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A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults with Cutaneous Sarcoidosis

The purpose of this research is to measure clinical safety and efficacy (effectiveness) of oral brepocitinib in adults with cutaneous sarcoidosis. Participation in this study is expected to last for up to 24 weeks (about 6 months). During treatment period, visits will be scheduled about every 4 weeks. Participants will be assigned to 1 of 3 treatments, there is a chance of receiving a placebo (non active ingredient treatment) however, you will not know nor will the study team know what treatment you have been assigned too. In addition, throughout the study at different time points you will answer questions, take the study treatment as directed by the study team, have your skin examined (biopsy), have labs drawn, have an ECG, and a chest x-ray.

Participants will attend a total of 7 in person visits throughout the study and visits will be scheduled about every 4 weeks during the Treatment Period. During the study you will be asked to answer questions to gather information on your health as well have you complete questionnaires. In addition, you will have the following assessments at different time points throughout the study: skin exam, ECG, Chest X-Ray, Skin photography, Skin punch biopsy, Pulmonary function testing, and blood tests.

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06978725
STUDY00026360
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Inclusion Criteria:
Must be 18-75 years of age
Skin biopsy required along with presentation of cutaneous sacroidosis symptoms for 6 months or longer
Weight requirements apply for participation, study coordinator will discuss
Must be willing to understand and comply with the study requirements
Certain medications are allowed at a maximum stable dose, study coordinator will discuss further

Exclusion Criteria:
Medical History will be discussed with study coordinator.
Women who are breastfeeding, pregnant, or planning to become pregnant, or WOCBP who are unwilling to apply a highly effect birth control method for the time specified during study participation
Skin Conditions
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Making Second Language Learning More Inclusive in the Elementary Classroom: A Metalinguistic and Multimodal Approach

This study aims to find out whether learning German can help children with language difficulties improve their English skills. Children will learn German grammar using colors, shapes, and simple explanations to help them understand how language works.

Participants will complete 20 one-hour Zoom sessions over 10 weeks. During these sessions, they will learn German using a visual and interactive approach that highlights both similarities and differences between German and English. Some sessions will involve fun learning activities, while others will include assessments of language, cognitive, and metalinguistic skills.

$300

No
 

Natacha Mally
Natacha Mally - at nmally@psu.edu
Division of Graduate Studies (UNIVERSITY PARK)
 

All
Younger than 18 years old
This study is NOT accepting healthy volunteers
NCT00000000
STUDY00026229
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Inclusion Criteria:
Children who likely have developmental language disorder (DLD; SLI)
Aged 7-11
Have English as their first language
Have significant difficulties understanding and/or expressing themselves in English

Exclusion Criteria:
Have a diagnosis of a neurodevelopmental disorder other than DLD (e.g., autism, ADHD, intellectual disability)
Are suspected of having another neurodevelopmental disorder, based on parent report or observed behavior
Have a hearing impairment
Children's Health, Education, Language & Linguistics
Not applicable
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Intersectionality and Mental Health: Developing a Culturally Sensitive Yoga Intervention for Black and Minoritized Young Adult Substance Users

The project aims to increase awareness and understanding of yoga's benefits for mental health, including substance use, and stress reduction among marginalized Black communities and to empower minoritized individuals with critical tools and techniques for managing stress. By addressing the multifaceted relationship between intersectionality, race-related stress, and mental health, including substance use, this study seeks to provide a comprehensive approach to improving health outcomes for marginalized Black young adults. Participants will engage in either a 1:1 semi-structured interview or a focus group discussion, both hosted by the principal investigator, to hear their perspectives on the accessibility and feasibility of engaging in yoga-based interventions for mental health and substance use. From this study, the researcher seeks to contribute to the development of effective yoga prevention and treatments strategies that provide coping mechanisms to deal with race-related stress, reduce substance use and related negative health outcomes, and promote resilience among affected populations.

The study will last over the course of one day and will take about two hours of your time. Participants in this study will take part in a focus group or a one-on-one interview to share their experiences, perspectives, and insights related to yoga, mental health, stress management, and substance use.

For interview participants, each individual will receive a $25.00 gift card and for focus group participants, each individual will receive a $40.00 gift card for their participation.

Yes
 

Mary Mbaba
Mary Mbaba - at mkm7561@psu.edu
Prevention Research Center (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT00000000
STUDY00026251
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Inclusion Criteria:
For focus groups: Participants must be between the ages of 18 and 30.
For focus groups: Participants must identify as Black or African American.
For focus groups: Participants must be open to discussing their past/present substance use, mental health, coping strategies, and perceptions of yoga as an intervention.
For interviews: Must be a licensed or otherwise qualified mental health professional (e.g., counselor, therapist, social worker, psychologist, psychiatrist, or substance use counselor).
For interviews: At least two years of professional experience working with marginalized populations, particularly young adults from racial/ethnic minority backgrounds, who are dealing with mental health issues, specifically substance use.

Exclusion Criteria:
For focus groups: Individuals outside the age range of 18-30 will be excluded.
For focus groups: Individuals who do not identify as Black or African American, or who do not meet the specified racial/ethnic categories, will not be eligible for participation in the focus groups.
For focus groups: Experiencing acute substance use or psychiatric issues that require immediate medical attention
For interviews: Professionals with fewer than two years of experience working with marginalized populations, particularly young adults facing racial/ethnic stress, mental health issues, or substance use, will be excluded.
For interviews: Individuals who do not hold a recognized mental health professional role (e.g., counselors, therapists, social workers, psychologists, or substance use counselors) will not be eligible to participate.
Addiction & Substance Abuse, Mental & Behavioral Health
Not applicable
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State College, PA ,

A Phase 2, Open-label, Multicenter Study to Assess the Efficacy and Safety of BW-20805 in Adult Subjects with Hereditary Angioedema

This is a voluntary clinical research study to investigate BW-20805 a injectable treatment for hereditary angioedema (HAE). The purposes of the study are to evaluate the safety and efficacy of the study drug for the treatment of HAE, the effectiveness of the study drug for preventing HAE attacks, and how the study drug works in the body and the relationship between the amount of the study drug taken and the effect on the body.

You will answer questions about your health, provide blood samples, undergo routine urine laboratory tests, receive the study drug, undergo electrocardiogram (ECG), complete questionnaires, undergo physical exams, and provide HAE attack information. There are a total of 13 visits.

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06846398
STUDY00026212
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Inclusion Criteria:
Documented diagnosis of Hereditary Angioedema Type 1 or Type 2.
Males or females 18 to 70 years of age at the time signing informed consent
Access to rescue treatment for Hereditary Angioedema

Exclusion Criteria:
Diagnosis of another form of chronic angioedema
Active or history of cancer within 5 years prior to screening
Infectious Diseases & Immune System, Allergies
Experimental drug compared to an approved drug
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Hershey, PA ,

A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBEXELIMAB IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS

Study to look at the safety and effectiveness of Obexelimab in patients with active Lupus who are currently receiving standard of care medications

There will be 13 in person visit over nine months, blood and urine will be obtained at 12 of these visits.

up to $650

Yes
 

Nancy Olsen
Jamie Carter - at jcarter3@pennstatehealth.psu.edu
Medicine: Rheumatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06559163
STUDY00025867
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Inclusion Criteria:
Systemic Lupus

Exclusion Criteria:
Active Lupus Nephritis
over 70 years old
Arthritis & Rheumatic Diseases
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

PSCI 24-138 NRG-CC011: Cognitive Training For Cancer Related Cognitive Impairment In Breast Cancer Survivors: A Multi-Center Randomized Double- Blinded Controlled Trial

If the participant decide to take part in this study, they will join one of two computerized cognitive training groups for 10 weeks and complete assessments before and up to at least six months after training. The computerized cognitive training will be delivered remotely online. Trained research staff will help the participant learn how to use the computerized training program. The participant will also be asked to complete questionnaires via mailed surveys or electronically online and a cognitive assessment over the telephone. A cognitive assessment checks for how the brain processes thoughts, such as concentrating, learning new things, remembering, and making decisions. The total participation in this study will be about 9 months.

Participants will join one of two computerized cognitive training groups. The computerized cognitive training will involve up to 40 hours of the assigned activity over a 10-week period. The 4 questionnaires and assessment times are as follows:•at the beginning of the study (prior to the first computerized training)•12, 24, and 36 weeks after joining the study.Participants will be asked to complete questionnaires via mailed surveys or electronically online and a cognitive assessment over the telephone.

$100.00

Yes
 

Hyma Polimera
PSCI Clinical Trials Office at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
Penn State Hershey Medical Group (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05896189
STUDY00026015
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Inclusion Criteria:
The participant must be ≥ 18 years of age.
The participant must have a first-time diagnosis of non-metastatic breast cancer which is Stage I-III.
The participant must have a score of < 12 on the PROMIS Adult v2.0 - Cognitive Function 4a.
Participants must be at least 6 months and no more than 5 years after completion of initial surgery +/- adjuvant chemotherapy/radiation therapy, and targeted therapies (e.g., PARP inhibitors, CDK4/6, or immunotherapy).
The participant must be able to understand, speak, read, and write in English or Spanish.

Exclusion Criteria:
Scoring ≤ 3 on the 6-item cognitive screen.
Patient Health Questionnaire-2 item (PHQ-2) score of ≥ 3.
Definitive clinical or radiologic evidence of metastatic disease
Current or past history of another cancer. Patients with history of only non-melanoma skin cancer or in situ cervical cancer without chemotherapy treatment would be eligible.
Previous exposure to chemotherapy treatment for another cancer or due to other medical condition (e.g., methotrexate exposure for treatment of rheumatoid arthritis).
Cancer
Survey(s)
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Hershey, PA ,

Voice Assistant to Provide Cognitive Stimulation Therapy at Scale

This project focuses on establishing a preliminary evidence base regarding the feasibility and acceptability of using smart speakers to deliver individual cognitive stimulation therapy (iCST) to persons living with dementia (PLwDs)

Fifteen dyads of persons living with dementia and their care partners will be recruited. Participants will engage with an Alexa-based Virtual Assistant (VA), and data will be collected via surveys and Zoom interviews.

$45 per hour

No
 

Saeed Abdullah
Ita Saragih - at ixs5315@psu.edu or 582-203-8955
Information Sciences and Technology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00024129
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Inclusion Criteria:
Family care partner and their family member with mild dementia
Ability to speak and understand English
See and hear well enough to participate
No major physical illness or disability affecting their participation
Personal in-home Wi-Fi access and personal device capable of participating in Zoom calls

Exclusion Criteria:
Persons living with dementia or their care partners who are unable to provide inform consent
Neurology, Mental & Behavioral Health
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PSCI# 25-028 LoTAM: A RANDOMIZED, PHASE III CLINICAL TRIAL OF LOW-DOSE TAMOXIFEN FOR SELECTED PATIENTS WITH MOLECULAR LOW-RISK EARLY-STAGE BREAST CANCER

This study is comparing standard of care endocrine therapy for 5 years versus low dose tamoxifen for 5 years in patients with resected invasive breast cancer.

Participants must come to all scheduled study visits, all medications they are taking including over the counter and tell the study doctor how you are feeling.

Yes
 

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

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06671912
STUDY00026751
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Inclusion Criteria:
Unilateral invasive adenocarcinoma of the breast that is histologically confirmed
No tumors that are considered pT4
No definitive clinical or radiologic evidence of metastatic disease
Age ≥ 18 years and female ___
ECOG Performance Status ≤ 2

Exclusion Criteria:
Abnormal or dysfunctional uterine bleeding within 1 year prior to study enrollment
Any patient with known atypia or endometrial pathology that the opinion of the treating investigator would place the patient at undue risk of endometrial cancer with tamoxifen
Any patient with a known hypercoagulable state that in the opinion of the treating investigator would put the patient at undue risk of venous thromboembolism with tamoxifen.
No synchronous or previous contralateral invasive or non-invasive breast
No previous history of ipsilateral invasive breast cancer or ipsilateral DCIS, regardless of the disease-free interval.
Cancer
Approved drug(s)
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Hershey, PA ,

PSCI 24-106 A: A Randomized Phase II Study of Venetoclax and HMA-based Therapies for the Treatment of Older and Unfit Adults with Newly Diagnosed FLT3-mutated Acute Myeloid Leukemia (AML): A MyeloMATCH Treatment Trial

As part of the myeloMATCH Older Adult AML basket, a comprehensive geriatric assessment will be implemented across intensive and non-intensive treatment studies to validate measures of fitness and frailty that predict for treatment-related morbidity and mortality. The overall goal of the geriatric assessment will be to validate measures to be incorporated in future older adult AML myeloMATCH studies to prospectively define “fitness” for intensive chemotherapy.

Subject will either get Azacitidine through a vein in their arm or subcutaneously and Venetoclax by mouth for up to 2 years, or will get Azacitidine through a vein in your arm or subcutaneously, Venetoclax and Gilteritinib as tablets that you take by mouth for up to 2 years.After you finish your study treatment, doctor will continue to follow condition for 10 years.

Yes
 

Joseph Cioccio
PSCI CTO Office at PSCI-CTO@Pennstatehealth.psu.edu or 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06317649
STUDY00026189
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Inclusion Criteria:
Patient must have a morphologically confirmed diagnosis of AML according to the WHO 2016 classification excluding APL with PML-RARA, AML with RUNX1-RUNX1T1, or AML with CBFB-MYH11.
Patient must have no prior therapy for AML with the exception of hydroxyurea and all-trans retinoic acid (ATRA), or leukapheresis. Patients with cytarabine-based emergency therapy prior to the start of therapy on this trial are eligible.
Patient must be assigned to this protocol by the myeloMATCH MSRP.
Patient must have the ability to understand and the willingness to sign a written informed consent document.
Creatinine clearance of ≥ 30 mL/min/1.73m2

Exclusion Criteria:
Patient must have prior therapy with hypomethylating agents or FLT3 inhibitors
Patient is pregnant or breast-feeding
Patients with a history of hepatitis C virus (HCV) infection have not been treated and cured.
Patient has the medical necessity for ongoing treatment with a strong CYP3A4 inducing drug.
Cancer
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

PSCI 24-129 Open-Label, Multicenter, Phase 1 Study to Assess the Safety of P-CD19CD20-ALLO1 in Subjects with Selected Relapsed/Refractory B cell Malignancies

This trial will examine the use of "off the shelf" CAR T in the treatment of cancers that have relapsed or do not respond to treatment.

Participants must keep all study visits, tell the study doctor how you are feeling and all medications you are taking including over the counter medications.

Yes
 

Shin Mineishi
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
NCT06014762
STUDY00026280
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Inclusion Criteria:
Males or females ≥ 18 years of age.
Must have prior biopsy proven confirmed diagnosis of DLBCL NOS (including DLBCL arising from indolent lymphomas), HGBL, PMBCL, and tFL or follicular lymphoma Grade 3B.
Must have relapsed/refractory disease
Must be willing to practice birth control

Exclusion Criteria:
Is pregnant or lactating
Concurrent or previous other malignancy within 2 years of study entry
Has active autoimmune disease
Has a history of hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), or human T-lymphotropic virus (HTLV) infection
Cancer
Experimental drug compared to an approved drug
I'm interested
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Hershey, PA ,

PSCI 24-106: Myelomatch, Master Screening And Reassessment Protocol (MSRP) For Tier Advancement In The NCI Myelomatch Clinical Trials

The purpose of the study is to see if blood and bone marrow samples can be tested in a timely manner for markers that could guide cancer treatment. The testing will look for markers that specific treatments may target. Based on test results, the subject will have the option to join a myeloMATCH treatment substudy for treatment or receive standard of care treatment from your doctor.

Participants will give bone marrow and blood samples for testing. Your samples will be tested for specific cancer biomarkers.After the study receives the results of your biomarker testing, the physician will tell you if there is a myeloMATCH treatment substudy available that matches your results.If a substudy is available the study doctor will give the subject more information about it and help the subject understand the details of the study.

Yes
 

Joseph Cioccio
Rachael Griffith - at rgriffith2@pennstatehealth.psu.edu or 717-531-7128
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT05564390
STUDY00026188
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Inclusion Criteria:
Participants must not have received prior anti-cancer therapy for AML or MDS.
Participants must be ≥ 18 years of age.
Participants must agree to have translational medicine specimens submitted per
Participants must not have a prior or concurrent malignancy that requires concurrent anti-cancer therapy.
Participants must have a Zubrod Performance Status evaluation within 28 days prior to registration

Exclusion Criteria:
Participants have received prior anti-cancer therapy for AML or MDS.
Participants are less than 18 years of age.
Participants did not agree to have translational medicine specimens submitted per
Participants have a prior or concurrent malignancy that requires concurrent anti-cancer therapy.
Participants did not have a Zubrod Performance Status evaluation within 28 days prior to registration
Blood Disorders, Cancer
Not applicable
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Hershey, PA ,

Cue Reactivity Responses in Alcohol and Cannabis Use

This study aims to examine how alcohol and cannabis cues (i.e. images of alcohol containing beverages or cannabis) influences brain responses in the lab and how cues in the natural environment influence self-reported craving and drug use.

Potential participants will complete a screening questionnaire over the phone, and if eligible, will also complete 3 in-person visits. These visits include an intake session in which eligibility is assessed, a MRI session, 2 weeks of smartphone based responding, and a third visit to complete a questionnaire.

$279

Yes
 

Eric Claus
Eric Claus - at edc5208@psu.edu or 814-865-2007
Biobehavioral Health (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00026494
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Inclusion Criteria:
Between the ages of 18-30
Able to read and write in English and complete study evaluations
Able to provide written and verbal consent
Must report regular use of alcohol and/or cannabis
Able to provide negative toxicology screenings for substances, except cannabis, nicotine, or alcohol prior to eligibility determination

Exclusion Criteria:
Women who are pregnant or lactating
Current regular illicit drug use (other than cannabis)
Any contraindications for MRI
Addiction & Substance Abuse
Not applicable
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State College, PA ,

PSCI 24-106 B: A Measurable Residual Disease (MRD) Focused, Phase II Study Of Venetoclax Plus Chemotherapy For Newly Diagnosed Younger Patients With Intermediate Risk Acute Myeloid Leukemia: A Tier 1 Myelomatch Clinical Trial

Participants take part in this research study because they have a new diagnosis of acute myeloid leukemia (AML). Study is looking at to see if treatment can be improved by adding venetoclax to the usual chemotherapy: cytarabine and daunorubicin (also known as 7+3), or azacitidine? This study wants to find out if this approach is better or worse than the usual approach for this type of cancer. The usual approach is defined as care most people get for AML.

Participants will either get cytarabine + daunorubicin + venetoclax for up to 11 days, or you will get azacitidine + venetoclax for up to two months, or you will get cytarabine + daunorubicin for up to 7 days. Subjects treatment may be extended by a few weeks if subject needs additional therapy. Doctor will continue to follow your condition for 5 years and watch subject for side effects and keep track of their health. After study treatment, subjects may also be offered another clinical trial through the myeloMATCH study. Subjects will be followed on this study even if they continue onto another study. Follow-up includes a clinic visit 28 days after subjects treatment is complete, and clinic visits every 3 months for the first year, every 6 months for the second year, and annually for years 3-5 after treatment is completed.  

Yes
 

Joseph Cioccio
Hannah O'Donnell - at hodonnell@pennstatehealth.psu.edu or 717-531-0003, ext=8199
Medicine: Hematology and Medical Oncology (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05554393
STUDY00026190
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Inclusion Criteria:
Age 18-59 years at time of induction therapy
Participants must have been registered to Master Screening and Re-Assessment Protocol
Previously untreated, de novo AML defined by >20% myeloblasts in the peripheral blood or bone marrow
ECOG performance status ≤ 3.
WBC must be <25x109/L.

Exclusion Criteria:
Prior therapy for AML except for hydroxyurea and leukapheresis to control blood counts.
Patients who are receiving any other investigational agents.
Pregnant women are excluded
Patients with isolated myeloid sarcoma are not eligible
active, uncontrolled bacterial, fungal, or viral infection
Blood Disorders
Experimental drug compared to an approved drug
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Hershey, PA ,

PSCI #24-150 A Phase 3 Open-Label, Randomized Study of PDS0101 Plus Pembrolizumabvs Pembrolizumab Alone in First Line Treatment of Immune Checkpoint Inhibitor (ICI) Naïve Subjects with Unresectable Recurrent and/or Metastatic (R/M) Human Papillomavirus 16 (HPV16)-Positive Head and Neck Squamous Cell Carcinoma (HNSCC).

This study will see if pembrolizumab alone or with PDS0101 is the better treatment for head and neck cancer.

Participants will need to come to all study visits, take the study medication as prescribed, tell the study team how you are feeling and report to the study team all new medications you are tsking including over the counter medications.

Yes
 

Danh Pham
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
NCT06790966
STUDY00026812
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Inclusion Criteria:
Subject is ≥18 years
Have a history of histologically- or cytologically-confirmed diagnosis of recurrent and/or metastatic squamous cell cancer of the head and neck
Subject has adequate organ function

Exclusion Criteria:
Primary tumor location of nasopharynx
Has had major surgery, including surgical resection of tumor, within 30 days prior
Has received radiotherapy prior
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 inParticipants with Active Subacute Cutaneous Lupus Erythematosus(SCLE) and/or Chronic Cutaneous Lupus Erythematosus (CCLE) With or Without Systemic Manifestations

Cutaneous lupus erythematosus is an autoimmune condition that causes red, scaly plaques on the skin, often in sun-exposed areas. Complications of cutaneous lupus erythematosus (CLE) include changes in skin pigment, scarring, disfigurement, fatigue, and reduced quality of life. There are no medications currently approved for the treatment of CLE. The purpose of this study is to find out of the study medicine, IMVT-1402, can help with the treatment of CLE.

Total duration of the study is approximately 63 weeks, with up to 55 visits (approximately 1 visit per week). 16 visits will occur in person and 39 visits will be phone call visits.Procedures involved in the study include: medical history collection, physical exams, skin assessments, skin biopsy, photographs, electrocardiogram (ECG), blood draws (at up to 15 visits), urine tests, and questionnaires.

Yes
 

Matthew Helm
DermatologyClinicalTrials@pennstatehealth.psu.edu 717-531-5136
Dermatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06980805
STUDY00026069
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Inclusion Criteria:
Confirmed diagnosis of cutaneous lupus erythematosus
At least 18 years old
Willing to follow all study guidelines

Exclusion Criteria:
Certain treatments are not allowed; coordinator will discuss specific treatments
History of HIV or other immunodeficiency
Pregnancy or breastfeeding
Skin Conditions
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Whole blood from healthy volunteers

This research is being done to find out what triggers an immune response in white blood cells. For example, understanding the triggers of the individual interferon responses may lead to future therapies that are more selective for treating an exaggerated immune response.

A single visit for a whole blood sample.

$30.00

Yes
 

Amanda Nelson
Amy Longenecker - at alongenecker@pennstatehealth.psu.edu
Dermatology (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00026777
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Inclusion Criteria:
Males and Females
18 yrs of age or older
No skin or systemic inflammatory disease
Willing to undergo a 1-time blood collection

Exclusion Criteria:
Subjects currently taking systemic immunomodulatory agents
Subjects who are currently pregnant
Subjects who have an autoimmune or inflammatory disease
Skin Conditions
Not applicable
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Hershey, PA ,

Impact of brief daily functional resistance training on lower extremity physical performance

Our research study is testing a brief exercise program designed to help older adults walk better. The exercise program is done from the comfort of the participants' home for only 5 minutes a day!

Meet with an exercise coach virtually via Microsoft TeamsCome to Penn State Hershey Medical Center 3 times for appointmentsWear a physical activity monitor 3 timesComplete surveys

115

Yes
 

Liza Rovniak
Allisyn Hetherington - at ahetherington@pennstatehealth.psu.edu or 717-531-7633
Medicine: General Internal Medicine (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06396247
STUDY00024492
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Inclusion Criteria:
65 years of age or older
Serious difficulty walking 3 blocks
Computer, iPad, smart phone with a camera

Exclusion Criteria:
Planning to have surgery in the next 12 months
Participating in another research project involving physical activity, falls or weight loss
Inability to walk 10 feet without an assistive device
Pain in chest when doing physical activity
Arthritis & Rheumatic Diseases, Muscle & Bone
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Hershey, PA ,

A randomized, double-blind, Phase 3 study comparing efficacy and safety of frexalimab (SAR441344) to placebo in adult participants with nonrelapsing secondary progressive multiple sclerosis.

A study that looks at the efficacy of Frexalimab compared to placebo in adults with nonrelapsing secondary progressive MS.

This study explores the efficacy and safety of Frexalimab compared to placebo in delaying disease disability progression in non-relapsing secondary progressive multiple sclerosis (nrSPMS). There will be about 53 in person visits over 4.5 years that consist of monthly IV medication administration, vitals, monthly blood draw for lab work, clinical outcome assessments, ECG, and Magnetic resonance imaging (MRI) roughly every 6 months. All study activities will be done at the Penn State Health Hershey Medical Center in the Neurology Clinic at 30 Hope Drive and Clinical Research Center (CRC) in the main hospital.

Up to $4300

Yes
 

Jikku Zachariah
Reba Chivari - at rchivari@pennstatehealth.psu.edu or 717-531-0003, ext=283114
Neurology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06141486
STUDY00026060
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Inclusion Criteria:
Ages 18-60
Previous diagnosis of remitting relapsing multiple sclerosis (RRMS) AND absence of clinical relapses for at least 24 months
Current diagnosis of secondary progressive multiple sclerosis (SPMS) and documented evidence of disability progression observed during the 12 months before screening
Must agree to use contraception for male and female participants
Must be able to sign informed consent or have a legally authorized representative (LAR)

Exclusion Criteria:
History of infectious disease/serious psychiatric illness/active substance use disorder/cirrhosis, acute liver disease/malignancy/autoimmune, cardiovascular, neurological disorders/any other history or presence of significant other concomitant illness.
Treatment with lymphoid irradiation, bone marrow transplantation, mitoxantrone, alemtuzumab, cladribine, daclizumab, cyclophosphamide, other strongly immunosuppressive treatments with very long-lasting effects.
Previous exposure to frexalimab, other investigational drug trials, allergy or sensitivity to any of the study interventions.
Contraindication for MRI: pacemaker, metallic implants/presence of metallic material in high risk areas, known history of allergy to any contrast medium, or history of claustrophobia that would prevent completion of all protocol scheduled MRI scans.
Neurology
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Hershey, PA ,

PSCI 24-106: A Randomized Phase II Study Comparing Cytarabine + Daunorubicin (7+3) Vs (Daunorubicin And Cytarabine) Liposome, Cytarabine + Daunorubicin + Venetoclax, Azacitidine + Venetoclax, And (Daunorubicin And Cytarabine) Liposome + Venetoclax In Patients Aged 59 Or Younger Who Are Considered High-Risk (Adverse) Acute Myeloid Leukemia As Determined By Myelomatch; A Myelomatch Clinical Trial

This study is being done to answer the following question: Can we shrink the amount of AML or get rid of it in your bone marrow and body by treating you with the standard approach of cytarabine + daunorubicin (7+3) or one of the following experimental groups: 1) cytarabine and daunorubicin with venetoclax 2) azacitidine and venetoclax, 3) daunorubicin and cytarabine liposome, or 4) daunorubicin and cytarabine liposome with venetoclax?Study will last 5 years. After study treatment, doctor will continue to follow condition for 5 years and watch for side effects. The follow-up care may be in-person clinic visits or phone calls. They will check subject every month for 1 year after they join the study. After that, they will check subject every 2 months for the second year, every 3 months for the third year, and every 6 months for the fourth and fifth years.

Study will last 5 years. After study treatment, doctor will continue to follow condition for 5 years and watch for side effects. The follow-up care may be in-person clinic visits or phone calls. They will check subject every month for 1 year after they join the study. After that, they will check subject every 2 months for the second year, every 3 months for the third year, and every 6 months for the fourth and fifth years.

Yes
 

Joseph Cioccio
PSCI Clinical Trials Office at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05554406
STUDY00026191
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Inclusion Criteria:
Participants must have been registered to Master Screening and Re-Assessment Protocol, MYELOMATCH, prior to consenting to this study. Participants must have been assigned to this clinical trial, via MATCHBox, prior to registration to this study.
Participants must have newly diagnosed, untreated acute myeloid leukemia (AML) per WHO criteria
Participants must have high-risk (adverse) AML per ELN 2017 criteria.
Participants must have newly diagnosed, untreated acute myeloid leukemia (AML) per WHO criteria

Exclusion Criteria:
Acute promyelocytic leukemia is excluded.
Participants with favorable or intermediate risk disease are excluded.
Participants with FLT3 mutations (ITD or TKD) are excluded.
Participants with t(9;22) translocation are excluded.
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

NRG-CC014: Radiation Therapy for High-Risk Asymptomatic Bone Metastases: A Pragmatic Multicenter Randomized Phase 3 Clinical Trial (PREEMPT)

This study is being done to answer the following question: Will preventative radiation therapy lower the number of bone metastases-related complications (such as fracture caused by the tumor in the bone and tumor pushing on the spinal cord) compared to the usual approach?We are doing this study because we want to find out if this approach is better or worse than the usual approach for your type of cancer. The usual approach is defined as care most people get for high-risk bone metastases that are not causing symptoms.

If the participant decides to take part in this study, they will either get the usual approach or they will get radiation therapy for up to 5 days plus the usual approach.After the participant finishes treatment, the doctor and study team will continue to follow their condition and watch for side effects. The doctor and study team will check the participant 3, 6, 12, and 24 months after they join the study.

Yes
 

Aruna Turaka
PSCI Clinical Trials Office at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
Radiation Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06745024
STUDY00027090
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Inclusion Criteria:
Patients with polymetastatic cancer defined as more than 5 sites radiographically-evident systemic metastatic disease (excluding intracranial disease).
“High-risk” asymptomatic bone metastasis(es)
Patients with any solid tumor type (excluding multiple myeloma)
Patients must have systemic disease evaluation through standard of care diagnostic imaging, including either CT chest/abdomen/pelvis or body PET/CT, with radiology report available.
Patients with treated brain metastases and no known leptomeningeal disease are eligible if these lesions have been treated prior to enrollment.

Exclusion Criteria:
A patient cannot be considered eligible for this study unless ALL of the above conditions are met.
Cancer
Approved drug(s)
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Hershey, PA ,

Uncovering Barriers in Clinical Trials for Cancer Care in the Penn State Cancer Institute patient population – survey feasibility study

This a pilot study that will evaluate the feasibility of assessing perceived barriers to accessing clinical trials in the PSCI patient population through a questionnaire.

Patient need to fill out a survey about accessing clinical trials to the best of their ability.

Yes
 

Monali Vasekar
Anne-Laure Strong - at astrong1@pennstatehealth.psu.edu
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00027071
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Inclusion Criteria:
18 years of age or older
Speak and write English
Have a history of cancer (both liquid and solid tumors)
Currently receiving or have received any form of systemic therapy for cancer at PSCI
Be treated at least in part at Penn State Hershey Cancer Institute for cancer

Exclusion Criteria:
Participants not meeting any inclusion criteria.
Cancer
Survey(s)
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Hershey, PA ,

User Perspectives on Usability and Noise of Common Luxury Multi-styler Devices: A Survey Study

We will ask people who currently use—or have used—hair-styling tools (e.g. Dyson Airwrap, Shark Flexstyle) to complete an online questionnaire about how easy the tools are to use and how loud they seem. Our goal is to understand user experiences and preferences so manufacturers can design quieter, more user-friendly devices.

There will be an online consent form and an eligibility questionnaire before an approximately 10 minute survey on Qualtrics.

No
 

Trisha Munyon
txm5437@psu.edu
Division of Graduate Studies (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
NCT00000000
STUDY00027136
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Inclusion Criteria:
18 or older.
Under age 60.
No diagnosed hearing impairments.
Shoulder length or longer hair in past 12 months.
Have used luxury multi-airstyler devices in past 12 months.

Exclusion Criteria:
Over 60 years old.
Under 18 years old.
Does not read English.
Diagnosed hearing impairment.
Have never used one of luxury multi-airstyler devices in question.
Prevention, Mental & Behavioral Health, Women's Health
Not applicable
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PSCI 24-073 TRANSPARENT: Single-Arm Study of Toripalimab in Combination with Cisplatin and Gemcitabine in Recurrent Metastatic Nasopharyngeal Carcinoma Systemic Treatment Naïve Participants

Participants will be required to come to all study visits. At those visits the following may occur, blood tests to see if you are well enough to participate or continue to participate in the trial, a physical exam by the study doctor, meeting with the study team to talk about how you are feeling followed by getting toripalimab and chemotherapy. At other time you will need to have scans to see if how your cancer has responded to the treatment. These visit will continue until your cancer grows back, doesn’t respond to the treatment or the study is stopped by the sponsor. Although toripalimab is approved for the treatment of NPC, it is not approved to be used with these other two drugs.

Participants will be required to come to all study visits. At those visits the following may occur, blood tests to see if you are well enough to participate or continue to participate in the trial, a physical exam by the study doctor, meeting with the study team to talk about how you are feeling followed by getting toripalimab and chemotherapy. At other time you will need to have scans to see if how your cancer has responded to the treatment. These visit will continue until your cancer grows back, doesn’t respond to the treatment or the study is stopped by the sponsor.

Yes
 

Danh Pham
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
NCT06457503
STUDY00026410
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Inclusion Criteria:
Adults only 18 years of age or older.
Recurrent/metastatic or recurrent NPC after curative treatment.
Measurable disease

Exclusion Criteria:
Disease that is suitable for local therapy administered that could be cured
Prior therapy administered in the recurrent or metastatic setting
Rapidly progressing disease
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

Rocking the foundation: Controlled whole-body vibration training for strength, balance, and gait performance in middle-aged adults.

Testing the effects of low-impact vibration training vs. body squatsonly on strength, balance, and walking outcomes in people aged 40-65 years.

There will be one study visit lasting approximately 2.5 hours. Following a short screening and consent process, study participants will complete a series of baseline tests to acquire information about body composition, walking ability, strength, and balance.Participants will then complete a workout consisting of vibration training group or a squats only. Each workout will last approximately 10-minutes. The tests will be repeated to assess any changes resulting from the training.

$25.00

Yes
 

Fabricio Saucedo
Fabricio Saucedo - at fns5045@psu.edu or 814-201-7065
Education, Human Development and Social Sciences (ALTOONA)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00026867
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Inclusion Criteria:
Participants must not have been involved in whole-body exercise, balance training or resistive exercise in the previous six months.
Participants must have no known history of musculoskeletal, neurological, cardiovascular, or pulmonary impairment that may affect their ability to perform the testing procedures will be included.
Participants will be male and female between the ages of 40 and 64.
Participants must not use a pacemaker.
Participants must be able to stand and walk independently with or without the aid of an assistive device.

Exclusion Criteria:
none
Men's Health, Sports Medicine, Women's Health
Not applicable
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Altoona, PA ,

PSCI #24-133 A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) versus Treatment of Investigator’s Choice (IC) in Patients with Platinum Resistant Ovarian Cancer

this trial will see if using Rina S is better in treating ovarian cancer than standard treatment.,

Participants will need to come in for all study visits, take the medication as instructed, report all side effects and all medications including over the counter ones to the study team.

Yes
 

Shaina Bruce
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Obstetrics and Gynecology (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06619236
STUDY00026778
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Inclusion Criteria:
Be at least 18 years of age
must have histologically or cytologically confirmed high grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
Patients must have received 1 to 4 prior lines of therapy.

Exclusion Criteria:
Have primary platinum-refractory disease
Known active central nervous system metastases or carcinomatous meningitis
Hospitalization or clinical symptoms due to gastrointestinal obstruction within the past 91 days
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

A PHASE III, MULTICENTER, DOUBLE-BLIND,PLACEBO-CONTROLLED STUDY TO ASSESS THEEFFICACY AND SAFETY OF INDUCTION THERAPYWITH RO7790121 IN PATIENTS WITH MODERATELYTO SEVERELY ACTIVE ULCERATIVE COLITIS

RO7790121 will be used in the adult patients with Ulcerative colitis, to find out if it is safe and efficient in treatment of ulcerative colitis. The subjects will receive either RO7790121 drug or a placebo. After 12 weeks, the participants who complete treatment can continue to the open label treatment and receive a drug. Induction will consist of about eleven visits to the study site. The subjects will receive four intravenous treatments of either a drug or the placebo.

All subject must show understanding of the study requirements and sign the informed consent. The participants will have study procedures done, such as colonoscopy with biopsies, blood draws, and if eligible, they will be randomized at the start of induction treatment. The treatment will consists of the study drug or placebo. They will receive treatment by infusion in five study visits. After twelve weeks, the patience will be evaluated and they could continue to the open label treatment.

$75 per completed visits including endoscopy, and up to $50 for travel compensation for completed visit. You can receive a total of $1380.00 for your participation in the study.

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06588855
STUDY00025536
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Inclusion Criteria:
Read, understood, and provided written informed consent
Age from 18 to 80 years at the time of signing
Bodyweight more or equal than 40 kg
Confirmed diagnosis of UC
Must have had at least one of the standard treatments in the past with inadequate response, loss of response, and/or intolerance

Exclusion Criteria:
Current diagnosis of Crohn's disease (CD)
Presence of ostomy or ileoanal pouch
Diagnosis or suspicion of primary sclerosing cholangitis.
Any major surgery within 6 weeks prior to screening
Evidence of or treatment for Clostridioides difficile (C. difficile)
Digestive Systems & Liver Disease
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Midlife Vascular Health Study

Several easy methods will be used to study how blood vessels change in middle-aged people. These methods include heating a small spot on the arm, using a small TENS unit, using an ultrasound with a blood pressure cuff on the arm, and taking a blood sample.

There will be 2 in-person visits, one will be ~1 hour, the other will be ~2. We will take a blood sample at each visit. The second visit will require you to be seated and resting the entire time.

75

Yes
 

Lacy Alexander
Auni Williams - at abw5795@psu.edu
Kinesiology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00026695
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Inclusion Criteria:
Aged 45-60

Exclusion Criteria:
diagnosed cardiovascular disease
nicotine use
current or recent hormone replacement therapy
bleeding disorders
beta-blockers or alpha-blockers
Heart & Vascular, Prevention, Neurology
Not applicable
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State College, PA ,