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PSCI# 25-118 A012303: ShortStop-HER2: Shortened Duration of Adjuvant Therapy in Patients with Early-Stage HER2+ Breast Cancer Who Achieve pCR After Neoadjuvant Chemotherapy with HER2 Blockade

This study is to see if patients with clinical stage I-III HER2+ breast cancer who achieve a pCR after neoadjuvant chemotherapy with HER2 blockade and receive a total of 6 months of HER2 blockade in the combined neoadjuvant + adjuvant (neo/adjuvant) setting will NOT have inferior (RFS) compared to patients who receive the standard total of 1 year of HER2 blockade.

Participants will get the HER2-targeted medication trastuzumab (with or without pertuzumab) for up to 51 weeks (approximately 12 months), or they will get the HER2-targeted medication trastuzumab (with or without pertuzumab) for up to 27 weeks (approximately 6 months). After participant finishes study treatment, your doctor will continue to follow your condition every 6 months for 5 years and watch for side effects or cancer coming back. Participants will see your doctor for 5 years after treatment. After that, every year for a total of 10 years after being enrolled on the study.

Yes
 

Cristina Truica
Cindy history of grade 3 or 4 toxicity related to trastuzumab - at cbrown18@pennstatehealth.psu.edu or 717-531-6564
Medicine: Hematology and Medical Oncology (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06876714
STUDY00028188
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Inclusion Criteria:
A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy
has not been naturally postmenopausal for at least 12 consecutive months
Patients (females and males) with clinical stage T1c-T3 (or Tx) and nodal stage N0-N1
Age ≥ 18 years
ECOG Performance Status 0-2

Exclusion Criteria:
T3N1 tumors, which are not eligible
Stage IV (metastatic) breast cancer
History of any prior (ipsi- or contralateral) invasive breast cancer
History of grade 3 or 4 toxicity related to trastuzumab
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

Usability of a Virtual Reality Laboratory for Sensory Integration

This is a usability study that will evaluate how allied health, education and technology professionals perceive a new virtual therapy environment designed for children with autism spectrum disorder. Participants will experience a guided session using a virtual reality headset and then complete questionnaires about usability, immersion, and any discomfort. The goal is to improve the tool before it is used in clinical settings.

There will be only one on-site meeting with one hour of duration. Participants will take part in an 25 minutes immersive experience in a virtual environment and complete one questionnaire before, and four questionnaires after the experience.

$30 Amazon gift card

Yes
 

Bibiana Mayer Steckel
Bibiana Mayer Steckel - at bfm5630@psu.edu or 814-218-2663
Fulbright Scholar Program
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT00000000
STUDY00028153
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Inclusion Criteria:
18 years of age or older
college degree in one of the following fields: Health, Education, AND/OR Technology
basic knowledge about Autism Spectrum Disorder (ASD), including familiarity with the diagnosis and the ability to identify some common symptoms or characteristics

Exclusion Criteria:
sensory impairments (e.g., vision or hearing loss) that would interfere with the use of virtual reality equipment
neurological or vestibular conditions that may be aggravated by immersive virtual reality
pregnancy
experience of nausea, dizziness, or vomiting on the day of the study session
Children's Health, Neurology, Mental & Behavioral Health
Not applicable
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Erie, PA ,

A Pilot Randomized Trial of a Mother-Child Dyadic Positive Affect Prevention Program for Reducing Mental Health Symptoms in Youth Exposed to Deprivation

The purpose of this voluntary research study is to test the effectiveness of the Positive Affect Intervention Program in reducing mental health symptoms for families experiencing financial hardship.

In this study, you and your child will attend some virtual study visits over 8 months. At each visit, you will complete some interviews, questionnaires, and discussion tasks with your child. You will be randomly assigned to either an 8-session prevention program or to receive weekly educational materials to read. You and your child will also be asked to complete some short daily phone surveys.

320 dollars

No
 

Katie Burkhouse
Katie Burkhouse - at klb5023@psu.edu
Psychology (UNIVERSITY PARK)
 

All
All
This study is also accepting healthy volunteers
STUDY00028042
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Inclusion Criteria:
Child age 8-12 years who can participate with their biological mother who is 18 years or older.
Child and biological mother can read and speak in English.
Child and mother have access to a computer or tablet with a video camera and internet that can be used for study appointments by Zoom.
Family is experiencing financial hardship.

Exclusion Criteria:
Children with diagnoses of autism spectrum disorders or developmental disorders.
Children or mothers with intellectual disabilities.
Children or mothers with a diagnosis of mania or bipolar disorder
Children or mothers with a diagnosis of a psychotic disorder (e.g., schizophrenia).
Children with conduct disorder; children or mothers with visual or hearing impairments that interfere with completing study measures and sessions.
Children's Health
Survey(s)
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PSCI# 24-172 TITLE PAGE A Randomised, Double-blind, Placebo-controlled, Phase III Study of Adjuvant Saruparib (AZD5305) in Patients with BRCAm Localised High-Risk Prostate Cancer Receiving Radiotherapy with Androgen Deprivation Therapy (EvoPAR-Prostate02)

This study will see if participants who have the addition of saruparib to their treatment will have a longer time period before/if their cancer spreads.

Before participating in the trial, p[otential; participants will need to sign a consent form to have their tumor tested for the BRCA mutation. If the participants have this mutation in their tumor, they will be invited to participate in this trial. While you are receiving treatment you will need to come to the clinic on certain days for treatment, getting safety assessments, collection of blood samples and to see how you are feeling. You will come to the clinic every four weeks. The treatment will last for 24 months

Yes
 

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

Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06952803
STUDY00027345
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Inclusion Criteria:
Participant must have a histologically documented diagnosis of prostate adenocarcinoma.
Participants with newly diagnosed high-risk and very high-risk (localised/locally advanced) prostate cancer
Confirmed BRCA1 or BRCA2 mutation

Exclusion Criteria:
Participants with a history of MDS/AML
Participants with any known predisposition to bleeding
Refractory nausea and vomiting
Cancer
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Open-label, long-term safety and efficacy study of Mim8 in participants with haemophilia A with or without inhibitors

This study is looking at how Mim8 works in people with hemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used to avoid bleeding episodes. Mim8 will be injected under the skin with a thin needle for up to 262 injections; the number of injections depends on how often injections are given.

Mim8 will be injected under the skin with a thin needle either once a week, once every two weeks or once a month. The study will last for up to 2.5 years. There will be fourteen in person visits and up to 2 phone visits. Completion of diary and PRO questionnaire.

$75 per visit up to $1050 (14 visits) to cover travel expenses

Yes
 

M. Elaine Eyster
Cynthia Campbell Baird - at cbaird@pennstatehealth.psu.edu or 717-531-5777
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
Younger than 18 years old
This study is NOT accepting healthy volunteers
NCT05685238
STUDY00023362
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Inclusion Criteria:
Congenital haemophilia A (FVIII activity <1%) with or without FVIII inhibitors
Aged <1 year
Body weight ≥3.2 kilograms
Previously Untreated Patients (PUPs) or Minimally Treated Patients (MTPs) (up to 5 exposure days)

Exclusion Criteria:
Exposure to non-factor haemostatic products for bleeding prophylaxis within 6 months
Known congenital or acquired coagulation disorders other than haemophilia A.
Previous or current treatment for thromboembolic disease
Any planned major surgery
Immune tolerance induction planned
Blood Disorders
Prefer not to display
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Hershey, PA ,

PSCI # 24-026 EA8231 A Phase III Randomized Trial of Pembrolizumab in Combination with Sacituzumab Govitecan vs Standard of Care in Anti-PD(L)1-Resistant Advanced Urothelial Cancer

This study is comparing Pembrolizumab in combination with Sacituzumab Govitecan vs. standard treatment for individuals who have drug resistant advanced urolethial cancer

Participants will need to come to the clinic to meet with the study team and to sign a consent form. Once it has been determined that it is safe for you to participate, you will come into the clinic for treatment every 21 days, or depending upon the treatment arm you are assigned. You will continue to come into the clinic for treatment until the medication stops working, you no longer want to participate in the study or the document feels it is not safe for you to continue. You will be followed for up to five years to see how you are doing.

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
NCT06524544
STUDY00028209
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Inclusion Criteria:
Patient must be ≥ 18 years of age.
Patient must have ECOG Performance Status 0-2.
Patient must have locally advanced (unresectable or not amenable to curative intent therapy) or metastatic urothelial cancer.
Patient must have histologically proven conventional urothelial carcinoma (UC) of any urinary tract origin [any histologic subtype except neuroendocrine (small or large cell)] are permitted so long as tumors include ≥ 1% urothelial histology).

Exclusion Criteria:
Patient must not have a known genetic UGT1A1 deficiency Gilbert’s Syndrome).
Patient must not be on systemic immunosuppressive medication, including steroids (if doses exceed the equivalent of prednisone 10 mg daily).
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

Integrated Health-Monitoring Smart Homes for Aging in Place

As more people around the world are getting older, there’s a growing need for homes that help seniors live independently while staying healthy, safe, and comfortable. This project explores how smart home technologies—like non-intrusive health monitors and privacy-respecting systems—can support aging in place. Instead of building these homes, the study gathers insights through surveys of older adults living independently to understand their needs, preferences, and concerns. Digital design tools (known as Building Information Modeling, or BIM) and Virtual Reality (VR) will be used to create simulated smart home environments based on the survey responses. These simulations allow researchers and participants to visualize and interact with potential home designs, helping older adults get familiar with future living spaces and stay socially connected through virtual activities that may reduce loneliness and support cognitive health. Artificial Intelligence (AI) is explored as a potential tool for enhancing smart home systems—such as monitoring health, detecting early signs of concern, and supporting memory and social interaction. While the homes are not being built, the project evaluates how these technologies might impact well-being, healthcare costs, and home durability. Findings will be shared through research papers, workshops, and online events to support the development of smarter, more supportive living environments for older adults.

Participants will be involved by taking a survey. We are still in the process of either choosing StudyFinder or Cloud Research. This study is designed to learn how older adults feel about smart home technologies that are meant to help them live safely and independently. Participants will be asked to complete a survey that includes questions about their comfort, safety, privacy, and interest in using devices like motion sensors, voice assistants, and virtual reality tools in their homes.

No
 

Sofia Vidalis
Sofia M Vidalis Sofia M Vidalis - at smv11@psu.edu or 717-948-6122
Science, Engineering and Technology (HARRISBURG)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00027864
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Inclusion Criteria:
age 65 or older
living independently
capable of independent living
preferable participants in PA
sufficient cognitive and physical ability to interact with smart home system

Exclusion Criteria:
under age 65
severe cognitive impairment
severe physical disabilities
unstable medical conditions
Privacy concerns
Education
Survey(s)
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A survey analysis of the relationship between physical activity and cognitive and mental health across the human lifespan

The purpose of this study is to evaluate the effect of lifetime self-report physical activity behavior on current cognitive and mental health status in populations of different ages through the lifespan. We will use a digital survey to obtain physical activity behavior reports, including intensity, duration, and physical activity type during several periods of each participant's life, and utilize online cognitive tests and mental health questionnaires to obtain current mental health and cognitive capacity.

Participants will complete an anonymous online survey that asks about their physical activity trends across their lifetime and their current mental health status. The survey will also direct the participants to several brief online cognitive tests. The survey will take approximately 20 minutes to complete. Participants who complete the survey will have the opportunity to fill out a separate form to be entered (via email address) into a drawing to win a $100 prize.

$100 compensation drawing entry

No
 

Owen Griffith
Maddie McLaughlin - at mgm6218@psu.edu
Kinesiology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00028408
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Inclusion Criteria:
Age 18-55
Fluent English speaker

Exclusion Criteria:
Currently recovering from a traumatic brain injury or concussion in the last three months
Suffer from chronic substance abuse (including tobacco, alcohol, or nicotine)
Suffer from any major psychiatric disorders that require mood stabilizers or stimulants to treat
Suffer from chronic migraines
Prevention, Neurology, Mental & Behavioral Health
Not applicable
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Exploring how university students use generative AI for writing

The objective of this study is to understand how university students use generative AI tools like ChatGPT, Gemini, and others when engaging in writing tasks, whether personally (e.g., writing emails) or academically (e.g., completing assignments), and how their cognitive processes work with these tools.

This study aims to understand how university students interact with generative AI tools like ChatGPT, Gemini, and others in writing tasks, both personally (e.g., writing emails, cover letter) and academically (e.g., completing assignments). We will conduct 1) brief demographic survey 2) interviews and 3) think-aloud sessions with students to understand how generative AI tools are used in writing.

$40

No
 

Jiyoon Kim
Jiyoon Kim - at jxk6167@psu.edu
Division of Graduate Studies (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00028286
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Inclusion Criteria:
University students
Aged 18 or older
Use Generative AI for writing tasks
English speaker

Exclusion Criteria:
Non-university students
Under 18 years old
Do not use Generative AI for writing tasks
Non-English speaker
Education
Not applicable
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FAMILY FUNCTIONALITY AS A PREDICTOR OF SUBSTANCE USE AND MENTAL HEALTH PROBLEMS IN EMERGING ADULTS: A MULTIVARIATE APPROACH

This is a quantitative study investigating the relationship between family functionality, substance use, and mental health among a population of emerging adults.

You will take a brief survey.

No
 

Matthew Bucher
Matthew Bucher - at fms5220@psu.edu or 717-704-6829
Survey Research Center (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00028185
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Inclusion Criteria:
Aged 18-29

Exclusion Criteria:
Under 18 years old
Over 29 years old
Addiction & Substance Abuse, Mental & Behavioral Health
Not applicable
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Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial Comparing Standard of Care Adjuvant Temozolomide With or Without 5-Aminolevulinic Acid (5-ALA) With Concomitant Low Intensity Diffuse Ultrasound (LIDU) Sonodynamic Therapy (SDT) System In Patients With Newly Diagnosed Glioblastoma After Completion of Chemoradiotherapy

This is a Phase 2b clinical research study, which is investigating the use of 5-Aminolevulinic Acid (5-ALA) combined with a Low-Intensity Diffuse Ultrasound (LIDU) system for Sonodynamic Therapy (SDT) in patients with newly diagnosed glioblastoma. LIDU is the name of the investigational SDT device developed by Alpheus Medical. SDT includes the combination of a sonosensitizing drug, also known as a sonosensitizer, that will only be absorbed by tumor cells, and ultrasound to activate the sonosensitizer and cause damage to the tumor cells. The SDT tested in this study includes the oral drug 5-Aminolevulinic Acid (5-ALA) as an investigational sonosensitizer. This investigational treatment is being tested as a potential treatment for your cancer, SDT has been shown in previous cell and animal studies to potentially have an anti-cancer effect.

In this research study there will be two treatment groups. One treatment group will receive standard of care maintenance temozolomide with 5-ALA + SDT, you will have a 50% of receiving this treatment group. The other treatment group wll receive standard of care maintenance temozolomide with placebo, an oral solution that will look like and taste like 5-ALA but will have no active ingredients in it, and sham SDT, a program will be run on the SDT device that will look and sound the same, but will not deliver ultrasound, you will have a 50% chance of receiving this treatment group. If you are eligible for the study, and agree to participate you will be randomized, like the flip of a coin, to one of the two treatment groups, neither you nor your doctors will know which treatment group you have been assigned.

Yes
 

Brad Zacharia
Micaiah Grien - at mgrien@pennstatehealth.psu.edu or 717-531-0003, ext=283063
Neurosurgery (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT07225621
STUDY00027595
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Inclusion Criteria:
Patient must provide informed consent
≥ 18 and ≤ 80 years of age at time of signing informed consent
Newly diagnosed Histologically proven glioblastoma
Completion of chemoradiation consisting of radiotherapy
Adequate bone marrow and organ function,

Exclusion Criteria:
Any component of the tumor in the infratentorial location
Bihemispheric disease or tumors that involve the bilateral corpus callosum,
Multi-centric disease (enhancing or non-enhancing) or multi-focal disease
Leptomeningeal disease
A diagnosis of gliosarcoma by histopathology
Cancer
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

PSCI 24-072 A Phase 3 Randomized Study Comparing Teclistamab in Combination with Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination with Daratumumab SC and Lenalidomide (Tal-DR) versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants with Newly Diagnosed Multiple Myeloma Who are Either Ineligible or not Intended for Autologous Stem Cell Transplant as Initial Therapy MajesTEC-7

This trial is designed for patients who are newly diagnosed with multiple myeloma (MM) but who do not want or cannot have an autologous stem cell transplant. Teclistamab and talquetamab have been used alone along with other drugs in the treatment of MM. this study hopes to add either drug to a standard treatment for MM at time of diagnosis to see how effective it is in keeping the MM quiet conpared to standard treatment alone.

Participants must be willing to come to all clinic study visits. The first cycle of treatment the participant will be hospitalized to make sure they do not have any side effects. You will be treated every four weeks as an outpatient until the treatment no longer works. You should tell your study team all side effects you feel and all medication you are taking.

$54.00 per completed visit. A caregiver may receive compensation of the same amount.

Yes
 

Kevin Rakszawski
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
NCT05552222
STUDY00027269
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Inclusion Criteria:
Be ≥18 years of age
Have a diagnosis of multiple myeloma
Be newly diagnosed and not considered a candidate for high-dose chemotherapy with ASCT

Exclusion Criteria:
Plasma cell leukemia
Received any prior therapy for multiple myeloma
Had a stroke, transient ischemic attack, or seizure within 6 months prior to randomization.
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

Glycemic effects of substituting pecans for snacks higher in saturated fat and added sugars in individuals with prediabetes

The purpose of this study is to investigate the effects of replacing snacks high in saturated fats and added sugars with pecans on blood sugar control, heart health and diet quality in individuals with prediabetes. Participants will be randomized into one of two groups. Group 1 will consume 1.5 oz of pecans per day in place of normally consumed snacks high in saturated fat and added sugars for 16 weeks. Group 2 will be asked to continue consuming their current diet for 16 weeks. Measures will be taken to evaluate blood sugar, heart health and dietary intake at the beginning and 16 weeks later.

• The total time commitment for this study is approximately 4 months. It may take up to 7 months to complete the study from the time that you do the clinic screening visit. • During the study, we will ask you to consume 1.5 oz of pecans per day for 16 weeks, or to use provided gift cards to purchase and consume your usual snacks/diet. • You will be asked to come to the Penn State Research Kitchen on campus once a month for 16 weeks to pick up your pecans or gift cards. • We will draw blood from you several times during the study, once at screening, and on two consecutive days at the start and end of the study (total 5 times). • At the start and end of the study, we will also measure your blood pressure and perform non-invasive tests of artery health. • You will also be asked to wear a continuous glucose monitor (CGM) for 14 days—7 days before the first testing visit and 7 days at the end of the study. The CGM is a small sensor worn on your arm that measures your blood sugar every 15 minutes. You will need to attend a non-fasting visit to have the CGM fitted (2 visits total). • At the start and end of the study, we will ask you to collect 12 saliva samples over two days at home. • At the start and end of the study, we will collect a small hair sample from the back of your head. • You will also be asked to collect a stool sample at the beginning and end of the study (2 total). • Compensation for this study is up to $150

150

Yes
 

Kristina Petersen
Stacey Meily - at DCHLab@psu.edu or 866-778-3438
Nutritional Sciences (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT07235358
STUDY00027744
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Inclusion Criteria:
Age 25-65 years
Prediabetes (HbA1c 5.7-6.4%)
BMI 25-40 kg/m2
Low intake of nuts and nut butters
Usually eat snacks (eat food between main meal times)

Exclusion Criteria:
Diagnosis of heart disease, stroke, kidney or liver disease
Current use of tobacco-containing products or (≤6 months) cessation
Pregnant or nursing individuals
Allergy to study foods
Alcohol intake > 14 drinks/week
Food & Nutrition, Heart & Vascular, Diabetes & Hormones
Not applicable
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State College, PA ,

Monitoring Digital Behaviors and Language Patterns for Early Cognitive Changes in Aging Adults

This study explores whether simple digital activities, such as watching short videos and answering easy questions, can help researchers understand early changes in memory, attention, and language. Participants will complete these tasks on a tablet, computer, or smartphone, either independently or with support. The study does not diagnose any condition. The goal is to learn whether everyday digital behaviors can provide early, low burden signals of cognitive change in older adults.

Participants will watch short and long videos on a tablet, computer, or smartphone and answer simple multiple-choice and short-answer questions about each video. They may also provide brief written or spoken explanations. The session takes about 20 to 40 minutes and can be completed independently or with researcher support. An optional second session may be completed after two to six weeks.

No
 

Mahfuza Farooque
Mahfuza Farooque - at mff5187@psu.edu or 814-863-5103
Computer Science and Engineering (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00028341
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Inclusion Criteria:
Adults aged 50 years or older
Able to provide informed consent independently
Able to watch short videos on a tablet, computer, or smartphone
Able to answer simple multiple-choice or short-answer questions
English-speaking

Exclusion Criteria:
Individuals unable to provide informed consent
Significant uncorrected vision or hearing problems that prevent video viewing
Severe cognitive impairment that prevents completing simple tasksInability to use a tablet, computer, or smartphone even with assistance
Education, Neurology, Mental & Behavioral Health
Survey(s)
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A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Ritlecitinib in Pediatric Participants 6 to Less Than 12 Years of Age with Severe Alopecia Areata

This study is being performed to make sure this medication helps people the way it's supposed to and to make sure it is safe. Within this study you will be assigned to 1 of 3 treatment arms, including 2 ritlecitinib dosage levels (50 mg and 30mg) and 1 placebo arm. You will be instructed to take your study medicine by mouth once a day for 24 weeks (approximately 6 months). In addition, to taking the study medication you will also need to attend in person visits within the research office at different time points throughout the study. Your total length of participation could last up to about 8 months.

Participants will be assessed for study eligibility at the screening visit after the informed consent form is reviewed, all questions have been answered, and the consent form has been signed. Should a participant qualify to participate in the research study they will attend 9 visits within the research office over approximately 28 weeks (7 months). At different time points throughout the study participants will have their hair examined, an ECG performed, a hearing test performed, blood drawn, and complete questionnaires. In addition to the study activities participants will be instructed to take their study medicine by mouth once a day and as directed by the study team.

Yes
 

Andrea Zaenglein
Dermatology Clinical Trials at dermatologyclinicaltrials@pennstatehealth.psu.edu or 717-531-5136
Dermatology (HERSHEY)
 

All
Younger than 18 years old
This study is NOT accepting healthy volunteers
NCT07029971
STUDY00027318
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Inclusion Criteria:
Must be 6 to less than 12 years old at the time of screening.
Must have a diagnosis of Alopecia Areata. Scalp hair loss will be assessed by the study doctor at both the Screening and Baseline visit.
Varicella Vaccination will be discussed with study coordinator during phone screening.

Exclusion Criteria:
Pre-existing hearing loss
Active autoimmune disorder (other than AA)
Certain medications are not allowed to be used during the study, study coordinator will discuss during phone screening.
Skin Conditions
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

PSCI 24-147 A MULTICENTER, RANDOMIZED, OPEN-LABEL, PHASE 3 TRIAL OF TRASTUZUMAB DERUXTECAN (ENHERTU®) PLUS CHEMOTHERAPY PLUS OR MINUS PEMBROLIZUMAB VERSUS CHEMOTHERAPY PLUS TRASTUZUMAB PLUS OR MINUS PEMBROLIZUMAB AS FIRST-LINE TREATMENT IN PARTICIPANTS WITH UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC HER2-POSITIVE GASTRIC OR GASTROESOPHAGEAL JUNCTION (GEJ) CANCER (DESTINY-GASTRIC05)

To see if the combination of trastuzumab deruxtecan (ENHERTU, T-DXd, DS-8201a) plus a fluoropyrimidine plus pembrolizumab versus SoC chemotherapy plus trastuzumab plus pembrolizumab is better in treating gastric or gastroesophageal junction cancer

Participants will need to come to the clinic twice before they are able to start study treatment. The first time is to sign a consent form allowing their tumor tissue that has been stored to be spent for testing. This test will look to see if the tissue has changes in it to see if the medication will work. If the tissue has the receptive changes a second consent form will be signed to participate in the study. You will need to have tests done to make sure it is safe for you to participate in the study. If the tests results determine that is it safe, you will begin treatment. The first month of treatment you will need to come to the clinic every week for blood tests and to see how you are feeling. After that you will need to come to the clinic once a month for treatment and blood tests. You will also have scans done at certain time in the study. Those scans will tell the doctor if the study treatment is working to make your cancer go away. You will stay on this treatment until it stops working. After that, you will come back to the clinic for two more visits to see how you are feeling.

Yes
 

Nelson Yee
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
NCT06731478
STUDY00027186
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Inclusion Criteria:
Previously untreated, unresectable, locally advanced or metastatic gastric or GEJ adenocarcinoma
Is willing and able to comply with scheduled visits, trial intervention plan, laboratory tests, other trial procedures, and trial restrictions.

Exclusion Criteria:
Lack of physiological integrity of the upper gastrointestinal tract (ie, severe Crohn disease that results in malabsorption) or malabsorption syndrome
Medical history of myocardial infarction within 6 months
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

PSCI 25-083 Long-term Follow-up of AAV2-hAQP1 Gene Therapy in Participants with Radiation-Induced Late Xerostomia

To evaluate the long-term safety of AAV2-hAQP1 in participants with radiation-induced late xerostomia

Participants who were on the parent trial and did not receive actual drug will be invited to be treated and then rolled over into long term follow up. For those who were treated with actual drug will roll over into a long term follow up. Long term follow up participants will be followed up monthly for 5 years.

$60 per visit

Yes
 

Neerav Goyal
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Otolaryngology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06544798
STUDY00027760
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Inclusion Criteria:
Received study drug in Study MGT-AQP1-201.

Exclusion Criteria:
Withdrew consent to participate in Study MGT-AQP1-201.
Cancer
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Hershey, PA ,

ALTE2131: Triptorelin and Protection of Ovarian Reserve in Adolescents and Young Adults with Cancer

This phase III trial compares the effect of giving triptorelin vs no triptorelin in preventing ovarian damage in adolescents and young adults (AYAs) with cancer receiving chemotherapy with an alkylating agents. Arm A: Patients receive triptorelin intramuscularly (IM) up to 14 days prior to standard chemotherapy. For patients whose chemotherapy exceeds 24 weeks, a second dose of triptorelin may be given 24 weeks after the first dose at the treating physician's discretion. Patients also undergo blood sample collection throughout the study. Arm B: Patients receive standard chemotherapy. Patients also undergo blood sample collection throughout the study.

A blood sample taken for the study; about 15 mL (one tablespoon of blood) will be drawn at each of these four times: before cancer treatment begins; at the end of cancer treatment;1 year after the end of cancer treatment; 2 years after the end of cancer treatment.

Yes
 

Lisa McGregor
cra@pennstatehealth.psu.edu
Pediatrics: Hematology/Oncology (HERSHEY)
 

Female
All
This study is NOT accepting healthy volunteers
NCT06513962
STUDY00026944
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Inclusion Criteria:
< 40 years of age at the time of enrollment
Patient must be a post-menarchal female
Newly diagnosed with first cancer, exclusive of breast cancer.

Exclusion Criteria:
Any planned radiation to the pelvis; or cranial radiation ≥ 30 Gy to the hypothalamus, inclusive of any total body irradiation (TBI)
Planned bilateral oophorectomy
Children's Health, Cancer
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Hershey, PA ,

AALL1821: A Phase 2 Study of Blinatumomab (NSC# 765986, IND# 147294) in Combination with Nivolumab (NSC# 748726, IND# 147294), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged &gt;/=1 to &lt;31 Years Old with First Relapse

This is a drug study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL).

All subjects on study will be treated with the medicine blinatumomab. Some subjects will also receive an additional medicine, nivolumab. Subjects will receive treatment on this study for about 1.5-2.5 months. Treatment is divided into 1-2 cycles. Before the start of therapy, patients will have a bone marrow evaluation for Immunophenotyping and will have their bone marrow tested for MRD on Day 36 of cycle 1 and Day 36 of cycle 2 during treatment.

Yes
 

Lisa McGregor
CRA@pennstatehealth.psu.edu
Pediatrics: Hematology/Oncology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT04546399
STUDY00028108
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Inclusion Criteria:
Patients less than 18 years old with first bone marrow relapse of B-ALL
Patients 18 years or older with first marrow relapse of B-ALL

Exclusion Criteria:
Female patients of childbearing potential without a negative pregnancy test within 7 days of enrollment
Lactating females are not eligible unless they agree to not breastfeed their infants.
Children's Health, Cancer
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Hershey, PA ,

A Multi-Center, Double-Blind, Randomized, Placebo Controlled Trial to Assess Efficacy and Safety of Omecamtiv Mecarbil in Patients with Symptomatic Heart Failure with Severely Reduced Ejection Fraction (COMET-HF)

To evaluate the effectiveness of omecamtiv mecarbil in reducing the number of heart failure events or hospitalizations in patients with severely reduced left ventricular ejection fraction &lt;30%.

Participate in about 13 in-person visits over 3 years with bloodwork at each in-person visit, participate in about 9 brief remote phone call visits, questionnaires at 5 of the in-person visits over the first year, first visit electrocardiogram (EKG), first visit Echocardiogram (ECHO) if not completed within the last 6 months, willing to be randomized to take oral study medication or placebo for the duration of the study (about 3 years).

Up to $1,500

Yes
 

John Boehmer
PSHVICTO@pennstatehealth.psu.edu 717-531-5967
Heart and Vascular Institute (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06736574
STUDY00026970
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Inclusion Criteria:
Diagnosis of Heart Failure for at least 3 months requiring treatment
Severely reduced ejection fraction less than 30%
Age is between 18 and 85

Exclusion Criteria:
Currently prescribed Digoxin or Milrinone
Acute cardiac issue such as a heart attack, heart surgery, or implant in the last 3 months
Active or planned pregnancy or breastfeeding
Current participation in another research study
History of any solid organ transplant
Heart & Vascular
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,