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Augmented Reality: Perceptions, Performance, and Language Enhancement

This is a single-center feasibility study assessing the Apple Vision Pro as a device for augmentative and alternative communication in patients with Amyotrophic Lateral Sclerosis who are experiencing impaired communication.Participants in this study will visit the study site once for approximately 1.5 hours. During the session, participants will complete questionnaires about their medical history, undergo an eye exam, and use an augmented reality headset that tracks the motion of the eyes to communicate.

Participants and their caregivers will complete a single visit at the Hershey Medical Center lasting approximately 1.5 hours. During this time, they will undergo an eye exam, answer a set of questionnaires, and use an augmented reality (AR) headset that tracks eye-gaze to communicate.

$25

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00024666
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Inclusion Criteria:
Diagnosis of motor neuron disease (ALS, PLS, PMA, or progressive bulbar palsy)
Use of augmentative and alternative communication device device (including but not limited to: eye tracking, switch control, scanning interface, written or typed communication).
Score of 1 or 0 on the ALS Functional Rating Scale (ALSFRS-R, Cedarbaum1999) speech sub-score and/or score of 2, 1, or 0 ALSFRS-R handwriting sub-score.

Exclusion Criteria:
Preexisting ocular or medical condition that would inhibit eye tracking or headset use.
Continuous use of face-mask noninvasive ventilator that would impair comfortable wearing of AVP headset for at least 60 minutes
History of visual impairment incompatible with device use
History of medical diagnoses that could be exacerbated by use of the augmented reality headset: uncontrolled migraines or chronic headache, dizziness, vertigo, or other inner ear conditions, dry eyes, skin allergies, seizures
Diagnosis of frontotemporal dementia or other severe cognitive impairment that is sufficient, in the opinion of the study neurologist, to interfere with the subject’s ability to provide informed consent and reliably complete questionnaires
Neurology
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Hershey, PA ,

A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of PLN-74809 (bexotegrast) for the treatment of idiopathic pulmonary fibrosis (BEACON)

This is a phase 2b clinical trial looking to see if the drug PLN-74809 (bexotegrast) is effective and safe in patients diagnosed with idiopathic pulmonary fibrosis (IPF).

If you choose to participate in this study and meet all the study entry requirements, you will be randomly assigned (by chance; like the flip of a coin) to receive either bexotegrast or placebo for the whole study. Neither your study doctor nor you will know whether you are receiving bexotegrast or placebo. You will be required to visit the Hershey Medical Center on at least 8 separate occasions over an approximate 58-week period. Procedures that will be performed during your visits include, but are not limited to, physical exams, blood tests, ECGs, completing questionnaires, lung functions tests, and CT scans.

1200

Yes
 

Rebecca Bascom
Timothy Sheehan - at tsheehan@pennstatehealth.psu.edu or 717-531-2925
Medicine: Pulmonary, Allergy and Critical Care (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06097260
STUDY00023219
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Inclusion Criteria:
>/= 40 years of age
IPF diagnosis ≤ 7 years prior to screening
If on Ofev or Esbriet, must be on stable dose for >/= 12 weeks
FVC >/=45% predicted
DLCO >/= 30% predicted and </= 90% predicted

Exclusion Criteria:
Taking medication for pulmonary hypertension
Obstructive lung disease
Current smokers
Active infection
IPF exacerbation within the last 6 months
Lung Disease & Asthma
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Identifying an Alternative to the Classic Presentation of Autism: The ISM Autism Presentation

This study aims to build upon a previous study that established a different presentation of autism called the ISM presentation by using a large sample size to either confirm or dispute this presentation as an alternative to classical autism.

Participants will be required to complete a survey expected to take no longer than an hour.

No
 

Zak Kabbara
Zouheir Kabbara - at zak5195@psu.edu or 478-737-4600
Division of Graduate Studies (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00024256
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Inclusion Criteria:
Reside in the USA
At least 18 years old
Either diagnosed with autism, suspected of having autism or typically developing

Exclusion Criteria:
Is unable to read independently or complete the survey
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Motion in action: Integrating multisensory inputs for posture stabilization and complex action acquisition

This study looks at how people use their eyes and body to interact with moving objects while standing up. Participants will stand at a robotic device and try to stop virtual objects moving at different speeds on a screen, similar to catching or blocking a ball. The research will help us understand how the brain coordinates sensory information to maintain balance.

Participants will be required to stand and interact with virtual objects by grasping a robotic manipulandum. A session will last approximately 120 minutes.

$30 per session

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
STUDY00026548
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Inclusion Criteria:
Between 18-40 years old
Right-hand dominant
Normal or corrected-to-normal vision (20/20)
Able to stand for up to 2 hours
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 such that informed consent cannot be obtained, or that participant would not be safe with the protocol
Medication that could make the participant drowsy or tired during the experiment
Neurology, Vision & Eyes
Not applicable
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State College, PA ,

PSCI 23-023 A PHASE III, MULTICENTER, RANDOMIZED, OPEN‑LABEL STUDY COMPARING THE EFFICACY AND SAFETY OF GLOFITAMAB (RO7082859) IN COMBINATION WITH POLATUZUMAB VEDOTIN PLUS RITUXIMAB, CYCLOPHOSPHAMIDE, DOXORUBICIN, AND PREDNISONE (POLA-R-CHP) VERSUS POLA‑R‑CHP IN PREVIOUSLY UNTREATED PATIENTS WITH LARGE B-CELL LYMPHOMA

To see if using glofitamab added to chemotherapy is better than chemotherapy alone.

Participants will be required to come to all study visits, report any new medications, prescription or over the counter that they are taking, make sure to tell the study doctor of any new symptoms you may be having.

$180/visit, $130 follow up visit

Yes
 

Seema Naik
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
NCT06047080
STUDY00025739
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Inclusion Criteria:
Age 1880 years at the time of signing Informed Consent Form and willingness to comply with study protocol procedures
Previously untreated participants with CD20-positive LBCL
IPI score 2-5
ECOG Performance Status of 0, 1, or 2
Life expectancy >/= 6 months

Exclusion Criteria:
Prior solid organ transplantation
Current Grade > 1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease
receiving systemic immunosuppressive agents
Significant or extensive history of cardiovascular disease
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

The effect of muscle shortening on the force-length characteristics of neighboring inactive muscles

We are trying to better understand the ways in which people contract their muscles. Specifically, we want to learn more about how connections between our muscles influence how they produce forces. Participants in this study will have their calf muscle group activated while we record the individual muscles' electrical activity and the length of the muscle fibers.This research will help us to understand the underlying mechanical function of muscles in a more realistic context. This understanding may also have profound implications for current computer models of muscles, which most often ignore the connectivity between muscles.

There will be one in-person visit. At this visit, participants will have their calf muscle group activated while we record the individual muscles' electrical activity and the length of the muscle fibers.

$50

Yes
 

Jonas Rubenson
Jonas Rubenson - at jxr75@psu.edu or 814-867-6209
Kinesiology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00019507
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Inclusion Criteria:
18-40 years old

Exclusion Criteria:
chronic or acute leg injury in last 12 months
heart condition
chest pain during exercise
balance or dizziness problems
prescribed drugs for blood pressure or heart condition
Muscle & Bone
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State College, PA ,

Locomotor Learning in Exoskeleton-Assisted Walking

The goal of this study is to explore how different ways of practicing, as well as paying attention, affect learning to walk while using an ankle exoskeleton. This pilot study will look at whether changing the settings of the exoskeleton and walking conditions frequently or not very often helps people walk better in follow-up tests. It will also examine if asking people to focus on their body (internal focus) or on their surroundings (external focus) improves their walking.

There will be three in-person visits over two days, walking in a lower limb exoskeleton will occur at all three visits.

$40.00

Yes
 

Rachael Yanalitis
Rachael Yanalitis - at rky5073@psu.edu or 412-804-8801
Mechanical and Nuclear Engineering (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00025992
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Inclusion Criteria:
Able-bodied: Able to walk continuously for 20 minutes and able to walk at least 60 minutes in a 75-minute block of time.
Normal ankle functionality
Age: 18-40 years old
Responsiveness: Subjects must be able to follow verbal instructions
Shoe size: Fit shoes sizes 6-10 (men) or 7-11 (women)

Exclusion Criteria:
Previous or existing neuromuscular or neurological pathologies, injuries, or illnesses affecting gait
Previous or existing lower limb musculoskeletal injuries or conditions (e.g. joint replacement)
Currently using blood thinners, since this could increase the risk of bruising
Pregnant women
Subjects with femoral retroversion (duck feet posture) significant enough to cause exoskeleton collisions while walking
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State College, PA ,

Thermoregulatory responses to heat stress in adults with major depressive disorder with and without antidepressant treatment.

The purpose of this study is to determine if, compared to non-depressed adults, differences exist in skin blood flow and sweating responses to passive heat stress in adults with clinically diagnosed depression, those with depression who are prescribed and taking SSRIs (Selective Serotonin reuptake inhibitors) and those with depression who are prescribed and taking SNRIs (Serotonin-Norepinephrine reuptake inhibitors).

For this study, you will be asked to come into the lab for a screening visit, a maximal exercise test visit, and one experimental visits. *Before the experimental visit, you will be asked to swallow a temperature-sensing capsule to measure your internal body temperature 1-2 hours prior to arriving at the lab. During the passive heat stress experiment, you will wear a suit lined with tubing through which hot water will run, causing your body to warm up. We measure your sweat and skin blood flow responses.

50

Yes
 

William Kenney, Jr.
Kat Fisher - at kgf5118@psu.edu
Kinesiology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT00000000
STUDY00026326
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Inclusion Criteria:
Clinical depression diagnosis
Depression treatment with SSRIs
Depression treatment with SNRIs
Adults aged 18-40

Exclusion Criteria:
History of Crohn's disease, diverticulitis, or other similar gastrointestinal disease
Use of psychoactive or psychopharmacological drugs other than SSRI and SNRIs within one year of participating.
Heart & Vascular, Mental & Behavioral Health
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State College, PA ,

PSCI 21-191: CG-745-2-08

The purpose of this voluntary research study is to learn more about an investigational drug (also known as the “study drug”) called ivaltinostat as a possible treatment for metastatic pancreatic adenocarcinoma.

Participants will be required to attend all study visits, receive drug treatment, have blood drawn, imaging assessments and tumor biopsy if needed

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05249101
SITE00001325
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Inclusion Criteria:
Provision of informed consent prior to any study specific procedures.
Age: ≥18 years
Histologically or cytologically confirmed pancreatic adenocarcinoma
Patients with or without radiographically measurable disease per RECIST v1.1 are eligible to participate.
Patients with metastatic disease are eligible.

Exclusion Criteria:
For Phase 2, radiographic progression of tumor per RECIST 1.1 between start of first line FOLFIRINOX chemotherapy for metastatic pancreatic adenocarcinoma and randomization.
Cytotoxic chemotherapy or non-hormonal targeted therapy within 21 days of Cycle 1 Day 1 is not permitted
Exposure to an investigational agent within 30 days or 5 half-lives (whichever is longer) prior to randomization.
Any previous treatment with a histone deacetylase (HDAC) inhibitor, including ivaltinostat.
Other primary cancers.
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

Cognitive Debriefing: Developing and instrument to measure Internalized Weight Bias among Adolescents

For many years, overweight and obesity has been highly stigmatized in society, and children are often bullied or teased for their weight. Over time, these experiences can cause adolescents to feel badly about themselves and view themselves as society views them. We call this process the internalization of weight bias or IWB. IWB can increase feelings of depression and anxiety and is associated with unhealthy eating behaviors. For this project, we wanted to create a questionnaire to measure this important topic, and get feedback from adolescents and professionals to make sure the questions are correct and easy to understand. We want to recruit 20 adolescents age 12-17 and medical professionals to review some questions and provide their feedback on these questions by participating in an interview. Participants will be compensated for their time.

We would like to interview teens and health professionals to review some survey questions and make sure that the questions we use to measure this concept are appropriate. These interviews will take 60-90 minutes over ZOOM.

30.00

No
 

Melissa Butt
Melissa Butt - at mab787@psu.edu or 717-531-0003, ext=282467
Public Health Sciences (HERSHEY)
 

All
Younger than 18 years old
This study is NOT accepting healthy volunteers
STUDY00021345
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Inclusion Criteria:
Teens (age 12-17)
Access to internet
Access to video conference
Permission from Parents

Exclusion Criteria:
No parental consent
No internet or video conference
Adults
Mental & Behavioral Health
Not applicable
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SARS Cov-2 Nasal Pharyngeal and Oral Pharyngeal Wash (SNOW) Trial SARS Cov-2 Nasal Pharyngeal and Oral Pharyngeal Wash (SNOW) Trial

Adults recently diagnosed with SARS-CoV-2 infection who use a 4-day combined intervention of nasal washes with 1% baby shampoo solution and oral gargles with Listerine Antiseptic® will have a reduced SARS-CoV-2 viral load compared to those using nasal and oral washes with normal saline. This combined intervention should be acceptable, tolerable and safe in this population. To test this, we are conducting a trial comparing the efficacy of a number of washes in reducing the oral and nasal SARS-CoV-2 viral load amongst adults.

At their home, participants will perform three nasal and oral rinses per day for 4 days and self-swab the nose and mouth before and after each morning rinse to collect specimens under the guidance of a zoom visit. On the morning of the 5th day participants will also self swab the nose and mouth for a final collection specimen. Participants will answer questions on an app and online platform.

100

Yes
 

Rena Kass
Dee Bagshaw - at ddm108@psu.edu or 814-863-7126
Surgery: General Surgery (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04802408
STUDY00016947
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Inclusion Criteria:
18 years of age or older
A positive test for SARS-CoV-2 infection within 5 days of enrollment
Currently in isolation

Exclusion Criteria:
History of nasal or sinus surgery
Non-English speaking
Lack of electronic device (computer, mobile phone etc) on which to access an app for study data collection
Adults that need inpatient care for COVID-19 or any of its complications
Adults that give a history of being unable to tolerate gargles or nasal washes
Infectious Diseases & Immune System, COVID-19, Prevention
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Harrisburg, PA ,
Hershey, PA ,
State College, PA ,

Home telemonitoring of bulbar function by acoustic measurement of swallowing and speech sounds in ALS

Most individuals with ALS experience changes in speech and swallowing over the course of the disease. In some, these are their initial indication of ALS. Identifying these changes, which may be rapid in some individuals, is complicated by the recent acceleration of virtual care delivery. This is a longitudinal home study of ALS patients to assess speech and swallowing function through use of smartphone application. The overall hypothesis is that this monitoring protocol can be used in a way that, 1) is satisfactory to the patient, 2) performs at least as well as standard clinical measures of dysarthria and dysphagia, and 3) resolves the development of emergence of speech and swallowing pathologies in ALS. Patients enrolling in this study will participate for approximately 24 weeks, during which they will have swallowing and speech tests performed, complete surveys, and perform audio recordings of speech on their cellphone. Healthy controls will be enrolled to judge the intelligibility of speech samples provided by patients in the study.

Patients enrolling in this study will participate for approximately 24 weeks, during which they will have swallowing and speech tests performed, complete surveys, and perform audio recordings of speech on a cellphone.

340

Yes
 

Andrew Geronimo
Cristie Crawford - at ccrawford5@pennstatehealth.psu.edu
Neurosurgery (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT04889898
STUDY00016872
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Inclusion Criteria:
At least 18 years of age
Possess a diagnosis of amyotrophic lateral sclerosis (ALS)
Have symptom onset within the last 6 years
Demonstrate changes in speech or swallowing as a result of ALS.
Possess a smartphone capable of running the study application or have home wireless internet service capable of transmitting study data from a study-issued smartphone.

Exclusion Criteria:
Possess a co-existing neurological or psychiatric illness in addition to their ALS diagnosis
Possess abnormal speech or swallowing processes due to a condition independent of their ALS diagnosis
Neurology, Language & Linguistics
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Hershey, PA ,
State College, PA ,

Collaborative Research: Enhancing Speech Science Training through Collaboration: Investigating Perception of a Variable Speech Signal

In this study, we will evaluate the factors that affect how well human listeners can perceive connected speech despite variability in the speech signal. Participants in the study will be asked to judge speech segments presented to you over headphphones. For instance, we may ask you to indicate whether the sound you hear a "pa" or "ba".

Yes
 

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

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00018207
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Inclusion Criteria:
Over 18 and under 65
Knowledge of English (Native and non-native)
Normal or Corrected to normal Vision

Exclusion Criteria:
Under 18 or Over 65
Lack of Knowledge of English
Vision that is not normal and has not been corrected to normal.
Language & Linguistics
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State College, PA ,

Recruitment for Nicotine and Tobacco Related Research at Penn State Hershey

The purpose of this project is to screen potential participants for multiple research studies being conducted by tobacco researchers at Penn State Hershey. Since there are multiple IRB approved studies enrolling at Penn State Hershey with similar but not identical inclusion/exclusion criteria, it is more efficient for the researchers and participants to have one phone number to call initially for basic screening. After completing this, the participant can be redirected for more specific screening if they are found to be potentially eligible for one of the studies.

Participants will fill out a 5-minute survey on tobacco use in order to find out which study they may be eligible for.

Depends on study

Yes
 

Jonathan Foulds
Nicolle Krebs - at smokingresearch@pennstatehealth.psu.edu or 844-207-6392
Public Health Sciences (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00002213
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Inclusion Criteria:
Age 21 or older
Current tobacco user

Exclusion Criteria:
Age less than 21
Smoking, Vaping, Nicotine and Tobacco, Addiction & Substance Abuse, Lung Disease & Asthma
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Harrisburg, PA ,
Hershey, PA ,
York, PA ,

Understanding Shooter Dynamics with VR

We are trying to characterize the movement of a shooter in a VR environment.

The study consists of one visit lasting approximately 30-40 minutes: 10 minutes for VR setup, 15 minutes for simulated test, and 5-15 minutes for post-experiment survey. During the simulated test, participants will be asked to move around in the environment and shoot NPCs.

$20

Yes
 

Alan Wagner
Chris McClurg - at cam7498@psu.edu
Aerospace Engineering (UNIVERSITY PARK)
 

Male
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00022246
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Inclusion Criteria:
At least 18 years of age.
Male.
Not prone to nausea when experiencing VR.

Exclusion Criteria:
Under the age of 18 years.
Do not identify as male.
Prone to nausea when experiencing VR.
Education, Mental & Behavioral Health
Prefer not to display
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State College, PA ,

Non-Hispanic Black Individuals and Vascular Function

This study will examine the impact of age, sex, and racial/ethnic background on vascular function.

There will be three (3) in-person visits: one screening, one experimental visit, and one visit to return equipment. Equipment includes a 24-hour Ambulatory Blood Pressure monitor and an 8-day accelerometer (physical activity tracker). Blood will be drawn at the screening and experimental visit. Participants will undergo tests for cardiovascular measures during the experimental visit.

$100

Yes
 

Lacy Alexander
Virginia Content - at vgc5042@psu.edu or 814-863-2140
Kinesiology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00023545
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Inclusion Criteria:
18-75 years of age
Male or Female
Identify as Non-Hispanic Black or Non-Hispanic White

Exclusion Criteria:
Individuals of mixed race
Tobacco consumption (e.g., smoking) or Recreational drug use (e.g., marijuana)
Pregnant and/or breastfeeding
Taking blood pressure medication
Diagnosed with metabolic and/or cardiovascular disease(s)
Heart & Vascular
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State College, PA ,

Oxidative Stress and Harmful Constituent Levels Associated with Little Cigars

The propose of this voluntary research study is to look at the effect of little cigars on biomarkers of potential harm with a focus on oxidative stress and inflammation. The study is also interested the effect of flavors in little cigar.

Subjects will attend 7 study visits over 7 weeks. They will be sent home with a selection of little cigars to use during the first week. Starting at week 2, they will be asked to smoke a certain cigar each week for the next 6 weeks at their study visit. They will be asked to answer a series of questionnaires and to provide biosamples (Exhaled Carbon Monoxide, Exhaled Breath Condensate, Buccal Cells, Urine and Spirometry).

600

Yes
 

Joshua Muscat
smokingresearch@pennstatehealth.psu.edu
Public Health Sciences (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT06310187
STUDY00023967
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Inclusion Criteria:
Aged 21-65
Daily tobacco smoker
No serious quit attempts in previous 30 days

Exclusion Criteria:
Pregant or trying to become pregnant
Respiratory diseases
Substance Abuse
Smoking, Vaping, Nicotine and Tobacco, Addiction & Substance Abuse
Not applicable
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Hershey, PA ,

Understanding Suicide and Self-Harm Among Young Adults in Daily Life

This study explores participants mood and how it changes from day to day and how mood and other things like personality and relationships influence thoughts of suicide or self-harm. Participants will both track and be able to visualize their mood and other experiences on a daily basis from their own smartphones.

There will be a set of questionnaires to complete online that will last between 45 and 90 minutes. Then participants will complete very brief (about 2 minute) surveys a few times per day on their smartphone over 12 weeks.

$140

No
 

Kenneth Levy
Alec Trahan - at atrahan@psu.edu
Psychology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT00000000
STUDY00018404
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Inclusion Criteria:
English-speaking
Undergraduate student at Penn State
Have thoughts of suicide or self-harm in the past 12 months
Own and use an Apple iOS or Android smartphone device

Exclusion Criteria:
Does not speak English
Not a Penn State undergraduate student
Does not own an Apple iOS or Android smartphone device
Unwilling/unable to download and utilize study smartphone app
Prevention, Sleep Management, Mental & Behavioral Health
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Studying speech perception in realistic listening conditions

The purpose of this study is to examine how various factors, such as the acoustics of the environment and background noise, affect the understanding of speech.

Researchers in the Graduate Program in Acoustics are looking for participants for a study related to speech intelligibility and room acoustics. The experiment will take approximately 1.5-2 hours of your time. The experiment will consist of listening to sentences and transcribing them under different acoustic and noise conditions. Your head movement will also be measured through a motion sensor. The compensation for your voluntary participation is a $25 Amazon gift card.

$25 Amazon gift card

Yes
 

Michelle Vigeant-Haas
Olivia Heui Young Park - at hkp5188@psu.edu
Acoustics (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00024788
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Inclusion Criteria:
18 years of age or older
native speaker of American English
no diagnosed speech, language, or hearing disorders
normal or corrected-to-normal vision

Exclusion Criteria:
younger than 18 years old
not a native speaker of American English
diagnosed with speech, language, or hearing disorders
not have normal or corrected-to-normal vision
Language & Linguistics
Not applicable
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State College, PA ,

Daratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (PSCI# 21-115) (EAA173).

The purpose of this study is to determine whether patients with high-risk smoldering multiple myeloma when treated with daratumumab in addition to lenalidomide and dexamethasone live longer when compared to patients with high-risk smoldering multiple myeloma patients treated with lenalidomide and dexamethasone. We would also like to know whether the period of time in which patients are free of multiple myeloma symptoms differs between the two treatment groups.Daratumumab is already approved by the FDA for use in combination with lenalidomide and dexamethasone in people who have received at least one prior medicine to treat multiple myeloma. It is not, however, approved for treatment of smoldering multiple myeloma, either alone or when combined with the treatment regimen of lenalidomide and dexamethasone, and therefore is considered experimental. Lenalidomide and dexamethasone are approved for treatment of multiple myeloma (symptomatic) but not for the treatment of smoldering multiple myeloma and therefore is also considered an experimental treatment.

We are asking you to take part in a research study because you have high-risk smoldering multiple myeloma. We do research studies to try to answer questions about how to prevent, diagnose, and treat diseases like cancer.

Yes
 

Seema Naik
psci-CTO@pennstatehealth.psu.edu
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03937635
SITE00001112
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Inclusion Criteria:
Patient must be 18 years or older.
Patient must be diagnosed with asymptomatic high-risk smoldering multiple myeloma (SMM) within the past 12 months.
A bone marrow aspirate and/or biopsy is required to be performed within 42 days prior to randomization and must demonstrate 10-59% clonal plasma cells.
Patient must have adequate organ and marrow function.
Patient must agree to register into the mandatory REMS program and be willing and able to comply with the requirements of REMS.

Exclusion Criteria:
Known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) <50% of predicted normal or known moderate or severe persistent asthma within 2 years prior to randomization.
Concurrent use of erythropoietin is not allowed while on study therapy.
Prior or glucocorticosteroid therapy for the treatment of multiple myeloma is not permitted.
Patients with monoclonal gammopathy of undetermined significance are not eligible.
Patient must not have Grade 2 or higher peripheral neuropathy per CTCAE.
Cancer
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Hershey, PA ,

Habitual Diet and Avocado Trial

This study aims to evaluate the effect of providing one avocado per day for consumption over a six month period on established health parameters, including visceral adiposity, hepatic lipid content, markers of metabolic syndrome and high sensitivity C-reactive protein (hsCRP), compared to habitual diet.The primary aim of this study is to determine whether providing one avocado per day for consumption for six months will produce a greater decrease in visceral adiposity as measured by magnetic resonance imaging (MRI) in Americans with an increased waist circumference as compared to habitual diet.

Yes
 

Richard Legro
Erin Hammett - at ehammett@psu.edu or 717-531-1510
Obstetrics and Gynecology (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
SITE00000366
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Inclusion Criteria:
>25 years of age
not currently eating >2 avocados per month
increased waist circumference (35+ inches for women, 40+ inches for men)

Exclusion Criteria:
does not eat or is allergic to avocados
not willing to undergo MRI scans
unstable medical conditions
lost/gained 10 or more pounds in past year
Food & Nutrition
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Hershey, PA ,

ABTECT-2 Induction-A randomized, double-blind, placebo-controlled, multicenter phase III study to evaluate the efficacy and safety of ABX464 once daily for induction treatment in subjects with moderately to severely active ulcerative colitis

This is a multicenter, randomized, placebo-controlled Induction study to evaluate the efficacy and safety of oral ABX464 given daily in inducing clinical remission in subjects with moderately to severely active ulcerative colitis (UC) who have inadequate response, no response, a loss of response, or an intolerance to either conventional or advanced therapies.The screening period is 28 days long, and a 28-day follow-up follows 8 weeks of induction treatment. Approximately 612 subjects (only adults at our site) will be randomized in this study. On Day 1, subjects will be randomized to one of the three arms. On Day 56, subjects can either continue participation in the maintenance study (ABX464-107) or end the study by entering four-week safety follow-up. Colonoscopy procedures will include biopsies of the most severely affected areas. The subjects will complete daily electronic Diaries. Blood samples will be collected at some visits. A cardiac safety sub-study is optional for eligible subjects.

Participants will be asked to sign the informed consent. There are at least five in-person visits, approximately every four weeks. There are two colonoscopy procedures with biopsies: first during the screening period and second evaluation at week 56 at the end of the study. Physical examination and vital signs will be taken at every visit. Stool sample for pathogens will be collected at screening. Blood tests will be taken to test for infectious diseases and other tests. There is an optional cardiac safety study. Pregnancy testing is required for eligible female subjects at every visit. Subjects will complete e-Diary questionnaires. There will be two eye exam visits. Participation in the study is voluntary.

Subjects will receive a flat amount per completed visit, up to maximum of $425.

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05507216
STUDY00023472
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Inclusion Criteria:
Age ≥ 18 years and weight ≥ 40 kg
must understand, sign and date the written voluntary informed consent.
Documented diagnosis of UC confirmed by endoscopy and histology
Inadequate response to immunosuppressants or treatment with biologics
Male partners and women WOCBP must agree to use highly effective contraception methods.

Exclusion Criteria:
Subjects with ulcerative colitis limited to an isolated proctitis.
Subjects with CD or subjects with heart disease, or history of malignancy
History or current evidence of toxic megacolon, fulminant colitis, bowel perforation.
Recent or planned bowel surgery.
Subjects on antidiarrheals and probiotics.
Digestive Systems & Liver Disease
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

An Open-label Study to Evaluate the Long-term Safety and Efficacy of CSL312(Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema

This phase 3b study will evaluate long-term safety and efficacy ofCSL312 (also known as garadacimab) when administeredsubcutaneously (SC) once monthly for at least 12 months.Subjects entering CSL312_3002 will be from 3 sources:• Subjects who participated in Study CSL312_2001• Subjects who participated in Study CSL312_3001• CSL312-naïve HAE subjects who have not participated ineither of the above studies

During the study, you will be expected to self-administer the study medication by injection under the skin once a month, complete a daily diary, provide blood and urine samples, complete questionnaires, undergo physical exams and have your vital signs recorded.You will visit the site 12 times.

$80.00 plus travel reimbursement

Yes
 

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

All
All
This study is NOT accepting healthy volunteers
NCT04739059
STUDY00017906
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Inclusion Criteria:
Able to understand and provide informed consent
Male or female
Diagnosed with clinically confirmed C1-INH HAE
Experienced ≥ 3 HAE attacks during the 3 months before Screening, as documented in the subject's medical record.
Aged ≥ 12 at the time of providing written informed consent or assent for minors

Exclusion Criteria:
Concomitant diagnosis of another form of angioedema, such as idiopathic or acquired angioedema or recurrent angioedema associated with urticaria.
Use of C1-INH products, androgens, antifibrinolytics or other small molecule medications for routine prophylaxis against HAE attacks at least 2 weeks before the first day of the Run-in Period.
Use of mAbs such as lanadelumab (Takhzyro®) 3 months before the first day of the Run-in Period.
Female subjects’ use of estrogen-containing medications with systemic absorption (eg, oral contraceptive or hormonal replacement therapy within 4 weeks prior to the Run-in Period).
Female or male subjects who are fertile and sexually active not using or not willing to use an acceptable method of contraception to avoid pregnancy during the study and for 3 months after receipt of the last dose of CSL312.
Infectious Diseases & Immune System
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Hershey, PA ,

Impact of Mental Illness on Blame Attribution and Perception of Dangerousness in Violent Crime Offenders: Implications for Sentencing

This study will be used for an undergraduate honors thesis, focused on mental health’s impact on perceived blameworthiness and dangerousness of violent crime offenders and sentencing suggestions for said offenders. In this study, participants will read a vignette about a crime (homicide or assault) being committed. After reading this scenario, participants will answer 4 questions about the individual who committed the crime. These questions will ask about blame attribution, sentencing suggestions, danger perception and likelihood of reoffending. The data will be analyzed through quantitative techniques.

Participants will read a vignette about a crime (homicide or assault) being committed. After reading this scenario, participants will answer 4 questions about the individual who committed the crime. These questions will ask about blame attribution, sentencing suggestions, danger perception and likelihood of reoffending. Participants will then answer one question about their gender and one question about the school year.

No
 

Ava Paravati
Ava Paravati - at afp5732@psu.edu or 914-327-6514
Division of Undergraduate Studies (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00025341
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Inclusion Criteria:
Undergraduate students at Pennsylvania State University Park above the age of 18

Exclusion Criteria:
All individuals who are not undergraduate students at Pennsylvania State University Park
Undergraduate students at Pennsylvania State University Park under the age of 18
Education, Mental & Behavioral Health
Not applicable
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Identifying the Cognitive, Psychological, and Neuroimaging Signatures of Head Trauma in Female Survivors of Intimate Partner Violence

We aim to investigate the impact exposure to head trauma in intimate partner violence (IPV) has on cognitive, psychological, and neural processes. Physical trauma as an outcome of IPV impacts an estimated 10 million people in the United States each year, with up to 90% of women exposed to IPV reporting episodes of abuse with head trauma. Women exposed to IPV are at a high-risk for developing mental illness and impaired cognitive function, which seems to be compounded in those with exposure to head trauma (HT).

The study includes interviews to discuss your any experiences you have had with physical abuse and head trauma, as well as current and past mental health history. Then you will complete questionnaires to see how you feel about your mental and physical health, followed by tests to assess your thinking abilities. Finally you will complete a magnetic resonance imaging (MRI) session to examine brain structure and function. All of the testing should take approximately 6 hours to complete.

$90

Yes
 

Frank Hillary
Elizabeth Rebuck - at exr5373@psu.edu or 814-865-0389
Psychology (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
SITE00000844
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Inclusion Criteria:
Female
Aged 18-60
Has previously experienced intimate partner violence

Exclusion Criteria:
Male
Currently experiencing intimate partner violence (within the past 3 months)
Non-English speaker
Neurological and developmental disorders
Neurology, Mental & Behavioral Health, Women's Health
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Study Locations

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Altoona, PA ,
Hershey, PA ,
State College, PA ,

PSCI# 19-005 EA9161

The is a drug study to compare the progression freesurvival of the three drug combination Ibrutinib-Obinutuzumab-Venetoclax (IOV) to Ibrutinib-Obinutuzumab (IO) in untreated CLL patients younger than 70 years of age.

pt will either get ibrutinib and obinutuzumab, plus venetoclax for up to 19 months or will get ibrutinib and obinutuzumab until doctor decides disease is getting worse or the side effects become too severe. After 19 cycles completed, doctor will follow condition every 90 days until progression and watch for side effects. They will check pt every 3 months for 2 years. After that, they will check pt every 6 months for 3 years. After that, they will check pt every 12 months for 5 years

Yes
 

Joseph Cioccio
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
NCT03701282
SITE00000485
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Inclusion Criteria:
Diagnosis of CLL according to the NCI/IWCLL criteria or SLL according to the WHO criteria
Negative FISH analysis for t(11;14)(IgH/CCND1) on peripheral blood or tissue biopsy
Age ≥ 18 years and < 70.
ECOG performance status between 0-2.
Life expectancy of ≥ 12 months.

Exclusion Criteria:
No deletion of 17p13 on cytogenetic analysis by FISH
No active hemolytic anemia requiring immunosuppressive therapy or other pharmacologic treatment.
No current use of corticosteroids.
No previous autoimmune complications
No other active primary malignancy
Cancer
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Hershey, PA ,

Effects of COVID-19 on Perceptions of Distance

This is a survey that will examine how different factors effects the perceived interpersonal distance between figures https://pennstate.qualtrics.com/jfe/form/SV_9GEF8ubzN3UIOUt

No
 

Karen Miller
Karen Miller - at kmm7444@psu.edu
Engineering Undergraduate Studies (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00016509
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Inclusion Criteria:
18 years of age or older

Exclusion Criteria:
Children under 18 years old
COVID-19
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A PHASE 1B OPEN-LABEL/ PHASE 2 DOUBLE-BLIND PLACEBO-CONTROLLED STUDY FOR PHARMACODYNAMIC ACTIVITY, PHARMACOKINETICS, SAFETY AND TOLERABILITY OF KAN-101 IN PATIENTS WITH CELIAC DISEASE-A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in People With Celiac Disease

At this time, there is no treatment available for celiac disease diagnosis. The study is designed to test safety, tolerability and pharmacokinetics of KAN-101 to treat celiac disease diagnosis. We will participate only in the Part C study portion. Part C is a Phase 2, double-blind, placebo-controlled, parallel design study to characterize the biomarker response (plasma IL-2) in peripheral blood following gluten challenge, safety, tolerability, and pharmacokinetics (how does drug move in the body) of KAN-101 in adult participants (18 to 70 years inclusive) with histology-confirmed celiac disease. Participants will be randomized 1:1:1:1, where one arm is placebo, and other arms are different drug doses. The study consists of a screening period to determine eligibility to participate, a run-in phase where participants are gluten-challenged for one day, a treatment phase where participants will receive a seven-days treatment, and observation period lasting 358 days where participants will have a post-dose gluten challenge on Day 15, and three other time-points. The study aims to enroll 120 subjects across all sites. Participants will be asked to come for the clinic visit, to have gluten challenged done in the clinic, and treatment infusions in the clinic. There are two follow-up visits planned. The participants will have required EGD w/biopsy, and will be offered optional EGD biopsy study, that collects specimens at two time points. All participants will have a blood work done to access eligibility for participation, and to test for drug PK and biomarkers in the response of the treatment. They will also have EKG and physical examinations, vital signs checked during the clinic visits. They will complete questions for patient reported symptoms. Eligible women participants will be tested for pregnancy, and contraception will be discussed for both male and female participants.

Participants will be asked to come to the clinic visits for the screening, gluten challenge, treatment visits and follow up. During the visits, participants will have blood tests done to determine eligibility for the study, or the test how the drug moves through the body and whether it works to dampen the celiac disease symptoms. The patients will have EGD with biopsies procedure done in the endoscopy suite, and they will be offered optional biopsies study. The gluten challenge will consist of drinking a glass of water containing 9g pre-prepared gluten challenge mix. The participants will be observed for four hours. The treatment is done via infusion in the clinic over 30-minutes,and observed for four hours after that. The participants will have to come in for three treatment visits within seven days (days 1, 4, and 7).

$1775

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05574010
STUDY00022990
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Inclusion Criteria:
subject is aged 18 to 70 years
positive celiac serology and histology
followed gluten free diet for more than a year

Exclusion Criteria:
have refractory celiac
have wheat allergy
have hypersensitivity to gluten
active GI disease
have Type 1 diabetes
Digestive Systems & Liver Disease
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Biobehavioral Health Risk and Resilience in College Students (PSU THRIVE Study)

This protocol is designed to examine biobehavioral health risks, resilience, grit, forgiveness and well-being in college students.

No
 

Laura Klein
Laura Klein - at lcklein@psu.edu or 814-883-8624
Biobehavioral Health (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00006962
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Inclusion Criteria:
Fulltime undergraduate student
18 to 24 years of age
English is a primary language

Exclusion Criteria:
Not enrolled as a full time undergraduate student
Under age of 18 years
Over age of 24 years
Not comfortable speaking English
Mental & Behavioral Health
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Developing a Recommendation System for Local Community Events

In this study, we investigate a recommender system for public, local events in Centre County, PA. Currently, there is no platform that aggregates all the events that take place in a community. The data is fragmented among many platforms and it can be difficult for people to find interesting things to do. Participants will interact with our software system and discuss their experiences through a survey and/or interview.

Yes
 

Tiffany Knearem
Tiffany Knearem - at tak54@psu.edu
Information Sciences and Technology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00014494
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Inclusion Criteria:
Must be 18 years or older
Must be a University Park student or local resident of Centre County

Exclusion Criteria:
Persons under 18 years of age
Persons who do not live in Centre County, PA
Education
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State College, PA ,