Heart & Vascular, Muscle & Bone
Experimental device
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Altoona, PA ,
State College, PA ,

Women and Infants' Stress and Health

The goal of this study is to understand how babies and their mothers learn to respond to stress during the early years of the baby's life. Participating women complete questionnaires and do a mildly stressful task alone (during pregnancy) or with their babies (at four different times over the first two years of the baby's life) and collect saliva samples that tell us about stress responses, either at home or at one of our lab sites. We aim to use what we learn to better support expecting parents who may be at risk for stress-related health problems and improve their children's resilience to stress throughout life.

Women are asked to participate in six sessions over Zoom and/or at the PACT Center between their 28th week of pregnancy and when their child is 2 years old. During these sessions, which last up to 2 hours each, mothers and babies will1.participate in mildly stressful tasks (like having the mother leave the room for up to 3 minutes and then return) and games to assess the baby’s emotional and cognitive development2.provide saliva samples by drooling into a tube (for the mother) or holding a cotton swab in their baby’s mouth to get it wet3.fill out questionnaires about themselves and their baby4.take part in clinical interviews that ask about mood and other markers of psychological ill-being

$220

Yes
 

Heidemarie Laurent
Sandra Rosario - at PRISMlab@psu.edu or 814-867-6482
Human Development and Family Studies (UNIVERSITY PARK)
 

All
All
This study is also accepting healthy volunteers
STUDY00019133
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Inclusion Criteria:
Pregnant (up to 32 weeks gestation)
18 or older
English speaking

Exclusion Criteria:
Unable to participate in either Harrisburg or State College study site at 15-24 months postnatal
Pregnancy & Infertility, Mental & Behavioral Health, Women's Health
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Harrisburg, PA ,
State College, PA ,

Slips of Action in Adolescents and Young Adults

Adolescence is a critical period during which many important healthhttps://irb.psu.edu/IRB/sd/ResourceAdministration/Project/ProjectEditor?Project=com.webridge.entity.Entity[OID[058ACDEB3E43384D816C7E390C2B83F6]]&amp;Mode=smartform&amp;WizardPageOID=com.webridge.entity.Entity[OID[E4552FC57E491543A6B7FD8268E23FD7]] habits form in humans. However, animal models provide mixed information about habit formation across development and there are relatively few human studies that address differences between habit formation in adolescents and adults. To address this gap, the proposed study will assess differences in habit formation in adolescents and adults as measured by the "Slips of Action" task, which seeks to discriminate between habitual and goal-directed learning of visual stimuli pairings.

There will be one in-person visit lasting about one hour. Visits will begin with informed consent. Participants will complete a computer task where they are asked to learn associations between pictures and then will be tested on the associated pairings. They will also complete questionnaires and cognitive tasks.

$20

Yes
 

Charles Geier
Katie Meeks - at kxm5964@psu.edu or 814-867-6472
Non-PSU Site
 

All
All
This study is also accepting healthy volunteers
STUDY00020521
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Inclusion Criteria:
Healthy adolescents between the ages of 13 to 17; (health based on parental report)
Healthy adults between the ages of 25 to 40
No learning disabilities (e.g., ADHD) or diagnosed psychological conditions (e.g. anxiety)
Right handed
Not on any medications known to influence behavior

Exclusion Criteria:
Outside of age ranges specified at baseline
Diagnosed neurological or psychological condition including severe anxiety and/or depression, schizophrenia, learning disability, ADD/ADHD, or autism
Significant family history of neurological or psychological disorders
Left handed
Participant is on any medication that may influence behavior
Addiction & Substance Abuse, Food & Nutrition, Mental & Behavioral Health
Not applicable
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State College, PA ,

The Impact of Menstrual Cup Distribution Programming on College Student Perpetuation of Period Stigma

This is a social sciences study to analyze the effect of menstrual cup introduction through the "CampusCup" free menstrual cup distribution program on the tendency of college students to perpetuate period stigma. A survey will be conducted across samples of students who participated in the CampusCup program, students who use menstrual cups independent of the CampusCup program, and students who have never used menstrual cups. The survey will address motivations behind menstrual cup usage and personal attitudes towards periods. The study seeks to investigate relationships between menstrual cup usage &amp; CampusCup participation and impacts on community attitudes towards menstruation.

No
 

Jessica Strait
Jessica Strait - at jls7571@psu.edu
Information Sciences and Technology (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00018450
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Inclusion Criteria:
Currently enrolled as an undergraduate student at a US-based university
At least 18 years of age
Has experienced a menstrual period in the last calendar year

Exclusion Criteria:
Not currently enrolled as an undergraduate student in a US-based university
Less than 18 year of age
Has not experienced a menstrual period in the last calendar year
Education, Mental & Behavioral Health, Women's Health
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Penn State Hershey Sitting and Health Study

This study aims to examine the effect of pedaling a compact elliptical device at the desk on employees' work productivity. This study also aims to evaluate the effect of different types of incentives on promoting desk-based pedaling.

Yes
 

Liza Rovniak
Liza Rovniak - at activitystudy@psu.edu
Medicine: General Internal Medicine (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT03274635
STUDY00008174
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Inclusion Criteria:
Penn State Hershey full time employee
Overweight or obese
Spend at least 5 hours per day sitting at a desk
Have eligible overweight/obese coworker who can do study together with you
18-70 years old

Exclusion Criteria:
Currently pregnant
Planned surgical or medical treatment that will prevent ability to complete study
Heart condition, or chest pain during physical activity
Planned travel or relocation during study period
Already have desk cycling device or treadmill at desk
Heart & Vascular, Prevention, Mental & Behavioral Health
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Hershey, PA ,

S1914 Randomized Phase III Atezolizumab + SBRT vs SBRT alone in high risk, early stage NSCLC (22-025)

To compare overall survival (OS) in patients with inoperable, early stage non-small cell lung cancer (NSCLC) randomized to stereotactic body radiation therapy (SBRT) with or without atezolizumab.

Patients will need to keep all of their radiation treatment appointments and keep all appointments with the study doctor. Patients will be expected to complete questionnaires and have extra blood samples taken at specific time point throughout the study.

Yes
 

Mitchell Machtay
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04214262
SITE00001213
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Inclusion Criteria:
History/physical examination within 90 days prior to registration
Age ≥ 18
ECOG performance status of 0 or 1 within 180 days prior to registration;
Pretreatment serum PSA, obtained prior to any androgen suppression therapy and within 180 days of registration.
Men of child-producing potential must be willing to consent to use effective contraception while on treatment and for at least 3 months afterwards

Exclusion Criteria:
PSA > 150 ng/mL
Definitive clinical or radiologic evidence of metastatic disease
Pathologically positive lymph nodes or nodes > 1.5 cm short axis on CT or MR imaging
HIV positive with CD4 count < 200 cells/microliter
Prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any reason
Cancer
Approved drug(s)
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Hershey, PA ,

Investigation of pulse starch impact on the gut microbiome

We are investigating how the starch from pulse crops (chickpeas, lentils and dry peas) affects the gut microbiome, particularly with regards to the production of butyrate, a microbial metabolite with a number of known health benefits. We are recruiting people from two groups, those that consume a lot of these pulses and those who rarely consume them. These participants will then track their food intake for 48 hours before collecting a fecal sample which they will return to the lab. We will then use these fecal samples to conduct laboratory fermentations with pulse starches processed in a number of different ways to see what factors are important for determining the amount of butyrate that is produced. This will serve as pilot data for designing future human clinical trials.

Yes
 

Darrell Cockburn
Darrell Cockburn - at dwc30@psu.edu or 814-863-2950
Food Science (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00013284
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Inclusion Criteria:
18-65 years of age
Either consume pulses twice or more per week or consume them once a month or less. Pulses are dry legumes such as chickpeas(Garbanzo beans), lentils or other dry peas and beans

Exclusion Criteria:
Currently or in the past month taking antibiotics
Taking a fiber supplement
Bowel problems such as IBD, IBS, chronic diarrhea or constipation
Pregnancy
Food & Nutrition
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State College, PA ,

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 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

Yes
 

Matthew Coates
August Stuart - at astuart@pennstatehealth.psu.edu or 717-531-0003, ext=281928
Medicine: General Internal Medicine (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00010688
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Inclusion Criteria:
Have a diagnosis of ulcerative colitis, Crohn's disease, or no lower GI diseases (healthy control)
UC and Crohn's patients: be willing to undergo a brief proctoscopy the day of the testing visit
Healthy controls: have had a colonoscopy in the last 5 years OR be willing to undergo a brief proctoscopy the day of the testing visit

Exclusion Criteria:
UC and Crohn's patients: moderate to severe disease activity on your recent colonoscopy
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)
Infectious Diseases & Immune System, Digestive Systems & Liver Disease, Pain Management
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Hershey, PA ,
State College, PA ,

SENTINEL LYMPH NODE BIOPSY VERSUS ELECTIVE NECK DISSECTION FOREARLY-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.

Yes
 

Neerav Goyal
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Otolaryngology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04333537
SITE00000806
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Inclusion Criteria:
Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the oral cavity
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

Exclusion Criteria:
Definitive clinical or radiologic evidence of regional (cervical) and/or distant metastatic disease
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.
Cancer
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Hershey, PA ,

NMTRC012: PEDS-PLAN – Pediatric Precision Laboratory Advanced Neuroblastoma Therapy

A study of the safety and feasibility of using molecularly guided therapy in combination with standard therapy followed by maintenance therapy with DFMO in patients with newly diagnosed high risk neuroblastoma.

Participating in this study requires that you visit the study hospital Penn State Hershey Medical Center multiple times over the course of the full study for evaluations (physical exam, blood draw, urine analysis, etc.) and scans (MRI/CT, MIBG). Weekly visits may occur at your home institution with your home treating oncologist. As a subject in this clinical trial you are expected to receive treatment on this phase of the study for a total of about 2 ½ years if you complete all portions. After treatment, you will have follow-up examinations and medical tests.

Yes
 

Valerie Brown
Suzanne Treadway, MS, RN, CCRP - at streadway@pennstatehealth.psu.edu or 717-531-3097
Pediatrics: Hematology/Oncology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT02559778
STUDY00003478
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Inclusion Criteria:
A confirmed diagnosis of neuroblastoma.
Must be 21 years of age or younger when diagnosed.
No prior systemic therapy with some exceptions.
Tumor samples will be obtained only in a non-significant risk manner and not solely for the purpose of the study.

Exclusion Criteria:
Receiving another study drug while on this study.
Female patients who are lactating are not eligible unless they agree not toe breast feed.
Children's Health, Cancer
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Hershey, PA ,

Reducing Perception Error in Diagnostic Radiology

This research is being done to find out the relationship between an individual’s mental state and how well they perform visual-perceptual tasks. This will allow us to understand the brain processes related to errors in image perception, to understand how mental states impact medical image interpretation. Overall, this research will help us develop training programs to reduce the amount of perceptual errors in diagnosing images

Yes
 

Michael Bruno
Lauren Spreen - at lspreen@pennstatehealth.psu.edu or 717-531-5857
Radiology (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00007773
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Inclusion Criteria:
Radiologists with different levels of experience
Healthy adults, with college or advanced degree
Normal or corrected to normal vision

Exclusion Criteria:
Non-English speaking
Pregnant or lactating
Presence of pacemaker, aneurysm clips, or any metal in the body
A history of welding or grinding
Claustraphobia
Education
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Hershey, PA ,

PSCI 22-141 CCTG MA.39: “Tailor RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive and T3N0 Breast Cancer

To compare the breast cancer recurrence-free interval (BCRFI) between patients that received regional RT or not, defined as time from randomization to time of invasive recurrent disease in the ipsilateral chestwall, breast, regional nodes, distant sites or death due to BC.

Women with low risk breast cancer will be randomized to either regional radiation therapy or no regional breast radiation therapy. Patients will be expected to keep all of their radiation appointment and complete all questionnaires.

Yes
 

Leonard Tuanquin
PSCI CTO at PSCI-CTO@pennstatehealth.psu.edu
Radiology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03488693
SITE00001308
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Inclusion Criteria:
Patients must be women with newly diagnosed histologically proven invasive carcinoma of the breast with no evidence of metastases, staged as per site standard of care
Patients must have been treated by BCS or mastectomy with clear margins of excision*.
Patients with T3N0 disease are eligible.
Patients with disease limited to nodal micrometastases are eligible.
Patients must be ER ≥ 1% and HER2 negative on local testing

Exclusion Criteria:
Patients with nodal disease limited to isolated tumour cells
Patients with pT3N1 and pT4 disease
Any prior history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated with radiation therapy
Synchronous or previous contralateral invasive breast cancer.
Patients who are pregnant.
Cancer
Not applicable
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Hershey, PA ,

A Randomized, Open Label Phase 3 Study Evaluating Safety and Efficacy of Venetoclax in combination with Azacitidine after allogeneic Stem Cell Transplantation in Subjects with Acute Myeloid Leukemia (AML)(M19-063)

This study is to determine the recommended Phase 3 dose of venetoclax in combination with azacitidine in Acute Myeloid Leukemia patients when given as maintenance therapy following allogeneic stem cell transplantation. It also is to determine if venetoclax can be effective in combination with azacitidine to improve Relapse Free Survival in Acute Myeloid Leukemia patients compared to Best Supportive Care (BSC) when given as maintenance therapy following allogeneic stem cell transplantation.

There are different phases of this study. The first phase is Screening, then there is the Treatment phase as well as a Follow up phase. Each phase will have testing and procedures that will require you to come to the study center.

50.00 Travel expenses

Yes
 

Shin Mineishi
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04161885
STUDY00015638
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Inclusion Criteria:
Adult male or female ≥ 18 years old; and, for Part 2 only, male or female at least 12 years old.
Subject must be diagnosed with Acute Myeloid Leukemia by World Health Organization (WHO) criteria (2017) and either be planning for allogeneic stem cell transplantation or have received allogeneic transplantation within the past 14 days.
Subjects that have previously been treated with venetoclax, can only be included if there was no history of disease progression during venetoclax treatment.
Grafts must be from one of the following sources: Bone marrow or peripheral blood stem cells or cord blood cells irrespective of degree of matching.
Subjects and/or their legally authorized representative (where permitted per local regulations) must voluntarily sign and date an informed consent form (and assent form for minors if required by applicable regulations)

Exclusion Criteria:
No malabsorption syndrome or other condition that precludes oral route of administration.
No history of any other malignancy within 2 years prior to study entry
Subject has no known evidence indicating leukemia relapse, which may include immunophenotype, cytogenetic or molecular methods.
No psychiatric illness/social situation that would limit compliance with the study.
No evidence of other clinically significant uncontrolled systemic infection.
Cancer
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Hershey, PA ,

PSCI 22-132 A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination With Immuno-Oncology Agents in Subjects With Unresectable Advanced or Metastatic Solid Tumors

The purpose of this voluntary research study is to evaluate potential new anticancer to treat people with tumors similar to yours. This study will provide information about the safety, the ability of your body to accept the study drug(s), the amount of study drug(s) and/or break-down products in your blood, and your body’s reaction to the study drug(s). Participants will be required to take study medication, have blood drawn, and have imaging tests such as CT, MRI, ECG, MUGA, ECHO, and bone scans.

Participants in the expansion stage will receive study treatment, imaging exams (ECHO, MUGA, ECG, CT, MRI, bone scans), blood draws, tumor assessments, and tumor tissue samples.

Yes
 

Monika Joshi
PSCI-CTO at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05176483
SITE00001372
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Inclusion Criteria:
Cytologically or histologically confirmed solid tumor that is unresectable, locally advanced or metastatic:
For all Expansion Cohorts except Cohort 3 (mCRPC): Measurable disease per RECIST
For Expansion Cohorts only: Archival tumor tissue material, if available, or fresh tumor tissue if it can be safely obtained.
Recovery to baseline or ≤ Grade 1 CTCAE v5 from AE(s) related to any prior treatments unless AE(s) are deemed clinically nonsignificant by the Investigator and/or stable on supportive therapy.
Age 18 years or older on the day of consent

Exclusion Criteria:
Prior treatment with XL092, nivolumab, ipilimumab, or relatlimab with the following exceptions, which are found in the protocol
Cohort 2 (ccRCC 2L), Cohort 3 (mCRPC), Cohort 5 (UC), Cohort 9 (NSCLC, 2L+), and Cohort 10 (CRC, 2L+): Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.
For Cohort 3 (mCRPC): Receipt of abiraterone within 1 week; cyproterone within 10 days; or receipt of flutamide, nilutamide, bicalutamide, enzalutamide, or other androgen receptor inhibitors within 2 weeks before first dose of study treatment.
Receipt of any type of anticancer antibody (including investigational antibody) or systemic chemotherapy within 4 weeks before first dose of study treatment.
Any complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment.
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

A Phase III De-escalation of Breast Radiation for Stage I, Hormone Sensitive, HER2 Negative Breast Cancer (PSCI# 21-098) (NRG-BR007)

This study is being done to answer the following question:Is treatment with hormonal therapy as good as the usual treatment of radiation and hormonal therapy in women with low-risk breast cancer who have had lumpectomy? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your breast cancer. The usual approach is defined as care most people get for low-risk, early stage breast cancer that is sensitive to hormones.

Pt will either have radiation therapy to the breast and take a hormonal drug for at least five years or you will only take a hormonal drug for at least five years.

Yes
 

Leonard Tuanquin
psci-cto@pennstatehealth.psu.edu 717-531-5471
Radiology (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04852887
SITE00001018
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Inclusion Criteria:
The patient must be > 50 years and < 70 years of age
The patient must have recovered from surgery with the incision completely healed and no signs of infection
The patient must have an ECOG performance status of 0 or 1
The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination
The tumor must have been determined to be HER2-negative by current ASCO/CAP guidelines

Exclusion Criteria:
Definitive clinical or radiologic evidence of metastatic disease
pT2 - pT4 tumors including inflammatory breast cancer
Patient had a mastectomy
Non-epithelial breast malignancies such as sarcoma or lymphoma
Paget's disease of the nipple
Cancer
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Hershey, PA ,

A multisensory evoked potential brain-computer interface for communication in ALS

A brain-computer interface (BCI) is a device that has the potential to restore communication by direct translation of brain signals. The BCI used in this study, the P300 Speller, relies on the generation of a P300 evoked potential when a user is presented a rare and unpredictable target stimulus amidst a larger pool of non-target stimuli. This evoked potential is used to perform selections on the computer. Those with advanced ALS demonstrate decreased capacity for BCI control using the P300 speller. With this study, we aim to use a combination of eye tracking and sensory testing to quantify sensory and cognitive processes necessary for the generation of a P300 response. We will test the performance of a multisensory P300 spelling task, where brain potentials are evoked using a combination of visual, auditory, and tactile stimuli. The goal is to demonstrate the perceptual benefits of multisensory integration and generate evidence for its use in this patient group.

A brain-computer interface (BCI) is a device that has the potential to restore communication by direct translation of brain signals. The BCI used in this study, the P300 Speller, relies on the generation of a P300 evoked potential when a user is presented a rare and unpredictable target stimulus amidst a larger pool of non-target stimuli. This evoked potential is used to perform selections on the computer.With this study, we aim to use a combination of eye tracking and sensory testing to quantify sensory and cognitive processes necessary for the generation of a P300 response. We will test the performance of a multisensory P300 spelling task, where brain potentials are evoked using a combination of visual, auditory, and tactile stimuli.

$40

Yes
 

Andrew Geronimo
Andrew Geronimo - at ageronimo@pennstatehealth.psu.edu or 717-531-0003, ext=282576
Neurosurgery (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00017522
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Inclusion Criteria:
18 years of age or older
Fluent in written and spoken English.
Able to visit the study site in-person for the study visits
(Patient Group Only) - Diagnosis of motor neuron disease, including ALS.
(Control Group Only) Neurologically healthy individuals matching the age, gender, and education level of the patient cohort.

Exclusion Criteria:
Those unable to undergo electroencephalography (EEG) due to either allergies to lotions, cuts on the scalp or active infections.
History of seizure disorder
Co-existing neurological or psychiatric illness that, in the opinion of the research team, exclude the subject from participation.
Neurology
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Hershey, PA ,

Neurobehavioral mechanisms of social and non-social risky decision making.

The purpose of this study is to understand the neural and behavioral mechanisms subserving social and non-social risky decision making.

There will be one in-person lab visit where you will play a decision-making game, while having an fMRI scan.

$31.25

Yes
 

Nina Lauharatanahirun
Nina Lauharatanahirun - at nina.lauhara@psu.edu
Biomedical Engineering (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00023716
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Inclusion Criteria:
18 years or older
Able to read and speak English
Normal to corrected vision in order to see a computer screen clearly
No history of head injury
No MRI contraindications

Exclusion Criteria:
Claustrophobia
History of head injury
Had an event where loss of consciousness > 10 minutes
Weighs more than 300 pounds
Does not read and speak English
Neurology
Not applicable
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State College, PA ,

Seeking support from romantic partners

The purpose of this study is to determine whether and how people's perceptions of the power in their romantic relationships shape the messages they use to seek support from their romantic partners.

No
 

Andrew High
Andy High - at ach208@psu.edu or 814-863-3969
Communication Arts and Sciences (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00013577
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Inclusion Criteria:
Are you currently in a romantic relationship?
Have you sought comfort, advice, information, esteem boosts, or emotional support from your romantic partner within the last 4 weeks?

Exclusion Criteria:
People who are under 18 years old
People who are not in a romantic relationship
People who did not seek support from their romantic partner in the last 4 weeks.
People who do not have access to technology to compete the survey.
Mental & Behavioral Health, Language & Linguistics
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Nicotine absorption, toxicant exposure, and subjective effects of a heat-not burn tobacco product

The purpose of this study is to evaluate the nicotine delivery, toxicant exposure, and subjective effects associated with the use of heat-not burn tobacco products, compared with electronic cigarettes.

Participants will attend 2 clinic visits at the Penn State Milton S. Hershey Medical Center lasting approximately 1 ½ hours each. Participants will be asked to refrain from using any tobacco or nicotine products for at least 14 hours prior to each visit. During the visit participants will try the new tobacco products in the study center while blood samples are collected through an IV catheter placed in the arm.

120

Yes
 

Jonathan Foulds
Allison Salkin - at asalkin@pennstatehealth.psu.edu or 844-207-6392
Public Health Sciences (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00013801
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Inclusion Criteria:
Ages 21-60
Current daily cigarette smoker (5 or more per day)

Exclusion Criteria:
Currently pregnant
History of a seizure disorder or had a seizure in the past 12 months
History of difficulty providing or unwilling to provide blood samples
Current user of an IQOS device
Current user of an electronic cigarette device
Smoking, Vaping, Nicotine and Tobacco, Addiction & Substance Abuse
Not applicable
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Hershey, PA ,

Measuring the impact of three types of resistant starch on fecal butyrate levels and the gut microbiome in healthy and obese individuals

This is dietary intervention trial that will examine the impact of consuming three different types of resistant starch on the gut microbiome and butyrate levels in normal weight and obese individuals. Participants will consume starch samples daily for 24 weeks, collecting weekly fecal samples that will be returned to the lab. Researchers will analyze the bacterial fermentation products in these samples, particularly butyrate and analyze the microbiome composition. This will allow identification of differences in resistant starch (a dietary fiber) processing between normal weight and obese individuals and will also determine if the three resistant starches tested have differing impacts on the microbiome and butyrate levels.

Yes
 

Darrell Cockburn
Darrell Cockburn - at dwc30@psu.edu
Food Science (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00008824
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Inclusion Criteria:
BMI greater than 30

Exclusion Criteria:
Diagnosis of Inflammatory Bowel Disease
Diagnosis of Diabetes
Pregnant
Taking antibiotics
Food & Nutrition
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State College, PA ,

Phase 2 Study of Bladder-SparIng ChemoradiatioN with Durvalumab (PSCI# 19-072) (EA8185)

The purpose of this study is to compare the usual treatment of chemotherapy and radiation to adding MEDI4736 (durvalumab) immunotherapy to the usual treatment. The addition of MEDI4736 (durvalumab) immunotherapy to the usual treatment may help shrink your cancer better than the current standard of care or usual approach for bladder cancer. But, it could also cause side effects, which are described in the risks section.This study will help determine if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking to see if the study approach increases the life of patients by 6 months or more compared to the usual approach.

If you decide to take part in this study, you will either get chemotherapy and radiation for 6-8 weeks, or you will get durvalumab immunotherapy in addition to chemotherapy and radiation for 6.5-8 weeks. After you finish your study treatment, your doctor will continue to follow you for up to 3 years. The follow-up will consist of visits to his or her office and CT scans of the bladder.

Yes
 

Monika Joshi
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04216290
SITE00000823
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Inclusion Criteria:
Patient must have an ECOG Performance Status of 0-2 at the time of registration.
Patient must have histologically proven pure or mixed urothelial cancer of the bladder.
Patient must be ≥ 18 years of age.
Must have adequate renal function as evidenced by calculated (Cockcroft’s formula) creatinine clearance or 24 hours actual creatinine clearance ≥ 30mL/min.
Patient must have a life expectancy of at least 12 weeks, as determined by the treating physician.

Exclusion Criteria:
Patients with clinical N3 disease are ineligible.
Patient must not have received any previous radiation therapy to the pelvic area.
Women must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.
Patients with a negative biopsy of nodes determined to be suspicious on imaging are not eligible.
Small cell carcinoma is excluded, however other variant histologies are permitted provided a component of urothelial carcinoma is present.
Cancer
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Hershey, PA ,