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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 ,

PSCI 23-002 CAMBRIA-2: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients with ER+/HER2-Early Breast Cancer and an Intermediate-High or High Risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease

We are asking you to take part in this voluntary research study because you have ER+/HER2- early breast cancer with no evidence of disease following surgery. The purpose of this voluntary research study is to better understand the studied disease and associated health problems.

Participants will be required to come to all study visits, take the medication an instructed, let the study team know what medications you are taking, especially over the counter ones and to report any changes in how you are feeling.

Yes
 

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

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05952557
STUDY00024347
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Inclusion Criteria:
Capable of giving signed informed consent
Patient must be ≥18 years
histologically confirmed ER+/HER2- early-stage resected invasive breast cancer

Exclusion Criteria:
inoperable locally advanced breast cancer
a history of previous breast cancer
Chronic gastrointestinal disease
Major surgical procedure or significant traumatic injury within 2 weeks of randomisation
Cancer
Experimental drug compared to an approved drug
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Hershey, 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 environment will 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 ,

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 ,

A randomised, double-blind, placebo-controlled, multicentre, Phase III trial evaluating long-term efficacy and safety of survodutide weekly injections in adult participants with noncirrhotic non-alcoholic steatohepatitis/metabolic associated steatohepatitis (NASH/MASH) and (F2) - (F3) stage of liver fibrosis

This is Phase III study to test whether survodutide (BI 456906) helps people with a liver disease called NASH/MASH who have moderate or advanced liver fibrosis. The purpose of the study is to find out whether the study drug works and how safe it is in participants diagnosed with MASH and liver fibrosis over a long-term treatment. To answer these questions, the study drug will be compared with a placebo. The overall study duration will be up to 7 years.

If you enroll in this study, you will undergo a series of testing. You will be asked to complete an initial assessment that includes a physical exam, vital signs, waist circumference, height, and weight measurements, questionnaires, a liver biopsy, blood draws, ECG, fibroscan, eye examination, and pregnancy test, if applicable. You will be randomized to either Survodutide once weekly or placebo (an inactive substance of no medical value). For treatment, you will be trained to inject yourself once a week with the study medicine. There will be 12 in person visits over the first year, and then - every 3 months within next 6 years - to re-supply the study drug and do safety testing. There will be up to 28 phone calls with the study staff.

$3,550 over 7 years

Yes
 

Karen Krok
Nataliya Smith - at stinelaboratory@pennstatehealth.psu.edu or 717-531-0003, ext=320223
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06632444
STUDY00025307
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Inclusion Criteria:
Age ≥18 years
MASH/NASH diagnosis
Stage 2 or 3 fibrosis
able to provide consent

Exclusion Criteria:
causes of chronic liver disease other than NAFLD
Chronic alcohol or drug abuse
Cirrhosis
Digestive Systems & Liver Disease
Experimental drug compared to a placebo/”sugar pill”
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Hershey, 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:
Native English speaker
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 ,

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 ,
Reading, 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 $150.

Yes
 

Jian-Li Wang
Xioayu Wang - at xwang13@pennstatehealth.psu.edu or 717-531-5857
Radiology (HERSHEY)
 

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

Exclusion Criteria:
History of diabetes, substance abuse, head trauma
Pregnancy or breastfeeding
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 ,

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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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 ,

The Ecology of Infant Emotion-Regulation

This study aims to understand how emotion regulation in infants develops within the context of family and community support. We're particularly interested in the relation between mother-infant synchrony, facilitated by family and community support, and infant emotion regulation. We will use a multi-method approach to collect simultaneous brain activation in mothers and infants, infant's physiological responses, and information about family and community support.

Participants complete an online survey, then come in for 1 in-person visit. This research aims to find out how patterns of brain activation in infants and mothers and infant physiological responses relate to the real life, face-to-face interactions that mothers and babies usually engage in.

50

Yes
 

Eunkyung Shin
Eunkyung Shin - at ems7249@psu.edu or 540-200-7894
Psychology (UNIVERSITY PARK)
 

All
All
This study is also accepting healthy volunteers
STUDY00025290
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Inclusion Criteria:
Infants who are 4 - 9 months and their mother.
Infants born 3 weeks within their due date.
Infants of a birth weight > 2500 g.
Infants with NO serious medical complications.
English-speaking families.

Exclusion Criteria:
Infants who were < 2500 g at birth.
Infants who experienced any serious medical complications.
Infants who were born > 3 weeks before the indicated gestational period.
Families who do not understand and do not speak English
Children's Health, Neurology
Not applicable
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Altoona, PA ,
State College, 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 ,

Assessment of nocturnal hypoventilation in amyotrophic lateral sclerosis

The overall goals of this study are to identify how measurement of carbon dioxide during sleep can improve recognition of respiratory distress in neuromuscular disease and thus improve timely access to respiratory therapies which prolong survival. Subjects in this study will participate for up to one year, during which their carbon dioxide levels will be measured in clinic and in their homes during sleep.

Subjects in this study will participate for up to one year, during which their carbon dioxide levels will be measured using deviced attached to the skin while in clinic and in their homes during sleep. Subjects will also complete surveys at the time of clinic visits.

50

Yes
 

Andrew Geronimo
Andrew Geronimo - at ageronimo@pennstatehealth.psu.edu
Neurosurgery (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00017603
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Inclusion Criteria:
Diagnosis of amyotrophic lateral sclerosis
18 years of age or older.
Plan to be followed up in person in the Hershey ALS Clinic for the next 12 months.
Experiencing early respiratory change.
Able to perform or have assistance performing home CO2 measurements.

Exclusion Criteria:
In hospice or in active transition to hospice
Use of any type of non-invasive ventilation, except in the case of CPAP for obstructive sleep apnea, or have a tracheostomy
Use of diaphragm pacer
Pre-existing pulmonary disease requiring supplemental oxygen for any portion of the day or night
Neurology
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Hershey, PA ,

PSCI 23-121 Phase III Randomized Trial of Stereotactic ablative radiotherapy (SAbR) for Oligometastatic Advanced Renal Carcinoma (SOAR)

This study is looking at patients with oligometastasis comparing chemotherapy and SABR with chemotherapy alone

• Blood counts and blood chemistry done at initiation and every three months to make sure you are not having any side effects from the study affecting your blood counts. • CT or MRI scans done at initiation and every three months to monitor the response of the treatment to your cancer • Physical exams done every three months to confirm your general well-being and to detect side effects from the study. Compete physical and well being form as set below: • Baseline • 3 months from start of treatment • 6 months from start of treatment • 9 months from start of treatment • 12 months from start of treatment • 18 months from start of treatment • 24 months from start of treatment

Yes
 

Stuthi Perimbeti
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
NCT05863351
STUDY00023912
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Inclusion Criteria:
must be 18 or older
patient may not have brain metastases
Patient may have any RCC histology except a histology that has a sarcomatoid component.
Patient must have a pathologically (histologically or cytologically) proven diagnosis of renal cell carcinoma (RCC) prior to randomization.
Patient must have primary site addressed by local therapy. If the primary RCC is intact, the patient must undergo local treatment to the primary before randomization.

Exclusion Criteria:
Patient must not have received any prior systemic therapy (except for adjuvant setting, see 3.1.9) for metastatic RCC.
Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used
Patients must not expect to conceive until after 6 months after the last dose of protocol medication
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured.
In order to participate in the QOL portion of the protocol, the patient must speak English or Spanish.
Kidney & Urinary System, Cancer
Approved drug(s)
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Hershey, PA ,

The association between perceived parenting styles, intolerance of uncertainty, and anxiety among young adults

This study aims to understand the association between young adults' perceived parenting, intolerance of uncertainty, and trait anxiety. Participant will be asked to complete a questionnaire that aims to answer the environment and parenting beliefs around which they were brought up, and if they face stressors and anxieties associated with them. This is a correlational study

No
 

Aishwarya Sastry
Aishwarya Sastry - at ams9680@psu.edu
Behavioral Sciences and Education (HARRISBURG)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00015652
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Inclusion Criteria:
18-34 years old
Geographical location: USA
All genders
All ethnicities

Exclusion Criteria:
Individuals below 18 years
Individuals over 34 years
Individuals residing outside USA
Prevention, Education, Mental & Behavioral Health
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The effects of local negative pressure on forearm and skin blood flow in humans

This study continues our exploration into the mechanisms underlying the control of blood flow. During the experiments, we noninvasively measure skin blood flow (SkBF) and forearm blood flow (FBF) with a FLPI and venous occlusion plethysmography (VOP), respectively. The FLPI uses a low energy laser to measure SkBF. VOP uses blood pressure cuffs on the upper arm and wrist, and an elastic strain gauge encircling the forearm between the cuffs to measure the change in forearm-circumference over time from which we calculate FBF. For each experiment, we collect SkBF and FBF data for a 20-minute baseline, expose the skin of the forearms to negative pressure and then collect SkBF and FBF data for an additional 30-90 minutes. Each subject participates in 2 experiments that differ only in the protocol for the application of negative pressure (i.e. continuous, pulse).

Yes
 

Lacy Alexander
Gabie Dillon - at gad27@psu.edu
Kinesiology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00012607
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Inclusion Criteria:
Men and women aged 18-40 years

Exclusion Criteria:
• Diagnosed cardiovascular, metabolic, or dermatological conditions that may impact the outcome measures of interest.
• Individuals that use nicotine-containing products
Illicit or recreational drug-use
• Taking corticosteroids, anticoagulants, NSAIDS, or blood thinners
Pregnancy
Heart & Vascular
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State College, PA ,

TMIST_EA1151

This study is being done to answer the following question: Can tomosynthesis mammography, three-dimensional x-ray imaging of the breast, lower your chance of developing life-threatening breast cancer through routine screening compared with digital mammography, two-dimensional x-ray imaging of the breast? We are doing this study because we want to find out which of the two usual approaches to breast cancer screening are better in the early detection of life-threatening breast cancers.

Yes
 

Rebecca Sivarajah
Swati Shah - at sshah@pennstatehealth.psu.edu
Radiology (HERSHEY)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
NCT03233191
SITE00000587
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Inclusion Criteria:
Women age 45 or older and under age 75 at the time of study entry
Patients must be scheduled for, or have intent to schedule, a screening mammogram.
Patients must be able to tolerate digital breast tomosynthesis and fullfield digital mammographic imaging required by protocol.
Patients must be willing and able to provide a written informed consent.

Exclusion Criteria:
Women of childbearing potential must not be known to be pregnant or lactating.
Patients must not have new symptoms or signs of benign or malignant breast disease
Patients must not have had a screening mammogram within the last 11 months prior to date of randomization.
Patients must not have previous personal history of breast cancer including ductal carcinoma in situ
Patients must not currently have breast enhancements (e.g., implants or injections).
Prevention, Cancer, Women's Health
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Hershey, PA ,

A Phase II/III Study of Maintenance Nivolumab versus Observation in HPV Positive OPCA (PSCI# 20-016) (EA3161)

The purpose of this study is to compare the usual treatment alone (radiation and chemotherapy) to adding maintenance nivolumab to the usual treatment. The addition of nivolumab to the usual treatment could shrink your cancer or prevent it from returning. But, it could also cause side effects, which are described in the risks section below. This study will help the study doctors find out if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking to see if the nivolumab increases the lifetime of the patient without progression for 10 years. This immunotherapy drug, nivolumab, is already approved by the FDA for use in advanced and incurable head and neck cancer. But, most of the time it is not used until the cancer is very advanced and chemotherapy stops working. In this study we believe the use of nivolumab has a chance of preventing the cancer from coming back for patients with your type of cancer. There will be about 286 people taking part in the first part (phase II) of the study and 458 more people taking part in second part (phase III), if the results of the phase II portion are promising and if there is evidence that nivolumab may prolong your life.

The purpose of this study is to compare the usual treatment alone (radiation and chemotherapy) to adding maintenance nivolumab to the usual treatment.

Yes
 

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

Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03811015
SITE00000750
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Inclusion Criteria:
Age ≥ 18 years.
ECOG performance status of 0 or 1.
Patients must have oropharynx cancer that is p16-positive by immunohistochemistry
Adequate baseline organ and marrow function
Adequate baseline liver functionality

Exclusion Criteria:
Patients with a history of allergic reactions attributed to platinum based chemotherapy agents
Patients must not have had prior systemic therapy or radiation treatment for p16 positive OPSCC
Patients must not have received previous irradiation for head and neck, tumor, skull base, or brain tumors
Patients must not have known hypersensitivity to nivolumab
Patients with evidence of distant metastases or leptomeningeal disease are excluded
Cancer
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Hershey, PA ,

Factors Influencing the Decision to Report Sexual Violence on Campus

Research project to understand why students do or do not choose to report sexual assault exposure to police or university officials.

One interview via video conferencing or in person. Optional follow up interview via video conferencing.

$35 for initial interviews; $12 for follow ups

No
 

Kamaria Porter
Kamaria Porter - at porterkb@psu.edu
Education Policy Studies (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00021495
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Inclusion Criteria:
Woman (cis-gender, nonbinary, Trans women)
experienced unwanted sex, assault, or harassment during higher education study
currently in undergraduate or graduate program
recently graduated, transferred, or pausing higher education program
Racial background is Black, Afro-Latina, Afro-Indigenous, Black Multiracial

Exclusion Criteria:
did not experienced unwanted sex, assault, or harassment during higher education study
Education, Women's Health
Not applicable
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Angiotensin-(1-7) Cardiovascular Effects in Aging

We will investigate the effects of acute intravenous infusion of the hormone, angiotensin-(1-7), on cardiovascular function in healthy older adults in a randomized, double blind, placebo-controlled, crossover study.

Participation in this study will include three separate visits to the Clinical Research Center within the Penn State Milton S. Hershey Medical Center. Participants will first have a screening visit to determine if they are able to participate in this study. If eligible based on the screening visit, they will participate in two study visits separated by at least one week. At each study visit, they will be infused with doses of a placebo or angiotensin-(1-7) for about two hours. Before and at the end of the infusion, we will measure blood pressure and blood flow, nerve activity with an acupuncture-type needle in your leg, and collect blood samples from a small plastic tube (catheter) placed in the arm. Cells will also be collected from inside the vein using the catheter if the participant is willing. The study visits will include intravenous infusion of angiotensin-(1-7) or saline for approximately two hours, starting with increasing doses and holding at a steady-state dose. Endothelial function will be measured and blood samples and endothelial cells (if willing) will be collected at baseline and at the end of infusions. Blood pressure, heart rate, and muscle sympathetic nerve activity via microneurography will be measured throughout the study.

$25 per hour; additional $25 per study visit for cell collection

Yes
 

Amy Arnold
Aimee Cauffman - at acauffman@pennstatehealth.psu.edu or 717-531-1617
Neuroscience and Experimental Therapeutics (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT05301192
STUDY00017401
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Inclusion Criteria:
Age 65 to 80 years
Body Mass Index between 18.5-30 kg/m2
Blood pressure less than 130/80 without medication
No serious chronic medical problems
Fluent in written and spoken English

Exclusion Criteria:
Current smokers
History of cardiovascular, liver, or kidney disease
Taking certain medications (such as SNRIs, NET inhibitors, anticoagulants, glucocorticoids)
Women who are pregnant, nursing, or taking hormone replacement therapy
Evidence of diabetes
Heart & Vascular
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,