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403 Study Matches

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 ,

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 450 subjects with biopsy-proven compensated cirrhosis due to NASH/MASH. Cohort 2 will enroll approximately 1700 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
NCT06528314
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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A Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate The Safety a Efficacy of Cretostimogene Grenadenorepvec In Participants With High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

The purpose of this Phase 2 clinical trial is to study treating patients with non-muscle invasive bladder cancer (NMIBC) with an investigational drug, Cretostimogene and DDM. Participants will be assigned to either Cohort A or Cohort B depending on whether they have previously been treated with BCG (Bacillus Calmette-Guerin) for NMIBC.

Eligible participants will receive the study drug, Cretostimogene every week for 6 treatments, followed by a maintenance period as directed by the Investigator. For the first 2 years after treatment initiation, participants will be assessed for disease status every 3 months by urine cytology and cystoscopy, with directed TURBT/biopsy (if indicated). CT urogram or MRU will be performed every 6 months. Thereafter, efficacy assessments will be performed at 6-month intervals for up to an additional 2 years

Yes
 

Jay Raman
urologyresearch@pennstatehealth.psu.edu
Urology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06567743
STUDY00027108
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Inclusion Criteria:
Bladder Cancer

Exclusion Criteria:
<18 years old
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

Validation of Biomechanics Technology in Golf

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

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

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

Yes
 

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

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

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

Driver Situation Awareness in Automated Driving Systems

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

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

$10/hour

Yes
 

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

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

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

PSCI 23-130 RASolve 301: Phase 3 Multicenter, Open Label, Randomized Study of RMC-6236 versus Docetaxel in Patients with Previously Treated Locally Advanced or Metastatic RAS[MUT] NSCLC

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

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

Yes
 

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

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

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

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

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

18 / hour

Yes
 

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

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

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

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

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

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

75.00 per visit travel reimbursement

Yes
 

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

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

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

Producing code-switched speech

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

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

$15

Yes
 

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

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

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

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

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

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

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06926595
STUDY00026938
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Inclusion Criteria:
Age 18 or older at the time of study enrollment.
Patients with acute leukemia (acute myeloid leukemia, acute lymphoblastic leukemia, mixed phenotype acute leukemia) or chronic myeloid leukemia with no circulating blasts and less than 5% blasts in the bone marrow.
Patients with myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia with no circulating blasts and less than 10% blasts in the bone marrow (exception allowed due to lack of difference in outcomes with <5% vs 5-10% blasts in this disease).
Patients with secondary acute myeloid leukemia progressing from pre-existing myelodysplastic syndrome, myeloproliferative disease (MPN), or MDS/MPN overlap syndrome.
Patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma who are indicated for allogeneic stem cell transplantation.

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

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

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

In this study, you and your child will attend some virtual and in-person study visits over 8 months. You will complete some interviews and questionnaires virtually. You will be randomly assigned to either an 8-session prevention program or to receive weekly educational materials to read. You and your child will come to the lab for in-person visits both pre and post program. During these visits, your child will complete some EEG tasks, and you and your child will complete some interaction tasks where your respiratory and heart rate data will be collected. You and your child will also be asked to complete some short daily phone surveys at home.

480 dollars

Yes
 

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

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

Exclusion Criteria:
Children with diagnoses of autism spectrum disorders, developmental disorders, or conduct disorders..
Children or mothers with intellectual disabilities.
Children or mothers with a diagnosis of mania or bipolar disorder
Children or mothers with a diagnosis of a psychotic disorder (e.g., schizophrenia); or with visual or hearing impairments that interfere with completing study measures and sessions.
Children currently taking psychotropic medications for at least two weeks prior to study participation (except use of stimulant medication which has to be discontinued for 36-hours prior to the EEG visit).
Children's Health
Survey(s)
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State College, PA ,

PSCI# 24-172 TITLE PAGE A Randomised, Double-blind, Placebo-controlled, Phase III Study of Adjuvant Saruparib (AZD5305) in Patients with BRCAm Localised High-Risk Prostate Cancer Receiving Radiotherapy with Androgen Deprivation Therapy (EvoPAR-Prostate02)

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

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

Yes
 

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

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

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

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

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

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

Yes
 

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

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

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

Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial Comparing Standard of Care Adjuvant Temozolomide With or Without 5-Aminolevulinic Acid (5-ALA) With Concomitant Low Intensity Diffuse Ultrasound (LIDU) Sonodynamic Therapy (SDT) System In Patients With Newly Diagnosed Glioblastoma After Completion of Chemoradiotherapy

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

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

Yes
 

Brad Zacharia
Sara Craig - at scraig2@pennstatehealth.psu.edu or 717-531-0003, ext=285799
Neurosurgery (HERSHEY)
 

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

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

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

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

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

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

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05552222
STUDY00027269
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Inclusion Criteria:
Be ≥18 years of age
Have a diagnosis of multiple myeloma
Be newly diagnosed and not considered a candidate for high-dose chemotherapy with ASCT

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

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

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

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

150

Yes
 

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

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

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

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

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

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

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06731478
STUDY00027186
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Inclusion Criteria:
Previously untreated, unresectable, locally advanced or metastatic gastric or GEJ adenocarcinoma
Is willing and able to comply with scheduled visits, trial intervention plan, laboratory tests, other trial procedures, and trial restrictions.

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

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

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

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

$60 per visit

Yes
 

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

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

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

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

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

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

Yes
 

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

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

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

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

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

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

Up to $1,500

Yes
 

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

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

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

The Impact of Short-term and Long-term Robot Adaptation on User Feedback

This is a human–robot interaction study that will examine how well a robot can learn to perform a coffee-brewing task with help from a human user. Participants will physically correct the robot’s movements when the robot is moving in the wrong way, and will complete a short survey about their experience.

Participants will complete one in-person session. They will stand next to a robotic arm, guide the robot through a coffee-brewing task under different conditions, give physical interactions, and complete a short survey about their experience.

20

Yes
 

Katie Fitzsimons
Junru Pang - at jvp6149@psu.edu or 585-748-2687
Mechanical and Nuclear Engineering (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00028336
Show full eligibility criteria
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Inclusion Criteria:
Adults over 18 years old
Right-handed
English speaker
Health individuals

Exclusion Criteria:
Children or teenager under 18
left-handed
Can not speak English
Not applicable
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State College, PA ,

Emotions and Decision Making in a Repeated Prisoner's Dilemma: A Multimethod Assessment Using Self-Report and Electrodermal Activity

This study explores how human emotions influence the choices they make in an interactive game involving monetary prizes. Participants will play 5 repeated rounds of a two-player decision-making game where, in each round, they choose either to cooperate with the other player or act in their own self-interest. The amount of money they earn depends on both their own choice and the choice of the other player in each round. Participants will not be able to see the person that they are playing with because a divider will separate the two. They will also not be told that the other “player” is actually a member of the research team who follows a predetermined pattern of choices in the repeated game. Throughout the study, participants will answer brief questions on their phone about how they are feeling,and they will wear a wrist worn device that measures natural changes in skin conductance, which reflects emotional arousal. By combining these self-reported feelings with physiological signals, the study aims to understand how emotions related to repeated decisions involving cooperation, self interest and monetary incentives.

Participants will attend one in-person session (20-30 minutes). They will wear a wrist device that records skin conductance (EDA) and complete brief online surveys about their mood. They will play a multi-round decision-making game involving monetary earnings with another player. Earnings will depend on both players choices summed over the rounds.

$4-$28

Yes
 

Emily Hidalgo
Emily Hidalgo - at ebh5466@psu.edu or 267-981-7708
Division of Undergraduate Studies (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00028379
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Inclusion Criteria:
Age 18 years or older
Penn State Undergraduate or Graduate student
Able to read and understand English
Able and willing to wear a wrist-worn device
Able to complete an in-person 20-30 minute study session

Exclusion Criteria:
Unable to provide informed consent.
Skin condition, allergy, or sensitivity at the wrist
Previous participation
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State College, PA ,

PSCI 25-034 TITLE PAGE A Phase III, Randomised, Open-Label, Multicentre Study of Datopotamab Deruxtecan or Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung17)

This will compare Dato-Dxd against docetaxel in previously treated advanced or metastatic non squamous NSCLC.

the first visit will be to sign a consent form to test for a specific biomarker in your archived tumor. If you have that biomarker you will then sign a consent form to participate in the study, if you wish. You will need to come to the clinic for bloodwork and scans to make sure it is safe for you to participate. If it is determined that it is safe for you to continue, you will come to the clinic every month for treatment of your cancer. These visit may also include seeing the doctor, having blood work and completing questionnaires.

$1200.00 You will only be compensated for completed visits.

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
NCT07291037
STUDY00027769
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Inclusion Criteria:
Participant must be ≥ 18 years old
Has pathologically documented Stage IIIB, IIIC, or Stage IV non-squamous NSCLC
Participants must have documentation of radiographic disease progression

Exclusion Criteria:
Squamous, mixed NSCLC, or SCLC histology
NSCLC disease that is eligible for definitive local therapy alone
History of another primary malignancy
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

EVENT-ALS: A Pilot Randomized Clinical Trial of Early Ventilation in ALS

The main purpose of this clinical trial is to determine whether early non-invasive ventilation (NIV) in individuals diagnosed with amyotrophic lateral sclerosis (ALS) is feasible and is associated with improved quality of life, symptoms, and carbon dioxide levels compared to usual care. Study subjects assigned to the “early NIV” group will start NIV earlier than subjects in the usual care group. The study population will included a total of 48 adults diagnosed with ALS at three Neurology ALS clinics in the United States. Subjects will participate in a total of 5 study visits over a 12-month period.

Once eligible, enrolled subjects are assigned to a group (early NIV or usual care), they will attend a total of 5 in person study visits at the ALS clinic over a 12-month period. At Visit 1, subjects will complete questionnaires and assessments and receive the initial study intervention. Follow-up visits at the ALS clinic will take place every 3 months (Visit 2/Month 3; Visit 3/Month 6; Visit 4/Month 9; Visit 5/Month 12) with the completion of questionnaires and assessments plus review of NIV data as applicable.

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 NOT accepting healthy volunteers
NCT07071935
STUDY00027686
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Inclusion Criteria:
Diagnosed with ALS using the Gold Coast Criteria within the last 6 months
Age ≥18 years
Willingness and ability to participate in study procedures
Provision of signed and dated informed consent form

Exclusion Criteria:
Current or prior use of NIV or CPAP therapy
Forced vital capacity <50% of predicted normal
Maximal inspiratory pressure > -60 cmH2O (eg, -50 or -40 cmH2O would be excluded)
Chronic use of supplemental oxygen at any part of the day
Current tracheostomy
Neurology
Approved device(s)
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Hershey, PA ,

A Phase 3, Randomized, Double-blind, Placebo-controlled, 3-Part Study to Evaluate the Efficacy and Safety of Orally Administered Deucrictibant XR Tablet for Prophylaxis and Deucrictibant Soft Capsule for On-demand Treatment of Angioedema Attacks in Adults with Acquired Angioedema due to C1 Inhibitor Deficiency

The purpose of this clinical research study is to learn more about the use of the investigational drug, deucrictibant, for the prevention and treatment of Acquired Angioedema due to C1 Inhibitor Deficiency (AAE-C1INH) attacks. The study consists of a Screening Phase (up to 10 weeks), followed by a 12-weeks Prophylaxis Treatment Phase (Part 1), an On-demand Treatment Phase (Part 2) and an Open-Label On-demand Treatment Phase (Part 3). 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 15 months (60 weeks). During this study you will be asked to complete an electronic diary daily. At the study visits you will have blood samples collected. Vital signs, EKGs, and physical exams will be performed.

If you decide to take part in this research study, you will have a screening phase (up to 10 weeks), followed by a 12-week Prophylaxis Treatment Phase (Part 1), an On-demand Treatment Phase (Part 2) and an Open-Label On-demand Treatment Phase (Part 3). 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 15 months (60 weeks). where you will have procedures to determine if you meet the requirements to be in the study. These include a physical exam and an electrocardiogram (ECG) which will measure the electrical activity of your heart. You will also be required to give blood and urine samples. You will also need to complete a daily electronic diary. If you are a woman who can have children, you will also need to take pregnancy tests.

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT07266805
STUDY00027989
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Inclusion Criteria:
Diagnosis of AAE-C1INH
Participant is assessed by the Investigator to have reliable access and ability to use available therapy to effectively manage AAE-C1INH attacks.
Female participants of childbearing potential must agree to the protocol-specified pregnancy testing and to be abstinent from heterosexual intercourse or to use an acceptable contraception method.
Capable of recording, without assistance, eDiary and ePRO data using an electronic device, as evidenced by the eDiary and ePRO training conducted during the Screening Period and upon entry/rollover to Part 2 and Part 3, as applicable

Exclusion Criteria:
Any concomitant diagnosis of recurrent angioedema other than AAE-C1INH
Any females who are pregnant, plan to become pregnant, or are currently breast-feeding
Evidence of current alcohol or drug abuse
History of epilepsy and/or other significant neurological diseases
Infectious Diseases & Immune System, Allergies
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Examining language use across the lifespan in English

This study examines how speakers change their language use as they age. Sociolinguistic interviews will be used to document and analyze features of English in Pennsylvania. Sociolinguistic interviews will be conducted between the investigator(s) and the participant(s). Participants will be invited to complete the recorded interviews at different intervals in time. The hypothesis is that language use will change as a speaker ages - as social pressures and lifestyle change, so will language.

In this study, the interviewer will ask you a series of questions about your life. The following are some example topics you may be asked about: Personal background (e.g., place of birth, school, work, family, life in Pennsylvania), Leisure, media, everyday life (e.g., hobbies, dreams, sports and social events) Life experiences (e.g., favorite childhood memories, experience during Covid lockdown) Personal beliefs (e.g., spirituality, superstitions) Language (e.g., thoughts about language use and change) The interview will be audio recorded (no video). You will also be asked to complete a background questionnaire so that we can learn more about your life. When filling out the background questionnaire, you are free to skip any questions you prefer not to answer. At the end of the study, we may ask you if you would be interested in being contacted for follow-up interviews.

$20.00

Yes
 

James Stratton
James Stratton - at james.stratton@psu.edu or 814-280-0692
Germanic and Slavic Languages and Literatures (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00028367
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Inclusion Criteria:
Speaker of English
18+ in age
Living in Pennsylvania

Exclusion Criteria:
Under the age of 18
Not a speaker of English
Not currently living in Pennsylvania
I'm interested
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Carlisle, PA ,
Harrisburg, PA ,
Hershey, PA ,
Mont Alto, PA ,
Schuylkill Haven, PA ,
State College, PA ,
Williamsport, PA ,
York, PA ,

PSCI# 25-139: NRG-GU012: Randomized Phase II Stereotactic Radiation Therapy (SABR) For Metastatic Unresected Renal Celil Carcinoma (RCC) Receiving Immunotherapy (SAMURAI)

To determine whether the addition of stereotactic ablative radiotherapy (SABR) to the primary tumor in combination with immunotherapy improves outcomes compared to immunotherapy alone in patients with metastatic, unresected, renal cell carcinoma (RCC).

The patient will either get immune therapy (either 2 immune therapy drugs or immune therapy plus a VEGF targeted therapy), or get immune therapy plus radiation therapy. The radiation treatments will be given on 3 different days over the course of 1-3 weeks. Immune therapy will continue until it is no longer working. After the treatment is stopped, the doctor and study team will monitor the patient every 6 months for 5 years after treatment and then annually for 3 years.

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05327686
STUDY00028353
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Inclusion Criteria:
Node-positive unresectable (TxN1Mx) or metastatic (TxNxM1)
Patients must have IMDC intermediate (1-2 factors) or poor risk disease (>3 factors)
Pathologically (histologically or cytologically) proven diagnosis of renal cell carcinoma
Patients with measurable disease (node positive or metastatic)
Candidate for standard of care therapy with either IO-IO or IO-VEGF combination regimen

Exclusion Criteria:
Patients with planned treatment of all metastatic disease with definitive therapy
Patients with untreated or unstable brain metastases or cranial epidural disease
Prior radiotherapy to the kidney that would result in overlap of radiation therapy fields treatment of the primary tumor
Any systemic therapy for metastatic renal cell carcinoma (RCC) that was initiated > 90 days before registration
Pregnancy and individuals unwilling to discontinue nursing
Cancer
Approved drug(s)
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Hershey, PA ,

PSCI 24-119 A Pilot Study to Evaluate the Feasibility, Safety, and Efficacy of Cannabigerol/Cannabidiol Oil for Chemotherapy-Induced Peripheral Neuropathy

This study will look at the safety and effectiveness of cannabigerol (CBG)/cannabidiol (CBD) in the treatment of chemotherapy induced peripheral neuropathy.

You must attend all scheduled study visits, tell the study doctor about all medications you are taking (including over-the-counter medicines), and let the study team know how you are feeling. Patients must come to clinic visits (about every 4 weeks) for health checks, blood tests and surveys, take the hemp oil (CBG/CBD) twice a day for 12 weeks, complete a drug diary, return unused oil on their next visit, and answer phone calls between visits.

$500.00 if substudy completed

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
NCT07016971
STUDY00027245
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Inclusion Criteria:
Adults aged 21 years or older
Patients with grade 1 or greater CIPN symptoms, such as neuropathic pain, paresthesia, or muscle weakness, persisting for more than 2 weeks
Patients who have completed platinum-based chemotherapy for colorectal carcinoma, biliary tract carcinoma, pancreatic carcinoma, esophageal carcinoma, gastric carcinoma, or small intestinal carcinoma within the past 2 years
Patients from Penn State Health
Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 1 months after the last dose of protocol therapy

Exclusion Criteria:
Current use of moderate or strong inhibitors or inducers of CYP3A4 or CYP2C19
Patients who have suicidal ideation or uncontrolled depression within the past year
Patients with known sensitivity to any components of CBG/CBD hemp extract
Patients with known sensitivity to coconut oil
History of or active arterial thromboembolic event
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

Investigating memory decisions in younger and older adults

This research aims to investigate how memory functions in cognitively healthy individuals by characterizing age-related differences in memory performance and cognitive processes.

Individuals will be asked to complete computer-based and paper-and-pencil tasks with a researcher. These tasks are designed to assess memory and cognition during a single session. This session can be separated at the request of the participant.

$10/hour

Yes
 

Nancy Dennis
Rebecca Wagner - at rmw5981@psu.edu
Psychology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00028412
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Inclusion Criteria:
Healthy individuals between the ages of 18-30 OR ages 60-85
Monolingual, native English speakers
Minimum high school education
No contradictions to typical aging

Exclusion Criteria:
Individuals with a history of neurological injury
Individuals with a dementia or other cognitive disorder diagnosis
Not applicable
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State College, PA ,

A Phase 2b/3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol to Evaluate the Efficacy and Safety of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease

The study will evaluate the effectiveness and safety of ICOTROKINRA compared to placebo in participants with moderate to severe Crohn's disease. The participants will be randomized to one of three treatment groups in a 1:1:1 ration and will receive one of the two drug induction regimens versus placebo. At week I-12 of induction treatment (study 1 or study 2 induction), the participants will be evaluated, and if they achieved clinical response or clinical remission, they could then continue treatment in the Maintenance study for 40-weeks. The response to icotrokinra in the study participants will be evaluated by blood draws to test for biomarkers and PK, study symptoms questionnaires (e.g. stool frequency and pain), and colonoscopy with biopsies. They will also have the physical evaluations, ECG, suicidality assessment, pregnancy testing and monitoring of hypersensitivity reactions, along with test for tuberculosis and other infections. In both induction studies and in the maintenance treatment, participants will receive one of the icotrokinra dose or placebo daily oral pill. After the completion of maintenance treatment, the participants could enter open-label extension study for the 4 years. The screening of potential subject will take six weeks, and at least two in-person visits. Eligible participants who signed informed consent can be enrolled in the induction treatment phase, with visit day 0, week 2, week 4, week 8 and week 12. The safety follow-up visit will be held four weeks after the last dose for eligible participants. Dosing will be done on-site during these visits: day 0, and weeks 2, 4, 8, and 12 if starting the maintenance. Biopsy samples will be collected at the screening and week 12 of induction/start of maintenance. During the maintenance phase of treatment for the responders there will be eleven in-person visits including M-0. Colonoscopy exam will be done at M-12, and M-40 weeks to evaluate a response to the treatment.

Participants will be required to sign the informed consent. There will be at least two screening visits on-site. If eligible, participants will be required to attend five in-person visits, comply to the instructions by the study team, have colonoscopy and blood draws done, take medication daily. They will be asked to complete daily diaries of the disease symptoms. Other tests that will be done to ensure safety are ECG, physical exams, target exams, answer questions on tuberculosis and other infections, provide stool samples and urine pregnancy tests if applicable.

$3,122

Yes
 

Kofi Clarke
Zvjezdana (Stella) Sever 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
NCT07196722
STUDY00027773
Show full eligibility criteria
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Inclusion Criteria:
Adult, >18 years of age
Able to sign informed consent and understand the study requirements
Diagnosed with IBD-Crohn's disease at least 12 weeks prior
Receiving active treatment for IBD that is not working
Must agree to the contraception requirements

Exclusion Criteria:
Less than 18 years of age
Pregnant
Not able to complete the questionnaires
Not able to take pills
Any planned major surgery
Digestive Systems & Liver Disease
Experimental drug compared to a placebo/”sugar pill”
I'm interested
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See this study on ClinicalTrials.gov
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Study Locations

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Location Contacts
Hershey, PA ,