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PSCI 24-013 A RANDOMIZED PHASE II, DOUBLE-BLIND, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF AUTOGENE CEVUMERAN PLUS NIVOLUMAB VERSUS NIVOLUMAB AS ADJUVANT THERAPY IN PATIENTS WITH HIGH-RISK MUSCLE-INVASIVE UROTHELIAL CARCINOMA

This trial is looking at what happens to muscle invasive bladder cancer when adding cevumeran to Nivolumab

Participants will be required to keep all study appointments, tell the study doctor about all medications they are taking, report any side effects to the study doctor.

$202 for each visit completed

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06534983
STUDY00025674
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Inclusion Criteria:
muscle-invasive UC of the bladder identified based on computed tomography (CT) or magnetic resonance imaging (MRI) scan of the pelvis, abdomen, and chest as cT3-T4 or N .
Surgical resection of muscle-invasive UC of the bladder or upper tract
Cisplatin ineligible
Absence of residual disease and absence of metastasis,
ECOG performance status of 0 or 1

Exclusion Criteria:
Pregnancy or breastfeeding,
Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment
Any prior neoadjuvant immunotherapy
Adjuvant chemotherapy or radiation therapy for UC following surgical resection
Absence of spleen
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

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

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

Yes
 

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

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

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

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

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

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

Yes
 

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

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

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

A PHASE 2, MULTICENTER, PLACEBO-CONTROLLED,RANDOMIZED, DOUBLE-BLIND, 48-WEEK STUDY TOEVALUATE THE EFFICACY AND SAFETY OF COMBINATIONTHERAPY OF K-877-ER AND CSG452 IN PATIENTS WITHNONCIRRHOTIC NONALCOHOLIC STEATOHEPATITIS (NASH)WITH LIVER FIBROSIS

This is a Phase 2, multicenter, double-blind, randomized, 52-week study to assess the efficacy and safety of K-001 medication compared with placebo in subjects with noncirrhotic NASH with liver fibrosis. This study will look at a study drug, called K-001, for participants with a liver condition called noncirrhotic nonalcoholic steatohepatitis (NASH). This condition is defined by a build-up of fat in the liver, which causes liver damage and inflammation. Due to this damage, the liver does not work as well. If left untreated, NASH can lead to liver fibrosis (scarring of the liver), liver cancer, or liver failure. K-001 is a once daily pill that contains combination of two medicines: K-877-ER and CSG452. The purpose of the study is to find out whether the study drug works and how safe it is in participants diagnosed with NASH with liver fibrosis. To answer these questions, the study drug will be compared with a placebo.

There will be 10 in person visits over 52-week study period. Various procedures will be completed such as a fibroscan, ECG, liver MRI, liver biopsy, blood draws. You will be randomly assigned by chance (like the flip of a coin) to receive the study drugs or placebo (inactive substance). You will be taking a pill once daily.

$1310

Yes
 

Jonathan Stine
Nataliya Smith - at nsmith9@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
NCT05327127
STUDY00023757
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Inclusion Criteria:
Age ≥18 years
NASH diagnosis
Stage 1, 2 or 3 fibrosis

Exclusion Criteria:
Causes of liver disease other than NAFLD
Chronic alcohol or drug abuse
Cirrhosis
History of liver transplant, or subjects listed for liver transplantation
Inability to provide informed consent
Digestive Systems & Liver Disease
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Interaction between cocoa and the fecal microbiome

There is a growing body of data demonstrating that polyphenols from foods including cocoa and chocolate are metabolized by the gut microbiome to produce small molecular weight metabolites that have greater systemic bioavailability and a potential role in the health-related effects of the parent compounds. The objective of this protocol is to collect fecal samples from human subjects, aged 18 - 40 years old, with overweight or obesity (BMI = 25 – 40 kg/m2), to use as a source of gut microbiota. These fecal samples will be used in in vitro fermentation experiments where fecal samples will be mixed cocoa powder or cocoa extracts in buffer. Samples from these fermentation experiments will be analyzed by chemical methods to identify the metabolites present and will be tested in bioassays to determine potential health-related bioactivities. Because biological sex can impact the composition of the microbiome, we plan to recruit both biological males and females.

There will be two in-person visits. Screening and consent collection will be done at the first and participants will receive supplies for stool collection. The participant will collect the stool samples at home and then return the sample at the second visit.

25

Yes
 

Joshua Lambert
Joshua Lambert - at jdl134@psu.edu or 814-865-5223
Food Science (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00024951
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Inclusion Criteria:
aged 18 – 40 yrs old
BMI of greater than 25 to 40 kg/m2
Free of chronic intestinal/colon diseases
Willingness to abstain from consumption of polyphenol-rich foods for 24 h
Proficiency with English (verbal and written)

Exclusion Criteria:
Active bacterial or viral gastrointestinal infection
Pre-existing chronic gastrointestinal diseases
Use of antibiotics within 30 days
Medical circumstances that prevent participation
Food & Nutrition
Not applicable
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State College, PA ,

Mental wellbeing during the Covid-19 pandemic: a study of essential workers and social media use

Through in-depth interviews, we examine how the Covid-19 pandemic has impacted the daily lives and mental well-being of essential workers, as well as their use of social media.

No
 

Saeed Abdullah
Johnna Blair - at jlb883@psu.edu
Information Sciences and Technology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00015851
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Inclusion Criteria:
Considered an “essential worker”---working outside of their homes during the Covid-19 pandemic (e.g. front line medical professionals, paramedics, hospital workers, grocery store employees, delivery drivers, factory workers, etc.)
Social media users (e.g. Twitter, Instagram, Facebook)
Adults 18 or older
Social media users

Exclusion Criteria:
Considered "non-essential" workers during the Covid-19 pandemic
those working from home during the Covid-19 pandemic
minors (those under 18)
those who do NOT use social media
Men's Health, Mental & Behavioral Health, Women's Health
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A Phase III double-blind, randomised, placebo-controlled trial toevaluate liver-related clinical outcomes and safety of once weeklyinjected survodutide in participants with compensated nonalcoholicsteatohepatitis/metabolic dysfunction associatedsteatohepatitis (NASH/MASH) cirrhosis

This is Phase III study to test whether survodutide (BI 456906) helps people with a liver disease called NASH/MASH who have cirrhosis. 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 cirrhosis over a long-term treatment. To answer these questions, the study drug will be compared with a placebo. The overall study duration is approximately 4.5 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, blood draws, ECG, fibroscan, eye examination, and pregnancy test, if applicable, liver biopsy (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 up to 28 in person visits over 4.5 years study duration - to re-supply the study drug and copmlete safety testing. There will be up to 16 phone calls with the study staff.

up to $3,800 over 4,5 years

Yes
 

Jonathan Stine
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
NCT06632457
STUDY00025316
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Inclusion Criteria:
Age ≥18 years
MASH/NASH diagnosis
Cirrhosis
Fibrosis stage 4
BMI ≥27 kg/m2 (≥25 kg/m2 for Asian trial participants)

Exclusion Criteria:
causes of chronic liver disease other than NAFLD
Chronic alcohol or drug abuse
History of liver transplantation or listed for liver transplantation
Digestive Systems & Liver Disease
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

A Phase 3 Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects with Relapsed/Refractory Follicular Lymphoma

The purpose of this study is to determine how effective and safe axi-cel is compared to standard of care, specifically chemo-immunotherapies, and use this information to determine the best choice of treatment in Subjects with Relapsed/Refractory Follicular Lymphoma

Attend all study visits receive study drug or SOChave blood drawn for various testsECHO or MUGA, ECG, PET/CT, and MRI if neededbone marrow biopsy if neededComplete questionnaires

Yes
 

Shin Mineishi
PSCI-CTO ONeal - at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471, ext=343429
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05371093
SITE00001300
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Inclusion Criteria:
Histologically-confirmed FL (Grade 1, 2, or 3a) per local diagnosis.
R/r disease as defined as one of the following options: a) First-line systemic chemoimmunotherapy and high-risk disease, defined as relapse or progression within 24 months of initiation of the initial course of chemoimmunotherapy (ie, POD24)
Clinical indication for treatment local symptoms due to progressive or bulky disease, systemic B symptoms, compromised organ function due to disease progression, cytopenias due to marrow involvement, or symptomatic extranodal disease.
At least 1 measurable lesion per the Lugano Classification
No known history or suspicion of central nervous system (CNS) lymphoma involvement

Exclusion Criteria:
History of large B cell lymphoma or history of transformed FL at any time during the subject’s lifetime including at the time of screening
FL Grade 3b
Small lymphocytic lymphoma
Lymphoplasmacytic lymphoma
Full-thickness involvement of the gastric wall by lymphoma
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

Exploring the feasibility of mobile eye-tracking to study informed consent in older adults

The study will explore the feasibility of using mobile eye-tracking hardware to study how older adults read an informed consent document. The primary objectives are to: (1) characterize gaze (eye-movements) of participants reading a standardized informed consent document using non-invasive mobile eye-tracking hardware, (2) conduct interviews with participants discuss how they read and understood the informed consent document, and (3) evaluate the associations between the data sources to describe how older adults read and understood the informed consent document. Participants will read an informed consent document on a computer on which an eye-tracker is mounted. After reading the document participants will answer surveys related to demographic information, health literacy, and experience with the hardware. They will then complete an interview in which they are asked about their experience reading the informed consent document.

There will be 1 in person visit. During the visit you will be asked to read an informed consent document on a computer screen. You will then answer questions about the consent document, complete an interview about the informed consent document, and complete surveys about your demographic information, health literacy, and experience participating in the study.

$60

Yes
 

Sydney Axson
Sydney Axson - at sba6003@psu.edu or 814-863-4204
Nursing (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00026585
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Inclusion Criteria:
age 65 and older
able to provide consent
able to read and speak english

Exclusion Criteria:
previous eye surgery
have the following eye conditions: cataracts, nystagmus, eyelid ptosis, amblyopia, strabismus
history of cognitive impairment that impairs capacity to consent
Education, Language & Linguistics
Not applicable
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Greater Philadelphia Area, PA ,
State College, PA ,

Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis

Restrictive (vs liberal) fluid treatment strategy during the first 24 hours of resuscitation for sepsis-induced hypotension will reduce 90-day in-hospital mortality.

Yes
 

Lawrence Kass
Nancy Campbell RN - at ncampbell1@pennstatehealth.psu.edu or 717-531-1707, ext=3
Emergency Medicine (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT00343402
SITE00000005
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Inclusion Criteria:
Age > 18 years
Suspected or confirmed infection
Sepsis induced hypotension

Exclusion Criteria:
> 4 hours from start of hypotension
> 3 L intravenous fluids
Pregnancy
Severe volume depletion
Immediate surgical intervention planned
Infectious Diseases & Immune System, Heart & Vascular
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Hershey, PA ,

Opioid Use and Criminal Justice: Intervening to Improve the Outcomes of Women

The new program will help women who have recently been involved in the criminal justice system and use opioids (heroin, fentanyl, prescription pain medications nonmedically) to join treatment programs for opioid addiction. The program will also assist women in finding and getting access to the social services they may need and provide opioid response training. Half of the recruited participants will be randomly selected to be in a trauma support group for women with addiction issues. The program will also help women with common barriers to staying in treatment, such as childcare and transportation.

Participants will be connected to drug treatment programs that offer medications to stop or reduce drug use. Participants will be assigned a peer recovery specialist; these are women in long-term recovery who will help the enrolled women with transportation, childcare, and completing any tasks they may have due to criminal justice involvement or child welfare. Half of our participants will be assigned to a support group of other women in recovery. Participants will complete surveys at three time points and will be paid $50 each time. Participants will also be given overdose response training and take-home-naloxone.

$575

Yes
 

Abenaa Jones
Abenaa Jones - at avj5462@psu.edu or 202-956-8557
Human Development and Family Studies (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00023933
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Inclusion Criteria:
Female
Use heroin, fentanyl, or prescription opioids without a prescription
interested in medications to reduce opioid use
18 years or older
live in Harrisburg area

Exclusion Criteria:
Not interested in medications to stop opioid use
not female
not older than 17
Addiction & Substance Abuse, Mental & Behavioral Health, Women's Health
Survey(s)
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Carlisle, PA ,
Harrisburg, PA ,
York, PA ,

Smart Connected Water Bottle and Lighting Devices: A Prenatal Pilot Study

We will conduct a pilot study to test feasibility of an innovative light device and blue-light glasses for promoting better sleep and a novel, smart water bottle for proper hydration. We will also examine women’s sleep and hydration behaviors in relation to their perceptions of pain, and obtain feedback from the participants on the overall patient intervention content to reduce prescription opioid use and promote behavioral pain management strategies after delivery.

Currently recruiting pregnant women who are in their 2nd or 3rd trimester.Attend a pre-session (in person OR remote) to explain the use of the water bottle, lighting devices, activity monitors, and weight scaleUse the devices for 22 days and complete surveys in your own homeAttend a post-session (in person OR remote) to return devices and participate an interview about the last 22 days

$100

Yes
 

Danielle Downs
Abigail Pauley - at amp34@psu.edu
Kinesiology (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00019938
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Inclusion Criteria:
Pregnant
2nd or 3rd trimester
18-45
Reside around State College, PA

Exclusion Criteria:
Sleep apnea/diagnosed sleep disorders
Diagnosed eating disorders/extreme dietary restrictions
Currently diagnosed with gestational diabetes
Currently diagnosed with pre-eclampsia
Not pregnant
Pregnancy & Infertility, Sleep Management, Women's Health
Survey(s)
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State College, PA ,

The Effects of Aircraft Seat Width on Passenger Comfort

The objective of this research is to determine the relationship between aircraft seat width and passenger comfort. Airlines are reducing the sizes of seats and improving their ability to fly planes at or near capacity. The combined effect is to decrease the quality of the experience of passengers. This work will help us to understand the degree to which comfort has been reduced.

Participants visit once, for about an hour. During that visit we will measure several body dimensions. Then the participant will evaluate a number of seating conditions for comfort and acceptability.

$20

Yes
 

Matthew Parkinson
Ming-Hua Chang - at AirplaneSeating@psu.edu
School of Engineering Design and Innovation (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00012135
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Inclusion Criteria:
We are particularly interested in small and large participants.
You must be a healthy adult aged 18 years or older.

Exclusion Criteria:
Individuals under 18 years of age are not eligible.
Education, Muscle & Bone, Mental & Behavioral Health
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State College, PA ,

PSCI 21-158 Radiopaque Hydrogel Rectal Spacer for Prostate Cancer Radiation Image Guidance

Prior to enrollment, potential subjects will be evaluated during the Screening Period to determine eligibility. The following assessments will be performed during the Screening Period:●Review of eligibility ●Placement of hydrogel spacer and fiducial marker after eligibility is determined Visit 2 or Day 2 or Post-test - Radiotherapy per standard of care.

Prior to enrollment, potential subjects will be evaluated during the Screening Period to determine eligibility. The following assessments will be performed during the Screening Period:●Review of eligibility ●Placement of hydrogel spacer and fiducial marker after eligibility is determinedVisit 2 or Day 2 or Post-test - radiotherapy per standard of care

Yes
 

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

Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05650021
STUDY00022554
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Inclusion Criteria:
Untreated cT1 – cT3 prostate cancer
N/A
N/A
N/A
N/A

Exclusion Criteria:
Extracapsular extension
Prior prostate surgery
Prior prostate radiotherapy
N/A
N/A
Cancer
Approved device(s)
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Hershey, PA ,

Bridging the Workforce Gap in the U.S. Semiconductor Industry

Emerging technologies, particularly in the semiconductor industry, are advancing at an extraordinary pace in the United States, creating an urgent demand for a highly skilled workforce. In 1990, the U.S. held 37% of the global semiconductor manufacturing market; today, that share has sharply declined to just 12% (MASH, 2024). Meanwhile, most semiconductor production has moved overseas, with Taiwan alone accounting for nearly 60% of global output. This concentration of manufacturing capacity in East Asia is increasingly concerning, especially given China’s strategic goal to secure Taiwan by 2030. As such, the U.S. semiconductor supply chain has become a critical national security issue, further emphasizing the immediate need to rebuild a robust domestic manufacturing workforce. To reverse this trend, it is estimated that the U.S. will need an additional 230,000 skilled workers to double its semiconductor market share and regain competitiveness on the global stage (Lightcast, 2023). Achieving this goal requires a significant investment in education and training programs. The HI-TECH (High-Impact Technology Experiential Career Hub) program directly addresses this challenge by offering 75 recent graduates from Career and Technical Education (CTE) programs summer internships in the semiconductor industry over the next three years. These internships will provide invaluable hands-on experience, positioning participants for lucrative, high-demand careers in this vital and rapidly expanding sector. Through this initiative, HI-TECH aims to play a key role in strengthening the U.S. workforce, enhancing national security, and securing America’s future competitiveness in the global semiconductor market.

Participants will be asked to complete an online survey (15-20 minutes) about their experiences with CTE programs, employment in the semiconductor industry, and workforce readiness. Some participants may also be invited to participate in a 30-45 minute interview (conducted via Zoom) to provide further insights.

No
 

Mark Threeton
Mark Threeton - at mdt177@psu.edu or 814-863-5361
Learning and Performance Systems (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00026520
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Inclusion Criteria:
18 years of age or older
Recent graduate (within the last two years) from a Career and Technical Education (CTE) programs
CTE administrator or educator involved in curriculum design for semiconductor-related fields

Exclusion Criteria:
Individuals under the age of 18
Individuals who did not complete a CTE program related to semiconductor technology
Individuals unwilling to complete an online survey or interview
Individuals who did not complete a CTE program related to semiconductor technology
Education
Survey(s)
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Feasibility, Safety and Acceptability of a Mobile Health Delivered Exercise Training Program in Patients with Nonalcoholic Steatohepatitis

This study will be a pilot study to evaluate the workability, safety and acceptability of Exercise and Liver FITness (EL-FIT), a mHealth exercise training program previously confirmed in patients with cirrhosis,(1) in patients with Nonalcoholic Steatohepatitis (NASH)

El-Fit NASH (Nonalcoholic Steatohepatitis) is a 9-week intervention trial for patients with NASH. Our goal is to evaluate the workability, safety and acceptability of Exercise and Liver FITness (EL-FIT), a mHealth exercise training program. The El-FIT application allows for participants to access to a library of guided workouts. All patients will be asked to complete a screening visit that includes a physical exam, height, and weight measurements & surveys. Participants will be asked to download the EL-Fit NASH application and use it for 8 weeks. In addition to using the application, participants will be asked to complete 3 check-in phone calls through-out the 8 weeks.

Yes
 

Jonathan Stine
Stine Laboratory at StineLaboratory@pennstatehealth.psu.edu or 717-531-0003, ext=320222
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06195943
STUDY00022771
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Inclusion Criteria:
18 years or older
Evidence of NASH
Posission of a Smart Phone

Exclusion Criteria:
Active cardiac Symptoms
Active or recent participation in exercise training program within the last 90 years
Active or recent weight-loss supplement use within the last 90 days
Active illicit substance use
Cancer that is active
Digestive Systems & Liver Disease, Sports Medicine
Not applicable
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Hershey, PA ,

PSCI 24-077 A Phase 1b/2 Study Assessing the Safety and Efficacy of Evexomostat (SDX-7320) in Combination with a PI3K Pathway Inhibitor plus Fulvestrant in Postmenopausal Women with Advanced Breast Cancer and PI3K Pathway Alterations Who Have Progressed on or Following Endocrine Therapy plus a CDK4/6 Inhibitor

this trial is looking at introducing a medication to control blood sugars elevations caused by CDK inhibitors.

Participants must agree to come to all study visits, report any new medications to the study team, agree to having blood work done at least 8-12 hours after eating something, take study medication as directed.

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
NCT05570253
STUDY00025502
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Inclusion Criteria:
Patient is an adult female ≥18 years old at the time of informed consent(s) and has signed informed consent(s) before any trial related activities and according to local guidelines.
Patient with histologically and/or cytologically confirmed diagnosis of HR+, HER2- breast cancer, as determined by the local laboratory.
Patient has identified PI3K pathway
Patient has locally advanced (not amenable to curative therapy or metastatic) breast cancer meeting any of the following categories:
Patient has measurable disease

Exclusion Criteria:
Patient has inflammatory breast cancer at screening.
Patient has known primary brain malignancy,
Patient has a known hypersensitivity to evexomostat, fulvestrant, alpelisib or capivasertib, or to any of their excipients.
Patient has had major surgery within 30 days
Patient has uncontrolled human immunodeficiency virus (HIV) infection.
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) vs. Radiotherapy with Concurrent Cetuximab in Patients with Locoregionally Advanced Head and Neck Cancer with a Contraindication to Cisplatin

The purpose of this study is to compare any good and bad effects of usual radiation plus the study treatment drug (durvalumab), to the usual therapy of radiation plus the drug (cetuximab) in patients with head and neck cancer who cannot take the drug cisplatin.

The purpose of this study is to compare any good and bad effects of usual radiation plus the study treatment drug (durvalumab), to the usual therapy of radiation plus the drug (cetuximab) in patients with head and neck cancer who cannot take the drug cisplatin.

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03258554
SITE00000527
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Inclusion Criteria:
squamous cell carcinoma
18 or older
Adequate hematologic function
Adequate hepatic function
Adequate renal function

Exclusion Criteria:
invasive malignancy within the past 3 years
Prior radiotherapy
Prior immunotherapy
Major surgery within 28 days prior to Step 1 registration
Uncontrolled hypertension
Cancer
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Hershey, PA ,

Effects of fasting on blood protein levels

Up to 50 older adults (age 60+ years) will participate in a two-visit CRC study with blood sampling (40 ml per visit) occurring before and after a breakfast meal. Specifically, there will be four (10 ml) blood draws during each of the visits, with each blood draw timed one hour apart (T1 to T4). The two visits (short- and long-fasting) will be randomly assigned and counterbalanced for the order in which they occur and will occur at least a week apart. During the short-fasting visit, participants will arrive fasting and be given breakfast after the second blood draw (T2). During the long-fasting visit, participants will arrive fasting and be given breakfast after the fourth blood draw (T4). Aside from blood draws, and vitals obtained at the start of each visit, participants will be seated comfortably in a chair in a small room by themselves. They will be checked upon periodically to ensure they are not falling asleep, they are comfortable, etc. They will also be given a small packet of written questionnaires to complete after T1 and after T3 (i.e., after the 1st and 3rd blood draws). Each visit will be between 3.5 and 4 hours.

There will be two in-person visits both will include four blood draws.

$100 total

Yes
 

Christopher Engeland
Abigail Smith - at ajs8854@psu.edu or 814-867-5428
Biobehavioral Health (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00021531
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Inclusion Criteria:
Men and women between the ages of 60-90
Fluent in English
Vaccinated for COVID-19

Exclusion Criteria:
Non-ambulatory
Having current severe psychiatric symptoms that interfere with testing
Alcohol or substance abuse, chronic medicinal use of opioids, glucocorticoids, anti-inflammatories, or active cancer treatment in the last 12 months
Education
Survey(s)
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State College, PA ,

Examining the relationship between caregiving factors, social determinants of health, and quality of life among parental caregivers of adults with profound autism: A mixed methods study

This is a survey study that will examine factors that impact the quality of life for parental caregivers of an adult child with profound autism.

Participants will be asked to take a survey about their experiences caring for their autistic adult-child and questions about their well-being.

No
 

Jessica Wellington
Jessica Wellington - at jdw6174@psu.edu
Division of Graduate Studies (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00024778
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Inclusion Criteria:
18 years of age or older
Primary parental caregiver for an adult-child (aged 18 and older) with profound autism
Reside in the United States
Able to read and understand English
Are able to provide informed consent

Exclusion Criteria:
The adult-child with profound autism does not live with the parental caregiver
Mental & Behavioral Health
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PSCI 23-012 THE JANUS RECTAL CANCER TRIAL: A RANDOMIZED PHASE II TRIAL TESTING THE EFFICACY OF TRIPLET VERSUS DOUBLET CHEMOTHERAPY TO ACHIEVE CLINICAL COMPLETE RESPONSE IN PATIENTS WITH LOCALLY ADVANCED RECTAL CANCER

This trial is using long course chemoradiation in combination with three different chemotherapy treatments to treat rectal cancer. Once therapy is completed patients will either have surgery or watch and wait. The goal is to see which therapy is better in achieving a complete response, if any.

Patients will be expected to come to the clinic for all radiation treatments and all chemotherapy treatments.

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05610163
SITE00001341
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Inclusion Criteria:
Clinical stage II or III rectal adenocarcinoma defined as T4N0 or any T with node positive disease (any T, N+); also T3N0 requiring APR or coloanal anastomosis
Tumor Site: Rectum; ≤ 12cm from the anal verge
No prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer within the past 5 years is allowed.
Not pregnant and not nursing,
Age ≥ 18 years

Exclusion Criteria:
No upper rectal tumors (distal margin of tumor >12 cm from the anal verge)
No recurrent rectal cancer; prior transanal excision, prior distal sigmoid cancer with a low anastomosis
No known mismatch repair deficient rectal adenocarcinoma
Cancer
Approved drug(s)
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Hershey, PA ,

PLS Natural History Study

This study will provide a strong basis and foundation for future clinical trials that use historical controls. The study will collect clinical data and biological specimens to create a dataset and biorepository to be shared with other researchers as a foundation for future clinical trials.

This is a volunteer study for participants diagnosed with Primary Lateral Sclerosis (PLS) or suspected to have PLS by a neurologist. You will be expected to attend scheduled visits in person or by telephone, complete study testing and audio/video recordings. The study includes clinical measurements to assess disease status and motor function, a number of questionnaires, collection of biospecimens including DNA, blood, and urine, and an electromyography (EMG) test. There will be 6 visits over 24 months, of these 6 three will be in-person visits (2-3 hours) and the other three will be telephone calls (lasting about 45 minutes to an hour). Blood and urine samples will be collected during these visits.

$100 per in person visit (three) and $50 for telephone visit (three) completed.

Yes
 

Zachary Simmons
nervemuscle@pennstatehealth.psu.edu 717-531-8257
Neurology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00018274
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Inclusion Criteria:
Adult participants (≥ 25 years of age)
Symptom onset was no more than 15 years prior to baseline
Ability to independently walk with or without an assistive device (e.g., walker) at the baseline evaluation
In cases where a molecular test has been done prior to enrollment in this study, HSP or HSP-related mutations are negative
Expected to have at least some bulbar symptoms (dysarthria, dysphagia, drooling or pseudobulbar affect); however, the absence of these symptoms will not exclude participants when molecular testing is negative for known HSP

Exclusion Criteria:
Unwilling or unable to give informed consent
UMN symptoms and signs only in the legs
Unwilling or unable to visit the study site asrequired
Clinically obvious cognitive impairment that precludes obtaining informed consent, as determined by the site PI
Participating in clinical treatment trials
Neurology, Muscle & Bone, Mental & Behavioral Health
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Hershey, PA ,

Phase III Trial of MEDI4736 (durvalumab) as Concurrent and Consolidative Therapy or Consolidative Therapy Alone for Unresectable Stage 3 NSCLC (EA5181) (PSCI# 21-041)

The purpose of this study is to compare the usual approach of chemo/radiation followed by one year of MEDI4736 (durvalumab) to chemo/radiation with MEDI4736 (durvalumab) followed by one year of MEDI4736 (durvalumab). The addition of MEDI4736 (durvalumab) during chemo/radiation could prevent your cancer from returning and extend your life. But, it could also cause side effects.This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the study drug extends the life of patients and/or prevents the tumor from coming back as compared to the usual approach.This drug, MEDI4736 (durvalumab), is already approved by the FDA for use in other cancers, and for use in your type of cancer after the completion of chemotherapy and radiation. At this time MEDI4736 (durvalumab) is not yet approved (experimental) when given with chemotherapy and radiation. There will be about 660 people taking part in this study.

The purpose of this study is to compare the usual approach of chemo/radiation followed by one year of MEDI4736 (durvalumab) to chemo/radiation with MEDI4736 (durvalumab) followed by one year of MEDI4736 (durvalumab). The addition of MEDI4736 (durvalumab) during chemo/radiation could prevent your cancer from returning and extend your life. But, it could also cause side effects.This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the study drug extends the life of patients and/or prevents the tumor from coming back as compared to the usual approach.This drug, MEDI4736 (durvalumab), is already approved by the FDA for use in other cancers, and for use in your type of cancer after the completion of chemotherapy and radiation. At this time MEDI4736 (durvalumab) is not yet approved (experimental) when given with chemotherapy and radiation. There will be about 660 people taking part in this study.

Yes
 

Patrick Ma
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Molecular and Precision Medicine (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04092283
SITE00000978
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Inclusion Criteria:
Patient must be = 18 years old.
Patient must have an ECOG Performance Status of 0 or 1.
Body weight > 30 kg of patients.
Patient must not have unintentional weight loss > 10% within 30 days prior to registration.
Patient must have a baseline ECG obtained within 6 weeks of registration.

Exclusion Criteria:
Patient must not have any active, known or suspected autoimmune disease and neuromuscular paraneoplastic syndromes
Patient must not have a history of active hepatitis B (chronic or acute) or hepatitis C infection.
Patient must not have a known active tuberculosis infection.
Patient must not have any severe infections within 4 weeks prior to registration including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.
Patient must not have signs or symptoms of severe infection (sepsis) within 2 weeks prior registration.
Cancer
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Hershey, PA ,

CAREER: No Time to Explain: Developing Robots that Actively Prevent Overtrust during Emergencies

The overall goal of this proposal is to develop robots that can help people correctly calibrate their trust in the robot. We look at this problem within the context of robot-guided emergency evacuation. We believe that robots stationed inside of buildings can serve as instantaneous first responders helping people safely evacuate during an emergency, thus saving lives. Participants will be asked to interact with an emergency guidance robot and decide whether to follow the robot to an exit.

Yes
 

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

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00016965
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Inclusion Criteria:
Over 18
Reasonable ability to see

Exclusion Criteria:
Under 18
Cannot see or read the consent form
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State College, PA ,

GPRPL Study

The purpose of this study is to find genetic causes of recurrent pregnancy loss (RPL). RPL is defined by two or more miscarriages under 20 weeks gestation and affects approximately 5% of women.The causes of RPL are not well understood. After all the currently recommended testing for RPL has been done, about half of women with RPL will still have no identifiable cause. This lack of knowledge makes it difficult to provide effective medical care for couples with RPL.This study will compare reading about 20000 genes in the entire human genetic library by whole genome sequencing in the miscarriage material and also your and your partner’s DNA from blood samples. The DNA in a person is a combination of the DNA from each of their biological parents. If you have healthy children we may ask your consent for them to give a blood sample for DNA extraction and testing. Similarly, we may ask the same for other family members such as grandparents if necessary. We may also request your permission to use stored DNA or miscarriage material from previous pregnancy loss if available. Testing of family members or previous miscarriage materials may help to understand DNA sequence variants or changes identified in the miscarriage sample.

There will be a one time collection of blood samples.

Yes
 

Sarah Horvath
OBGYNResearch@pennstatehealth.psu.edu
Obstetrics and Gynecology (HERSHEY)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
SITE00001050
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Inclusion Criteria:
Women with current pregnancy loss
Two or more prior losses of clinically recognized pregnancies
Prior losses are unexplained

Exclusion Criteria:
Known cause for pregnancy loss and/or prior losses
Pregnancy & Infertility
Prefer not to display
I'm interested
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Hershey, PA ,

ALL ALS-ASSESS

This study will follow symptomatic ALS participants and control participants for 2 years, measuring a wide range of ALS outcome measures and gathering long term survival data.

Study visits will be conducted both in an in-clinic setting (on-site) and remotely (off-site) over the course of 24 months (2 years). The symptomatic ALS cohort participants can either participate in on-site or off-site visits, depending on their location and ease of access to one of the participating sites.During this 2-year period, symptomatic ALS participants will complete a screening visit (2-3 hours to complete), a total of 7 in-person study visits (1-3 hours to complete) and 24 remote self-assessment activities (completed each month, takes 35-45 minutes to complete). Participants and will need access to a personal device (i.e. a computer and/or smartphone or tablet) and an internet connection to participate in this study. All control participants will participate on-site, completing their on-site visits every 12 months.Biospecimens will be collected at regular intervals to support biofluid biomarker analyses. Biospecimens will include plasma, serum, whole blood for generation of induced pluripotent stem cells (iPSCs) and DNA for whole genome sequencing, and cerebrospinal fluid (CSF). For on-site symptomatic ALS and control participants, CSF will be collected through optional Lumbar Puncture (LP) procedure. Only plasma, serum and whole blood will be collected for off-site participants through home phlebotomy collection process.

Up to $350

Yes
 

Zachary Simmons
nervemuscle@pennstatehealth.psu.edu 717-531-8257
Neurology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00024206
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Inclusion Criteria:
Age 18 years or older
Capable of providing informed consent
Willing to follow study procedures
Diagnosis of ALS by a physician
Access to a smartphone, computer or tablet, and internet (need not be in the home – access to a public library or other available computer with internet connection is sufficient)

Exclusion Criteria:
Significant cognitive impairment, clinical dementia, or unstable psychiatric illness, including psychosis, active suicidal ideation, suicide attempt, or untreated major depression that would interfere with the study procedure.
Clinically significant unstable medical condition (other than ALS) that would render the participant unlikely to be able to complete 12 months of follow-up, according to Investigator’s judgment.
Optional Lumbar Puncture - Medically unable to undergo LP; allergy to Lidocaine or other local anesthetic agents; use of anticoagulant medication or antiplatelet medications (aside from aspirin 81mg) that cannot be safely withheld prior to LP.
Neurology
Not applicable
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Hershey, PA ,

Endometriosis and microvascular dysfunction

Endometriosis, is a disorder that occurs in women, is when tissue that should be normally found inside the womb is also found in sites outside of the womb. This disorder impairs the function of the endothelium, the cells that line the body’s blood vessels (endothelium). The endothelium helps to control blood flow in healthy vessels. Women with this disorder not only have an increased risk for high blood pressure and high cholesterol, they also have an increased risk for cardiovascular disease. They have a higher risk for cardiovascular disease, too. With this study, we will learn how endometriosis impairs the lining of blood vessels and increases the risk for disease. We will test two different intervention strategies to reduce long-term cardiovascular disease risk in women with endometriosis.

There will be 3 in person visits, blood draws will occur at all visits. On 2 of the visits blood flow experiments will be conducted. Participants will take oral medications.

390

Yes
 

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

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05059626
STUDY00018347
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Inclusion Criteria:
Women, 18-45 years of age
Endometriosis

Exclusion Criteria:
Tobacco consumption (e.g. smoking)
Pregnant and/or breastfeeding
Taking blood pressure medication
Heart & Vascular, Pregnancy & Infertility, Women's Health
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Altoona, PA ,
Harrisburg, PA ,
Hershey, PA ,
State College, PA ,
Williamsport, PA ,

Examine Three Different Functional Analysis Methods Using Innovative Measurements to Identify Their Properties

This study compares three different functional analysis methods using the same measurements to find the better method. Each participant will be assigned one method to produce a diagram using the given method and one online survey after the in-person experiment. Each participant will be given detailed instructions and information regarding the method to ensure there are no knowledge gaps. 

For the experiment, participants will be assigned to a group of four people from different engineering subfields to evaluate a product using one of three functional analysis methods. Each group will be randomly assigned a product to evaluate and a functional analysis method to use. After the experiment, each participant will be asked to complete an online survey asking for their experiences and thoughts. 

Yes
 

Kathryn Jablokow
Haixing Piao - at hbp5181@psu.edu or 856-796-6269
Engineering (GREAT VALLEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00023656
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Inclusion Criteria:
Junior, Senior, Graduate Stduents
Chemical Engieering
Electrical Engineering
Industrial Engineering
Mechanical Engineering

Exclusion Criteria:
Freshmen
Sophmore
Education
Not applicable
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State College, PA ,

Human-Centric Non-Invasive Physiological Sensing System for Early Detection of Workers’ Heat Stress in the Field

This study will examine different structural designs of stretchable, skin-like sensors on the surface of human skin for workers.

There will be one in person visit;Subjects will first be asked to sit still for 3 minutes and then move their skin by the research team for another 3 minutes.

Yes
 

Huanyu Cheng
Huanyu Cheng - at huc24@psu.edu or 814-863-5945
Engineering Science and Mechanics (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00020880
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Inclusion Criteria:
no existing skin conditions or open wounds, or other disorders that make them have altered temperature responses
be over 18 years old
must understand English
resources from Penn State, University Park

Exclusion Criteria:
people with a metal allergy
Men's Health, Women's Health
Prefer not to display
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State College, PA ,

Self-Help for Stress Related to COVID-19

This is a study on internet-based self-help for stress related to the COVID-19 pandemic. College and university students who screen high on perceived stress or measures of risk for anxiety, depression, or eating disorders during the COVID-19 pandemic will be invited to participate in this study. Participants will be randomly assigned to receive access to an internet-based self-help program for stress resilience and coping with the COVID-19 pandemic or care as usual. Symptoms of stress, anxiety, depression, and eating disorders, as well as secondary outcomes, will be assessed via questionnaire at baseline (pre-randomization), one month post-randomization, and three months post-randomization.

Participants will be randomly assigned to receive access to an internet-based self-help program for stress resilience and coping with the COVID-19 pandemic or care as usual. Symptoms of stress, anxiety, depression, and eating disorders, as well as secondary outcomes, will be assessed via questionnaire at baseline (pre-randomization), one month post-randomization, and three months post-randomization.

Up to $50 (raffle-based)

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
NCT04762173
STUDY00015766
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Inclusion Criteria:
Experiencing significant stress related to COVID-19 pandemic
Fluent in English
Current college or university student

Exclusion Criteria:
Unable to provide informed consent
Under 18 years of age
Not a college or university student
Not fluent in English
Mental & Behavioral Health
I'm interested
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See this study on ClinicalTrials.gov