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Identification of Critical Thermal Environments for Aged Adults

The earth’s climate is warming, and the number of heat waves has increased in recent years. At the same time, the number of adults over the age of 65 is growing. Humans sweat and increase blood flow to the skin to cool their body when they get hot. Older adults do not do this as well as young adults. This makes it harder to safely exercise in warm and/or humid conditions. It is important to learn about safe limits of heat and humidity for older adults to exercise. Also, nearly 40% of adults over age 50 take aspirin to lower their risk for heart disease. Our lab has shown that aspirin lowers the control of body heat.In this study, we will determine critical temperature and humidity environments above which normal body temperature cannot be maintained in young and older adults. We will also look at how aspirin may change critical temperature and humidity thresholds in older adults.

There will be 4 in person visits and sit, walk, or cycle at a low intensity in an environmental chamber.

360

Yes
 

William Kenney, Jr.
Susan Slimak - at sks31@psu.edu
Kinesiology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT04284397
STUDY00014062
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Inclusion Criteria:
Healthy subjects 18 and older
Asymptomatic and no signs/symptoms of disease

Exclusion Criteria:
Have any conditions to advise against low-intensity physical activity
History of Crohn's disease, diverticulitis, or other similar gastrointestinal disease
Medications that could alter cardiovascular responses or body temperature regulation during exercise (blood pressure reducers, fever reducers, anti-depressants, etc.)
Tobacco or recreational drug use
Post-menopausal women taking hormone replacement therapy
Heart & Vascular, Sports Medicine
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State College, PA ,

ATHN 10: Rare Coagulation Disorders Project

This is a multi-center project in which the American Thrombosis & Hemostasis Network (ATHN) will offer free genotyping to individuals with Rare Coagulation Disorders (RCD).

One tube of blood will be collected during a routine clinic visit.

Yes
 

M. Elaine Eyster
Bree Kelly - at jhawthorne@pennstatehealth.psu.edu or 717-531-0003, ext=281498
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
SITE00000669
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Inclusion Criteria:
Subject must have an established Rare Coagulation Disorder diagnosis (
Must currently receive or have received care at and ATHN affiliated HTC
Subject must have opted into the ATHNdataset

Exclusion Criteria:
Subject is unwilling to sign informed consent form
Blood Disorders
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Hershey, PA ,

Understanding experiences of international students with healthcare and antibiotics

This study examines the experiences of international students with regard to upper respiratory illnesses, healthcare, and use of antibiotics in their home countries and in the United States. The findings of the study will inform the development of training to improve healthcare providers’ communication skills for discussing antibiotics with international students.

Complete one online survey, which takes approximately 20 minutes.

10.00

No
 

Erina Farrell
Erina Farrell - at elm26@psu.edu
Communication Arts and Sciences (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00021922
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Inclusion Criteria:
18 years of age or older
College/university undergraduate or graduate student at a U.S. university
born and raised in and is currently a citizen of China, India, or South Korea
English speaking
lived in the United States for less than 7 years

Exclusion Criteria:
Less than 18 years of age
Not a college or university student at a U.S. university
Not born or raised in and currently citizen of China, India, or South Korea
Not English speaking
Lived in the United States more than 7 years
Infectious Diseases & Immune System
Not applicable
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Modifiable Prevention and Early Intervention Targets for Unhealthy Eating Behaviors: A Study in First Year Undergraduates

This is a research study investigating the prevalence and manifestation of unhealthy eating behaviors and the relationships of energetic status, cognitive function, and reproductive health in a population of first year college students.

Phase 1 will involve a minimum of 1-2 visits, and completion of surveys about your general health, exercise and nutrition history, eating behaviors and attitudes, stress, and reproductive health, as well as cognitive testing and hair sampling. For those who qualify, Phase 2 will involve approximately 4 additional visits. Each visit will be about 2 hours. The visits include completion of surveys about general health, exercise and nutrition history, eating behaviors and attitudes, stress, and reproductive health, as well as cognitive testing and physiological measurements including blood and hair sampling, and tests of metabolism. Study participation will last at minimum about 1 week, and at maximum completion of Phase 1 and Phase 2 will occur over the course of a full academic year.

$25 per visit, up to $75

Yes
 

Nancy Williams
Jaime Rodden - at whel@psu.edu
Kinesiology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00022878
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Inclusion Criteria:
First Year College Student
Age 18-25 Years
BMI 16.5-30 kg/m2
No apparent metabolic, endocrine, or musculoskeletal disease.

Exclusion Criteria:
Pregnancy or intention to become pregnant in the next 9 months
Serious or chronic health condition (including thyroid illness, metabolic disease)
Unwilling to adhere to study protocol
Lactating
Does not speak English or are unable to give consent
Mental & Behavioral Health, Women's Health, Men's Health
Not applicable
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State College, PA ,

Penn State SELF - Student Engagement, Learning and Flourishing

Substance misuse is a leading national problem, with young adults at high risk. We aim to develop a university resource that elucidates biobehavioral underpinnings of problematic student substance use at University Park campus. This initiative would inform services needed, provide engaged learning opportunities, connect with faculty, and catalyze high-impact, interdisciplinary research. In addition to this primary rationale, this study will allow us to capture detailed information about other critical student experiences such as food and housing insecurity, experiences of discrimination, and daily health practices to prevent the transmission of COVID-19. Participants will be asked to take a baseline survey followed by a 21- daily diary protocol (brief 5 minute survey each day for 21 days. For more information or to register interest in participating please see: https://projectself.psu.edu/register-your-interest/

No
 

Stephanie Lanza
Courtney Whetzel - at projectSELF@psu.edu
Methodology Center (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00015710
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Inclusion Criteria:
Undergraduate at PSU
Enrolled at UP
18-24 years old

Exclusion Criteria:
Non-students
Part-time students
Students located in the EEA
Older than 24
No graduate students
Smoking, Vaping, Nicotine and Tobacco, COVID-19, Mental & Behavioral Health
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Understanding University Students' Daily Interaction with ChatGPT through the Lens of Self-Determination Theory

This study aims to learn about how university students interact with ChatGPT and how ChatGPT's support of autonomy, competence, and relatedness could either help or hinder students' ability to learn. We will interview students to understand how ChatGPT supports student learning and identify any challenges that may arise.

There will be a 60-minute interview.

$10

No
 

Jiyoon Kim
jxk6167@psu.edu
Division of Graduate Studies (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00024072
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Inclusion Criteria:
Students
Use ChatGPT for their daily lives
Over 18 years old
Speak English
Students from non-EU countries

Exclusion Criteria:
Non-students
Under 18 years old
Do not use ChatGPT for their daily lives
Non-english speaker
Students from EU countries
Education
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Driver Training on the Advanced Driving Assistant System

This research aims to study the training knowledge that is essential for drivers to use Advanced Driving Assistant Systems safely and properly and identify the optimal training approaches.

If you participate in the first experiment, you will receive training of the in-vehicle system via videos and manuals, complete a driving task on the driving simulator, and answer questions from questionnaires. If you participate in the second experiment, there will be two visits. In the first visit, you will receive training via watching and interacting with online videos, watching an experimenter operating ADAS at the test track, or practicing the functions of ADAS in a vehicle at the test track. The functions in the training include adaptive cruise control, lane-keeping assistance, and Highway Driving Assist. In the second visit, you will complete a driving task on the driving simulator and answer questions from questionnaires.

$30 for experiment1 and $60 for experiment 2

Yes
 

Yiqi Zhang
Ruby Kim - at rubykim@psu.edu
Industrial and Manufacturing Engineering (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00020300
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Inclusion Criteria:
Being over 18 years old
Being fluent in English
Have a valid driver license for at least one year
have normal vision or corrected vision only wearing contact lenses

Exclusion Criteria:
NA
Education, Mental & Behavioral Health, Women's Health
Not applicable
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State College, PA ,

Defining the role of slow eye movements on limb motor control in younger and older adults

The purpose of this study is to define how eye movements contribute to eye-hand coordination in individuals of the age group 18-50 (young adults) and 65-80 (older adults). Specifically, the aim of the study is to understand how slow eye movements affect arm and hand movements. All procedures to be used in our study will be non-invasive. The task during the study will be performed with a robotic handle that participants will grasp with their right hand. They will interact with visual stimuli by moving the robotic handle. The robotic environmentwill attempt to simulate real-world mechanical interactions, such as those experienced during catching a ball.

During this study, we will ask you to come to our laboratory located in 23 Recreation Building,Pennsylvania State University, on two days separated by a maximum of 48 hours. Both sessions will last approximately 90-120 minutes. During the first session, we will review the procedures with you and if you agree to participate, you will sign this form and then proceed to perform the study. You will perform about 20-25 blocks of hand movements. Each block will consist of 24-30 trials and each trial will last between 3-5 seconds.The second day will be identical to the first day but the order of trials within a block will be changed.

$10/hour

Yes
 

Tarkeshwar Singh
Tarkesh Singh - at tsingh@psu.edu or 814-865-7851
Kinesiology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00024035
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Inclusion Criteria:
Participants should be between 18-80 years old.
Participants will be right-hand dominant individuals.
They will have normal or corrected-to-normal vision.
Participants should be able to sit upright in a chair for long periods (up to 2 and a half hours) with rest.
Participants should be able to grasp and move objects with both hands.

Exclusion Criteria:
Any history of neurological disorders.
Any history of musculoskeletal disorders
Eye or vision problems (e.g., cataracts, glaucoma, a detached retina or macular degeneration).
Cognitive impairment
Medication that could make the participant drowsy or tired during the experiment.
Neurology, Muscle & Bone, Vision & Eyes
Not applicable
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State College, PA ,

Respect and Satisfaction in Same-Sex Romantic Relationships

The purpose of this study is to expand on previous research looking at respect and relationship satisfaction among heterosexual relationships and compare it to that of same-sex relationships to find where they are similar or different. Participants will complete self-report measures regarding their romantic relationships, including respect toward partner, satisfaction, and attitudes toward love. 30 minutes will be required for the study.

No
 

Michelle Yarwood
Michelle Yarwood - at mxg925@psu.edu or 814-867-4851
Psychology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00014276
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Inclusion Criteria:
age 18 years or older

Exclusion Criteria:
younger than 18 years of age
Men's Health, Mental & Behavioral Health, Women's Health
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Identifying views of Military Veterans Regarding Contemporary War and Conflict Reporting

This study will involve surveying and interviewing US military veterans and non-veterans regarding their perceptions of the quality, accuracy, and themes of contemporary war and conflict reporting.

No
 

Hans Schmidt
Hans Schmidt - at hcs10@psu.edu or 610-892-1251
Academic Affairs (BRANDYWINE)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00007749
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Inclusion Criteria:
College Student
Military Veteran
Current Member of the Military
Non-Military Civilians

Exclusion Criteria:
Under age 18
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Daily Thought Monitoring Study for Anxiety and Depression

This study aims to assess the relations among our daily thought patterns, positive emotions, everyday experiences, and cognitive functioning abilities. Eligible participants will complete a series of online questionnaires, a short 15- to 25-minute psychological interview, and brief cognitive functioning tests at Day 1 and Day 16. All visits will occur via Zoom. In between study visits on Day 1 and Day 16, they will be prompted to complete smartphone-delivered assessments of cognitive functioning, symptoms, and experiences for 14 days, 5 times a day. This is important to inform clinicians and researchers on how best to develop effective digital mental health therapies.

During Day 1, participants will undergo a brief 15- to 25-minute clinical interview over Zoom. After the clinical interview, if participants meet the study eligibility criteria, we will continue with the procedures outlined below. Otherwise, if they are ineligible for the study, we will mention that this study is not suitable for them and provide the contact of mental health treatment services. Eligible participants will then conduct a series of self-report questionnaires and performance-based cognitive functioning tests for the next 35 minutes. Participants will then complete a series of 14-day brief ecological momentary assessments administered on their smartphone five times a day, for 14 days. Last, participants will return for a 35- to 45-minute visit on Day 15 to complete a series of self-report questionnaires and performance-based cognitive functioning tests.

15

No
 

Michelle Newman
Seung Yeon Baik - at sbb5887@psu.edu or 814-996-9787
Psychology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00018534
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Inclusion Criteria:
Over 18 years of age
Owns an Android or iPhone
Fluent in the English language
Scores on self-report questionnaires suggest person does or does not struggle with depression and/or anxiety
Pregnant women will be allowed to participate

Exclusion Criteria:
Owns a Life’s Good Android phone brand that does not support the app
Unable to consent
Younger than 18 years of age
Reports struggling with suicidal thoughts
Judged to have alcohol, substance use, and/or eating disorder
Men's Health, Mental & Behavioral Health, Women's Health
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Understanding Information Needs and Challenges faced by International Spouses during Adjustment

The study examines ways in which technology can be designed to provide support and services to international spouses during their adjustment to a new host environment. In particular, we would like to investigate the needs of spouse’s communities, the challenges faced by this population during adjustment, and propose design implications for developing systems and services to improve their access to social services and to promote community development and civic engagement.

Yes
 

Jomara Sandbulte
Jomara Binda - at jmb89@psu.edu
Information Sciences and Technology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00007486
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Inclusion Criteria:
Individuals who understand English
Individuals who hold a dependent (F-2/J-2) visa status

Exclusion Criteria:
Non-English speakers
Age under 18
Non-dependents (F-2/J-2) visa status
Anyone who cannot consent to participate in this study
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State College, PA ,

Attention and Emotional Development in Children

Children with attention problems often feel anxious or worried, and likewise, children who are anxious or worried often have problems with attention. We are looking for children aged 8-12 who may or may not have problems with attention or anxiety to help us understand what happens in the brain that could explain why. You will receive up to $100 gift card for your participation, and informal clinical feedback on your child.

Two in person visits of 2 hours each to the University Park campus, scheduled at the participant(s) convenience

$100

Yes
 

Cynthia Huang-Pollock
Christina Hlutkowsky - at ChildAttention@psu.edu or 814-863-0250
Psychology (UNIVERSITY PARK)
 

All
All
This study is also accepting healthy volunteers
STUDY00005954
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Inclusion Criteria:
Children aged 8-12

Exclusion Criteria:
Children outside of the 8-12 age range
History of seizures or photosensitive epilepsy
Children's Health, Mental & Behavioral Health
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Altoona, PA ,
State College, PA ,

PSCI# 18-049 A PHASE II, DOUBLE-BLINDED, PLACEBO-CONTROLLED RANDOMIZED TRIAL OF SALVAGE RADIOTHERAPY WITH OR WITHOUT ENHANCED ANTI-ANDROGEN THERAPY WITH APALUTAMIDE IN RECURRENT PROSTATE CANCER

To determine whether, in men with post-prostatectomy PSA recurrences, salvage radiation (SRT) with enhanced anti-androgen therapy with apalutamide will improve biochemical progression-free survival (bPFS) compared to SRT alone.

To determine whether, in men with post-prostatectomy PSA recurrences, salvage radiation (SRT) with enhanced anti-androgen therapy with apalutamide will improve biochemical progression-free survival (bPFS) compared to SRT alone.

Yes
 

Joseph Miccio
Kathleen Rizzo - at kar23@psu.edu
Radiation Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03371719
SITE00000428
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Inclusion Criteria:
Pathologically (histologically) proven diagnosis of prostate adenocarcinoma.
Post-prostatectomy patients with a detectable serum PSA (≥0.1, but ≤1.0 ng/mL) at study entry (within 90 days of Step 1 registration) a
pN0 or pNx
History/physical examination within 90 days prior to Step 1 registration
Karnofsky performance status of 70-100 within 90 days prior to Step 1 registration

Exclusion Criteria:
Definitive clinical, radiologic, or pathologic evidence of metastatic disease (M1) or lymph node involvement (N1)
Prior invasive malignancy (except non-melanomatous skin cancer, carcinoma in situ of the male breast, penis, oral cavity, or stage Ta of the bladder, or stage I completely resected melanoma) unless disease free for a minimum of 2 years
Prior systemic chemotherapy for the study cancer
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
Prior whole gland ablative therapy
Cancer
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Hershey, PA ,

Study Driver Characteristics in Mixed Traffic with a Driving Simulator

This is a driving simulator behavioral study. This study aims to investigate drivers' subjective feelings and driving performance in mixed traffic shared by automated vehicles and human-driven vehicles.

This study aims to investigate the effects of drivers’ driving style and automated vehicle penetration rate on drivers’ subjective feelings and driving performance in mixed traffic shared by automated vehicles and human-driven vehicles. There will be one in-person visit for the experiment. This experiment involves driving on a driving simulator and filling out several questionnaires.

$15/hour

Yes
 

Yiqi Zhang
Book Chen - at hbc5417@psu.edu
Industrial and Manufacturing Engineering (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00020200
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Inclusion Criteria:
Being fluent in English
Have a valid US driver license for at least one year
Have normal vision or corrected vision only wearing contact lenses

Exclusion Criteria:
NA
Education, Mental & Behavioral Health, Language & Linguistics
Not applicable
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State College, PA ,

Second Language Learners’ Language Development in Different Modes: Focusing on Complexity, Accuracy, and Fluency

The current study aims to investigate the development of English as a Second Language (ESL) learners' language skills over time, focusing on the interplay between the mode of production (i.e., speech versus written mode) and linguistic features related to complexity, accuracy, and fluency. To address this question, the study will collect spoken and written data from ESL learners in the U.S. at five measurement points throughout an academic year (FA23 to SP24), analyzing their production data using various complexity, accuracy, and fluency measures. The objective is to contribute to the existing body of second language (L2) development research by examining whether the interaction among time, production mode, and proficiency, as well as the varying relationships among the measures, significantly influence the observed outcomes.

Over the course of an academic year (FA23 to SP24), participants will attend five in-person visits, spaced at 7-week intervals. During each visit, they will be asked to write an essay for 20 minutes and deliver a 5-minute spoken monologue in response to prompts similar to those found in the TOEFL speaking section.

$75 ($15 per visit)

Yes
 

Minjin Kim
Minjin Kim - at mmk6337@psu.edu
Division of Graduate Studies (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00022713
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Inclusion Criteria:
18 or older
non-native English speakers
first-year undergraduate students or students in Intensive English Communication Program

Exclusion Criteria:
younger than 18
native English speakers
not living in the US
Education, Language & Linguistics
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State College, PA ,

Asymmetries in Cognitive Aspects of Motor Control and Learning

This study will improve our understanding of movement control and how strokes of different sides affect overall independence. Participants will complete the visit seated at a chair with sensors connected to the less-affected arm. They will then play a short virtual reality game and complete several questionnaires and assessments.

Yes
 

Robert Sainburg
Shanie Jayasinghe - at sjayasinghe@pennstatehealth.psu.edu or 717-531-0003, ext=283146
Kinesiology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00015871
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Inclusion Criteria:
Right handed (pre-stroke)
Neurological confirmation of unilateral stroke
Severe paresis on one side only
Adults over the age of 18
Chronic stage of stroke (>3 months post stroke)

Exclusion Criteria:
Left-handed (pre-stroke)
Neuro radiological confirmation of extensive periventricular white matter changes
History of neurological diseases other than stroke
Significant joint pain that is activity limiting
Neurology
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Hershey, PA ,

PSCI# 24-014 OPTIMICE-PCR: DE-ESCALATION OF THERAPY IN EARLY-STAGE TNBC PATIENTS WHO ACHIEVE PCR AFTER NEOADJUVANT CHEMOTHERAPY WITH CHECKPOINT INHIBITOR THERAPY

this trial is examining what happens if a less toxic therapy is given to triple negative breast cancer subjects who's tumor is completely gone after receiving pre surgery chemotherapy.

Participants will need to come to all research visits, reports any side effects of medication, if they are taking any over the counter medications.

Yes
 

Cristina Truica
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
NCT05812807
STUDY00024629
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Inclusion Criteria:
Age ≥ 18 years
ECOG Performance Status 0-2
Triple Negative Breast Cancer
Patients must have received neoadjuvant chemotherapy in combination with pembrolizumab for a minimum of 6 cycles. All systemic chemotherapy must have been completed preoperatively.
An interval of no more than 12 weeks between the completion date of the final surgery and the date of randomization.

Exclusion Criteria:
No stage IV (metastatic) breast cancer
No history of any prior (ipsi- or contralateral) invasive breast cancer. Prior DCIS is allowed.
No evidence of recurrent disease following preoperative therapy and surgery.
No known active liver disease, e.g. due to HBV, HCV, autoimmune hepatic disorders, or sclerosing cholangitis
Cancer
Approved drug(s)
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Hershey, PA ,

Advanced fMRI Study on the Functional Abnormality of BNST in Anorexia Nervosa Restricting-type

This research is being done to better understand how certain parts of the brain may react differently in people who have a particular eating disorder, anorexia nervosa, which may help us understand why they respond to food in the way they do. This may help us design more effective treatments for people with anorexia nervosa.

You will complete a package of surveys for personality, psychopathology, an evaluation of taste functions, and an MRI/fMRI examination.

Up to a total of $100.

Yes
 

Jian-Li Wang
Nicholas Corbett - at ncorbett@pennstatehealth.psu.edu or 717-531-0003, ext=323023
Radiology (HERSHEY)
 

Female
All
This study is also accepting healthy volunteers
STUDY00021467
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Inclusion Criteria:
Age 10 to 24 years-old female
Anorexia nervosa restricting type patients
Healthy volunteer with normal body weight
Right-handed
Fluent in written and spoken English

Exclusion Criteria:
Left-handed
Pregnancy or breastfeeding
History of diabetes, substance abuse, head trauma
Allergy to milk and milk products
Cannot have MRI due to claustrophobia or specific implants
Children's Health, Mental & Behavioral Health
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Hershey, PA ,

Audio-based mental health intervention study

This study tests the effect of an audio-based mental health intervention for symptoms of depression. Participants will be asked to listen to an audio program and perform exercises to support their mental health as suggested by the program. Participants will be asked to complete questionnaires about their depression and related mental health symptoms at pre-intervention, mid-intervention, post-intervention, and follow-up.

The study takes place over five total weeks, with four survey sessions (the first two of which are live on Zoom), and two weeks of brief daily surveys. Detailed information is below.For the first day, participants would be asked to complete Visit 1, which involves an interview, listening to a mental health audio program, and completing surveys. One week later, participants would be asked to complete Visit 2, which involves listening to another mental health audio program and completing surveys. One week after that, participants would be asked to complete Visit 3, which involves completing surveys. Three weeks after that, participants would be asked to complete Visit 4, which involves completing surveys. For the week following Visits 1 and 2, participants would also be asked to complete daily surveys.

Up to $40

No
 

Gavin Rackoff
Gavin Rackoff - at gnr18@psu.edu
Psychology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT05555745
STUDY00020667
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Inclusion Criteria:
Age 18 or older
Moderate or higher depression symptoms as indicated by survey and interview

Exclusion Criteria:
Below 18 years of age
Score below moderate depression symptom range in survey and/or interview
Mental & Behavioral Health
Not applicable
I'm interested
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See this study on ClinicalTrials.gov

SHIELD

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

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

Yes
 

Nancy Olsen
Jamie Carter - at jcarter3@pennstatehealth.psu.edu or 717-531-4921
Medicine: Rheumatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05799378
SITE00001380
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Inclusion Criteria:
Have a diagnosis of systemic lupus
Be treated with hydroxychloroquine for at least 7 years
60 years of age or older
stable disease without recent flares

Exclusion Criteria:
abnormal eye exam related to use of hydroxychloroquine
taking more than 5 mg/day prednisone
any signs of active lupus disease.
Infectious Diseases & Immune System, Arthritis & Rheumatic Diseases
Not applicable
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Hershey, PA ,

Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer (PSCI# 21-217) (NRG-GU010)

The purpose of this study is to use the Decipher risk score to guide intensification (for higher Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment to better match therapies to an individual patient’s cancer aggressiveness. The study will test your tumor tissue for many different genes that all together indicate the risk of your cancer spreading; this is called the Decipher risk score. If you have a higher Decipher risk score, you will be assigned to the part of the study that compares the use of 6 months of hormone therapy and radiation treatment (usual treatment) to the use of darolutamide (BAY 1841788) plus the usual treatment. The purpose of this study is to determine whether the additional drug can reduce the chance that your cancer will come back and spread.

The purpose of this study is to use the Decipher risk score to guide intensification (for higher Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment to better match therapies to an individual patient’s cancer aggressiveness.The study will test your tumor tissue for many different genes that all together indicate the risk of your cancer spreading; this is called the Decipher risk score.If you have a higher Decipher risk score, you will be assigned to the part of the study that compares the use of 6 months of hormone therapy and radiation treatment (usual treatment) to the use of darolutamide (BAY 1841788) plus the usual treatment. The purpose of this study is to determine whether the additional drug can reduce the chance that your cancer will come back and spread.

Yes
 

Joseph Miccio
psci-cto@pennstatehealth.psu.edu 717-531-5471
Radiation Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05050084
SITE00001119
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Inclusion Criteria:
Age ≥ 18
ECOG Performance Status of 0-2 within 120 days prior to registration;
For patients with a history of hepatitis C virus (HCV) infection must have been treated and cured.
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months

Exclusion Criteria:
Definitive clinical or radiologic evidence of metastatic disease
Previous bilateral orchiectomy
Prior radiotherapy to the prostate/pelvis region that would result in overlap of radiation therapy fields.
Active testosterone replacement therapy; any replacement therapy must be stopped at least 30 days prior to registration
Inability to swallow oral pills.
Cancer
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A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab (CDX-0159) in Adults with Active Eosinophilic Esophagitis (The “EvolvE” Study)

This is a phase 2, randomized, double-blind, placebo-controlled, parallel-group study evaluating the efficacy and safety profile of barzolvolimab (CDX-0159) in patients with active EoE. The study will enroll approximately 60 patients.This study consists of four distinct phases lasting approximately a year. Each patient will receive 1 dose (2 injections) every 4 weeks. The participants will be required to sign the informed consent before any procedures are performed. If eligible for screening, they will need to have standard lab tests (blood and urine), EKG, pregnancy test if applicable, and tests for COVID-19. They will also be required to have EGD with biopsies done during the screening period and at weeks 12 and 28. If eligible to continue, the participants will be randomized on day 1, when they will receive their first treatment. They will be required to come back to the clinic in two weeks and four weeks after that. They will have to complete the e-diary questionnaires at home.

There will be ten in person visits, including screening, placebo-controlled treatment and active (open label) treatment. In addition, there are four follow up visits every 4 weeks. The participants must sign the informed consent. There are going to have vital signs checked at every visit. Some visits have a physical exam. There are blood tests, urine tests, ECG, and COVID -19 tests done. The participants will have EGD procedure with biopsies at screening, and at 12 and 28 weeks of treatment. There will be four study treatments administered in the clinic. The concomitant medications, and adverse events will be monitored and documented. Serum and urine pregnancy tests will be performed if applicable. Participants will be asked to complete electronic diary daily.

$75 per visit; you may receive travel reimbursement $50, and $50 meal compensation for visit 1, 2, 5, 7, and 9

Yes
 

Kofi Clarke
Z. Stella Chroneos - at zchroneos1@pennstatehealth.psu.edu or 717-531-8259
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05774184
STUDY00022619
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Inclusion Criteria:
Read, understood, and provided written informed consent
Male or female, ≥ 18 years of age
Documented diagnosis of EoE by endoscopy
Must be symptomatic, with dysphagia twice a week
Must have been on a stable diet

Exclusion Criteria:
Diagnosis of hypereosinophilic syndrome
Known active Helicobacter pylori infection
History of achalasia, Crohn’s disease, ulcerative colitis or celiac disease.
Esophageal dilation within 3 months prior to screening visit
Women who are pregnant or nursing.
Digestive Systems & Liver Disease
Experimental drug compared to a placebo/”sugar pill”
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Drawing and Anxiety Study Phase 2

This study will test the efficacy of novel guided drawing activities for reducing anxiety in young adults

For this study, your teen will be asked to in a 90 minute in-person lab visit. Cardiac data will be recorded as your teen engages in a drawing activity. Your teen will also answer questionnaires during the visit and again approximately one week later, online via Qualtrics. This final questionnaire will take approximately 30 minutes to complete.

$25

Yes
 

Sarah Myruski
Bridget Cahill - at bqc5600@psu.edu
Psychology (UNIVERSITY PARK)
 

All
Younger than 18 years old
This study is also accepting healthy volunteers
NCT00000000
STUDY00021234
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Inclusion Criteria:
Youth must be at least 13 years of age and no more than 17 years of age at the time of recruitment
Youth must be able to speak, understand and read English.

Exclusion Criteria:
1.Youth who are not at least 13 years of age or are 18 years of age or older at the time of recruitment.
2.Youth who cannot speak, understand, and read English.
Education, Mental & Behavioral Health
Not applicable
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State College, PA ,

A Phase 2a/b, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of OG-6219 in 3 Dose Levels, in Women 18 to 49 Years of Age with Moderate to Severe Endometriosis-related Pain

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

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

$1477.00

Yes
 

Stephanie Estes
Amyee McMonagle - at amcmonagle@pennstatehealth.psu.edu or 717-531-4484
Medicine: Endocrinology, Diabetes and Metabolism (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05560646
SITE00001406
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Inclusion Criteria:
premenopausal women
age 18-49
documented surgical diagnosis of endometriosis
moderate to severe endometriosis pain
regular menstrual cycles

Exclusion Criteria:
hysterectomy or bilateral oophorectomy
chronic pelvic pain not endometriosis related
pregnant or breastfeeding
hereditary abnormal hemoglobin or hemolytic anemia
uncontrolled hypertension
Women's Health
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

A PHASE III, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF ADJUVANT GIREDESTRANT COMPARED WITH PHYSICIAN'S CHOICE OF ADJUVANT ENDOCRINE MONOTHERAPY IN PATIENTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE EARLY BREAST CANCER (PSCI# 20-133) (GO42784)

The purpose of this study is to compare the effects, good or bad, of giredestrant versus an approved endocrine therapy (a treatment that blocks or removes hormones), on patients with breast cancer. In this study, subjects will get either giredestrant or a drug chosen specifically by the study doctor. Subjects can participate in this study based on breast cancer characteristics, current condition, and how well previous anti-cancer therapies were tolerated.

• You should not join another research study.• For women: If you can become pregnant, you must use a reliable non-hormonal birth control method during the study and for 9 days after your final dose of giredestrant or, if you are in the group receiving approved endocrine therapy prescribed by the study doctor, a period of time that your study doctor will discuss with you. This will be 21 days after if you are prescribed letrozole or anastrozole, 30 days after if you are prescribed exemestane, and 60 days after if you are prescribed tamoxifen. Talk with your study doctor about what birth control method may be best for you. Depending on the study treatment you receive, you might be restricted from donating eggs during this same period. Tell your study doctor right away if you get pregnant during this period. If you get pregnant, the study doctor will want to follow up with you on the outcome of the pregnancy and collect information on the baby.• For men: you must agree to take precautions as outlined below for each treatment arm:–If you are in the group receiving approved endocrine therapy prescribed by the study doctor, you study doctor will discuss with you what precautions you will need to take.–If you are in the group receiving giredestrant, and your partner is pregnant or able to become pregnant, you must use a condom during the study and for 9 days after your final dose of giredestrant. This will be 21 days after if you are prescribed letrozole or anastrozole, 30 days after if you are prescribed exemestane, and 90 days after if you are prescribed tamoxifen. You must not donate sperm during this same period. Tell your study doctor right away if your partner becomes pregnant during these periods. The study doctor or research staff will advise you of the possible risks to your unborn child and will make an effort to contact your partner to get her permission to collect information about the pregnancy and the baby. No matter what your partner decides, you can continue to take part in this study.• You should not use certain medications during this study. Your study doctor will talk to you about these medications.

Yes
 

Monali Vasekar
Kelly Hansard - at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5317
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04961996
STUDY00019397
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Inclusion Criteria:
Participants (females, regardless of menopausal status, and males) who are age  18 years at the time of signing the Informed Consent Form
Participants who have documented ER+ tumor by immunohistochemistry, as assessed locally on a primary disease specimen and defined as  1% of tumor cells stained positive according to the ASCO/College of American Pathologists (CAP) guidelines
Participants who have documented HER2- tumor, as assessed locally on a primary disease specimen and defined according to ASCO/CAP guidelines
Participants must have undergone definitive surgery of the primary breast tumor(s)
Participants who received or will be receiving adjuvant chemotherapy must have completed adjuvant chemotherapy prior to randomization

Exclusion Criteria:
Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 9 days after the final dose of giredestrant, or within the time period specified per local prescribing guidelines after the final dose of TPC
Participants who have received treatment with investigational therapy within 28 days prior to initiation of study treatment or is currently enrolled in any other type of medical research
Participants receiving or planning to receive a CDK4/6i as adjuvant therapy
Participants who have active cardiac disease or history of cardiac dysfunction
Participants who have been diagnosed with Stage IV breast cancer
Cancer
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Hershey, PA ,

A Randomized Controlled Pilot Study of the Use of Cannabidiol in the Management of Endometriosis Pain

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

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

$175

Yes
 

Kristin Riley
Robinn Moyer - at rmoyer3@pennstatehealth.psu.edu or 717-531-6272
Obstetrics and Gynecology (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04527003
STUDY00013752
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Inclusion Criteria:
Females ages 18-45 years at the time of enrollment
Diagnosed with endometriosis by surgical diagnosis with direct visualization and/or histopathologic confirmation of endometriosis

Exclusion Criteria:
Women that are pregnant, breastfeeding or trying to conceive
Women with chronic daily opioid use ( > 14 days / month)
Women that are currently using Cannabis based products
Non-English speaking or inability to read and understand English
Pain Management, Women's Health
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Hershey, PA ,

Eye-hand coordination during upright stance

The study will determine how the brain controls eye and hand movements during quiet upright stance.

There will be one visit to the lab (approximately 2 hours) in which participants will be required to make reaching movements towards virtual targets while standing upright. Participants will be required to wear comfortable shoes.

$20

Yes
 

Tarkeshwar Singh
Tarkeshwar Singh - at tsingh@psu.edu or 814-865-7851
Kinesiology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00019952
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Inclusion Criteria:
1)Participants should be between 18-65 years old
3)Participants will be right-hand dominant individuals
4)They will have normal or corrected-to-normal vision
5)Participants should be able to stand upright for long periods (up to 2 and a half hours) with rest every 5-10 minutes or as requested by the participant
6)Participants should be able to grasp a handle and move objects with both hands

Exclusion Criteria:
Any history of neurological disorders (e.g., Parkinson’s disease, Alzheimer’s disease, Multiple Sclerosis)
Any history of musculoskeletal disorders (e.g., carpal tunnel syndrome)
Any history of cardiovascular disease (e.g., Coronary Artery disease, Peripheral Artery disease, Carotid Artery disease, Hypertension, Congenital Heart disease, Congestive Heart failure, Myocardial Infarction, Cardiac Arrythmias, Stroke).
Any history of conditions or diseases that increase risk for syncope (e.g., Anemia, Myocardial Ischemia, Kidney disease).
Any history of conditions or diseases of the vestibular system
Neurology, Vision & Eyes
Not applicable
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State College, PA ,

Multimodal brain MRI-guided understanding of non-motor outcomes in Parkinson's post DBS

This study will explore the relationship between multimodal brain MRI findings and cognitive/mood outcomes in Parkinson's Disease (PD) patients following Deep Brain Stimulation (DBS). Patients already planning to undergo DBS for PD who choose to take part in this study will have study visits before and after DBS to collect motor, neurobehavioral and physical therapy measurements.

Patients who are already planning to undergo DBS for PD who choose to take part in this study will have study visits before and after DBS surgery to collect motor, neurobehavioral and physical therapy measurements. While many of these components are part of as standard of care, some assessments will need to be collected specifically for research purposes. There are two in-person visits (one before DBS surgery and one approximately 3-6 months after surgery). As part of the study, an MRI to gather data to answer our research questions will be conducted. This is in addition to the clinical MRI that is part of the regular assessment to determine if an individual is suitable for the DBS surgery.

$130 if components of study are completed

Yes
 

Sol De Jesus
Amanda Snyder - at TBRC@pennstatehealth.psu.edu or 717-531-5233
Neurology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00016574
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Inclusion Criteria:
Age at least 18
Diagnosed with Parkinson's Disease
Undergoing DBS as part of standard of care
Able to provide informed consent

Exclusion Criteria:
Age less than 18
General contraindications to surgery
Pregnant or nursing women
Unable to undergo MRI for any reason
Atypical Parkinsonism
Neurology
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Hershey, PA ,

Using Exercise to Relieve Arthralgia (Joint Pain) and Improve AI Adherence in Older Survivors (REJOIN): A Pilot Study

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

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

$160

Yes
 

Nancy Olsen
Nancy Olsen - at nolsen@pennstatehealth.psu.edu
Medicine: Rheumatology (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03955627
STUDY00010776
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Inclusion Criteria:
Age 60 and older
Female
Breast Cancer Survivor
Preparing to Start AI medication
ER+ diagnosis

Exclusion Criteria:
Already taking AI medication (greater than 24 weeks)
Gross Cognitive Impairment
Recent Joint Surgery
Cardiac event/Stroke within last 6 months
Not willing to come to HMC for Exercise Sessions
Cancer
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Hershey, PA ,