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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 ,

National Study of College Students Formerly in Foster Care

This study will examine the educational experiences and outcomes of youth who have experience with the foster care system in the United States. We are interested in understanding the protective and risk factors that influence college success for youth in foster care. This study involves a three round interview process. Each interview will be approximately 60-90 minutes.

No
 

Royel Johnson
Bridget Parler - at bap62@psu.edu
Non-PSU Site
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00012790
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Inclusion Criteria:
Identify as having experience being in the foster care system in the United States
Must be currently enrolled in a college or university
Must be at least 18 years old

Exclusion Criteria:
Does not identify as previously been in foster care in the United States
Under 18 years of age
Education
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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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Altoona, PA ,
Hershey, PA ,
State College, PA ,

EA9161: A Randomized Phase III Study of the addition ofVenetoclax to Ibrutinib and Obinutuzumab versus Ibrutiniband Obinutuzumab in Untreated Younger Patients withChronic Lymphocytic Leukemia (CLL)

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 ,

PSCI 24-015 S2212 SHORTER ANTHRACYCLINE-FREE CHEMO IMMUNOTHERAPY ADAPTED TO PATHOLOGICAL RESPONSE IN EARLY TRIPLE NEGATIVE BREAST CANCER (SCARLET), ARANDOMIZED PHASE III STUDY

To see if participants with early stage triple negative breast cancer randomized to receive anthracycline-free, taxane-platinum neoadjuvant chemotherapy with pembrolizumab have a better breast cancer event-free survival (BC-EFS)compared to participants randomized to taxane-platinum-anthracycline neoadjuvant chemotherapy with pembrolizumab.

keep all study appointmentsreport to your study team any side effects or any changes in medication

Yes
 

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

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05929768
STUDY00024644
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Inclusion Criteria:
Participants must have histologically confirmed ER-negative, PR-negative, and HER2-negative breast cancer
Participants must have breast and axillary imaging with mammogram and/or ultrasound and/or MRI within 49 days prior to randomization.
Participants must not have metastatic disease
Participants must not have received prior systemic therapy or radiation therapy
Participants must be ≥ 18 years old.

Exclusion Criteria:
Participants must not be pregnant or nursing.
Participants must not have a prior or concurrent malignancy
Participants must not have received a live vaccine within 30 days prior to randomization.
Participants must not have active autoimmune disease
Participants must not have severe or active infections
Cancer
Approved drug(s)
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Hershey, PA ,
Reading, PA ,

Behind virtual world building: Studying virtual reality environmental characteristics

This is a user study to investigate the environmental characteristics of virtual reality (VR). This study will provide empirical evidence of the essential characteristics based on users’ feedbacks. During your visit, you will receive a brief training about using a VR headset and navigating in the virtual environment. After the training, you will explore the virtual environment, complete tasks in VR, and answer questions regarding your feelings to our VR application.

Yes
 

Jiawei Huang
Jiawei Huang - at jzh87@psu.edu or 734-355-5327
Geography (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00011790
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Inclusion Criteria:
students at Penn State
healthy participants

Exclusion Criteria:
students that are cognitive impaired
students under 18
students with contagious disease
Education, Language & Linguistics
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State College, PA ,

A Phase II Study of Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer (RaPhLRR Study)

Participants in this study will receive a drug called ribociclib with the endocrine therapy of your physician’s choice. Ribociclib is taken as a pill. Endocrine therapy is taken as a pill or given as a shot. You will have tests, exams and procedures that are part of your regular care and for study purposes. Also, as part of routine care, you will be checked every 4 to 12 weeks to make sure your cancer hasn’t come back. You will receive ribociclib combined with endocrine therapy for up to 3 years. After that you will continue endocrine therapy alone for another 2 years (5 years total) as part of your regular care.

Participants will be required to: - receive ribociclib along with standard endocrine therapy drugs - have blood drawn - imaging scans (CT, PET-CT, bone scans, mammograms, MRI) - keep a medication diary - optional biopsy - ECG-a test that looks at the way your heart beats - ECHO-a test that looks at the way your heart pumps

Yes
 

Monali Vasekar
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
NCT05467891
STUDY00022070
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Inclusion Criteria:
Written informed consent and HIPAA authorization for release of personal health information obtained prior to performing any study-specific screening procedures.
Male or female age ≥ 18 years at the time of consent.
ECOG Performance Status of 0-1 within 28 days prior to registration.
If patient is receiving tamoxifen or toremifene, a washout period of 28 days prior to registration is required.
Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer based on the most recently analyzed tissue sample and all tested by local laboratory.

Exclusion Criteria:
Patient with a known hypersensitivity to any of the excipients of ribociclib.
Patient who has received prior CDK4/6 inhibitor for recurrent disease. Patients who received a CDK4/6 inhibitor in the adjuvant setting may participate if they have been off therapy for at least 1 year prior to diagnosis of recurrent disease.
Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects.
Pregnant or breastfeeding or planning to become pregnant during the trial
Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

A Phase Ib/11 Study of Propranolol with fixed-dose Pembrolizumab in Patients with Unresectable Stage III and Stage IV Melanoma

This research is being done to find out the safety of propranolol and, identify the maximum tolerated dose of propranolol that can be administered in combination with pembrolizumab in patients with unresectable stage III and stage IV melanoma. This study will evaluate this novel combination of pembrolizumab and propranolol to see what effect it may have on how your cancer responds to the treatment combination.

Phase II*propranolol twice a day.*pembrolizumab by an infusion every 3 weeks.*May receive treatment with pembrolizumab and propranolol for up to24 months from the time they began treatment with the combination.Procedures to be done:. A medical history  A physical exam ECOG Performance Status Perceived Stress Scale questionnaire An assessment of tumor by scan. Scans may include:o Computed tomography (CT), with or without contrast. o Magnetic resonance imaging (MRI) or head CT with IV contrast  Blood tests:o Approximately 2 tablespoons for routine testing, such as a complete blood count and acomprehensive metabolic panel Pregnancy test Urinalysis Electrocardiogram A sample of tumor from a previous biopsy or sample taken Phase 1 portion of the study, these evaluations/tests will also occur on Day 8 of Cycle 1 Review concomitant medications. Physical Exams ECOG Performance Status Perceived Stress Scale questionnaire Blood tests:o Every 3 weekso At 3 weeks and 6 months or discontinuation of treatment (whichever comes sooner) and atdisease progressiono Every 3 weeks: Approximately 1 tablespoon for tests that monitor your blood sugar levelsand thyroid functiono Every week for the first 6 weeks then every cycle for another 6 weeks Assessment of cancer by CT or MRI. These assessments will be performed every 12 weeks(± 14 days). The first assessment will be after completing Cycle 4. If their cancer is found to be improving,repeat the CT and MRI scans in about 12 weeks. EKG: Once treatment begins, this will be done every cycle prior to receiving pembrolizumab for the first 5 cycles. Adverse events Tumor Biopsy: A tumor biopsy (only in phase II) will be obtained at the 12 weeks after initiation oftreatment.Tumor biopsy will be optional for phase II patients..Safety Follow-Up:After all study treatment has stopped, end of treatmentvisit, which will be approximately 30 days after their last dose of study drug or before starting a newtreatment Medical History:  Concomitant medications complete physical examination ECOG Performance Status Perceived Stress Scale assessment Adverse events Survival status Blood tests:o Follow- Up Phase3 Month and 6 Month Follow- up After Treatment blood collected.The following assessments will be performed at 3 months and 6 months after the safety follow-up visit.Review concomitant medications Physical examination ECOG Performance Status Adverse events Survival Status Blood tests: CT of chest, abdomen and pelvis, or other areas as needed Long Term Survival Follow- Up:After your 3 month and 6 month follow up visits or if they progress, will be contacted every 6 months (±30 days)

Yes
 

Joseph Drabick
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
NCT03384836
STUDY00010009
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Inclusion Criteria:
Age >=18 years.
Participants must be newly diagnosed, treatment-naive with histologically confirmed stage IIIC unresectable melanoma or stage IV melanoma.
Have measurable disease per RECIST v1.1
Have an ECOG performance status 0-1

Exclusion Criteria:
Participants who have received previous immunotherapy for any cancer (excluding melanoma) including PD-1/PD-L1 inhibitors but not interferons and CTLA-4 inhibitors.
Participants with chronic autoimmune diseases
Other invasive cancers diagnosed < 3 years back that required systemic treatment. If diagnosed with other invasive cancer ≥ 3 years, should have complete recovery from all systemic toxicity except neuropathy and alopecia
Cancer
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Hershey, PA ,

Advancing the use of immersive virtual environments to study the effects of racism on eating behavior in an Asian American population

During the COVID-19 pandemic, Asian Americans have faced a rise in overt racism, with thousands of hate incidents reported. This has had a bigger impact on young Asian American adults, leading to emotional distress and health problems. A theory by Harrell suggests that experiencing racial discrimination can harm mental and physical well-being due to stress. Past studies have shown a connection between racial discrimination stress and health issues like obesity and mental disorders. However, there's a need to understand the cultural and emotional factors involved. This research aims to explore how racial discrimination affects Asian Americans' food choices by looking at stress responses and cultural influences. Using surveys, experiments, psychophysiology, and virtual reality, the study will investigate how cultural identity affects stress reactions and subsequent food decisions after racial discrimination experiences.

Hello,We are recruiting Asian Americans with Japanese, Chinese, or Korean heritage for a paid research study.We want to understand how racism affects food choice in a virtual reality (VR) environment. To participate in this study, you will need to complete an informed consent form, and answer questions prior to your arrival at the lab. You will have to come to the lab to watch a video of anti-Asian racism incidents that happened during the COVID-19 pandemic, and answer questions before and after the video. Last, you will make food choices in the VR environment. Participation will require three hours or more of fasting before arrival at the lab.You will be paid $25 in a gift card for your participation. If you come to the lab but do not complete the study, you will still be paid.Please continue to the next page to read the informed consent if you are interested in participating. If you are not, please exit this page.&lt;&lt;LINK TO REDCap SURVEY HERE&gt;&gt;

$25 gift card

Yes
 

Travis Masterson
Bianca Braga - at bqc5625@psu.edu
Nutritional Sciences (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT00000000
STUDY00023365
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Inclusion Criteria:
Self-identified as Asian American of Japanese, Chinese or Korean heritage
Aged between 18 and 21 at the start of the study
Born in the US
Self-reported having fasted for at least 3 hours prior to the start of the study

Exclusion Criteria:
Not self-identified as Asian-American of Japan, China or Korea heritage
Not aged between 18 and 21 at the start of the study
Not born in the US
Self-reported having fasted for less than 3 hours prior to the start of the study
Has epilepsy or a cognitive disability
Food & Nutrition, Mental & Behavioral Health
Not applicable
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State College, PA ,

Understanding the Media Literacy Competencies of Today’s College Students

This study will involve surveying college students regarding their media literacy competencies and experiences with media literacy education.

No
 

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

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00013446
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Inclusion Criteria:
College student
18 years of age or older

Exclusion Criteria:
Not 18 years of age or older
Education
I'm interested
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The perception and experiences of newly diagnosed type 2 diabetes patients (T2D) on the impact of patient-provider communication on subsequent decision to engage in diabetes self-management education (DSME).

This study seeks to explore the perception and experiences of newly diagnosed type 2 diabetes patients about how their interaction with their provider at diagnosis led to their uptake of diabetes education.

No
 

Michelle Boakye
Michelle Boakye - at mdb521@psu.edu or 814-699-1783
Nursing (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00014668
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Inclusion Criteria:
Age 18 or older
Any gender
Newly diagnosed type 2 diabetes patient within the past 12 months
Have attended at least one diabetes education after diagnosis
Able to provide consent in English

Exclusion Criteria:
Patients who are below 18 years
Patients who have a different type of diabetes either than type 2
Patients diagnosed with Type 2 diabetes more than 12 months
Newly diagnosed diabetes patients who have not attended diabetes self-management education
Diabetes & Hormones
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Concussion-Prognosis

Using micro-RNA in saliva coupled with survey data as a prognostic tool with the ability to guide clinical management of concussions

During their baseline visit participants will complete a saliva swab, surveys, balance test and brief neurocognitive test.Day 7, participants will complete a saliva swab and 2 surveys.Day 30, participants will complete a saliva swab and 4 surveys.The baseline visit is the only in-person visit, day 7 and day 30 are done remotely.All surveys are completed online and day 7 and day 30 saliva swabs are sent home with the participants and sent back in a prepaid mailer on day 30.

$40

Yes
 

Jayson Loeffert
Brennen Harding - at bharding@pennstatehealth.psu.edu or 717-531-5656
Family and Community Medicine (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT04582682
SITE00000820
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Inclusion Criteria:
13-18 years old
Diagnosis of concussion

Exclusion Criteria:
more than 48 hours after injury
Neurology, Sports Medicine
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Hershey, PA ,

Prospective Cohort Assessing Novel Biomarkers of Early Pregnancy

The purpose of this research is to take and store blood, urine samples from pregnant women diagnosed by a positive pregnancy test or by ultrasound imaging. The purpose of this study is to determine a better way to diagnose the location and/or viability (chance of survival) of a pregnancy, as compared to current clinical care. Many women are found to be pregnant by a hCG (human chorionic gonadotropin) test which detects a hormone that is indicative of pregnancy. However, in early pregnancy, it is often difficult to see the pregnancy by ultrasound, which is called a pregnancy of unknown location (PUL). In early pregnancy, doctors do many tests (including blood tests and ultrasounds) to try to determine how far along the pregnancy is, whether it is healthy, and most importantly whether the pregnancy is growing in the right place. The doctors running this research project are trying to see if there are substances (biomarkers) in the blood or urine of a pregnant woman that can tell whether the pregnancy is a normal, healthy pregnancy, an ectopic pregnancy, or if pregnancy is not viable (miscarriage). To do this, blood and/or urine samples are being collected from women who have a pregnancy of unknown location, an ectopic pregnancy, women who are having a miscarriage, and women with a healthy growing pregnancy. The study will then look at a pre- determined panel of biomarkers that have been shown to be elevated (higher) or decreased (lower) in different types of pregnancy to determine the effectiveness and accuracy of this test in earlier diagnosing the viability and location of early pregnancy.

There will be one visit at the visit participants will be consented and following consenting blood and urine will be collected.

$25.00

Yes
 

Sarah Horvath
OBGYN Research at OBGYNResearch@pennstatehealth.psu.edu or 717-531-0003, ext=320358
Obstetrics and Gynecology (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00018551
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Inclusion Criteria:
Pregnancy diagnosed by a positive serum human chorionic gonadotropin (hCG) test
Live intrauterine pregnancy through 14 weeks, diagnosed by ultrasound demonstrating fetal heart motion
Diagnosed ectopic pregnancy
Pain or bleeding or at risk for ectopic pregnancy
Women seeking confimation of a pregnancy with a urine or serum pregnancy test (less than 14 weeks)

Exclusion Criteria:
Not a Penn State Health Patient
Pregnancy & Infertility, Women's Health
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Hershey, PA ,

POSTA: Protocol for Oral Somatosensation and Texture Appreciation

The purpose of this study is to collect normative data related to orofacial (lip/tongue) somatosensation (touch sensation) in healthy adults across the adult lifespan. This data will be compared to a select clinical population, those with Parkinson's disease.

There will be one data collection session lasting approximately 90 minutes. Participants may be invited back for a second session approximately 4 weeks later to repeat the testing sessionDuring the sessions, participants will answer a series of questions about their eating and drinking preferences, they will be asked to provide a speech sample by repeating a series of syllables, words, and sentences, as well as providing a spontaneous speech sample.All participants will be asked to complete a series of sensory tests where small plastic objects are placed on their lip, tongue, and finger tip. Participants will be asked when they feel the pressure/texture and when they do not.

Yes
 

Nicole Etter
Nicole Etter - at oppal@psu.edu or 814-863-2021
Communication Sciences and Disorders (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00024173
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Inclusion Criteria:
18 years or older
English-speaking
Hearing and cognition within functional limits to complete speaking tasks
Clinical Group: Diagnosed with Parkinson's disease (PD)

Exclusion Criteria:
Have an injury to the lower face
have an active lesion to the lower face (ie cold sore, fever blister, etc)
have had a dental visit in the last month that involved general or local anesthesia to the oral region
exhibit symptoms of Tardive Dyskinesia secondary to anti-psychotic drug use
report current or recovering from a viral illness like Bell’s Palsy or Shingles
Food & Nutrition, Neurology
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State College, PA ,

Linking olfactory deficits to memory impairment and AD neurodegeneration

The purpose of this voluntary research study is to find out more about changes in the brain as we age. This study is trying to determine if magnetic resonance imaging (MRI), genetic variations, amyloid positron emissions tomography (PET), neuropsychological testing, and smell tests can be used to evaluate memory loss and cognitive impairment.

You will be asked to come to the research site once a year for 5 years.Annual (and semi-annual) procedures include completing smell tests, neuropsychological tests, magnetic resonance imaging (MRI). One-time procedures include provide blood sample, amyloid PET scan (if indicated), and optional lumbar puncture.

Up to $250 a year

Yes
 

Prasanna Karunanayaka
Rommy Elyan - at relyan@pennstatehealth.psu.edu
Radiology (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00018557
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Inclusion Criteria:
Individuals between ages 55-85

Exclusion Criteria:
Non-English speaking
Smell impairment
Women who are pregnant or breastfeeding
Currently smoke
Have claustrophobia
Neurology
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Hershey, PA ,

Mindfulness, Neuroscience and Daily Life Study

This study will examine whether a guided drawing activity helps to reduce anxiety in young adults. This will add to our understanding of how drawing can be used to manage anxiety symptoms and bolster emotion regulation. 

This study will require two in person lab visits that take approximately 2 hours each and separated by four weeks where participants will have their brain and heart rate activity monitored while completing mindfulness activities. After the first in person visit, participants will complete two 30 minute audio/questionnaire sessions a week for four weeks (8 total) before returning to the lab for the second visit where participants can expect to complete a similar experience as their first in person visit. Two weeks after the second in person lab visit, participants will complete a Qualtrics questionnaire that will take approximately 30 minutes to complete. Total overall participation of approximately 8 to 8 1/2 hours.

$175

Yes
 

Sarah Myruski
Margaret Penner - at mep5756@psu.edu
Psychology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT00000000
STUDY00025015
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Inclusion Criteria:
Adults ages 18-25
Able to read, speak and write in English

Exclusion Criteria:
Those who are not yet 18 and 26 or over
Not able to read, speak and write in English
Neurology, Mental & Behavioral Health
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State College, PA ,

Accessibly of Conversational Agents with Deaf or Blind Users

Using small focus groups, this work aims to understand the experiences, challenges, perceptions, and opportunities for the use of conversational agents (e.g Amazon Alexa and Siri) for users with visual or hearing impairments, with the goal of developing more accessible and inclusive systems.

Yes
 

Johnna Blair
Johnna Blair - at jlb883@ist.psu.edu or 814-706-8412
Information Sciences and Technology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00010384
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Inclusion Criteria:
Either, blind or visually impaired,
Or, hard of hearing or deaf using cochlear implant or other aided hearing device
Currently 18 years of age or older
English language speakers

Exclusion Criteria:
Minors, under the age of 18
Non-English language speakers
Language & Linguistics, Vision & Eyes
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State College, PA ,

PSCI-22-042: M23-362 Epcoritamab monotherapy R/R DLBCL or Classic FL (Previously Grade 1-3a) outpatient

The purpose of this voluntary research study is to optimize the approach to safely administer a study drug called epcoritamab in the outpatient/non-hospital setting.

Complete interview, questionnaires, and subject diaryECGClinical laboratory testsBiopsy sample, archival or freshCT/PET-CT/MRITreatment of epcoritamab

Yes
 

Seema Naik
Laurie ONeal - at loneal1@pennstatehealth.psu.edu or 717-531-0003, ext=343429
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05451810
SITE00001234
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Inclusion Criteria:
Subjects must voluntarily sign and date an informed consent,
Adult male or female, at least 18 years old
Diagnosis of R/R DLBCL or R/R FL grade 1, 2, or 3a, with documented CD20+ mature B-cell neoplasm according to WHO classification 2016 or WHO classification 2008 based on representative pathology report
Subject must have 1 or more measurable disease sites:  Fluorodeoxyglucose (FDG)-avid lymphomas:
Subject must have Eastern Cooperative Oncology Group (ECOG) performance status 0 – 2

Exclusion Criteria:
Central nervous system (CNS) involvement
inadequate organ functions
central nervous system involvement
history of primary mediastinal lymphoma.
history of severe allergic or anaphylactic reactions to anti-CD20 monoclonal antibody therapy.
Cancer
Not applicable
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Hershey, PA ,

Exploring the Immediate Psychosocial and Self-Management Support Needs of Individuals Newly Diagnosed with Type 2 Diabetes (T2D)

To find out the kind of support someone newly diagnosed with type 2 diabetes will need following diagnosis.

No
 

Michelle Boakye
Michelle Boakye - at mdb521@psu.edu or 814-699-1783
Nursing (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00017593
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Inclusion Criteria:
newly diagnosed with type 2 diabetes(past 12 months)
Age 20 years or older
agree to participate in online focus group

Exclusion Criteria:
old cases of type 2 diabetes
individuals below 20 years
diagnosed with other types of diabetes
Diabetes & Hormones
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Exploring International Students’ Development of English as a Lingua Franca Pragmatic Competence

This study explores how international students show and develop pragmatic strategies to effectively communicate with peers and colleagues from diverse language and cultural backgrounds at Penn State. Participants recruited from the StudyFinder are invited to complete an online survey, and will receive an Amazon gift card as a token of appreciation.

No
 

Shuyuan Liu
Shuyuan Liu - at szl290@psu.edu
Applied Linguistics (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00012216
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Inclusion Criteria:
International students enrolled at Penn State

Exclusion Criteria:
Is not an international students enrolled at Penn State
Education, Language & Linguistics
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Investigating the emotional and behavioral response in humans playing games against a humanoid robot

We would like to study the emotional and behavioral response of a human playing games against a robot. Games such as Connect Four and card games will be used.

Yes
 

Alan Wagner
Vidullan Surendran - at vus133@psu.edu
Aerospace Engineering (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00010076
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Inclusion Criteria:
Over the age of 18
Physically and mentally able
Basic proficiency of english

Exclusion Criteria:
Under the age of 18
Unwilling to have video footage of the experiment taken
I'm interested
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State College, PA ,

Seamless, Adaptive, Phase2b/3, Double-blind, Randomized, Placebo-controlled, Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR-MD-02) for the Prevention of Esophageal Varices in NASH Cirhosis

This trial will evaluate the study drug Belapectin in patients with NASH (Non-Alcoholic Steatohepatitis) Cirrhosis. The purpose of this voluntary research study is to find out about the safety and efficacy of the study drug and for the prevention of esophageal varices in NASH Cirrhosis..

If you consent to participate, you will be asked to have some screening tests and procedures, as described in the table below. This period of up to 3 visits within 2 months is called Screening Period. Based upon results of tests and procedures completed during these visits, your study doctorwill be able to decide if you meet the requirements to participate in this study. If you meet the study requirements to participate in this study, your study doctor will discuss with you when you should start the study treatment.

Yes
 

Jonathan Stine
Nataliya Smith - at nsmith9@pennstatehealth.psu.edu or 717-531-0003, ext=320223
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04365868
STUDY00018518
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Inclusion Criteria:
Adults age >18-75 years old
early stage cirrhosis
diagnosis of NASH

Exclusion Criteria:
end stage cirrhosis
substance abuse
other liver disease
history of organ transplant
Digestive Systems & Liver Disease
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Hershey, PA ,

Pennsylvania Adoptees Longitudinal Study (PALS)

This study will examine various factors within the home of children adopted from the child welfare system between the ages of 4 and 10 that may impact their development. The first visit will occur remotely via Penn State Health Microsoft Teams; the second visit is optional and will occur within 4 weeks of the first visit at the Transforming Lives of Children Center in Harrisburg, PA; and the third visit will occur one year after the first visit, when research staff will travel to participants' homes. This research will help understand the factors that impact the development of children adopted from the child welfare system and how we may better serve these children and their families.

The child and parent will be asked to complete interviews, questionnaires and various tasks. Parents may also be asked to complete questionnaires online.Participation will last for one year and include the following:-One visit occurring remotely via PSH Microsoft Teams-One visit at the Transforming the Lives of Children Center in Harrisburg, PA, four weeks after Zoom visit (optional)-Final visit at home will occur one year after the first Zoom visit

$225

Yes
 

Brian Allen
pals@pennstatehealth.psu.edu 717-531-0003, ext=321713
Pediatrics: Child Abuse (HERSHEY)
 

All
All
This study is also accepting healthy volunteers
STUDY00013344
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Inclusion Criteria:
Child age between 4 and 10
Child legally adopted by the caregiver
The same caregiver will participate in each of the visits

Exclusion Criteria:
Child diagnosed with intellectual disability
A biological parent resides in the same home as the child
Children's Health, Mental & Behavioral Health
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Altoona, PA ,
Carlisle, PA ,
DuBois, PA ,
Erie, PA ,
Greater Philadelphia Area, PA ,
Greater Pittsburgh Area, PA ,
Harrisburg, PA ,
Hazleton, PA ,
Hershey, PA ,
Mont Alto, PA ,
Reading, PA ,
Schuylkill Haven, PA ,
Sharon, PA ,
State College, PA ,
Wilkes-Barre/Scranton Area, PA ,
Williamsport, PA ,
York, PA ,

Graduate Students’ Experience with Online Professional Profiles and Social Media

With the development of information and communication technologies, Social Network Sites and other online platforms can be great resources for career-related information and social networking. Despite the evidence of possible professional benefits, it remains unclear whether graduate students’ experiences with building online career profiles and social networking are positive. Therefore, this study aims to understand graduate students’ experience with professional practices on the Internet concerning their motivations, benefits, and risks.

No
 

Chuhao Wu
Chuhao Wu - at cjw6297@psu.edu
Information Sciences and Technology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00019028
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Inclusion Criteria:
18 years or older
An active graduate student at University Park campus

Exclusion Criteria:
NA
Education
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AFFIRM: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis

This is a multicenter evaluation of seladelpar, administered as a once-daily oral capsule, in a placebo-controlled study in subjects with Primary Biliary Cholangitis (PBC). This study (156 weeks) will enroll approximately 192 subjects. The population to be studied is patients with PBC and compensated cirrhosis restricted to Child-Pugh (CP)-A or CP-B.Primary ObjectivesEfficacy: To evaluate the effect of seladelpar compared to placebo.Safety: To evaluate the safety of seladelpar over 156 weeks of treatment compared to placebo.Study visits: up to 18 in person visits. Blood samples will be collected at each visit for safety measures as well and questions about your health and medicines you might be taking.

There will be 18 in person visits. safety assessments will be conducted at each visit. Participants will be required to take study drug as directed.

$1350

Yes
 

Karen Krok
Laurie Peiffer - at lpeiffer@pennstatehealth.psu.edu or 717-531-5226
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06051617
STUDY00022898
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Inclusion Criteria:
diagnosis of PBC
Elevated Alkaline Phosphatase (ALP)
documented cirrhosis

Exclusion Criteria:
history of liver transplant
decompensated cirrhosis
portal vein thrombosis
hospitalization for liver complication within 12 weeks
HIV
Digestive Systems & Liver Disease
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Modeling Transition Speeds in Elderly Human Walking

This study will involve elderly humans walking on a treadmill transitioning through prechosen speeds.

There will be one, two hour in person visit. Participants will change into specific lab provided clothing for study and reflective stickers will be placed on participants by the researcher. Participants will then get on the treadmill and will walk at prescribed constant speeds for about 5 minutes total. Then participants will perform 10 speed transition trials each of which lasts about 4 minutes.

$15

Yes
 

Ashley Zeman
Ashley Zeman - at apz5261@psu.edu or 724-759-1651
Division of Undergraduate Studies (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00021984
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Inclusion Criteria:
65+ years old
Can continuously walk for up to 4 minutes
Be able to follow verbal instructions

Exclusion Criteria:
Active or existing neuromuscular, cardiovascular, vascular, or neurological pathologies, injuries, or illnesses affecting gait
High BMI (>30)
Neurology, Muscle & Bone
Not applicable
I'm interested
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State College, PA ,