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A wearable transcutaneous CO2 sensor for detection of hypercapnia in ALS

Amyotrophic lateral sclerosis (ALS) progresses to chronic hypercapnic (excessive carbon dioxide) respiratory failure due to chronic hypoventilation. Transcutaneous carbon dioxide (tCO2) monitoring has the potential to advance home care needs in ALS if the size, complexity, and cost of the sensor can be reduced. The aim of this study is to perform clinical validation of a novel tCO2 sensor in the setting of ALS monitoring. Simultaneous measurements of tCO2 will be performed in ALS clinic using the prototype device alongside a commercial device and standard clinical metrics of respiratory function. A group of control participants will also be recruited. Participants will be queried on technology acceptance related to commercial and experimental devices. The clinical study is designed to test 1) the concurrent validity of the prototype wearable against commercial standard and 2) user opinion about the acceptance of this technology as a device for health monitoring.

The study involves a single visit lasting 1.5 hours. You will undergo two 15-minute recordings of CO2 from sensors placed on the skin. These will occur approximately one hour apart. You will then be asked about your experiences during the recordings in a brief interview.

$20

Yes
 

Andrew Geronimo
Andrew Geronimo - at ageronimo@pennstatehealth.psu.edu or 717-531-0003, ext=282576
Neurosurgery (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00027035
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Inclusion Criteria:
18 years of age or older.
[Patients only] Diagnosis of ALS based on Gold Coast Criteria
[Healthy controls only] Age and sex matched to the patient cohort
[Healthy controls only] Neurologically healthy

Exclusion Criteria:
Use of any type of non-invasive ventilation (NIV), except in the case of continuous positive airway pressure (CPAP) for obstructive sleep apnea
Use of a tracheostomy
Use of diaphragm pacer
Use of supplemental oxygen for any portion of the day or night
Other neurological or psychiatric illness
Neurology
Experimental device compared to an approved device
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Hershey, PA ,

SIBERATE-1: A PHASE III, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, TREAT-THROUGH STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION AND MAINTENANCE THERAPY WITH RO7790121 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE

This study will evaluate the safety and efficacy of a novel drug R07790121 compared to placebo in Crohn's disease patients. This drug is an antibody which binds to TL1A, a known important molecule in the regulation of Crohn's disease pathways. The patients who agree to participate and sign the informed consent, will receive a drug or placebo by intravenous infusion on days 0, 2, 6, and 10 of the Induction phase of treatment. During the Maintenance phase of treatment, weeks 12-52, the patients will be randomized to two doses of the drug or placebo that will be given by subcutaneous injection every four weeks. In the Open label phase of treatment, patients will receive the drug every two or every four weeks. All participants will have in-person clinic visits, will be asked to complete daily study questionnaires, provide specimens (stool, blood, urine), and have procedure done (endoscopy, ECG, blood work).

There are two screening visits to find out if subject is eligible to participate. The informed consent must be signed at the first visit, before any procedures. The subjects will be randomized for an induction treatment in two drug arms and one placebo (1:3). The Induction treatment will take 12 weeks and include five visits to the site. They may continue treatment into the Maintenance phase, weeks 12-52, There are ten visits, every four weeks. If disease returns or worsens, the subject may start the open label treatment during the maintenance. Each visit will have blood draws done, vitals check, and some have physical exam.

$75 per completed visit and $50 for travel. Total will depend on the number of visits completed

Yes
 

Kofi Clarke
Z. Stella Sever Chroneos - at zchroneos1@pennstatehealth.psu.edu or 903-245-5819
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06819878
STUDY00026608
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Inclusion Criteria:
Age over 18 to 80 years
Moderately to severe active CD (Crohn's disease)
Involvement of ileum an/or colon, with at least 4 segments or 3 segments if after bowel sugery
Agrees to use contraception, if Women Of Child Birth Potential must not be pregnant
Prior therapy failure

Exclusion Criteria:
More than 2 missing segments of colon
short bowel syndrome
presence of ileostomy, colostomy, or ileal-anal pouch
current diagnosis of Ulcerative colitis (UC)
presence of abscess
Digestive Systems & Liver Disease
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

PSCI 25-051 NRG-GU014: Randomized Phase II Trial of Pembrolizumab and Radiation vs. Radiation and Concurrent Chemotherapy for High-Grade T1 Bladder Cancer (PARRC TRIAL)

This study will look to see if radiation plus immunotherapy is better than radiation and chemotherapy.

The participant will either get chemotherapy and radiation therapy for up to 4-7 weeks, or they will get radiation therapy for 4-7 weeks plus the immunotherapy drug, pembrolizumab, given every 6 weeks for about one year (for a total of 9 doses). After the participant finishes the study treatment the study doctor will continue to follow their condition for almost 10 years, either by telephone or clinic visit, and watch them for side effects. The study doctor will monitor the participant every 3 months for 2 years, then every 6 months for 3 years and then annually for 5 years.

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06770582
STUDY00026967
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Inclusion Criteria:
Histologically confirmed recurrence with high-grade T1 urothelial carcinoma
Age ≥ 18
Not Pregnant and Not Nursing

Exclusion Criteria:
No history of pelvic radiation therapy
Patients must have recovered from acute cardiac illness
No glucocorticoids
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

Neural and Sensorimotor Mechanisms of Visuomotor Actions: Linking Brain Activity, Muscle Coordination, and Visual Attention

This study explores how the brain, eyes, and muscles work together when people use their hands to track or catch moving objects. Participants will sit and use their right hand on a tablet to follow a moving virtual ball while wearing non-invasive sensors that record brain waves (EEG), muscle activity (EMG), and eye movements. The goal is to understand how the body prepares for and responds to motion using vision and movement control. The findings may help scientists improve therapies and technologies for people with movement difficulties, such as after a stroke or brain injury.

Participants will attend one in-person session lasting approximately 2 hours. During the session, they will wear an EEG cap, EMG sensors, and an eye tracker while completing a hand-tracking task using their right hand on a tablet.

20

Yes
 

Tarkeshwar Singh
Tarkeshwar Singh - at tsingh@psu.edu
Kinesiology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00027514
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Inclusion Criteria:
Aged 18–35 years
Right-handed
Normal or corrected-to-normal vision
No history of neurological, psychiatric, or motor disorders
Able to sit comfortably for up to 2 hours

Exclusion Criteria:
History of epilepsy or seizure disorders
Presence of metal implants in the head (excluding dental fillings)
Skin sensitivity or allergies to adhesives or EEG gel
Use of medications that affect the nervous system
Neurology, Sports Medicine, Vision & Eyes
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State College, PA ,

Parent Regulation, Engagement, Stress, and Health

The proposed research is designed to provide a stronger scientific understanding of the etiology of harsh discipline and the role of parent and child individual and dyadic regulatory processes as potentially malleable mechanisms that underlie and maintain harsh discipline use. The study involves observations of parents and children in the lab and parent questionnaires over multiple time points.

Participation includes two office visits and one online survey, spread out over two years. The first visit occurs when children are 2-3 years old and then again at 4 years old. At these office visits, parents and children complete tasks and play games together, and parents fill out surveys. We will ask you and your child to wear electrode stickers that attach to the skin to measure heart rate and breathing. We will also ask to collect a small hair sample and a few saliva samples from both you and your child throughout the visit. The office visits take approximately 3 hours each. Later, when children turn 5 years old, parents receive an emailed link to a set of online surveys that can be completed at home. It typically takes about 60 minutes to complete the surveys.

$430

Yes
 

Erika Lunkenheimer
Elizabeth Merz - at ezm5809@psu.edu or 814-689-9545
Psychology (UNIVERSITY PARK)
 

All
Younger than 18 years old
This study is also accepting healthy volunteers
STUDY00013109
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Inclusion Criteria:
Child between the age of 2.5 years and 3.25 years
Ability to communicate with child in English
Access to Wi-Fi and a laptop at home

Exclusion Criteria:
Child diagnosed with a serious developmental delay or disability
Parent diagnosed with a cognitive, sensory, or motor disability
Child or parent taking medication that gives them an irregular heart rate or irregular breathing
Mental & Behavioral Health
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State College, PA ,

PSCI# 25-079 NRG-CC015: Harnessing E-Mindfulness Approaches For Living-After Breast Cancer---HEAL-ABC

This study is comparing 3 arms, one in which patients will participate in Mindfulness (MAPs) Live Online. One in which patients will participate in Mindfulness (MAPs) digitally and one in which patients will participate in the control group, which is meditation only.

Screening visit will be in person. Patients will complete up to 3 hours per week of the assigned activity over a 6-week period. Participation in this study will last about 9 months.

Yes
 

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

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06748222
STUDY00027407
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Inclusion Criteria:
The participant must provide study-specific informed consent prior to Registration and, for participants treated in the U.S., authorization permitting release of personal health information.
The participant must have been ≥ 18 or <51 years of age at the time of breast cancer diagnosis.
The participant must have a first-time diagnosis of non-metastatic breast cancer which is Stage 0, I, II, or III.
The participant must have a score of ≥ 5 and ≤ 14 on the Patient Health Questionnaire-8 item (PHQ-8).
The participant must be able to understand, speak, read, and write in English or Spanish.

Exclusion Criteria:
Patient Health Questionnaire-8 item (PHQ-8) score of < 5 or > 14.
Any history or current evidence of recurrent or metastatic breast cancer.
Current or past history of another cancer. Participants with a history of only non-melanoma skin cancer or in situ cervical cancer without chemotherapy treatment would be eligible.
Currently pregnant or planning to become pregnant in the near future.
Participants who are enrolled in other cancer control or behavioral intervention trials that require frequent assessments or training activities.
Cancer
Not applicable
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Hershey, PA ,

Moments that matter: Mapping the temporal dynamics within human autonomous agent teams

The purpose of this study is to better understand how human teams with non-human virtual agent team members operate and function.

If you agree to be in this study, you will be fitted to sensors that will measure your neurophysiological (i.e., brain and cardiac) signals while you complete group tasks in person or in virtual reality. This interaction will be recorded and coded. You will also be asked to complete several questionnaires about your demographics, behaviors, and emotions.

$25-$40

Yes
 

Nina Lauharatanahirun
Nina Lauharatanahirun - at nina.lauhara@psu.edu or 814-865-4319
Biomedical Engineering (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT00000000
STUDY00027669
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Inclusion Criteria:
Between the ages of 18 and 65 years
English speaking
Willing/able to travel to Penn State University Park location research site
No cardiovascular, metabolic, or neurological condition
Willing to wear EEG sensors

Exclusion Criteria:
Pregnancy
Report or diagnosis of a neurological injury or disorders related to cardiovascular-respiratory, metabolic or brain function
Cannot speak or read English
Not willing to wear EKG sensors
Not willing to wear EEG sensors
Education
Not applicable
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State College, PA ,

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE SAFETY AND EFFICACY OF EFRUXIFERMIN IN SUBJECTS WITH NON-CIRRHOTIC NONALCOHOLIC STEATOHEPATITIS (NASH)/METABOLIC DYSFUNCTION-ASSOCIATED STEATOHEPATITIS (MASH) AND FIBROSIS

This is Phase III study to test whether efruxifermin (EFX) helps people with a liver disease called NASH/MASH who have moderate or advanced liver fibrosis. The purpose of the study is to find out whether the study drug works and how safe it is in participants diagnosed with MASH and liver fibrosis over a long-term treatment. To answer these questions, the study drug will be compared with a placebo. The overall study duration will be up to 5 years.

Your participation in the study will last about 4 years and 11 months which includes 3 months for screening procedures (to understand if you are eligible to participate in the study), 4 years and 7 months of study drug treatment and a 30-day follow up at the end of the study. This will involve up to 36 visits to your Study Doctor. During the study, you will be asked to inject a short needle into the soft tissue under the skin (subcutaneous) in the stomach or upper thigh once a week.

Up to $3,500 over the study duration (about 4 years 11 months)

Yes
 

Karen Krok
Nataliya Smith - at HepatologyResearch@pennstatehealth.psu.edu
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06215716
STUDY00026367
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Inclusion Criteria:
Age 18-80
Diagnosis of NASH/MASH
Previous history or presence of Type II Diabetes
Body mass index (BMI) Greater than on equal to 25.0 kg/m2

Exclusion Criteria:
Presence of cirrhosis on liver biopsy
Type 1 diabetes
Under the age of 18 or over the age of 80
Digestive Systems & Liver Disease
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Using Art Therapy to Teach Coping Skills to Adults with Autism Spectrum Disorder

This is a study that will examine the effectiveness of using Art Therapy techniques for improvement and maintenance of self-reported coping skills and symptoms co-occurring with Autism.

The study will last approximately 18 weeks. Participants will be randomly assigned to one of three groups. The assessment only group participants will spend approximately 30 minutes completing online assessments weekly. Participants assigned to the psychoeducational group will meet weekly in person for approximately 45 minutes. Participants assigned to the full art therapy intervention group will meet weekly in person for approximately 1.5 hours. Participants will be asked to complete follow-up assessments at 1 and 3-months after the last week of the assigned group.

Yes
 

Andrea Layton
Stacey Hanley - at shanley@pennstatehealth.psu.edu
Psychiatry and Behavioral Health (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00027382
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Inclusion Criteria:
Between the ages of 18 and 25 at the time of consent
English as a primary language spoken.
A primary diagnosis of ASD, as indicated by the SRS-2.
A minimum verbal IQ of 80 (determined by the administration of the K-BIT 2)
Ability to self-report (i.e., understand and answer questions at an appropriate comprehension level; self-report questions to be asked by study coordinator

Exclusion Criteria:
A high school student at the time of consent.
Inability to provide consent.
Safety concerns (i.e. psychiatric higher level of treatment such as inpatient hospitalization, intensive Outpatient Programs, or partial hospitalization) within the past 3 months
Mental & Behavioral Health
Not applicable
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Harrisburg, PA ,
Hershey, PA ,

A Long-term, Open-label Study to Evaluate the Safety and Efficacy of Orally Administered Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults with Hereditary Angioedema

The purpose of this clinical research study is to learn more about the use of the investigational drug, deucrictibant, for the prevention of HAE attacks and safety in patients when used in long-term treatment. Investigational drug means that it has not yet been approved in any country for the treatment of HAE. Deucrictibant tablets are designed to block the effects of bradykinin and thus prevent HAE attacks from starting. You will receive deucrictibant tablets for 130 weeks. All participants in the study will receive one 40mg deucrictibant tablet every day. From now onwards, deucrictibant will be referred to as “study drug”. The study drug is a tablet that you will take by mouth. Every day you will have to take 1 tablet with a glass of water, at approximately the same time each day either without a meal or with a light meal. Your study doctor will provide you with detailed instructions on how and when to take the tablets.

There will be approximately 11 in person visits, and approximately 4 virtual visits. At the in person visits, blood will be drawn, EKGs performed, vital signs collected, and the study doctor will perform exams. You will need to complete a daily electronic diary, and take the study medication, an oral pill, daily.

Yes
 

Timothy Craig
Kristina Richwine - at krichwine@pennstatehealth.psu.edu or 717-531-4506
Medicine: Pulmonary, Allergy and Critical Care (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT06679881
STUDY00026993
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Inclusion Criteria:
Provision of written informed consent.
Documented clinical history consistent with HAE (cutaneous or submucosal, nonpruritic swelling without accompanying urticaria)
C1 esterase inhibitor (C1INH) functional level <50% of the normal level must be shown by chromogenic assay performed by the central laboratory as part of the Screening procedures.
History of at least 1 attack in the last 3 consecutive months prior to Screening
Female participants of childbearing potential (or who become of childbearing potential during the study) must agree to the protocol specified pregnancy testing and to use an acceptable contraception method.

Exclusion Criteria:
Any diagnosis of angioedema other than HAE
Any females who are pregnant, plan to become pregnant, or are currently breast-feeding
History of epilepsy and/or other significant neurological diseases
History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse
Infectious Diseases & Immune System
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Hershey, PA ,

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Orally Administered Deucrictibant Extended-release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults with Hereditary Angioedema

The purpose of this clinical research study is to learn more about the use of the investigational drug, deucrictibant, for the prevention of HAE attacks. You will either receive 40mg deucrictibant or a placebo tablet every day for 24 weeks. The study drug is a tablet that you will take by mouth. Every day you will have to take 1 tablet with a glass of water, at approximately the same time each day either without a meal or with a light meal. The study consists of a Screening Phase which may last up to 10 weeks, a Treatment Phase (24 weeks), and a Follow-up Phase (up to 4 weeks). These are all described below. If you provide your consent to take part in the study and you are declared eligible to participate, your overall study participation will last approximately 10 months (38 weeks).

There will be approximately eight in person visits, blood will be drawn at six of these visits, an EKG will be performed at five of these visits, vital signs will be performed at seven of these visits, and a physical exam will be performed at five of these visits. You will be required to complete questionnaires at each visit, and complete an electronic diary.

Yes
 

Timothy Craig
Kristina Richwine - at krichwine@pennstatehealth.psu.edu or 717-531-4506
Medicine: Pulmonary, Allergy and Critical Care (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT06669754
STUDY00026257
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Inclusion Criteria:
Provide written informed consent
Documented clinical history consistent with HAE
History of 3 HAE attacks within 3 consecutive months prior to the screening visit.
Female participants of childbearing potential must agree to the protocol specified pregnancy testing, and use an acceptable contraception method from enrollment until 30 days after the last study drug administration.

Exclusion Criteria:
Any females who are pregnant, plan to become pregnant, or are currently breast-feeding
History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse.
Any diagnosis of angioedema other than HAE
Prior gene therapy for any indication at any time.
Infectious Diseases & Immune System, Allergies
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Metabolic biomarkers in ALS

Our overall objective is to recruit a case control study of metabolic profiles. We are hoping to learn more about metabolic profiles for people with ALS (Amyotrophic lateral sclerosis - Lou Gehrig’s Disease) and the changes that occur during disease progression. Study participants will be divided into two cohorts: ALS patients and healthy volunteers. The ALS patients will provide blood samples every 6 months, as long as possible. The healthy volunteers will only provide one blood sample upon enrollment in the study.

ALS patients will: - Review and sign informed consent - Attend a study visit lasting 15-30 minutes every 6 months - Provide blood sample every 6 months - Allow study team to access electronic medical record to collect ongoing clinical data at each study visit Healthy volunteers will: - Review and sign informed consent - Attend a single study visit lasting 15-30 minutes - Provide blood sample at enrollment - Provide height &amp; weight - Provide information about Medcial history &amp; medications as they pertain to diabetes and high cholesterol

Yes
 

Zachary Simmons
Heidi Runk - at nervemuscle@pennstatehealth.psu.edu or 717-531-8257
Neurology (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00027566
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Inclusion Criteria:
Age 18 years or older
ALS diagnosis using Gold Coast Criteria or healthy controls
Cognitive ability to consent or legally authorized represenative

Exclusion Criteria:
Diagnosis of any other neurodegenerative condition
Neurology
Not applicable
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Hershey, PA ,

PSCI# 25-059: Consolidative Use of Radiotherapy to Block (CURB2) Oligoprogression in Patients With Metastatic Non-Small-Cell Lung Cancer – A Randomized Phase 3 Trial

The purpose of this study is to compare the usual approach to a new technique in radiotherapy delivery called stereotactic body radiotherapy (SBRT) while continuing the current treatment of immunotherapy with or without chemotherapy.

Participants will meet with the study team to discuss the study. After it has been determined that is save for them to enroll, they will need to attend all appointments. Participants will be coming to the clinic at least monthly for infusion therapy and daily for radiation. It is important that participants let the study team know how they are feeling.

Yes
 

Joseph Miccio
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Radiation Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06686771
STUDY00027267
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Inclusion Criteria:
Metastatic disease detected on imaging and histologically confirmed NSCLC
Oligoprogression on first-line ICI +/- chemotherapy systemic therapy after at least 3 cycles
All sites of oligoprogression can be safely treated with SBRT or ablative radiotherapy
ECOG performance status of 0, 1 or 2.
Participants must be ≥ 18 years of age.

Exclusion Criteria:
Presence of leptomeningeal disease.
Pregnancy
Serious medical conditions in which radiotherapy of target lesions is contraindicated
Participants who are not actively on ICI alone or ICI + chemotherapy.
Concurrent treatment with other anti-cancer therapy, including investigational agents.
Cancer
Approved drug(s)
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Hershey, PA ,

AREN2231: Risk Adapted Treatment of Unilateral Favorable Histology Wilms Tumors (FHWT)

The purpose of this study is to improve the treatment of children and young adults with all stages of FHWT, so that more patients are cured without relapse, and that side effects from treatment are lessened without decreasing cure rates. This study will use information on higher or lower risk features of FHWT to adjust the treatment of each subject based on their risk of relapse.

All patients will receive chemotherapy (regardless of stratum assignment) starting with 1 cycle (3 weeks) of VA (vinCRIStine, DACTINomycin) chemotherapy. Some patients will have changes in treatment based on information learned after enrollment. For all patients, at least one callback is required to be completed prior to randomization and/or prior to any change in treatment or continuation of the same treatment.

Yes
 

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

All
All
This study is NOT accepting healthy volunteers
NCT06401330
STUDY00026986
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Inclusion Criteria:
Patients must be <30 years old at enrollment
Patients must have newly diagnosed Stage I-IV Favorable Histology Wilms Tumor

Exclusion Criteria:
Patient with a diagnosis of Stage V Bilateral Wilms Tumor
Patients who in the opinion of the investigator are not able to comply with the study procedures are not eligible
Patients with any uncontrolled, intercurrent illness including but not limited to symptomatic congestive heart failure
Patients with known Charcot-Marie-Tooth syndrome
Patients receiving concurrent chemotherapy for a different diagnosis.
Children's Health, Cancer
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Hershey, PA ,

BLack families Overcoming Obstacles through Mothers' Strengths (BLOOMS)

The purpose of this pilot study is to test women of color's willingness to participate in web- and laboratory-based assessments of their experiences with adversity, their cognition, indicators of poor mental and physical health, risky behaviors during pregnancy, and how they cope with stressful situations. If participants have a 3-to-5-year-old child, we will also ask if they would like their child to participate in various thinking games and biological data collection. If so, we will also assess their preschool-aged child's willingness to participate in various protocols, comprehension of protocol instructions, and ability to complete various tasks.

There will be one in-person visit to the Biobehavioral Health building to collect: -Questionnaires -Height, weight, and waist circumference -Blood pressure -Complete a challenge task -Cognitive tasks -Heart rate monitoring Participants will be asked to complete 7 days' worth of daily assessments on their phone after their in-person study visit. After completing the daily assessments, participants may be selected to participate in a follow-up interview about their experiences throughout the study. Participants will be compensated for their participation in all three portions of the study (in-person visit, daily assessments, and follow-up interview).

$88

Yes
 

Gabriela Revi
Gabriela Revi - at BLOOM@psu.edu or 814-343-1549
Biobehavioral Health (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00027101
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Inclusion Criteria:
Identify as Black
Fluent in English
Ages 18-64
Lives in Centre County
Identifies as a woman

Exclusion Criteria:
Does not identify as Black
Does not identify as a woman
Discomfort with having a heart monitor on their chest
Does not have a smartphone
Food & Nutrition, Mental & Behavioral Health, Women's Health
Not applicable
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State College, PA ,

Transdiagnostic Sleep and Circadian Treatment for Autistic Adolescents

The overarching goal of this research is to adapt, optimize, and pilot a transdiagnostic sleep and circadian intervention so that its contents and delivery are effective and sustainable for autistic adolescents

Participants will complete assessments at two time points and engage in a 6 week behavioral sleep intervention with a trained clinician.

$75.00

Yes
 

Kristina Lenker
KRISTINA LENKER - at klenker2@pennstatehealth.psu.edu or 717-531-0003, ext=280299
Psychiatry and Behavioral Health (HERSHEY)
 

All
Younger than 18 years old
This study is also accepting healthy volunteers
STUDY00027612
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Inclusion Criteria:
Diagnosed with Autism
Sleep problems
Ages 13-17 yrs
English speaking

Exclusion Criteria:
A history of IQ < 70
A history of psychotic, bipolar or seizure disorders
Untreated sleep apnea, a history of narcolepsy, or restless legs syndrome
Children's Health, Sleep Management, Mental & Behavioral Health
Not applicable
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Hershey, PA ,

PSCI 23-146 A Phase 3 Randomized Open-Label Study of Adjuvant Pembrolizumab With or Without MK-2870 in Participants With Resectable Stage II to IIIB (N2) NSCLC not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy Followed by Surgery

this trial will compare Pembrolizumab with and without MK-2870 in participants with lung cancer for disease free survival.

Participants will be required to com to all study visits, report all medications they are taking, including over the counter medications and tell the study team how they are feeling.

$50 for each completed visit

Yes
 

Takefumi Komiya
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
NCT06312137
STUDY00026209
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Inclusion Criteria:
Has histological or cytological confirmation of squamous or nonsquamous NSCLC,
Able to undergo surgery based on opinion of investigator after consultation with surgeon.
Able to receive pembrolizumab and platinum-based chemotherapy
Has not achieved pathologic Complete Response at surgery
18 years of age

Exclusion Criteria:
Has Grade ≥2 peripheral neuropathy.
Has history of documented severe dry eye syndrome,
Has active inflammatory bowel disease
Has active inflammatory bowel disease
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

A Phase III Trial of One vs. Two Years of Maintenance Olaparib, with or without Bevacizumab, in Patients with BRCA1/2 Mutated or Homologous Recombination Deficient (HRD+) Ovarian Cancer Following Response to First Line Platinum-Based Chemotherapy

This study is being done to answer the following question: Does the use of Olaparib for one year keep your ovarian cancer from growing or returning as well as the usual approach of two years? If you decide to take part in this study, you will either get the study drug Olaparib for one or two years, with or without bevacizumab for one year, until your disease gets worse or the side effects become too severe. After you finish your treatment, your doctor and study team will watch you for side effects. They will check you every 3 months for 2 years after treatment. After that, they will check you every 6 months for 3 years. This means you will keep seeing your doctor for 5 years after treatment.

The patient will either get the study drug Olaparib for one or two years, with or without bevacizumab for one year, until their disease gets worse or the side effects become too severe. The doctor and study team will watch for side effects. They will check every 3 months for 2 years after treatment. After that, they will check every 6 months for 3 years. This means checking with the doctor for 5 years after treatment.

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
NCT06580314
STUDY00027597
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Inclusion Criteria:
Patients with newly diagnosed, pathologically confirmed, FIGO Stage III or IV ovarian cancer of the following types:
high grade serous, high grade endometrioid, and/or other epithelial ovarian cancer with BRCA1/2 deleterious alteration (germline or somatic).
Patients must have: 1) Documented variant (tumor or germline) in BRCA1 or BRCA2 that is predicted to be pathogenic or suspected pathogenic (deleterious alteration).
OR 2) BRCA 1/2 wildtype AND known HRD deficient tumor determined by any commercial or academic, CLIA-certified laboratory (e.g., Myriad MyChoice©)
Patient must have undergone cytoreductive surgery (primary or interval).

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

Characterizing the effect of an electrolyte and carbohydrate-based hydration beverage on hydration status in young adults.

This study will determine how well water, an electrolyte and carbohydrate based drink, and an electrolyte only drink hydrate the body. This study will measure how long the water from these drinks stay in your body. We will look at different hormones and electrolytes in the blood and urine to determine which drink keeps fluid in your body the longest.

There will be 4 in person visits. The first is a screening visit which will take about an hour. During the next three visits we will have you drink 1 L of a beverage and we will measure your blood and urine for a few hours after you drink it to determine how well it hydrates you. There will be a blood draw at each of the 4 visits.

150

Yes
 

William Kenney, Jr.
Kat Fisher - at kgf5118@psu.edu or 307-203-7657
Kinesiology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT00000000
STUDY00027463
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Inclusion Criteria:
Healthy
Regularly Active
18-40 yrs old
Men and women

Exclusion Criteria:
cardiovascular, kidney or digestive disease
Pregnancy and breastfeeding
smoking
diuretics
prostate issues interfering with urination
Food & Nutrition
Not applicable
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State College, PA ,

PSCI 24-076 A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY OF IFINATAMAB DERUXTECAN (I-DXD) IN SUBJECTS WITH PRETREATED ADVANCED OR METASTATIC ESOPHAGEAL SQUAMOUS CELL CARCINOMA (ESCC) (IDeate-Esophageal01) (A PHASE 3 STUDY OF I-DXD IN SUBJECTS WITH PRETREATED ESCC)

This trial will be examining the use of a drug, ifinatamab in the treatment of patients with advanced or metastatic esophageal squamous cell cancer.

After signing consent, participants will have blood tests and scans to see if they are well enough to participate. If the participate, they will need to come to the clinic to see the study team then get the experimental treatment. Participants will continue treatment until the medication no longer works, they no longer want to participate, or the study doctor feels it is not safe for them to continue.

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
NCT06644781
STUDY00026270
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Inclusion Criteria:
Subjects aged ≥18 years
Has histologically or cytologically documented unresectable locally advanced (Stage II to IVA if T2-T4 or N1-3 M0), or metastatic (Stage IVB) ESCC
Has disease progression post platinum-based and ICI treatment

Exclusion Criteria:
Has received prior treatment with orlotamab, enoblituzumab, or other B7-H3 targeted agents, including I-DXd.
Has received any topoisomerase inhibitor.
Has histologically or cytologically confirmed adenosquamous carcinoma subtype.
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

PSCI # 25-038 A Phase 3 Randomized, Open-Label, Multicenter Study of Sonrotoclax Plus Anti-CD20 Antibody Therapies Versus Venetoclax Plus Rituximab in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

This trial will examine which combination is better in treating Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Sorotoclax or Venatoclax.

There are three parts to this study. Screening, when you will meet the study team, sign the consent for and have tests performed to make sure that it is safe for you to participate in the study. If you join the study you will be chosen to participate in one of four arms, each with different medication to treat you disease. During the first cycle of treatment you will need to be seen by the study team between 4 and 7 times, depending upon the treatment. You will continue on the study medication until it no longer works, you have finished the trial or the doctor feels that it is no safe for your to continue ( among other reasons). The third part of the study is follow up. you will have a study visit in the clinic 30 after the last day of taking the study drug. That will be followed by after treatment follow up visits every three months until your cancer returns, if it returns. Then you will be followed every three months to see how you are doing.

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
NCT06943872
STUDY00027116
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Inclusion Criteria:
Must be ≥ 18 years of age
Must have confirmed diagnosis of CLL/SLL
Must have received ≥ 1 prior therapy for CLL/SLL
Must not have received any maintenance therapy.

Exclusion Criteria:
Patients who have active symptomatic COVID-19 infection
Patients with a history of confirmed progressive multifocal leukoencephalopathy
Prior allogeneic stem cell transplant with active GVHD
Received a live, attenuated vaccine within 4 weeks
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

A Phase 3, External and Synthetic Placebo-Controlled Randomized Study with Dose-Up for Non-Responders to Investigate Safety and Efficacy of Ritlecitinib 50 mg and 100 mg Once Daily in Adult and Adolescent Participants 12 Years of Age and Older with Alopecia Areata

Alopecia areata (AA) is an autoimmune disease that causes non-scarring hair loss that can be relapsing and chronic. It affects patients of all ages, races, and genders. Symptoms can range from patchy hair loss usually affecting the scalp, to complete scalp hair loss (alopecia universalis) or complete loss of hair on the scalp, face, and body (alopecia totalis). AA has a detrimental impact on patients' emotional wellbeing, self-esteem, social interactions, and quality of life, and psychiatric conditions such as anxiety and depression are more common in patients with AA compared to healthy controls. The purpose of this study is to find out if the study medicine, Ritlecitinib, can help with the treatment of AA.

Study participation will last approximately 57weeks. During the study, participants will attend 9 in person visits in the research office. At different timepoints the participant will have their hair examined, blood drawn, have an ECG and chest x-ray done, have photos taken of their scalp and face, answer questionnaires, and take study medication as directed by the study team.

Yes
 

Jeffrey Miller
DermatologyClinicalTrials@pennstatehealth.psu.edu 717-531-5136
Dermatology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT06873945
STUDY00026810
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Inclusion Criteria:
Be at least 12 years of age
At least 50% hair loss on the scalp with no regrowth for at least 6 months
Current episode of hair loss no longer than 10 years

Exclusion Criteria:
Other types of hair loss such as androgenetic alopecia, traction and scarring alopecia, or telogen effluvium
Other scalp conditions that could interfere with alopecia assessment
Certain medications are not allowed; study coordinator will discuss
Skin Conditions
Experimental drug compared to an approved drug
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Hershey, PA ,

A Community-Based Pickleball Program for Adults with Autism Spectrum Disorder

This study will test whether playing pickleball, a fun and easy-to-learn paddle sport, can improve physical coordination and reduce core autism symptoms in adults with autism spectrum disorder (ASD). Participants will be placed in either an early start group or a delayed start group using a delayed control trial design. The early start group will attend two 90-minute pickleball classes per week for the first 8 weeks and then resume regular activities for the next 8 weeks. The delayed start group will continue regular activities for the first 8 weeks and then transition into the pickleball classes for 8 weeks. All participants will complete pickleball skill assessments at their first and last class to measure improvement, and three testing sessions during the study will assess sensory-motor processing, autism symptoms, mental health, and quality of life. By comparing the two groups, this study aims to determine whether pickleball supports better physical and emotional health for autistic adults and whether it can help participants feel more confident, connected, and engaged in social settings.

Participants will attend three in-person testing sessions (baseline, mid-study, and post-study) where they will complete surveys and a videogame-based sensory-motor assessment. They will also participate in two 90-minute coach-led pickleball classes per week for 8 weeks. Pickleball skill assessments will be completed during their first and last pickleball class.

$100

Yes
 

Christopher Sciamanna
Daniel Lidstone - at dbl5689@psu.edu
Medicine: General Internal Medicine (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00027574
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Inclusion Criteria:
Adults aged 18–45 years
Clinical diagnosis of autism spectrum disorder (ASD)
Able to participate in group activities without caregiver support
Able to understand and communicate in English
Available and able to attend at least two pickleball sessions per week during the 8-week program

Exclusion Criteria:
Currently playing a ball or racquet sport at least once per week
Use of mobility aids that limit court-based movement
Moderate-to-severe joint pain
Neurological conditions (e.g., cerebral palsy, epilepsy, severe head injury)
Clinical diagnosis of intellectual and developmental disability
Neurology, Sleep Management, Mental & Behavioral Health
Not applicable
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Harrisburg, PA ,
Hershey, PA ,

Effects of catheter ablation on cardiopulmonary afferents in patients with atrial fibrillation

Catheter ablation for patients with atrial fibrillation (AF ablation) is an effective treatment to improve abnormal heart rhythm (i.e., atrial fibrillation, AF). Autonomic nervous system controls things your body does automatically without thinking, such as regulate heart rate, blood pressure, and respiratory control.It has been reported that AF ablation might improve abnormal autonomic nervous system in patients with AF in addition to improve abnormal heart rhythm. However, the detail is still unclear. In the proposed study, we aim to verify the effect of AF ablation on autonomic nervous system in patients with AF. We will evaluate autonomic nervous system using various approaches in AF patients before and after AF ablation, as well as healthy subjects. The results obtained from this study will provide important insights into the research area of AF treatments.

Patients with atrial fibrillation will have three visits to the research lab with each visit lasting 3-3.5 hours. • Visit 1 (pre-AFib ablation): will occur about 1-2 weeks prior to your procedure • Visit 2: approximately 1 month after your ablation procedure • Visit 3: approximately 3 months after your ablation procedure Patients who are healthy volunteers will ONLY have one visit to the research lab that lasts 3-3.5 hours. Various physiological measurements will be recorded during this time including microneurography, blood pressure, heart rate and blood flow.

You will receive $25 per hour for your participation in this research study

Yes
 

Takuto Hamaoka
Cheryl Blaha - at cblaha@pennstatehealth.psu.edu or 717-531-1605
Heart and Vascular Institute (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT00000000
STUDY00026734
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Inclusion Criteria:
Males and females (including females taking oral contraceptives)
50-85 years of age
Are of any race or ethnicity
Capable of speaking English
Capable of giving informed consent

Exclusion Criteria:
Pregnant or nursing woman
Incapable of speaking English
Decisional impairment
Age < 50 or > 85 years old
Have any history of chronic diseases including heart failure, severe lung diseases, renal failure, peripheral neuropathy, epilepsy or seizure disorders and other chronic diseases
Heart & Vascular
Not applicable
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Hershey, PA ,

Platform Wars: Evaluating postural and strength adaptations with Wii Fit Balance vs. Whole-body vibration in college students.

This study will aim to see if there is a difference in strength and balance changes among college students when comparing the Wii Fit Balance and whole-body vibration training.

The study duration will be six-weeks, in which study participants will be involved in either a gaming training group or a vibration platform training group. Participants will complete a baseline session and post-training assessment, each lasting two hours. During both of these visits measures of balance, strength, and walking ability will be acquired. In the six weeks of the study,18 individual vibration or gaming training sessions will be completed. The respective training sessions will take place three times a week for 6 weeks and will last 10-minutes each.

$20.00

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
STUDY00027085
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Inclusion Criteria:
Able to stand and walk independently with or without the aid of an assistive device.
Male and female between the ages of 18 and 25.

Exclusion Criteria:
Involved in whole-body exercise (organized dance, Pilates, yoga, tai-chi, calisthenics), balance training, Wii training, or resistive exercise (free weightS, powerlifting, Olympic or strongman lifting, circuit training) in the previous 6 months.
Known history of musculoskeletal, neurological, cardiovascular, or pulmonary impairment that may affect ability to perform the testing procedures.
Use of a pacemaker.
Major general medical disorders, such as recent surgeries, implants in trained body parts (i.e., artificial joints), acute hernias, discopathies (i.e., slipped disks), rheumatoid arthritis, epilepsy, and/or acute thrombosis.
Using sedatives of any type upon enrollment to the study.
Men's Health, Sports Medicine, Women's Health
Not applicable
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Altoona, PA ,
State College, PA ,

Glycemic Effects of a Mediterranean-Style Dietary Pattern Containing Potatoes in Adults with Prediabetes

The purpose of this research study is to determine if a healthy Mediterranean diet containing one medium potato/day has equivalent or non-different effects on risk factors for type 2 diabetes and heart disease as a healthy Mediterranean diet without potatoes. Participants will be randomly assigned to one of the test diets and be asked to consume this diet for 12 weeks (84 days). Testing will be conducted at the beginning and end of the study.

This study runs for about 3 months. During this time, you will be randomly assigned to one of the test diets and be asked to consume this diet for 12 weeks (84 days). We will provide you with all of the food you need to follow this diet. This will include 3 meals, snacks and some beverages prepared in the Penn State Research Kitchen, which will meet your energy and nutrient needs. During the study, we will ask you not to eat any foods outside of those provided by the study. You may have up to 5 days off the diet during the 12 week period. Testing will take place on two separate days at the beginning and end of the study (4 testing days total). For these visits, you will need to fast for 12 hours prior and avoid alcohol for 48 hours. At these visits, we will collect a blood sample, measure your weight, and perform non-invasive tests to assess your vascular 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 visit to have the CGM fitted (2 visits total). Additionally, we will ask you to collect a stool sample twice during the study.

500

Yes
 

Kristina Petersen
DCHLab@psu.edu
Nutritional Sciences (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00027785
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Inclusion Criteria:
Age 25-65 years
BMI 25-40 kg/m2

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 ,

Mechanisms of Action: The Impact of Emotional Well-Being Intervention in Increasing Optimism and Biological Markers

This study aims to support midlife adults by enhancing their emotional well-being and reducing psychological stress, which may affect cardiometabolic health. We are evaluating a novel 4-week program that integrates three components—emotional well-being–enhancing writing, chair-assisted squats, and slow-paced breathing—using a factorial design. Eighty adults aged 40–65 with a sedentary lifestyle will be randomly assigned to one of eight groups that include different combinations of these activities. Participants will engage in their assigned activities via Zoom five times per week over four weeks. Emotional well-being and stress will be assessed through self-report at multiple time points, and physiological health (e.g., blood pressure, heart rate, heart rate variability, inflammation) will be measured during in-person visits before and after the program. The study will also evaluate the feasibility, acceptability, and preliminary effects of each intervention component and their combinations.

Participants will engage in a four-week program involving three components: EWB-enhancing writing exercises, chair assisted squat, and slow-paced breathing. They will complete these activities five times per week, with each session lasting 30 minutes.Participants will undergo cardiovascular assessments at Penn State University’s Biobehavioral Health (BBH) Building at baseline and post-intervention. These assessments will include heart rate variability measured via a standard three-lead electrocardiogram (ECG) and continuous blood pressure measured non-invasively using a finger cuff device that captures beat-to-beat waveforms.

$300

Yes
 

Harold Lee
Rui Wang - at rmw6108@psu.edu
Biobehavioral Health (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00026780
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Inclusion Criteria:
Age 40-65 years
Sedentary lifestyle
Able to engage in chair assisted squat
Willingness to participate in all study components
Ability to provide informed consent

Exclusion Criteria:
Age outside 40–65 years – individuals younger than 40 or older than 65 will be excluded
Physical limitations preventing chair assisted squat
Lack of technology or access – no computer/laptop and stable internet for Zoom and Qualtrics participation.
Inability to provide informed consent
Significant medical conditions that could be exacerbated by the intervention (e.g., severe cardiovascular disease)
Heart & Vascular, Prevention, Mental & Behavioral Health
Survey(s)
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State College, PA ,

PSCI# 25-001 TITLE PAGE A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination with Platinum-based Chemotherapy for the First-line Treatment of Patients with Metastatic Squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung02)

This study is comparing using rilvegostomig or pembrolizumab with a platinum based chemotherapy. The doctor, subject and study team will not know if the subject is receiving rilvegostomig or pembrolizumab.

After signing consent to agree to join the study, the subject will have lab work and scans of their body to see if they are wll enough to participate. If they begin study treatment, they must come to all study visits. It is important that the subject tell the study team if there has been a change in their medications and how they are feeling. Subjects will continue treatment until the treatment no longer is working, they no longer want to participate of the study doctor feels it is not safe for them to participate any further. Once study treatment is finished, subjects will be followed to see how they are feeling and what new treatments for their cancer they are getting.

$75.00 for each visit completed for a minimum of $300. Compensation may be more if additional visits are completed.

Yes
 

Takefumi Komiya
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
NCT06692738
STUDY00027369
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Inclusion Criteria:
Participant must be ≥ 18
Histologically or cytologically documented squamous NSCLC
Minimum life expectancy of 12 weeks
Minimum body weight of 30 kg.

Exclusion Criteria:
Severe or uncontrolled systemic diseases
History of organ transplant
Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

Activate: A Study of Engaged Teaching Methods across college courses

The IRB proposal is to conduct research to enhance effectiveness of teaching and learning in college.

Consent for Exempt Research The Pennsylvania State University Title of Project: A Study of Effective Teaching Methods across College Courses Principal Investigator: Yi-An Burleson, Ph.D. Email: ylb5007@psu.edu You are invited to volunteer to participate in a research study. This summary explains information about this research. The study is to collect data to know ways to improve college teaching and learning. Participants will fill out online surveys in teaching and learning in addition to demographic information (e.g. gender, ethnicity, year of study, etc.). It may take 40-50 minutes to complete all of the questions in the surveys. You are strongly encouraged to take the surveys at the beginning of a semester/quarter/term and then at the end of a semester/quarter/term. You are welcome to take the surveys in more than one semester/quarter/term but no more than twice per semester/quarter/term. There may be mild discomfort in feelings, but no risk beyond mild discomfort is involved in the study. If you feel distressed after taking the surveys, you are encouraged to seek counseling resources at college counseling centers. A list of counseling resources is available on request. Other than your email, no other identifying information will be collected. All of the information you provided will be kept confidential by storing it on password protected devices and two-factor authenticated (2FA) online Drive. You can get access through the Sona system/Study Finder of Penn State University. If you are a student at Pennsylvania State University, you can earn 3 points per course by sending an email to indicate that you in the study (with the name of the study), signing up on the Sona system, and indicate that you consent to participate by, clicking “Yes, I consent to participate. My responses to the following questions indicate that I agree to participate” on top of the Google Form at https://forms.gle/H3p2SnErkhpWmYYm7 and then fill out the online surveys at the end of the consent form. You can fill out the survey in the beginning and end of the semester for multiple semesters. If you have questions, complaints, or concerns about the research, you should contact Yi-An Burleson, Ph.D. at ylb5007@psu.edu. If you have questions regarding your rights as a research subject or concerns regarding your privacy, you may contact the Human Research Protection Program at 814-865-1775. Your participation is voluntary and you may decide to stop at any time. You do not have to answer any questions that you do not want to answer.

No
 

Yi-An Burleson
Yi-An Burleson - at ylb5007@psu.edu
Social Sciences and Education (BEAVER)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00021216
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Inclusion Criteria:
Adults (age 18 and above)
Students enrolled in a 4-year university
can read and understand English

Exclusion Criteria:
Participants who are not enrolled in any 4-year university
Participants who are under age 18
Participants who cannot read English
Prevention, Education
Survey(s)
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A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE SAFETY AND EFFICACY OF EFRUXIFERMIN IN SUBJECTS WITH COMPENSATED CIRRHOSIS DUE TO NONALCOHOLIC STEATOHEPATITIS (NASH)/METABOLIC DYSFUNCTION-ASSOCIATED STEATOHEPATITIS (MASH)

This is a Phase 3, randomized, double-blind, placebo-controlled study evaluating the clinical benefit and safety of EFX in subjects with compensated cirrhosis due to NASH/MASH. The study will enroll in 2 cohorts. Cohort 1 will enroll approximately 750 subjects with biopsy-proven compensated cirrhosis due to NASH/MASH. Cohort 2 will enroll approximately 400 subjects with a clinical diagnosis of compensated cirrhosis due to NASH/MASH.

You will be required to visit the study clinic at specific times points. Laboratory and safety assessments will be completed at each visit. You will need to take the study drug as directed. Study procedures that will be performed include Liver Imaging scans, Liver Stiffness Exams, Electrocardiogram, Bloodwork, Liver Biopsy and an Endoscopy.

Yes
 

Karen Krok
Wes Heinle - at jheinle@pennstatehealth.psu.edu
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05039450
STUDY00026213
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Inclusion Criteria:
Age 18-80
Previous history or presence of type 2 diabetes
Body mass index (BMI) ≥ 25.0 kg/m2

Exclusion Criteria:
Type 1 diabetes
Poorly controlled high blood pressure
Any current or prior history of decompensated liver disease
Digestive Systems & Liver Disease
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,