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The Role of Prediction in Understanding Spoken Language

In this study, we are studying how listeners use information in spoken language to anticipate upcoming information. We study this in typical listening conditions (e.g., when others are speaking simultaneously).

In a single visit lasting between 60 ~ 90 minutes, you will be asked to listen to speech played over headphones and verify/click on the pictures on the screen if they are mentioned. While you do so, your gaze behavior will be tracked. At the end, we will ask you questions about your general language history and complete answer some simple questions about words and sentences.

18

Yes
 

Navin Viswanathan
Navin Viswanathan - at navin@psu.edu or 814-867-2340
Communication Sciences and Disorders (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00020916
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Inclusion Criteria:
Over 18 years of age
Working Knowledge of English
No History of Language or Speech Disorders

Exclusion Criteria:
Under 18
History of Language or Speech Disorders
Language & Linguistics
Not applicable
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State College, PA ,

Development of AI-Trust Model in Electronic Finances

The purpose of this study is to create a model that can predict a quantifiable change in human trust based on the performance of artificial intelligence. This is done through a 30 turn financial simulation where participants must invest "money" in stocks while being given the option to use or not use the assistance of an artificial intelligence.

No
 

Torsten Maier
Torsten Maier - at torstennamaier@psu.edu or 812-781-0014
Industrial and Manufacturing Engineering (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00016151
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Inclusion Criteria:
English speaking/literate
18 years of age or older
Access to a computer

Exclusion Criteria:
Non-English speaking/literate
17 years of age or younger
No access to a computer
Education
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(NIVOLUMAB) AND IPILIMUMAB FOLLOWED BY NIVOLUMAB VS. VEGF TKI CABOZANTINIB WITH NIVOLUMAB (PSCI# 19-109) (A031704)

The purpose of this study is to compare the usual treatment of advanced kidney cancer (treatment with ipilimumab and nivolumab followed by nivolumab alone) to the usual treatment with ipilimumab and nivolumab, followed by nivolumab with cabozantinib. This study will help the study doctors find out if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking to see if adding cabozantinib to nivolumab can increase the percentage of patients alive at 3 years from 60% to 70%.

We are asking you to take part in a research study. We do research studies to try to answer questions about how to prevent, diagnose, and treat diseases like cancer.We are asking you to take part in this research study because you have advanced or metastatic kidney cancer.

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
NCT03793166
SITE00000692
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Inclusion Criteria:
Histologic documentation of renal cell carcinoma with clear cell component
Age ≥ 18 years
Karnofsky performance status greater than or equal to 70%
Hemoglobin ≥8 g/dL
Platelet Count ≥ 100,000/mm3

Exclusion Criteria:
No prior previous systemic therapy for renal cell carcinoma.
No cancer therapy less than 28 days prior to registration; this includes radiation therapy.
Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects.
No history of HIV or active hepatitis B/C, or tuberculosis
No uncontrolled hypertension (systolic BP >150mmHg or diastolic BP
Cancer
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Hershey, PA ,

Pain and the Brain in Different Virtual Reality Environments

Research has shown that exposure to different environments alters perceived pain intensity. To explore whether pain differs in various VR environments, we are going to use virtual reality to immerse participants in different settings. At the end of every immersion, we are going to induce controlled experimental thermal pain to participants (like holding a hot cup of coffee) to understand whether their pain differs. We are also going to measure their stress, affect and brain activity using behavioral, electrophysiological (skin conductance and heart rate) and functional Near-Infrared Spectroscopy (fNIRS) methodology. The results have the potential to improve pain treatment in medical settings, where virtual reality is regularly used as a non-pharmacological analgesic, but also to inform architectural design and urban planning, so our cities and homes promote improved pain outcomes.

There will be one in-person visit that will last ~3.5 hours. During the visit you will be immersed in Virtual Reality environments, you will experience painful (but tolerable) heat stimulations, like holding a hot cup of coffee, and you will be asked to rate your pain intensity. We will record your brain activity using functional Near Infrared Spectroscopy (fNIRS) as well as your palm sweatiness and pulse. You will be compensated $25 per hour for your time.

~$85

Yes
 

Elizabeth Losin
Theoni Varoudaki - at tvaroudaki@psu.edu
Biobehavioral Health (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00024939
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Inclusion Criteria:
Adults 18-55 years old.
Fluent English speakers.
Living in the U.S.
Born in the United States or moved to the United States prior to 10 years of age.
Do not have a history of vertigo, motion or simulation sickness.

Exclusion Criteria:
Wear glasses and cannot wear contacts.
Pregnancy.
Current presence of pain.
Self-reported color blindness.
Recent history (within two years) of myocardial infarction.
Pain Management
Not applicable
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State College, PA ,

A Phase 2b, Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Saroglitazar Magnesium in Subjects with Nonalcoholic Steatohepatitis and Fibrosis

To evaluate the effect of Saroglitazar Magnesium compared with Placebo on liver scarring in patients with NASH.

There will be 11 in person visits, various procedures will be completed such as a fibroscan, liver biopsy, blood draws and DXA scan. You will be randomly assigned by chance (like the flip of a coin) to receive either Saroglitazar 4 mg or Saroglitazar 2 mg or placebo (inactive substance).

1,325

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
NCT05011305
STUDY00020176
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Inclusion Criteria:
Age 18-75
NASH diagnosis
Stage 2 or 3 fibrosis

Exclusion Criteria:
causes of chronic liver disease other than NAFLD
Chronic alcohol or drug abuse
Cirrhosis
Inability to provide informed consent
history of liver transplant
Digestive Systems & Liver Disease
Experimental drug compared to an approved drug
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Hershey, PA ,

Designing for Supportive Accountability: Using Conversational Agents to Sustain Patient Engagement in PTSD

The purpose of this study is to better understand the use and acceptance of conversational agents (CAs) aiming to support individuals with post-traumatic stress disorder (PTSD). Specifically, we will focus on examining CA prototypes that can provide useful information and support individuals with PTSD while sustaining adherence and engagement. This study corresponds to Phase 1 of the NSF grant (e.g., participatory design). The outcomes of the study will be used to advance to Phase 2 of the grant (i.e., system development"). A separate IRB application will be submitted for Phase 2. Toward this goal, we will interview individuals living with PTSD to assess the feasibility, acceptability, and correctness of the prototype of CAs.

1. Individuals who self-report having been diagnosed with PTSD2. Participants are adults, aged 18 years or older.

$30 gift card

No
 

Hee Jeong Han
Hee Jeong Han - at heejeonghan@psu.edu
Information Sciences and Technology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00021763
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Inclusion Criteria:
Individuals who self-report having been diagnosed with PTSD
Adults, aged 18 years or older.
Participants pass the screening test (the Primary Care PTSD Screen for DSM-5(PC-PTSD-5) and PTSD Checklist for DSM-5 (PCL-5)) identifying whether a participant have PTSD based on self-reported scales
English-speaking participants

Exclusion Criteria:
Minors, under the age of 18 at the time of the study.
Mental & Behavioral Health
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von Willebrand Factor in Pregnancy (VIP) Study: A Multicenter Study of Wilate Use in von Willebrand Disease for Childbirth

Specific guidance is lacking for pregnant women with von Willebrand Disease (VWD) and delivery planning in terms of how high a von Willebrand factor (VWF) level should be achieved. Specifically, guidance is lacking on whether replacement therapy drugs (Wilate & Tranexamic Acid) should target a VWF minimum level. This study is a prospective study to document the rate of primary postpartum hemorrhage (PPH) and the effectiveness of the dosing of Wilate, looking to provide increased management and guideline recommendations.

Pregnant women will come to clinic at 34-38 weeks of pregnancy, observation at time of labor or C-Section, during delivery,72 hrs. post delivery & 5-7 days vaginal delivery or 7-10 days if C-Section.

Yes
 

Peter Cygan
Cynthia Campbell-Baird, RN - at cbaird@pennstatehealth.psu.edu or 717-531-5777
Medicine: General Internal Medicine (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04146376
STUDY00015893
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Inclusion Criteria:
VWD patients who are pregnant
Type I National Heart, Lung & Blood Institute criteria
Gestational weeks 34-38

Exclusion Criteria:
Presence of disorders of hemostasis, platelet dysfunction or collagen disorders
Presence of liver or renal disease
Suspicion or diagnosis of preeclampsia or eclampsia, HELLP syndrome, TTP or DIC
Blood Disorders, Pregnancy & Infertility
Approved drug(s)
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Hershey, PA ,

PSCI 24-114: A Phase II Study Of Tailored Adjuvant Therapy In Pole-Mutated And P53- Wildtype/NSMP Early-Stage Endometrial Cancer (Rainbow Blue & Taper)

This study is to find out if there are types of early-stage endometrial cancer that require less treatment than the usual approach. Based on laboratory testing of the cancer and the extent of spread at time of surgery. The study doctor may recommend Sub-study A or Sub-study B. Based on this assessment, subjects may receive no therapy (observation) or less therapy (de-escalated therapy) than the subject would have received as part of your usual treatment.

Treatment that will be recommended to the subject will be based on laboratory testing of the cancer and the extent of spread at time of surgery. The study doctor might recommend that the subject participate in Sub-study A or Sub-study B. Based on this assessment, the subject may receive no therapy (observation) or less therapy (de-escalated therapy) than the subject would have received as part of their usual treatment After the subject finishes study treatment, and even if they stop treatment early, the study doctor will continue to follow the subject's condition, watch the subject for side effects and keep track of the subjects health. The subject will be seen after 3 months and 6 months, then every 6 months for 3 years, and then every year after starting the study until the study closes. The subject may be seen more often if subject's study doctor thinks it is necessary.

Yes
 

Shaina Bruce
Kelly Sentz-Brenneman - at ksentzbrenneman@pennstatehealth.psu.edu" <ksentzbrenneman@pennstatehealth.psu.edu or 717-531-7417
Obstetrics and Gynecology (HERSHEY)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
NCT06388018
STUDY00025890
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Inclusion Criteria:
Patients must have histologically confirmed Stage I to III endometrial carcinoma which can be endometrioid, serous, clear cell, un/dedifferentiated, carcinosarcoma or mixed.
Patients’ Eastern Cooperative Group (ECOG) performance status must be 0, 1, or 2.
Patients’ age must be greater than18 years.
Patients must have had surgery consisting of hysterectomy (total abdominal, laparoscopic or robotic-assisted) and bilateral salpingo-oophorectomy. Lymph node dissection can be performed as per institutional standards (sentinel or full lymphadenectomy)
HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.

Exclusion Criteria:
Prior Neoadjuvant chemotherapy for current endometrial cancer diagnosis.
Prior pelvic radiation.
Clinical evidence of distant metastasis as determined by pre-surgical or post-surgical imaging (CT scan of chest, abdomen and pelvis or whole-body PET-CT scan)
Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years.
Women's Health
Approved drug(s)
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Hershey, PA ,

22-061 Relugolix Versus Leuprolide in Patients with Prostate Cancer: A Randomized, Open-Label Study to Assess Major AdverseCardiovascular Events (REPLACE-CV)

The purpose of this research study is to compare and see if medications used in ADT treatment, either relugolix or leuprolide acetate, lower the risk of cardiovascular events in patients with prostate cancer. You (or your caregiver) will be asked to complete questionnaires electronically (such as computer, tablet, or smartphone) and/or share information via phone calls every three months until the end of your participation in the study. You will receive the study medications for treatment (either relugolix or leuprolide acetate)

Participants will be required to complete questionnaires electronically (such as computer, tablet, or smartphone) and/or share information via phone calls every three months until the end of your participation in the study. You will receive the study medications for treatment (either relugolix or leuprolide acetate)

$150 per year

Yes
 

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

Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05605964
SITE00001315
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Inclusion Criteria:
Has voluntarily signed and dated the informed consent form prior to baseline visit;
Is a male and 18 years of age or older on the day of signing and dating the informed consent form;
Patient has sufficient cognitive function in the investigator’s opinion to complete the questionnaires and other activities related to the study
Has histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate
Is, in the opinion of the investigator, a candidate for at least 1 year of continuous ADT for the management of prostate cancer with one of the following clinical disease state presentations:Evidence of biochemical (prostate-specific antigen

Exclusion Criteria:
Any significant cardiovascular conditions per the investigator within 1 month before study entry
Any major cardiovascular or cerebrovascular procedures planned within 1 month after enrollment;
Patients with QT interval corrected for heart rate (QTc) determined using Fridericia’s formula (QTcF; QTcF = QT/[R-R interval {RR}^0.33]) > 470 msec within 6 months of screening
Uncontrolled hypertension (systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg) at the time of screening
Previously received GnRH receptor agonist
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

POE23-01 - TINI 2: Total Therapy for Infants with Acute Lymphoblastic Leukemia II

This study is being done to improve upon the previous TINI study treatment. It replaces one of the chemotherapy cycles with a type of immunotherapy called blinatumomab. The use of blinatumomab in this study is investigational. In addition, infants that have persistent disease will receive a new investigational drug called ziftomenib that specifically targets infant ALL cells.

You will have exams, tests, and procedures while on the study to evaluate whether you can participate in the study and how you are doing while on the study. These include physical exams, blood tests, urine tests, bone marrow aspirate and biopsies, heart tests, lumbar puncture, and chest x-ray.Treatment on this study from Day 1 of Remission Induction period through the end of Maintenance period will last almost 2 years. After study treatment is completed, you will have blood tests and other evaluations. You will be seen every 4 months for the first year, every 6 months for the second year, and then once a year for up to 10 years.

Yes
 

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

All
Younger than 18 years old
This study is NOT accepting healthy volunteers
NCT05848687
STUDY00025408
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Inclusion Criteria:
less than or equal to 365 days of age
Newly diagnosed CD19 positive acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia.
Limited prior therapy

Exclusion Criteria:
Patients with prior therapy, other than therapy specified in inclusion criteria
Patients with mature B-cell ALL that does not have a KMT2Ar or patients with acute myelogenous (AML) or T-cell ALL
Patients with Down syndrome
Cancer
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Hershey, PA ,

Characterizing resilience to food-cue induced overeating in children

This is a behavioral and neuroimaging study that will examine how food commercials affect the way a child eats and responds to food. Children enrolled in the study will complete 5 in-lab sessions that include eating meals and snacks, watching TV, and playing computer games. For one of these sessions, children will complete an fMRI scan. On the first and last visit to the lab, children will receive a DXA scan to assess their body composition.

We are looking for children to help us learn about how kids respond to different types of foods and food advertisements. The study consists of 5 visits to our facilities in Noll and Chandlee Labs, located on the University Park Campus. For 3 visits your child will eat test meals and snack buffets in our laboratory. On 1 visit we will use fMRI to take pictures of your child’s brain. We will use a DXA to scan for lean muscle and conduct an IQ test. These procedures are not harmful. You and your child will fill out questionnaires.Your child will also play computer games and watch commercials.

$250.00-450.00

Yes
 

Kathleen Keller
Ben Baney - at bab349@psu.edu or 814-753-1005
Nutritional Sciences (UNIVERSITY PARK)
 

All
Younger than 18 years old
This study is also accepting healthy volunteers
NCT05073185
STUDY00015835
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Inclusion Criteria:
In order to be enrolled, children must be of good health based on parental self-report.
Be 7-9 years-old at enrollment.
Not be taking any medications known to influence body weight, taste, food intake, behavior, or blood flow.
Have no learning disabilities (e.g., ADHD).
The biological mother must have a body mass index either between 18.5 - 25 kg/m2 (low-risk group) or greater than or equal to 30 kg/m2 (high-risk group).

Exclusion Criteria:
They are not within the age requirements (< than 7 years old or > than 9 years-old at baseline).
If they have a learning disability, ADD/ADHD, language delays, autism or other neurological or psychological conditions.
If they have a pre-existing medical condition such as diabetes, rheumatoid arthritis, Cushing’s syndrome, Down’s syndrome, severe lactose intolerance, Prader-Willi syndrome, HIV, cancer, renal failure, cerebral palsy, or can't engage in moderate exercise.
If they don’t speak English.
Biological mother must have a body mass index either between 18.5 - 25 kg/m2 (low-risk group) or greater than or equal to 30 kg/m2 for mothers (high-risk group), or they are excluded.
Children's Health, Food & Nutrition, Prevention
Not applicable
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State College, PA ,

Emotion dynamics and alcohol use in NIAAA-defined recovery from alcohol use disorder

This study uses a baseline assessment and 28 days of ecological momentary assessment to examine the association of emotion dynamics to craving and alcohol use among people in the first year of cessation of heavy drinking and remission from DSM-5 AUD.

There will be one in person visit. Participants will be asked to complete baseline questionnaires. After the baseline assessment, participants will complete 28 days of daily diary questions on their cell phone. A prompt will be sent to the phone 3 times per day. It should take 5 minutes (15 minutes total/day) to complete the questions.

184

Yes
 

Brad Linn
Brad Linn - at blinn1@pennstatehealth.psu.edu or 717-531-0003, ext=321641
Molecular and Precision Medicine (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00024054
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Inclusion Criteria:
Aged between 18-68
Have a history of a previous (AUD) in the past year
Live within commuting distance of the Penn State Clinical Research Center

Exclusion Criteria:
Acute psychosis
Bipolar disorder
Cognitive impairment
Active drug use disorder other than nicotine or cannabis dependence
Lack of sufficient familiarity with the English language to comprehend recruitment and consent procedures
Men's Health, Addiction & Substance Abuse, Mental & Behavioral Health
Not applicable
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Hershey, PA ,

The Sexual Relationships Study

The purpose of this study is to examine the sexual relationships among heterosexual female college students (ages 18-22) via Qualtrics (a web-based survey). Utilizing latent class analysis with a distal outcome, the proposed cross-sectional study seeks to do the following: Aim 1. Examine the heterogeneity in relationship quality among female college students. Research question 1: Is there a latent class structure that adequately represents the heterogeneity in relationship quality among female undergraduate students participating in penile-vaginal sex? If so, what are the types and their corresponding prevalence?Aim 2. Examine the association between relationship characteristics and latent class membership.Research question 2: Are relationship characteristics (partner type, relationship duration, exclusivity/monogamy, and frequency of sex) predictive of membership in latent classes of relationship quality?Aim 3. Examine the association between latent classes of relationship quality and condom use.Research question 3: Which identified latent class of relationship quality is significantly associated with condom use at last penile-vaginal sex?Please note that the indicators measuring relationship quality will include the following variables: 1) trust, 2) love, 3) passion, 4) commitment, 5) relationship satisfaction, 6) sexual satisfaction, 7) intimacy, and 8) decision-making dominance.

No
 

Jessica Salas
Jessica Salas-Brooks - at jis5940@psu.edu or 704-249-4252
Biobehavioral Health (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00006941
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Inclusion Criteria:
Be enrolled at Pennsylvania State University (University Park Campus)
Be between the ages of 18-22 years
Be a female college student
Be sexually active with male partners in the previous 3 months

Exclusion Criteria:
Are not enrolled at Pennsylvania State University (University Park Campus)
Are under the age of 18 or over the age of 22.
Are not a female college student
Are not sexually active with male partners in the previous 3 months
Women's Health
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NMTRC014: NMTT- Neuroblastoma Maintenance Therapy Trial Using Difluoromethylornithine (DFMO)

A study of DFMO for patients with neuroblastoma in remission.

Participating in this study requires that you visit the Penn State health Medical Center multiple times over the course of the full study for evaluations (physical exam, blood draw, urine analysis, etc.) and scans (MRI/CT, MIBG).If you agree to take part, you will receive treatment on this study for about 2 years and will be followed for survival for 5 years after the last dose of study drug. You will be asked to return to the research site approximately 15 times.

Yes
 

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

All
All
This study is NOT accepting healthy volunteers
NCT02679144
STUDY00004295
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Inclusion Criteria:
A confirmed diagnosis of neuroblastoma.
Must be in complete remission (CR).
Tests and scans will be required to confirm remission.

Exclusion Criteria:
Patients below the defined minimum of height and weight.
Patients who are currently receiving another study drug may not participate.
Patients who are currently receiving other anticancer agents may not participate.
Children's Health, Cancer
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Hershey, PA ,

Exploring the effects of nighttime indoor light exposure on children with autism spectrum disorder

This study aims to identify potential differences in psychological and physiological responses to indoor light at night and to offer recommendations for optimizing the sleep patterns, circadian rhythms, and sensory regulation of children with ASD.

Parents and/or caregivers of children with ASD will fill out surveys and collect saliva samples.

20

No
 

Dorukalp Durmus
Merve Oner - at mjo5773@psu.edu
Architectural Engineering (UNIVERSITY PARK)
 

All
Younger than 18 years old
This study is NOT accepting healthy volunteers
STUDY00025039
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Inclusion Criteria:
Children with ASD
Aged 9-15
Sleep difficulties

Exclusion Criteria:
Candidates who cannot guarantee that they will refrain from using non-steroidal anti-inflammatory and psychotropic medications
Disorders such as sleep apnea, restless legs syndrome, or periodic limb disorder during sleep
Children with fragile X syndrome, Down syndrome, neurofibromatosis, or tuberous sclerosis complex and children who had a non-febrile unprovoked epileptic seizure within the last two years
Sleep Management, Mental & Behavioral Health
Not applicable
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Contempt as a Mixed Emotion

This study will investigate whether contempt is a positive, negative, or mixed emotion.

No
 

Michelle Yarwood
Victor Ellis - at vde5011@psu.edu
Psychology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00016610
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Inclusion Criteria:
age 18 years or older

Exclusion Criteria:
younger than 18 years of age
Mental & Behavioral Health
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A Phase 3 RandOmized Study Comparing PERioperative Nivolumab Vs. Observation in Patients with Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC) (EA8143) (PSCI 18-025)

This study is a phase 3 study that will be comparing recurrence-free survival (RFS) between patients withlocally advanced renal cell carcinoma randomly assigned toperioperative nivolumab in conjunction with radical or partialnephrectomy with patients randomized to surgery alone.

You are being asked to take part in this research study because you have cancer in your kidney, which is planned to be removed by a surgeon. The standard treatment for your disease is to remove the kidney or part of the kidney that contains the cancer by surgery. You are then monitored after surgery with imaging scans and exams to watch for any possiblesigns of recurrence (close observation)

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
NCT03055013
SITE00000234
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Inclusion Criteria:
Newly Diagnosed higher risk RCC of any histology
No clinical or radiological evidence of distant metastases
No concurrent or prior systemic or local anti-cancer therapy for RCC is permitted
Age must be greater than or equal to 18 years old
ECOG Performance status must be 0 or 1

Exclusion Criteria:
Women must not be pregant or breast feeding
History of RCC that was resected with curative intent within the past 5 years
Prior or current prostate cancer is excluded
Active known or suspected autoimmune disease
Uncontrolled adrenal insufficiency
Kidney & Urinary System, Cancer
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Hershey, PA ,

PSCI 22-156 HCRN BRE17-141

The purpose of this voluntary research study is to see if neratinib, endocrine therapy, and trastuzumab completely shrink breast tumors before having breast cancer surgery. You will need to have the following exams, tests, or procedures: blood draws, ECG, Echo or MUGA, ultrasound, MRI, receive study treatment, and breast biopsy.

Participants will be required to receive study treatments, laboratory assessments, undergo breast biopsy, and radiologic assessments,

Yes
 

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

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04987203
SITE00001343
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Inclusion Criteria:
Anatomic, clinical stage I-III, invasive breast cancer, greater than 10mm.
HER2-positive (by most recent ASCO-CAP criteria)
ER > 50% and PR > 50%.
Resectable breast cancer in which pre-operative therapy is appropriate (T > 10mm and/or node-positive).
Archival tissue from the diagnostic pre-treatment biopsy is required.

Exclusion Criteria:
Locally advanced or inflammatory breast cancer.
Evidence of metastatic disease.
Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial:
Active infection requiring systemic therapy.
Requirement for use of a moderate or strong CYP3A4 inhibitor or inducer during the study
Cancer
Experimental drug compared to an approved drug
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Collective Punishment and Identity Fusion: An Examination

This study, part of a broader dissertation on terrorism and radicalization, aims to experimentally determine how collective punishment fuses individual identities to that of an ingroup, expanding extant knowledge of identity fusion theory.

Yes
 

Connor Somgynari
Connor Somgynari - at cjs72@psu.edu
Political Science (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00012346
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Inclusion Criteria:
Over age 18
Identification as Republican or Democratic
English Speaker

Exclusion Criteria:
Under age 18
Political identification as independent (not republican or democrat)
Non-English Speakers
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State College, PA ,

BCC020: A Dose Escalation Study Using Difluoromethylornithine(DFMO) and AMXT-1501 followed by a Randomized Controlled Trial of DFMO with or without AMXT-1501 for Neuroblastoma, CNS Tumors, and Sarcomas

The purpose of this study is to evaluate the investigational drug AMXT-1501 (a pill taken by mouth) in combination with the study drug difluoromethylornithine (DFMO) for infusion administered intravenously (IV; a liquid that continuously goes into your body through a tube that has been placed during a surgery into one of your veins). An investigational drug is one that has not been approved by the U.S. Food &amp; Drug Administration (FDA), or any other regulatory authorities around the world for use alone or in combination with any drug, for the condition or illness it is being used to treat.

You will undergo a number of standard tests and research-related procedures before being able to enroll on this study.

Yes
 

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

All
All
This study is NOT accepting healthy volunteers
NCT06465199
STUDY00025296
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Inclusion Criteria:
0-21 years of age at diagnosis

Exclusion Criteria:
Currently receiving another investigational drug
Cancer
Prefer not to display
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A Multicenter, Randomized, Double-blind, Vehicle-controlled, Phase 3 Efficacy and Safety Study of Patidegib Gel 2% for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects with Gorlin Syndrome

Participants 18 years and older who meet the diagnostic criteria for the basal cell nevus (Gorlin) syndrome will be assigned to receive either Patidegib Gel 2% or Placebo (no active medicine) to apply twice daily for 12 months. The assignment will be made according to sex assigned at birth, age, and number of BCC lesions at the treatment area at Baseline. The primary endpoint is a comparison between the 2 treatment arms of the number of new BCCs at Month 12 compared to Baseline. The BCCs will be imaged and tracked consistently throughout the study to identify new BCCs and to confirm their diagnosis by dermoscopy (handheld instrument with a 15x magnification lens and a cross-polarized light source).

Participants will participate in 15 visits over approximately 14 months (attend 6 in person visits along with 9 phone call visits). In addition, participants will receive study medication to apply twice a day for 12 months and undergo clinical tests at various time points, which include blood tests, ECG, complete questionnaires/diary, skin exam and skin photographs.

Compensation is provided for eligible participants.

Yes
 

Elizabeth Billingsley
Samantha Gettle - at dermatologyclinicaltrials@pennstatehealth.psu.edu or 717-531-5136
Dermatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06050122
STUDY00023809
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Inclusion Criteria:
Must be confirmed to have a PTCH1 mutation
Diagnostic criteria present for Gorlin Syndrome
10 BCCs present on face at Randomization (Baseline/Day 1)

Exclusion Criteria:
Certain medications are not allowed during study; study coordinator will discuss
uncontrolled systemic disease
uncontrolled skin disease on the face.
Skin Conditions
Experimental drug compared to a placebo/”sugar pill”
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A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Brensocatib in Participants with Chronic Rhinosinusitis Without Nasal Polyps – The BiRCh Study

The purpose of this study is to find out if the experimental drug (brensocatib) improves symptoms of Chronic Rhinosinusitis Without Nasal Polyps and is safe. Study treatments include the study drug and mometasone furoate nasal spray (referred to as mometasone). The study drug will either be brensocatib (“active” drug that contains “real” drug) or placebo (looks like brensocatib but does not have any “real” drug in it). Mometasone will be taken by all participants throughout the study as routine care.

If you choose to participate in the study, the following main activities and procedures are required.•Complete questionnaires asking about your chronic rhinosinusitis symptoms and quality of life•Measure the amount of air you can breathe in through both sides of your nose (nasal airflow)•Electrocardiogram (ECG) and vital signs•Physical examination, including examinations of your mouth and skin•Provide blood and urine samples•Sinus computed tomography (CT) scan•Attend 9 study visits•Nasal endoscopy

Unknown at this time

Yes
 

Timothy Craig
Kara Grim - at kgrim@pennstatehealth.psu.edu or 717-531-4513
Medicine: Pulmonary, Allergy and Critical Care (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06013241
STUDY00023061
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Inclusion Criteria:
Ages 18 to 75
Participants who have at least a 12-week history before Screening Visit of Chronic Rhinosinusitis without nasal polyps
Received a course of antibiotics or steroids to treat symptoms of Chronic Rhinosinusitis within 1 year or previous surgery for Chronic Rhinosinusitis

Exclusion Criteria:
Diagnosis of nasal polyps
Diagnosis of Cystic Fibrosis or Primary Ciliary Dyskinesia
Scheduled sinus surgery at any time during the study or have had nasal surgery within 4 weeks of the first study visit
Participants with seasonal allergic rhinitis whose symptoms occur during the treatment period of the study
Current smoker
Allergies
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Observational Study for Pediatric Rheumatic Diseases: The CARRA Registry

The original Childhood Arthritis &amp; Rheumatology Research Alliance (CARRA) Registry was first established in 2010 to advance alliance infrastructure,facilitate expanded clinical and translational pediatric research, and transform the culture of pediatric rheumatology toward universal participation in research. Continuation of the CARRA Registry as described in the protocol attached to this IRB submission will support data collection onpatients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis for future CARRA studies. In particular, this observational registry will be used to answer pressingquestions about therapeutics used to treat pediatric rheumatic diseases, including examining safety questions. The Duke Clinical Research Institute (DCRI) is serving as the CARRA Clinicaland Data Coordinating Center (CDCC) for this protocol.

In addition to allowing the researchers to collect data on you from your medical record, we will ask you and your parents/caregivers to complete a short survey that takes about 15 minutes to completeThe research team will follow up every 6 months by reviewing your medical record and asking you and your parents/caregivers to complete a short survey that takes about 15 minutes to complete.If you agree to take part, you will be in the study for 10 or more years.

Yes
 

Timothy Hahn
Meredith Buckley - at mbuckley@pennstatehealth.psu.edu
Pediatrics: General Pediatrics (HERSHEY)
 

All
Younger than 18 years old
This study is NOT accepting healthy volunteers
STUDY00008987
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Inclusion Criteria:
Onset of rheumatic disease prior to age 16 years for Juvenile Idiopathic Arthritis
Onset prior to age 19 years for all other rheumatic diseases
Willing to participate in a registry you will be followed during your treatment and have information about you disease and treatment collected.

Exclusion Criteria:
More than 21 years of age.
Arthritis & Rheumatic Diseases
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Hershey, PA ,

Interpersonal contrast avoidance of anxiety and depression

This research aims to learn more about your daily thoughts, behaviors, and their impact on social relationships. We want to understand the different qualities of day-to-day thoughts, how these might affect your mood, and how this may influence how you behave in social interactions. We will first ask you to complete a set of structured questionnaires and a brief 30-minute psychological interview via Zoom. This will be followed by a training session in which you will learn how to use your smartphone to track your social interactions and related daily thoughts and behaviors eight times a day for eight days.

You will undergo an initial assessment visit conducted on Zoom, where you will provide informed consent and undergo screening through a brief 30-minute clinical interview. Based on your responses, we will know if you can participate in the study. If eligible, you will be invited to the second part of the study. If so, during the same session, you will then receive a brief half-hour training session reviewing instructions on using a mobile application to complete daily surveys and then complete a series of online questionnaires.When you leave this session, for the next eight days, you will complete eight (approximately 2-minute) questionnaires daily between 10 a.m. and 10 p.m. On the third day, you will attend a compliance check via Zoom to review your progress in the present study.

$20

Yes
 

Adam Calderon
Adam Calderon - at afc6160@psu.edu
Psychology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00022977
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Inclusion Criteria:
At least 18 years of age
Scores on self-report questionnaires suggest person does or does not struggle with anxiety and/or depression
Owns a smartphone
Fluent in the English language in terms of speaking, listening, reading, and writing.

Exclusion Criteria:
Younger than 18 years of age
Does not own a smartphone
Unable to speak, read, listen, and write English fluently.
Men's Health, Mental & Behavioral Health, Women's Health
Not applicable
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State College, PA ,

Robots that Learn Games by Asking People Questions

The study goal is to develop robots that can learn simple games by interviewing humans. The robot interview strategies are represented as Markov Decision Process policies, and are developed offline through robot interactions with simulated interviewees. The investigator can set the simulated interviewee to respond to the robot's queries with different amounts of information. The games include board games like Connect 4, Quarto, and Checkers. The communication between the robot and simulated interviewee is in a formal language like first order logic. After a simulated dialogue, the robot will have more or less knowledge of the game, depending on the conditions of the simulated interviewee. Human subjects will interact with the robots in two ways. First, to test the utility of the new knowledge, human subjects will participate in experiments where they play the game with virtual robots that have learned the game under different conditions. Second, to investigate the kinds of misunderstandings of questions and answers that might arise if the robot could interview a human, we will present subjects with extracts from the formal language dialogues that we have mapped to English in different ways, and ask subjects to imagine how they would express the same meaning in English, or answer questions in different ways, or what sorts of misunderstandings they might imagine in a real dialogue.

Yes
 

Rebecca Passonneau
Maryam Zare - at muz50@psu.edu
Computer Science and Engineering (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00014432
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Inclusion Criteria:
Over 18 years of age
Ability to communicate in written and spoken English
Able to give informed consent

Exclusion Criteria:
Below 18 years of age
Unable to communicate in written and spoken English
Unable to give informed consent
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State College, PA ,

PSCI 22-114: A PHASE 2/3, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF NKTR-255VS PLACEBO FOLLOWINGCD-19 DIRECTED CAR-T THERAPYIN PATIENTS WITH RELAPSED/REFRACTORY LARGE B-CELL LYMPHOMA.

This is a drug study that will evaluate how well the investigational drug works compared to a placebo following CAR-T cell therapy. Participants will be required to keep all your scheduled visits, receive drug treatment, blood draws, imaging, and possibly a tumor biopsy.

Participants will be required to receive the study treatments including CAR-T infusion, blook tests, imaging, tumor biopsy, and study medications.

Yes
 

Shin Mineishi
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
NCT05664217
SITE00001327
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Inclusion Criteria:
Male or female ≥ 18 years of age at the time of consent.
Received standard of care therapy with axi-cel or liso-cel (Stage 1 and Stage 2), or tisa-cel (Stage 2 only)
Received lymphodepleting chemotherapy regimen according to the respective FDA (or SmPC) label for CAR-T cell therapy.
Fluorodeoxyglucose (FDG)-avid disease on PET imaging within 30 days prior to CAR-T cell infusion
FDG avid lesion(s) on PET/CT scan following bridging therapy and prior to lymphodepletion, where applicable.

Exclusion Criteria:
Use of therapeutic doses of corticosteroids (≥ 5mg/day prednisone or equivalent) or other systemic immunosuppression within 7 days prior to leukapheresis or within 72 hours prior to CAR-T cell infusion. Topical and/or inhaled steroids are permitted
Prior treatment with any CD19-directed CAR-T cell therapy other than the treatment planned per Inclusion Criterion 2.
For allogeneic hematopoietic cell transplant recipients, active graft versus host disease (GVHD) and/or systemic GVHD therapy during screening or up to 30 days prior to leukapheresis.
Known active hepatitis B (detectable hepatitis B DNA) or hepatitis C (detectable hepatitis C RNA).
Known human immunodeficiency virus (HIV) infection
Cancer
Experimental drug compared to a placebo/”sugar pill”
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VIBRANT: VIB4920 for Active Lupus Nephritis

A randomized placebo-controlled study to evaluate the efficacy and safety of VIB4920 in study participants with active lupus nephritis

Patients come for in-person visits at the Penn State Hershey main hospital location. There will be blood draws, physical exams, and questionnaires spread out across 60 weeks.

Yes
 

Nancy Olsen
Peri Newman - at pnewman@pennstatehealth.psu.edu or 717-531-0003, ext=287327
Medicine: Rheumatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05201469
SITE00001277
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Inclusion Criteria:
Lupus nephritis
Systemic lupus erythematosus

Exclusion Criteria:
Pregnant
Transplant
Kidney & Urinary System, Arthritis & Rheumatic Diseases, Muscle & Bone
Experimental drug compared to a placebo/”sugar pill”
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What’s in a grammar? A microcomparative study of negation in American Englishes

In contexts where people speak different dialects of the same language, how much overlap is there between the dialects, and what are the genuine grammatical differences? This study explores this question through a series of three experiments examining how people from three different dialects understand a variety of negative sentences (e.g., I didn't eat nothing). The results will contribute to our understanding of linguistic diversity.

Participants will sit at a computer and have their eye movements tracked by a camera as they read or listen to sentences and look at pictures on the screen.

$15 per hour

Yes
 

Frances Blanchette
fkb1@psu.edu
Psychology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00022446
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Inclusion Criteria:
native speaker of American English

Exclusion Criteria:
non-native speaker
not 18 or older
Language & Linguistics
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State College, PA ,

Vernacular Feature Comprehension and Perception in Persons with Aphasia

This study investigates whether persons with aphasia understand and process sentences with vernacular features in a manner similar to more typical populations. Participants will rate sentences on their naturalness and on whether they make sense, and they will also read sentences while we track their eye movements.

Yes
 

Frances Blanchette
Frances Blanchette - at fkb1@psu.edu
Psychology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00014402
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Inclusion Criteria:
1.Diagnosis of aphasia
2.Sustained stroke more than 6 months prior to consent
3.Native speakers of English
4.Completed at least a high school education
5.Normal or corrected-to-normal vision and hearing

Exclusion Criteria:
1.History of degenerative neurological disorders (e.g., Alzheimer’s disease), acquired neurological disorders other than aphasia from stroke (e.g., traumatic brain injury), developmental neurological disorders (e.g., autism), or psychiatric disorders
2.An active medical condition that could compromise participation (e.g., cancer undergoing acute treatment)
3.Taking medications that are known to exert significant effects on cognitive processes
4.Do not meet the above inclusionary criteria
Language & Linguistics
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Hershey, PA ,
State College, PA ,

Using ERPs and eye-tracking to study language learning and processing in adult learners.

In an increasingly global environment, both within the US and abroad, the ability to rapidly gain native-like linguistic competence is a critical asset. The ability to use an L2 in a way that is both expected and recognized by its native speakers is important both to the broad public, and to specific sectors, such as military personnel, that must develop native-like competence in a foreign language in a limited amount of time. The studies conducted under this IRB protocol will examine how learners/speakers of a second language acquire and process multi-word units (e.g., carry a business; run a store) in their second language, and how knowledge from the first language might influence the learning and processing of multi-word units in a second language.

Participants will complete a number of simple tasks on a computer in English and/or in Spanish (depending on language background).

$12/hour (behavioral sessions); $18/hour (EEG sessions); $20 bonus at completion of study when at least 3 behavioral sessions or 2 EEG sessions are required.

Yes
 

Manuel Pulido
Manuel Pulido - at mfp149@psu.edu
Spanish, Italian and Portuguese (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00011115
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Inclusion Criteria:
Be a native speaker of English or Spanish
Not fluent in other languages
No history of neurological or language disorders
Normal or normal-to-corrected vision
Right-handed

Exclusion Criteria:
Native speaker of a language different from English or Spanish
Older than 45 years old
Left-handed or ambidextrous
A history of neurological disorders or language disorders
Education, Language & Linguistics
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State College, PA ,