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PIANO: A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women with Inflammatory Bowel Disease

The study will investigate the role of standard medications for IBD on pregnancy outcomes. The subjects will be pregnant IBD patients receiving standard therapies. This study will also test whether the IBD medication transferred across placenta predicts the risk of infection. As many women receive these drugs during their reproductive years this information will guide future therapies for women with IBD and their children.

The participants will sign the informed consent. They will complete the questionnaires. There are four to five in the first year of pregnancy. After that, the questionnaires are annual, up to eighteen years after the birth of the child. The participants will have a blood sample done in the second trimester. They will send the sample to the sponsor.

Yes
 

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

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00027468
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Inclusion Criteria:
Adult, >18 years of age
Pregnant
Diagnosed with IBD-Crohn's disease
Receiving active treatment for IBD

Exclusion Criteria:
Less than 18 years of age
Not pregnant
Not able to complete the questionnaires
Digestive Systems & Liver Disease
Survey(s)
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Hershey, PA ,

Validation of Biomechanics Technology in Golf

The purpose of this study is to compare accuracy and repeatability of biomechanical metrics between technologies during golf swings. This study also aims to identify differences in swing characteristics between various skill levels and environments.

You will be screened with a Health History Questionnaire via email, online survey, or in-person. You will come to either the Suzy and Jim Broadhurst Golf Teaching and Research Center (GTRC) or the Penn State Golf Courses with your golf clubs to provide consent, collect blood pressure and heart rate, answer golf-related questions, and perform golf-related tasks (full swing shots with various clubs). Various technologies will be used to measure the biomechanics of your swing. The total time of participation is expected to be about 60-90 minutes.

When you have finished the golf-related activites, you will be provided with a brief piece of instruction from one of the Center’s two Class-A PGA Professionals.

Yes
 

Joe Lesueur
Joe LeSueur - at jvl7292@psu.edu or 814-867-3198
Recreation, Park and Tourism Management (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00027952
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Inclusion Criteria:
Currently plays golf
18-55 years old
Physically capable of playing a full round of golf (18 holes)
A known or estimated handicap less than 35 and/or average score less than 120
Healthy and active (> 75 minutes of moderate exercise weekly)

Exclusion Criteria:
Major symptoms or known cardiovascular, pulmonary or metabolic disease
2 or more cardiovascular risk factors according to the Health History Questionnaire
A musculoskeletal injury within the past 3 months
Experiencing pain during a golf swing
Sports Medicine
Not applicable
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State College, PA ,

Assessing the Human Alignment of Counterfactual Evaluation Metrics in Recourse Generation

This study aims to understand how well current methods for evaluating Counterfactual recourse recommendations match human preferences. Participants will review different Machine learning model generated Counterfactual options and provide feedback on which options they find more practical and feasible. The goal is to improve Counterfactual generation systems so that they can offer recommendations that better align with what people actually want or need.

The participants will attend two Zoom sessions. During each session, they will compare loan profile options and indicate their preferences and acceptable change limits. A researcher will record their responses in the survey form. Each session will last approximately 30–45 minutes. Participants will receive $10 for completing the first session and $15 for completing the second session.

25

No
 

Amulya Yadav
Firdaus Choudhury - at Firdaus@psu.edu
Information Sciences and Technology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00026097
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Inclusion Criteria:
18 years of age or older
able to communicate in English
have access to a device with Zoom capability
willing to attend two 30–45 minute Zoom sessions

Exclusion Criteria:
Under 18 years of age
cannot provide informed consent
without access to the internet or Zoom
Education
Survey(s)
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Driver Situation Awareness in Automated Driving Systems

This research is being done to investigate the effect of human-machine interface design on promoting driver situation awareness restoration and effective human-AI collaboration under varied takeover situations.

You will complete a set of questionnaires and evaluate the design of the automated driving system by driving on a driving simulator. During the drive, you will be asked to drive in automated mode and focus on tasks unrelated to driving until the system issues a takeover request. The form of the takeover request will change in the experiment. You will be wearing eye tracking glasses while performing the driving task. After the driving tasks, you will complete questionnaires about your perception of the system.

$10/hour

Yes
 

Yiqi Zhang
Yiqi Zhang - at yuz450@psu.edu
Industrial and Manufacturing Engineering (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00028110
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Inclusion Criteria:
Having a valid driving license for at least two years
Fluent in English
Age 18 or older
Normal vision or vision that is corrected with contact lenses

Exclusion Criteria:
Anyone who only wears glasses to correct their vision
Education, Mental & Behavioral Health
Not applicable
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State College, PA ,

Ready Set Recharge! Pilot Study

The objective of this study is to pilot test a text-message and electronic delivered educational intervention, Ready, Set Recharge focused on the mental health benefits of physical activity ( PA) in undergraduate students at Penn State University.

Participants interested in participating in this study will be directed to complete a pre-program survey that will take less than 30 minutes to complete. After completion of the survey, participants will be enrolled in the program which is 8 weeks in duration. The program is entirely online and participants will be sent weekly text messages with links to content to read about physical activity and mental health. Participants will also be taught strategies they can try to increase their physical activity behavior in their own life. Participants will compete weekly surveys that take less than 5 minutes to complete. At the end of the 8-weeks, participants will complete a post-program survey that will take less than 30 minutes to complete.

$25

No
 

Erica Rauff
Erica Rauff - at recharge@psu.edu
Biobehavioral Health (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00026868
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Inclusion Criteria:
Undergraduate student at Penn State
Can read and understand English
18 years of age or older

Exclusion Criteria:
Not a current undergraduate student at Penn State
Unable to read or understand English
Under the age of 18
Mental & Behavioral Health
Not applicable
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PSCI 23-130 RASolve 301: Phase 3 Multicenter, Open Label, Randomized Study of RMC-6236 versus Docetaxel in Patients with Previously Treated Locally Advanced or Metastatic RAS[MUT] NSCLC

This trial is looking at the progression free survival and overall survival in patients treated with docetaxel alone and those treated with docetaxel and RAS G12X-C

This study has 4 periods: 1. Pre-screening period (to provide your tumor genetic information) 2. Screening period (before you begin the study to see if you qualify for the study). This is when you will have all the testing done to make sure it is safe for you to join the study. it may require several trips to the hospital. 3. Study Treatment period (when you will receive the study treatment; this occurs in 21-day cycles). this is when you will be taking the study medication. For the first cycle of treatment you will need to come to the clinic about 3 times to make sure you are ok while taking the study drug. From cycle 2 onward you will need to come to the clinic twice. 4. Follow-up period (to check on you after your study treatment is finished) and then we will check to see how you are doing every three months. It is important that you come to all of your visits.

Yes
 

Patrick Ma
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
NCT06881784
STUDY00026897
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Inclusion Criteria:
Age: ≥ 18 years
Histologically confirmed NSCLC, either locally advanced or metastatic, not amenable to curative surgery or radiotherapy.
Evidence of progressive disease (PD)

Exclusion Criteria:
Radiation therapy ended ≥2 weeks before randomization
Chemotherapy and Antibody Therapy; ≥3 weeks of randomization
Symptomatic congestive heart failure
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

The effect of input conditions on language learning: The roles of salience, modality and context.

The present study will examine the role of different input conditions on the learning of words and morphosyntactic units in a new language. We specifically aim to examine the effects of variables researched in the field: type of knowledge (explicitly stated via pre-training, or incidental; Pellicer-Sánchez et al., 2021), salience (manipulated via input properties; Ellis & Sagarra, 2010) and modality (visual or auditory; Borro, 2021) play on learning outcomes. Our goal is to examine how cognitive processes underlying learning are affected by our manipulations, and the impact on learning outcomes. We hypothesize that pre-training will enhance speakers' ability to detect target vocabulary and structures to be learned. While the literature is mixed on the role of salience, across the experiments described below, we will explore the impact of low-level salience (e.g., text enhanced visually) and psychological salience (the amount of repetition / expectedness of a target items. We will also investigate the less investigated effect of modality.

This is a language learning study. There will be up to two visits to the research lab. Sessions will consist of simple tasks consisting of readings sentences, remembering words, and completing memory tasks. EEG data will be collected via a wearable EEG cap; eye-tracking data will be collected while reading and completing some of the tasks are on a computer.

18 / hour

Yes
 

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

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00027420
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Inclusion Criteria:
Must speak English proficiently
Must be between 18 and 45 years old.
Right handed
Normal or corrected-to-normal vision
No history of neurological disorders or language disorders, or current condition requiring psychoactive medication (e.g. antidepressants, antianxiety medications, ADHD stimulants, etc.)

Exclusion Criteria:
Ages younger than 18 or older than 45 years old.
Speakers with low English proficiency.
Left-handed or ambidextrous
Uncorrected vision
A history of neurological disorders or language disorders, or current condition requiring psychoactive medication (e.g. antidepressants, antianxiety medications, ADHD stimulants, etc.)
Education, Neurology, Language & Linguistics
Not applicable
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State College, PA ,

A Phase 1 Single and Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SR604 in Healthy Participants (Part A) and the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SR604 in Participants with Hemophilia A or Hemophilia B (Part B)

SR604 is a monoclonal antibody that blocks anticoagulant activity, which improves clotting in patients with the clotting disorders of Hemophilia A & B. This study is looking at treatment options for Hemophilia A & B. There will be 4 cohorts (1B, 2B, 3B & 4B). Our site will be starting study drug SR604 dose escalation with 0.1mg/kg (2B), then 0.2mg/kg (3B) with the final dose 0.4mg/kg (4B). Lower doses will start in the first cohort & dose escalation will continue in subsequent cohorts after a 3-month monitoring period in each cohort. See page 44 of the protocol for patient numbers in each cohort.

Participants will receive subcutaneous SR604 every 4 weeks for 3 months. Total visits to site will be 15. Blood draws will be obtained at each of these 15 visits.

75.00 per visit travel reimbursement

Yes
 

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

Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06349473
STUDY00026729
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Inclusion Criteria:
BMI 18-30 (>50 kg & < 90)
Severe congenital Hemophilia A
Severe and/or moderate congenital Hemophilia BA
Patients with inhibitors are permitted

Exclusion Criteria:
History of smoking/nicotene, alcohol abuse or illicit drugs within 1 year of screening
Hemophilia A pts. currently treated with hemlibra
Active infections requiring antibiotic/antiviral therapy
Blood Disorders
Not applicable
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Hershey, PA ,

Menopause Stage and Depression Symptomatology

This study aims to examine differences in physiological variables (inflammation and heart rate variability) at different menopausal stages and whether these differences influence depression symptomatology. There will be one 3.5-4 hour in person study visit that includes completion of questionnaires, cognitive tests, electrocardiogram (ECG) recordings, and one blood draw.

There will be one 3.5-4 hour in person study visit that includes completion of questionnaires, cognitive tests, electrocardiogram (ECG) recordings, and one blood draw. If you are still having menstrual periods, you will be asked to record menstrual bleeding on a menstrual calendar for 3 cycles.

75

Yes
 

Molly Wright
Molly Wright - at mpw5810@psu.edu or 813-310-1889
Division of Graduate Studies (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00027757
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Inclusion Criteria:
40-55 years old
assigned female at birth
English fluent
less then 2 years past the final menstrual period if postmenopausal
if on antidepressants, on a stable dose for 8 weeks

Exclusion Criteria:
history of hysterectomy or bilateral oophorectomy
taking hormone medications in past 3 months
on strong anti-inflammatory medications
history of cardiovascular (other than hypertension) or neurological disease
Diagnosis of Bipolar or Psychotic Disorder
Mental & Behavioral Health, Women's Health
Not applicable
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State College, PA ,

Producing code-switched speech

Bilinguals frequently mix languages, even mid-sentence, when communicating with other bilinguals, a practice known as code-switching. This study aims to understand how bilinguals weave together different ways of producing the same sounds, corresponding to the languages they use, when code-switching. Participants will read aloud a list of sentences in Spanish, or in Spanish with switches to English partway through. They will also complete English and Spanish proficiency tasks and a questionnaire about their language background.

Participants will participate in a single session in our lab, lasting about an hour. During this time participants will: Produce words and sentences in Spanish and English. These will be audio recorded. Read and make decisions about words in Spanish and English. Name pictures in Spanish and English. These will be audio recorded. Complete a questionnaire about your language background.

$15

Yes
 

Matthew Carlson
Matthew Carlson - at mtc173@psu.edu
Spanish, Italian and Portuguese (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00028114
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Inclusion Criteria:
Bilingual speaker of Spanish and English
Speaker of Puerto Rican Spanish

Exclusion Criteria:
History of speech or language disorders
Language & Linguistics
Not applicable
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State College, PA ,

A Clinical Investigation of the Adjustable Continence Therapy (ACT) for Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency

The purpose of this study is to find out if an implant of ACT is safe and effective in reducing urinary incontinence. The study will involve about 132 women that have urinary incontinence. This system is investigational. After placement of the devices, participants will be followed for 12 months on a regular visit schedule. Annual visits may continue for up to 5 year. ACT® is an implantable device for treating stress urinary incontinence. One end of the device is a balloon that is attached by a tube to a port at the other end of the device.

Participants will attend a screening visit, the implantation visit, post-op assessment, 6 week, 3 month, 6 month, 12 month, and annual follow up visits for necessary device adjustments.

600

Yes
 

Susan MacDonald
Sneha Patel - at spatel42@pennstatehealth.psu.edu or 717-531-0003, ext=283173
Urology (HERSHEY)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
NCT04248283
STUDY00023525
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Inclusion Criteria:
Stress Urinary Incontinence with primary intrinsic sphincter deficiency
Failed at least 6 months of previous treatment for stress urinary incontinence

Exclusion Criteria:
Prior pelvic radiation
Currently undersoing radiation therapy
Pregnant/lactating women
Kidney & Urinary System, Women's Health
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Hershey, PA ,

Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) with Low-Dose Post-Transplant Cyclophosphamide for Prophylaxis of Graft-versus-Host Disease in Hematological Malignancies

This study is testing whether a lower dose of a medicine called cyclophosphamide (25 mg per kg), given after an allogeneic stem cell transplant, can reduce serious side effects and improve outcomes. We are enrolling people who are receiving a reduced-intensity or non-myeloablative (less intensive) stem cell transplant. We will follow participants for one year after their transplant to see if they stay free from severe graft-versus-host disease (GVHD), cancer relapse, or death. We will also look at overall survival, rates of GVHD, infections, donor cell recovery, and other side effects.

You must attend all scheduled study visits, tell the study doctor about all medications you are taking (including over-the-counter medicines), and let the study team know how you are feeling. Before joining the study, you will have routine health checks. These include breathing tests (called pulmonary function tests, or PFTs) to see how well your lungs work, and a heart scan (MUGA scan or echocardiogram) to see how well your heart is pumping. As part of this study, you will be given a low dose of cyclophosphamide (25 mg/kg) on day +3 and +4 after your stem cell transplant. You will be carefully monitored for any side effects, and the study team will evaluate your risk for graft-versus-host disease (GVHD) and disease relapse.

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
NCT06926595
STUDY00026938
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Inclusion Criteria:
Age 18 or older at the time of study enrollment.
Patients with acute leukemia (acute myeloid leukemia, acute lymphoblastic leukemia, mixed phenotype acute leukemia) or chronic myeloid leukemia with no circulating blasts and less than 5% blasts in the bone marrow.
Patients with myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia with no circulating blasts and less than 10% blasts in the bone marrow (exception allowed due to lack of difference in outcomes with <5% vs 5-10% blasts in this disease).
Patients with secondary acute myeloid leukemia progressing from pre-existing myelodysplastic syndrome, myeloproliferative disease (MPN), or MDS/MPN overlap syndrome.
Patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma who are indicated for allogeneic stem cell transplantation.

Exclusion Criteria:
Prior allogeneic stem cell transplant.
Active central nervous system (CNS) involvement by malignant cells.
Uncontrolled bacterial, viral, or fungal infections (currently taking medication with progression or no clinical improvement).
Cancer
Approved drug(s)
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Hershey, PA ,

A Prevention Strategy For The Indication Of Prune Consumption In Perimenopausal Females: Can Prunes Attenuate Bone Loss?

This project will be an 18-month dietary intervention of prune consumption during the late perimenopausal period of the menopause transition investigating if prune intake can slow down the rapid period of bone loss (bone mineral density) that occurs in the late transmenopause. The study will also investigate the effects of prune intake on inflammation, gut permeability, gut microbiome, and bone strength and geometry. Women transitioning into menopause will be randomized to either a group that will consume 6 prunes/day or to a no-prune group that will avoid prunes for the entire duration of the 18-month intervention. Both groups will consume calcium and vitamin D supplements daily. Study procedures will include collection of blood, urine, and stool samples, bone and body composition scans, completion of health-related questionnaires, exercise records, and daily compliance logs.

Participants will be asked to consume calcium and vitamin D supplements daily for 18 months and will be randomized into either a group that will be asked to consume 6 prunes daily for 18 months, or a control group that will be asked to avoid prunes and similar fruits (for example, blueberries, blackberries, pomegranates) for 18 months. There will be 10 in-person visits and 13 virtual visits (Zoom calls). In-person visits include questionnaires, blood draws, and bone and body composition scans. The study also involves urine and stool sampling.

$300

Yes
 

Mary Jane De Souza
Ana Carla Salamunes - at prunes@psu.edu or 814-863-4488
Kinesiology (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
NCT07120997
STUDY00027323
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Inclusion Criteria:
44-55 years
Overall good health
Non-smoking
Ambulatory
At least one episode of no menses of ≥60 days within the past 12 months but no more than 18 months since final menstrual period

Exclusion Criteria:
History of vertebral fracture or fragility fracture of the wrist, humerus, hip or pelvis after age 45 years
Taking hormonal medication or hormonal contraception
Taking medication for osteoporosis
Untreated hypo- or hyperthyroidism
Hyper- or hypoparathyroidism
Food & Nutrition, Muscle & Bone, Women's Health
Not applicable
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State College, PA ,

Circadian Misalignment and Sleep Quality Among Night-Shift Healthcare Workers

This study examines whether night-shift healthcare workers who experience greater differences in their sleep timing between days off and after night shifts also report poorer sleep quality. Participants will complete a brief anonymous online survey about their typical sleep patterns and overall sleep quality.

Complete a one-time anonymous online survey (5-10 minutes) about sleep patterns and sleep quality. Survey includes questions about typical sleep times on days off and after night shifts, plus brief demographics and work information.

No
 

Zakir Khawaja
Zakir Khawaja - at zkk5042@psu.edu or 484-821-7011
Division of Undergraduate Studies (LEHIGH VALLEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00028230
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Inclusion Criteria:
Age 18 years or older
Currently employed as a night-shift healthcare worker
Have worked night shifts for at least 3 months

Exclusion Criteria:
Under age 18
Currently not employed as a night-shift healthcare worker
Less than 3 months of night-shift experience
Prevention, Sleep Management, Mental & Behavioral Health
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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 and in-person study visits over 8 months. You will complete some interviews and questionnaires virtually. 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 come to the lab for in-person visits both pre and post program. During these visits, your child will complete some EEG tasks, and you and your child will complete some interaction tasks where your respiratory and heart rate data will be collected. You and your child will also be asked to complete some short daily phone surveys at home.

480 dollars

Yes
 

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, developmental disorders, or conduct 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); or with visual or hearing impairments that interfere with completing study measures and sessions.
Children currently taking psychotropic medications for at least two weeks prior to study participation (except use of stimulant medication which has to be discontinued for 36-hours prior to the EEG visit).
Children's Health
Survey(s)
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State College, PA ,

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. For Arm 3 - Parent stipend of $115 per visit.

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
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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
Sara Craig - at scraig2@pennstatehealth.psu.edu or 717-531-0003, ext=285799
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
NCT07029711
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 ,