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562 Study Matches

NMTRC006B: An Intermediate Expanded Use Trial of DFMO(eflornithine HCl)

This research study is to provide expanded access to a new investigational drug DFMO (difluoromethylornithine) for patients with neuroblastoma, medulloblastoma, and certain rare tumors that have no other curative options. DFMO is an oral drug that inhibits a certain enzyme (protein) in blood which is associated with a bad outcome in neuroblastoma cases. Cancer cells have pathways that drive the cancer to grow and DFMO targets the specific pathway of this enzyme to turn these cells off.

If you are enrolled on this study, DFMO will be started in clinic on Day 1. After this first day you will be seen in clinic approximately once every 30 days for the first 6 months of study and once every 90 days for the last 18 months of study. These visits will last about 2 hours, and involve a physical exam, blood tests, and other testing.

Yes
 

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

All
All
This study is NOT accepting healthy volunteers
NCT03581240
STUDY00023046
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Inclusion Criteria:
0-30 years of age at the time of initial diagnosis
Not eligible for DFMO studies NMTRC014, BCC015, or BCC016

Exclusion Criteria:
Currently receiving another investigational drug
Cancer
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Hershey, PA ,

HEALEY ALS Platform Trial - Master Protocol

The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS. The trial is designed as a perpetual platform trial. This means that there is a single Master Protocol dictating the conduct of the trial. The Master Protocol describes the overall framework of the platform trial, including the target population, inclusion and exclusion criteria, randomization scheme, study endpoints, schedule of assessments, trial design, the mechanism for adding and removing interventions, and the statistical methodology and recommended statistical methods for evaluating interventions.

The HEALEY ALS Platform Trial is a research trial that tests the safety and effectiveness of multiple treatments in ALS. A regimen is a specific course of treatment, each with a different study drug.The following things will happen in this research study: Blood and urine sample collection; Completion of questionnaires; Physical and neurological exams; Vital signs, current and historical review of medical information about general health and medication use review; Muscle strength testing; Measurement of the electrical activity of the heart with an electrocardiogram (ECG); and Measurement of respiratory (breathing) function.Participants will also take either the study drug, or placebo, according to the study schedule

Yes
 

Zachary Simmons
Heidi Runk - at hrunk@pennstatehealth.psu.edu or 717-531-0003, ext=287177
Neurology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04297683
SITE00000630
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Inclusion Criteria:
Diagnosed with amyotrophic lateral sclerosis (ALS)
Slow vital capacity (SVC) at least 50% predicted
Time since onset of weakness due to ALS within 36 months
Able to swallow pills and liquids

Exclusion Criteria:
Exposure at any time to any gene therapies under investigation for the treatment of ALS
Clinically significant unstable medical condition (other than ALS) that would pose a risk to you
Neurology
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia Phenotypes Based on Objective Sleep Duration: A Sequential Cohort/Randomized Controlled Trial

This study will examine whether patients who have insomnia with different sleep characteristics demonstrate a differential response to two common insomnia treatments, Cognitive Behavioral Therapy for Insomnia (CBT-I) and trazodone. All participants will complete a trial of CBT-I, followed by a medication trial in some participants. Participants will be evaluated with structured interviews; self-report questionnaires; in lab sleep recording; activity monitoring; saliva, blood, & urine collection for routine clinical measures; blood pressure monitoring and an EKG. All outcomes will be assessed again following the end of treatment.

Study involvement is 9-12 monthsPhone Screen to determine basic eligibility.There are 5-6 in person visits (first is consent/screening visit)3-4 of the in person visits are overnight visits to the sleep labUp to 18 other visits for treatment may be done in person or by video conference.Data is collected at home for 6-8 weeks during the 12 month period (activity monitor & blood pressure)Online self-completed surveys & structured interviews are required.A single blood sample and saliva samples will be collectedPregnancy Test, 12-Lead EKG, Medication may need to be taken in addition to the CBT-I Sessions

$465.00

Yes
 

Alexandros Vgontzas
Carrie Criley - at SONOSleep@pennstatehealth.psu.edu or 717-531-4123
Psychiatry and Behavioral Health (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06281756
STUDY00022285
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Inclusion Criteria:
Chronic Insomnia more than 3 months
Elevated or High Blood Pressure with or without treatment
Body Mass Index <40

Exclusion Criteria:
Pregnant/Breastfeeding
Unstable Medical Condition
Severe Sleep Apnea
Substance Abuse
Severe Mental Illness (ie, psychosis)
Sleep Management
Approved drug(s)
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Hershey, PA ,

Advising between middle-aged adults and their parents

This study utilizes interview methods to examine factors that influence the exchange of advice and outcomes of advising between adults aged 40+ and their parents aged 65+.

Participate in a single in-person or Zoom interview of 60-90 minutes focused on the exchange of advice between themselves and their parent or adult child.

50.00

No
 

Erina Farrell
Erina Farrell - at erinafarrell@psu.edu or 814-865-1948
Communication Arts and Sciences (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00021378
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Inclusion Criteria:
Person aged 40+ with parent aged 65+ OR person aged 65+ with child aged 40+
Exchanges advice with parent or adult child
Both parent and child agree to participate
Mental and physical ability to participate in interview
English-speaking

Exclusion Criteria:
Person not 40+ / parent not 65+
No exchange of advice between parent and child
Parent or adult child does not agree to participate
Lacking mental or physical ability to participate in interview
Non-English-speaking
Mental & Behavioral Health
Not applicable
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Singlehood in the Emerging Adult Years: The use of Technology to Communicate

The goal of this study is to understand the use of dating apps in emerging adults (ages 18-29 years old). Using an online survey, participants will be asked a series of questions about their well-being, romantic relationship history, and about their use of dating apps.

You will be asked to take a brief, 15-25 minute online survey, and you may be asked to upload a few screenshots from your phone.

No
 

Nicole Watkins
Nicole Watkins - at nkw5323@psu.edu or 570-963-2573
Social Sciences and Education (SCRANTON)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00023596
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Inclusion Criteria:
1.Must be between the ages of 18-29
2.Must be fluent in English
3.Reside in the US
4.Must self-identify as single (romantic relationship status) at the time of participation
5.Must own and use an IPHONE

Exclusion Criteria:
1.Adults over the age of 29
2.Children under age 18
3.Those who do not have an IPHONE
4.Not fluent in English
5.Do not self-identify as single at the time of participation (romantic relationship status)
Men's Health, Mental & Behavioral Health, Women's Health
Not applicable
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Nocturnal stress: Psychophysiological mechanisms

This study will examine the relationships among time-of-day, light exposure, and stress markers. Physiological measures of stress will be assessed both in the laboratory using a gold-standard emotion induction task.

This is a week-long study consisting of two in-person visits and five out-of-lab days. During the in-person visits, you will be connected to equipment that measures your physiological data and participate in a task with different sounds. During the out-of-lab days, you will wear a sensor that will collect your physiological data and answer questionnaires.

$135

Yes
 

Derek Spangler
Derek Spangler - at dqs6050@psu.edu
Biobehavioral Health (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00020882
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Inclusion Criteria:
No diagnosis of a cardiovascular, metabolic, and/or neurological condition
Not a regular (>1x day) user of nicotine products
Willing to participate in 2 in-lab sessions and 5 out-of-lab days of wearing a sensor
Willing to have gender-matched lab member attach electrodes to the participant while their shirt is removed
Willing to abstain from alcohol use for 24 hours, caffeine consumption for 6 hours, eating for 2 hours, and vigorous exercise for 2 hours prior to the study session

Exclusion Criteria:
Not willing to be exposed to startling and stressful sounds
Not willing to have gender-matched lab member attach electrodes to the participant while their shirt is removed
Not willing/able to wear biosensor at home for 5 consecutive days
Diagnosis of a cardiovascular, metabolic, and/or neurological condition
Regular (>1x day) user of nicotine products
Food & Nutrition, Heart & Vascular, Mental & Behavioral Health
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State College, PA ,

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

No
 

Jacob Corey
Jacob Corey - at jjc6062@psu.edu or 814-865-1691
Kinesiology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00012768
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Inclusion Criteria:
At least 18 years of age
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

Exclusion Criteria:
Under the age of 18
Does not speak fluent english
does not have a physical disability
Has not participated in physical activity in the last year
Arthritis & Rheumatic Diseases, Neurology, Muscle & Bone
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Memory and Aging Study

This research is being done to find out more about changes in the brain as we age and to determine if MRI, genetic (DNA) variations, and neuropsychological tests can be used to evaluate memory loss and cognitive impairment.

Yes
 

Prasanna Karunanayaka
Lauren Spreen - at lspreen@pennstatehealth.psu.edu
Radiology (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
PRAMS040153EP
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Inclusion Criteria:
Diagnosis of Alzheimer's disease
Diagnosis of Mild Cognitive Impariment
Normal Controls-Cognitively normal functioning

Exclusion Criteria:
Neurological disease (e.g., stroke, tumor, Parkinson's disease, etc.)
Psychiatric disorder (e.g., bi-polar, schizophrenia, etc.)
History of chemotherapy
Presence of a cold or viral infection
Presence of a pacemaker, aneurysm clips, or any metal in body
Neurology
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Study Locations

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Hershey, PA ,

Penn State Exercising Women's Study

This study aims to assess energy status in young sedentary and exercising women as it is related to menstrual status, bone health, psychological health, sleep variables, and cardiovascular function.

There will be three to four visits to the laboratory. Procedures include questionnaires, a blood draw, providing a hair sample, providing two saliva samples, cardiovascular measurements, and bone scans, as well as resting metabolic rate, cognitive, aerobic fitness, and countermovement jump testing. Participants will be asked to collect urine samples throughout one menstrual cycle, or 28 days for amenorrheic females. Exercise and physical activity will be recorded and monitored for seven days via logs and wearables. Food intake will be recorded for three days. Collegiate athletes will be tested twice; in-season and off-season.

Yes
 

Mary Jane De Souza
Ana Carla Chierighini Salamunes - at whel@psu.edu or 814-863-4488
Kinesiology (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00019437
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Inclusion Criteria:
Women
Age 18-30 years
Body Mass Index between 16-29.9 kg/m2
For sedentary participants: less than 2 hours of purposeful exercise per week and regular menstrual cycles for the last 6 months (i.e. cycles between 26 and 35 days in length)
For exercising participants: exercise at least 2 hours per week AND/OR participate in collegiate athletics. Exercising participants can have regular or irregular menstrual cycles for the last 6 months.

Exclusion Criteria:
Pregnant or lactating
Currently a smoker or history of regular smoking
Taking any hormonal medication in the past six months, other than oral contraceptives
Serious or chronic health condition (including heart condition, thyroid illness, metabolic disease)
Hysterectomy or oophorectomy
Food & Nutrition, Muscle & Bone, Women's Health
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State College, PA ,

Intraparticipant speaking rate differences within and across sessions

The purpose of this study is to assess if healthy adults speak at a consistent speaking rate when asked to read a standard passage or answer an open ended prompt.

There will be 2 visits that each take approximately 20 minutes. We will meet in person or via Zoom. At each visit you will be asked to read three paragraphs and answer some open ended questions/prompts.

No
 

Nicole Etter
Nicole Etter - at oppal@psu.edu
Communication Sciences and Disorders (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00023863
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Inclusion Criteria:
18 years or older
English-speaking
Hearing and cognition within functional limits to complete speaking tasks

Exclusion Criteria:
Currently seeking treatment for speech or voice concerns
History of neurologic disease, injury, or event including traumatic brain injury, stroke, multiple sclerosis, amyotrophic lateral sclerosis, Parkinson’s disease, etc.
Language & Linguistics
Not applicable
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PSCI 22-127 NRG-BN012: A RANDOMIZED PHASE III TRIAL OF PRE-OPERATIVE COMPARED TO POST-OPERATIVE STEREOTACTIC RADIOSURGERY IN PATIENTS WITH RESECTABLE BRAIN METASTASES

Individuals with cancer that has spread to their brain who have 1-4 lesions, or breast cancer history and may or may not have treatment and are within 8 weeks of surgery, will be randomized to either surgery first followed by radiation or radiation first followed by surgery.

Subjects are expected to come to all Radiation/Gamma Knife appointments and continue onto surgery/resection.

Yes
 

Sean Mahase
PSCI-CTO at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
Radiation Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05438212
SITE00001293
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Inclusion Criteria:
Radiographic confirmation of 1-4 brain metastases, one of which requires resection, as defined by MRI with contrast obtained within 14 days prior to registration
Known active or history of invasive non-CNSprimary cancer based on documented pathologic diagnosis within the past 3 years.
All brain metastases must be located ≥ 5 mm from the optic chiasm and outside the brainstem.
Lesions chosen for surgical therapy must be deemed appropriate targets for safe, gross total resection by the treating surgeon
Age ≥ 18

Exclusion Criteria:
Prior cranial radiotherapy,
Evidence of leptomeningeal disease
Primary histology of germ cell tumor, small cell carcinoma or lymphoma
Inability to undergo MRI with contrast.
More than one brain metastasis planned for resection
Cancer
Not applicable
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Hershey, PA ,

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.

Yes
 

Kristin Riley
Patricia Rawa - at prawa@pennstatehealth.psu.edu
Obstetrics and Gynecology (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05348005
STUDY00019024
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Inclusion Criteria:
Women aged 18 to 45 years, inclusive,
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

Exclusion Criteria:
Has an implantable device (e.g. pacemaker, etc.)
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
Pregnant
Pain Management, Women's Health
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Hershey, PA ,

Effects of antibiotic use on fecal microbiome and resistome

This study will investigate the changes in the human fecal microbiomes and resistomes in response to antibiotic treatment.

No
 

Jasna Kovac
Jasna Kovac - at jzk303@psu.edu or 814-699-1680
Food Science (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00011756
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Inclusion Criteria:
over age 18
English speaking/reading
Books a medical appointment for upper respiratory tract infection

Exclusion Criteria:
Patient took antibiotics in the past week
Patient participated in STUDY00012891 previously
Reason for medical visit is not upper respiratory tract infection
Patient is pregnant
Patient has a medical history that includes diagnosis of any intestinal related disease
Infectious Diseases & Immune System, Lung Disease & Asthma
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Online Investigation of Spoken Language Processes

This online study aims to examine whether factors like language history and visual information influence spoken language processes in typical listening environments.

No
 

Navin Viswanathan
Navin Viswanathan - at splacolab@psu.edu
Communication Sciences and Disorders (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00016192
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Inclusion Criteria:
English Speakers
Between 18 and 65 years of age

Exclusion Criteria:
Those with diagnosed speech, hearing or language issues
Language & Linguistics
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The effect of video job description on recruitment: A comprehensive study

The purpose of this study is to see how online job advertisements can influence people to apply for jobs. Participants will see job advertisements and answer questions regarding each job ad.

No
 

Pooyan Doozandeh Masooleh
Pooyan Doozandeh - at pzd143@psu.edu or 484-809-1549
Division of Graduate Studies (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00016106
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Inclusion Criteria:
At least 18 years of age
Knowing English
Being interested to pursue employment in one of these three categories of jobs: academic (lecturer, professor), computer-related (programmer, cyber-security, etc.), or service-based (laborer, operator, technician, etc.)

Exclusion Criteria:
People without access to a computer (i.e., laptop, desktop)
Younger than 18 years of age.
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A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Fazirsiran in the Treatment of Alpha-1 Antitrypsin Deficiency–Associated Liver Disease With METAVIR Stage F2 to F4 Fibrosis

This research study of fazirsiran (FAZ-i-sir-an; also called TAK-999 or the “study drug”) because you have alpha-1 antitrypsin deficiency-associated liver disease (AATD LD) with METAVIR stage F2 to F4 fibrosis (METAVIR is a system used to score the amount of inflammation and fibrosis seen in a liver biopsy).In AATD, abnormal (Z-AAT) proteins build up in liver cells, leading to varying amounts of liver problems. The goal of treatment with fazirsiran is to prevent and improve the build up of these abnormal proteins that cause liver injury and fibrosis

-The total amount of time you may be involved in the study is about 4 ½ years (230 weeks).-Screening Period of up to 70 days.-Treatment Period of 196 weeks or about 4 years. During the study, you will get the study drug or placebo at the study site.-Follow-up Period of 6 months. You will have visits 6, 12, and 24 weeks after your last injection of the study drug or placebo.-You will have lung function tests (PFT and DLCO) to check how your lungs are workingAt every visit during the treatment period you will have:-Your vital signs will be measured, this includes your heart rate, blood pressure, breathing rate, temperature, and amount of oxygen in your blood.-You will have a brief physical exam.-Your weight will be measured.-You will have an ECG.-Collect lab samplesDuring specific study visits during the treatment period the following tests will be performed:-An abdominal ultrasound-FibroScan-CT scansYou will complete questionnaires.

Yes
 

Timothy Craig
Kristina Richwine - at krichwine@pennstatehealth.psu.edu or 717-531-4506
Medicine: Pulmonary, Allergy and Critical Care (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05677971
STUDY00021539
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Inclusion Criteria:
The participant, of any sex, is aged 18 to 75 years, inclusive
The participant must use highly effective contraception
The participant must have suitable vein access for blood sampling
Participant agrees not to smoke at any time during the study.
The participant must have a diagnosis of the PiZZ genotype AATD

Exclusion Criteria:
The participant is receiving long-term around-the-clock oxygen (O2) supplementation or supplemental O2 with continuous positive airway pressure (CPAP), or bi-level positive airway pressure (BiPAP) for acute respiratory failure.
The participant has a recent lower respiratory tract infection, such as pneumonia, within the last 6 months before screening.
The participant is expected to have severe and unavoidable high-level exposure to inhaled pulmonary toxins during the study such as may occur with occupational exposure to mineral dusts or metals.
The participant has a history of malignancy within the last 5 years
The participant has evidence of other forms of chronic liver diseases
Allergies, Lung Disease & Asthma, Digestive Systems & Liver Disease
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Endometriosis and microvascular dysfunction 3

Endometriosis, is a disorder that occurs in women, is when tissue that should be normally found inside the womb is also found in sites outside of the womb. Endometriosis is a disorder that is associated with systemic inflammation. This disorder impairs the function of the endothelium, the cells that line the body’s blood vessels (endothelium). The endothelium helps to control blood flow in healthy vessels. Women with endometriosis not only have an increased risk for high blood pressure and high cholesterol, they also have an increased risk for cardiovascular disease. With this study, we will learn how systemic inflammation in endometriosis impairs the lining of blood vessels and increases the risk for cardiovascular disease.We will use a short term intervention with a non-steroidal anti-inflammatory to examine how inflammation impact endothelial function in women with endometriosis

There will be 4 in person visits, at all visits blood will be drawn. Two of the visits will be experimental visits where we will measure skin blood flow and blood flow in the brachial artery. Participants will be required to take a placebo or the drug salsalate for 4 days prior to each experimental visit.

$450

Yes
 

Lacy Alexander
Susan Slimak - at sks31@psu.edu or 814-863-8556
Kinesiology (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
NCT05069740
STUDY00018369
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Inclusion Criteria:
Women, 18-45 years of age
With and without Endometriosis

Exclusion Criteria:
Tobacco consumption (e.g. smoking)
Pregnant and/or breastfeeding
Taking blood pressure medication
Known allergy to Salsalate
Heart & Vascular, Pregnancy & Infertility, Women's Health
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Study Locations

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Altoona, PA ,
Harrisburg, PA ,
Hershey, PA ,
State College, PA ,
Williamsport, PA ,

Testing Responses of Young Adults to Intervention Messages (TRY AIM) Trial

The purpose of this voluntary research study is to determine the effects of different methods of promoting physical activity with wearable devices and technology.

Participants will participate in an 18-month study with virtual study visits.-Use provided digital tools (activity tracker and messages) to monitor physical activity-Set goals to increase physical activity levels based on national guidelines-Monitor weight and complete questionnaires at five times throughout the study (at the beginning, 3 months, 6 months, 12 months and 18 months)

Up to $235 and a Fitbit tracker and BodyTrace scale

No
 

Constantino Lagoa
Gabrielle Ryan - at tryaim@psu.edu or 814-865-7935
Electrical Engineering (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT05794178
STUDY00019311
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Inclusion Criteria:
Participants capable of reading, speaking and understanding English and of giving informed consent.
Participants between the ages of 18-29 years.
Participants must be free of visual impairment that would interfere with the receipt of text messages on their phone.
Participants must be willing to wear a Fitbit tracker almost continually (23.5 hours/day) for a 12- month period of time.
Participants interested in setting goals to increase their physical activity levels over the 12-month study.

Exclusion Criteria:
Participants engaging in 150 or more minutes of moderate- or greater intensity PA /week as assessed by a research grade accelerometer.
Participants with contraindications to normal physical activity on the Physical Activity Readiness Questionnaire.
Participants who require an assistive device for mobility or have any other condition that may limit or prevent participation in moderate-intensity physical activity.
Participants with a prior diagnosis of cancer, cardiovascular disease, diabetes or metabolic syndrome.
Participants who are pregnant or planning to become pregnant within the next 12 months.
Men's Health, Prevention, Women's Health
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Cardiovascular effects of a healthy dietary pattern containing eggs: a controlled-feeding study

The purpose of this research study is to determine if a healthy diet containing 2 eggs/day has similar effects on risk factors for heart disease as a healthy diet containing 3 eggs/week.

This study runs for about 3 months. During this time, you will be provided with two diets in random order to consume for 28 days. These diets will meet your energy and nutrient needs and include 3 meals, 2 snacks and some beverages. During this time, we will ask you not to eat any foods outside of those provided by the study. You will have a 1-month break between the two diets. Testing will be conducted on two separate days at the beginning and end of each diet period (a total of 8 testing days). For these visits, you will need to fast for 12 hours prior and avoid alcohol for 48 hours prior. At these visits, we will take a blood draw, measure your body weight, and perform non-invasive tests to assess your vascular health.

400

Yes
 

Kristina Petersen
Fatemeh Jafari - at dchlab@psu.edu or 866-778-3438
Nutritional Sciences (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT06120400
STUDY00022655
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Inclusion Criteria:
Age 30-60 years
LDL-C ≥115 mg/dL and ≤190 mg/L
BMI of 25-35 kg/m2
Self-reported intake of <14 eggs/week for the prior 3 months

Exclusion Criteria:
Diagnosis of heart disease, stroke, kidney or liver disease
Current use of tobacco-containing products or (≤6 months) cessation
Pregnant or lactating individuals
Allergy to study foods
Food & Nutrition, Heart & Vascular
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State College, PA ,

Investigating Design Aspects of Immersive Virtual Field Trips and Site Experiences

This study investigates the effects and effectiveness of different options for designing immersive virtual reality tours of real-world places. Participants will wear a Virtual Reality headset and watchseveral short tours featuring different environments (museum, forest, harbor, Mayan site). After each tour, participants will be asked for their opinion on certain design aspects of the tour app.

Yes
 

Alexander Klippel
Mahda Bagher - at mmm6749@psu.edu
Geography (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00013169
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Inclusion Criteria:
at least 18 years old
English speaking
able to wear a VR headset + sit and turn in a swivel chair while watching the short VR tours
able to listen to the tour's audio commentary

Exclusion Criteria:
younger than 18
non-English speaking
Education
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State College, PA ,

Trust in Realistic Situations

We are exploring how a robot's competence, benevolence and integrity influence one's decision to rely on a robot and accept its guidance. We're also exploring different ways to interact with robot using virtual reality and in person experimentation.

Yes
 

Alan Wagner
Alan Wagner - at azw78@psu.edu
Aerospace Engineering (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00017695
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Inclusion Criteria:
An adult over the age of 18
Able to complete the consent form
Able to see

Exclusion Criteria:
Anyone under the age of 18
Individuals that have uncorrected seeing difficulties that would prevent them from being able to complete the survey will be excluded
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State College, PA ,

Cardiovascular Effects of Angiotensin 1-7 in Obesity Hypertension

The purpose of this study is to see if the hormone angiotensin-(1-7) lowers blood pressure and sympathetic activity and improves the function of blood vessels and in obese subjects with hypertension.

This is an outpatient study that requires a screening visit, and if eligible, two study visits in the Clinical Research Center within the Penn State Health Milton S. Hershey Medical Center. The screening visit will take about one hour and includes a brief physical examination and medical history, a urine pregnancy test if female and of childbearing potential, measurement of heart rhythm, collection of blood samples, and measurements of body composition. If eligible based on the results of the screening visit, participants will be invited to participate in two study visits that are about four hours and are separated by at least one week. Participants will complete food recall and activity questionnaires prior to each study visit. A urine pregnancy test will be given for females of childbearing potential. Participants will lie down on a bed and a catheter will be placed in a vein in each arm to draw blood samples and to give study medications. Equipment will then be placed to measure heart rate, blood pressure, and the amount of oxygen in the blood. A blood pressure cuff on the arm will be inflated for up to five minutes to measure blood flow in the arm using ultrasound and blood samples will be collected. Small electrodes will then be inserted into a nerve and just under the skin on one leg to measure nerve activity, which will remain in place until the end of the study. Participants will then receive either angiotensin-(1-7) or normal saline through the catheter in the arm for up to 120 minutes. Angiotensin-(1-7) is a substance that the body produces naturally; however, in this form, it is considered experimental, which means the Food and Drug Administration has not approved it for this use. Participants will receive angiotensin-(1-7) at one study visit and normal saline at the other study visit. The treatments will be randomly assigned so that the order in which they receive each treatment will be determined purely by chance, and neither the participant nor study investigators will know which treatment is received at each study visit. Blood pressure, heart rate, oxygen in the blood, and leg nerve activity will be measured continuously while giving angiotensin-(1-7) or normal saline. Near the end of treatment, blood flow in the arm will be measured again. At the end of the last dose, another blood sample will be taken. Participants will then be allowed to recover for at least 20 minutes and then all equipment will be removed. After the study visit, participants will be asked to complete a questionnaire if they had the nerve activity measurements, and a nurse will contact them to check on general well-being and answer any questions.

$25 per hour

Yes
 

Amy Arnold
Aimee Cauffman - at acauffman@pennstatehealth.psu.edu or 717-531-1617
Neural and Behavioral Sciences (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06482853
STUDY00008170
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Inclusion Criteria:
Age 18-60 years
Obesity (defined as body mass index between 30-40 kg/m2)
Hypertension (defined as seated blood pressure greater than 130/80 mmHg)
Able and willing to give informed consent
Fluent in written and spoken English

Exclusion Criteria:
Pregnant or breastfeeding women or women taking hormone replacement therapy within 6 months
Current smokers
Type I or type II diabetes
History of major cardiovascular disease, immune or liver diseases, impaired renal or liver function
Morbid obesity (body mass index greater than 40 kg/m2)
Heart & Vascular
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

HERMES: Effects of ziltivekimab versus placebo on morbidity and mortality in patients with heart failure with mildly reduced or preserved ejection fraction and systemic inflammation.

To see how ziltivekimab taken once monthly versus placebo, both added to standard of care, in reducing the risk of cardiovascular death and heart failure events in participants with heart failure iwht mildly reduced or preserved ejection fraction and systemic inflammation.

Return for on site visits 14 times, participate in 6 phone calls, complete questionnaires, blood samples taken at each on-site visit, electrocardiogram completed on 5 visits, injection of study medication.

approximatley $1,120

Yes
 

John Boehmer
PSHVIResearchCoordinators@pennstatehealth.psu.edu 717-531-5967
Heart and Vascular Institute (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05636176
STUDY00022895
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Inclusion Criteria:
diagnosis of decompensated heart failure
age 18 years or above

Exclusion Criteria:
participation in other clinical study
unstable medical therapy for heart failure
active hepatitis C
pregnant females or females not using effective contraceptive
Heart & Vascular
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,
Reading, PA ,

How Does the Intersection of Gender and Language Affect Stigma in Opioid Use Disorder?

This research experimental study aims to investigate the impact of gender and language on stigma related to opioid use disorder (OUD) among college students. Participants, aged 18 and older, will be randomly assigned to read vignettes describing individuals with OUD, varying in gender and language use. After reading, participants will complete a brief survey assessing their perceptions of stigma associated with OUD. The study seeks to uncover how stigmatizing language and gender-specific societal expectations interact to shape attitudes, contributing to a better understanding of OUD stigma in the college-aged population.

Participants will engage in a structured series of activities. Initially, they will complete a demographics questionnaire, providing essential information such as age, gender, and college affiliation. Subsequently, participants will be presented with one of four vignettes designed to systematically manipulate language and gender variables related to OUD stigma. Following the vignette exposure, participants will respond to The Perceived Stigma of Substance Abuse Scale (PSSAS) as part of the survey.

No
 

Paul Christopher, Jr.
Paul Christopher - at pmc5584@psu.edu
Penn State Harrisburg
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00024114
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Inclusion Criteria:
College Students
18 years or older

Exclusion Criteria:
18 years or younger
Not a college student
Addiction & Substance Abuse
Not applicable
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Validation of Cell-free mitochondrial DNA (cf-mtDNA) Saliva Collection Methods

The reproducibility, reliability, and validity of saliva collection techniques is an important issue that needs to be addressed to achieve consistency in the emerging field of mitochondrial psychobiology. The objective of the current study is to increase scientific rigor by utilizing robust and well-controlled methods in the collection and testing of saliva samples. Given the non-invasive and convenient nature of saliva collection, it is likely that research using saliva-derived cell-free mitochondrial DNA (cf-mtDNA) will increase. Therefore, to ensure that the results obtained from the current study are trustworthy and meaningful, we are proposing a small, highly controlled randomized study design that will integrate three methods of saliva collection. The study will adopt a rigorous and systematic approach to data collection, analysis, and interpretation. Through the implementation of these methods, we seek to achieve a higher degree of accuracy and reliability in cf-mtDNA saliva-based measurements.

Each participant will be asked to collect 3 randomized saliva samples (i.e., one static Salivette®, one active Salivette®, and either a second active Salivette® or a passive drool) upon awakening for 10 business days. All collection materials be pre-labeled with the day, type of sample, and order to make it easy for participants to quickly and accurately deposit samples upon awakening. Once saliva samples are collected, participants will be asked to promptly return the samples to the provided plastic bag and store the bag in their at-home freezers. All samples will be stored there until the end of the 10-day study. After the saliva is returned to the freezer, participants will complete a short (3-5 min) morning survey on the provided mobile device which has been pre-loaded with the M2C2 application. The morning survey asks questions about sleep, morning outlook, and anticipatory stress and positive experiences. In the evenings, participants will be prompted (via banner notification on screen and audible beep) to complete a slightly longer (8-10 min) survey. This survey asks questions about the respondent’s daily experiences (stressors, mood, physical symptoms). Within the application, there are three brief, objective cognitive tasks. Upon completion of the 10-day protocol, respondents will return the mobile device and saliva samples. Participants may bring all saliva samples back to the lab during regular business hours, or they may schedule a time for a member of the study team to pick up the samples. Depending on the distance between the laboratory and the participant’s home, the need for ice packs will be assessed on an individual basis.

50

Yes
 

Idan Shalev
Lauren Petri - at laurenpetri@psu.edu
Biobehavioral Health (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00023371
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Inclusion Criteria:
healthy adult
between the age of 18-50 years
must be English speaking
cannot be pregnant or breastfeeding
must not use tobacco

Exclusion Criteria:
Younger than 18
Individuals who work nightshift
Individuals who do not have access to an at-home freezer
Individuals who have an irregular sleep-wake cycle
Individuals who currently use tobacco
Infectious Diseases & Immune System, Mental & Behavioral Health
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State College, PA ,

PSCI 22-082 Tropion-Breast03

This is an investigational drug study comparing the Investigational treatment with treatments called capecitabine and pembrolizumab as stand-alone treatment agents or in combination. Study participants will be required to attend all study visits, complete the tests and procedures, receive study treatment, and complete questionnaires.

Participants must attend all visits, receive study treatment, have blood drawn, complete questionnaires, have imaging scans done (ECG, ECHO or MUGA, CT, mammogram or breast MRI), keep a diary, have an eye exam, and provide a tumor sample.

Yes
 

Monali Vasekar
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
NCT05629585
SITE00001344
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Inclusion Criteria:
Participant must be ≥ 18 years at the time of screening.
Histologically confirmed invasive TNBC.
Residual invasive disease in the breast and/or axillary lymph node(s) at surgical resection following neoadjuvant therapy.
Completed at least 6 cycles of neoadjuvant therapy containing an anthracycline and/or a taxane with or without carboplatin, with or without pembrolizumab.14
No evidence of locoregional or distant relapse. Radiological scans before treatment are not required and should be obtained as per local institutional practice.

Exclusion Criteria:
Stage IV (metastatic) TNBC.
History of prior invasive breast cancer, or evidence of recurrent disease following preoperative therapy and surgery.
As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, including history of allogeneic organ transplant and active bleeding diseases, ongoing or active infection,
History of another primary malignancy except for adequately resected basal cell carcinoma of the skin or squamous cell carcinoma of the skin, in situ disease that has undergone potentially curative therapy
Persistent toxicities caused by previous anticancer therapy, excluding alopecia, not yet improved to Grade ≤ 1 or baseline.
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

An Examination of Student-Mentor Relationships

This is a self-report survey and questionnaire study that examines whether members of marginalized groups are more motivated than members of dominant groups to give referent power to high status others in attempts to belonging.

No
 

Maria Sanchez
Maria Sanchez - at mfs5350@psu.edu
Psychology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00007731
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Inclusion Criteria:
All Genders
All races/ethincities
Participants between 18 and 25

Exclusion Criteria:
Participants YOUNGER than 18
Participants OLDER than 25
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Return to Work Survey Development for Breast Cancer Survivors

The purpose of this study is to develop and test a survey to gain information that will improve our understanding of the return to work experience for breast cancer survivors. Study participants will answer questions on a questionnaire and undergo a one-on-one interview about those questions to ensure the wording and content is appropriate.

This is a questionnaire development study. Participants will be asked to complete a series of questions on a questionnaire form. Next, participants will sit for a one-on-one interview to discuss the questions and answer choices on the questionnaire.

Yes
 

Meghan Vidt
Jared Heitzenrater - at jheitzenrater@pennstatehealth.psu.edu or 717-531-0003, ext=323324
Biomedical Engineering (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00019881
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Inclusion Criteria:
Previous diagnosis of breast cancer, stage 0-III
Last cancer treatment was 2-5 years ago
Received breast cancer treatment at Penn State Health
Employed outside the home at least part time (>20hr/wk) before and after cancer treatment

Exclusion Criteria:
Last cancer treatment was less than 2 years or greater than 5 years ago
Underwent prophylactic treatment due to increased risk, such as testing positive for BRCA gene (breast cancer)
Unemployed or does not participate in the workforce for pay either before or after cancer
Currently being treated for any type of cancer
Has experienced a work-related injury that does not allow work, is receiving Worker's Compensation, or is currently in litigation for work-related injury
Cancer
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Hershey, PA ,

22-111 A Phase 1/2 Open-label Study to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of Modakafusp Alfa (TAK-573) as a Single Agent in Patients With Relapsed Refractory Multiple Myeloma

This study involved testing a drug for the treatment of relapsed/refractory multiple myeloma. The trial consists of three parts: the first part looks at the safety of the drug when given to patients; the second and third part looks the dose of the drug at how the drug is used through the body and how it acts on multiple myeloma.

Participants will need to attend the scheduled visits, provide medical history, blood samples, complete questionnaires, radiology exams, bone marrow aspirate and/or biopsy, and take study medication

Yes
 

Seema Naik
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
NCT03215030
SITE00001303
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Inclusion Criteria:
MM defined by the IMWG criteria with evidence of disease progression and: a)Is in need of additional myeloma therapy as determined by the investigator.
Aged 18 years or older.
For patients in Parts 2 and 3 only: Measurable disease defined as one of the following: a)Serum M-protein ≥500 mg/dL (≥5 g/L).
During Part 1 only, patients not meeting the above criteria for measurable disease should, at least, have measurable bone marrow plasmacytosis (≥10%) and/or plasmacytoma (≥1 cm in diameter) detected by physical examination or imaging.
ECOG performance status of ≤2.

Exclusion Criteria:
Patient has polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome, monoclonal gammopathy of unknown significance, smoldering myeloma, solitary plasmacytoma, amyloidosis,
Patients who have received autologous SCT 60 days before first infusion of modakafusp alfa or patients who have received allogeneic SCT 6 months before first infusion.
Graft-versus-host disease that is active or requires ongoing systemic immunosuppression.
Part 1: Until the MTD/OBD is defined, patients who have received daratumumab (or other investigational anti-CD38 antibody) for at least 5 months (steady state) require a 90-day wash-out period before receiving modakafusp alfa.
Patient has not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE Grade ≤1 or baseline,
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

Minoritization and transnational social hierarchies: Caste and race in the Indian immigrant context

The study looks to understand how caste and race play out among Indian students, especially Indian immigrant students. Caste is the predominant social category in India. However, as Indian students migrate into to the USA, the social category of race is introduced and social category of caste is not understood outside of the Indian community. Through qualitative interviewing, it is aimed in this study to determine how migrating to the USA and becoming a minority and a person of color can potentially change how Indians view caste and caste identities in India. The primary hypothesis of the study is that the process of becoming becoming a minority through immigration can be used to think back on caste, and to think forward on race in both India and the USA.

No
 

Ashwin Mohan
Ashwin Mohan - at akm73@psu.edu or 518-992-8324
Curriculum and Instruction (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00017989
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Inclusion Criteria:
Adults 18 years old or above
Citizen/Resident of India for at least 5 years OR one or both parents have been citizens of India for at least 5 years
Students/Faculty members at Penn State

Exclusion Criteria:
Subjects who do not meet the inclusion criteria
Subjects who do not speak English
Education
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