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PSCI# 23-137 NRGF-001: ACTIVITY MONITORING TO IMPROVE PATIENT CARE DURING CHEMORADIOTHERAPY FOR LOCALLY ADVANCED NON-SMALL CELL LUNG CANCER (LA-NSCLC)

this trial looks at the difference in health between lung cancer subjects who do deliberate exercise measured by a fit bit and those who do not.

Participants will need to commit to all appointments. All those assigned to the fit bit arm must agree to wear it as instructed. You will wear the activity monitor for approximately 4 months. There are approximately 13 visits in total that you would need to come to the clinic.

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
NCT04878952
STUDY00024680
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Inclusion Criteria:
Pathologically (histologically or cytologically) proven diagnosis of NSCLC
Planned initiation (within the 30 days after study registration) of fractionated (≥15 treatments) thoracic radiotherapy with concurrent chemotherapy.
Age ≥ 18
Ambulates independently or with a cane (use of a walker not permitted)

Exclusion Criteria:
Patients with a history of another cancer that is expected to affect the toxicity profile of thoracic chemoradiotherapy for NSCLC
Patients receiving concurrent treatment for another cancer that is expected to affect the toxicity profile of thoracic chemoradiotherapy
Cancer
Approved device(s)
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Hershey, PA ,

Can Twitter be the platform that leads to the rise of ’Crisis Reporters’?

Citizen journalism refers to production of journalistic content by ordinary citizens such as ‘current affairs-based blogging, photo and video sharing, and posting eyewitness commentary on current events’. In our study we try to redefine ‘citizen journalism’ to ‘crisis reporting’ that includes sharing updates and actionable news using Twitter. To this end we wish to propose a study where we interview people to understand the feasibility of the same. In addition, as supporting data, we would use historical data from Twitter. This would be done keeping in mind a particular event which would be the Texas snowstorm.

No
 

Sanjana Gautam
Sanjana Gautam - at sqg5699@psu.edu
Division of Graduate Studies (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00017565
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Inclusion Criteria:
Above 18 years of age
Present in Texas during the snowstorm
Have an active Twitter account

Exclusion Criteria:
Below 18 years of age
Not present in Texas during the snowstorm
Do not have an active Twitter account
Mental & Behavioral Health
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A Phase Ib/II Study of Venetoclax (ABT-199) in Combination with Liposomal Vincristine in Patients with Relapsed or Refractory T-cell or B-cell Acute Lymphoblastic Leukemia (EA9152) (PSCI 18-047)

This study is being done to determine what effects (good and bad) the therapy venetoclax has on your type of cancer (acute lymphoblastic leukemia, also known as ALL). This investigational therapy will be added to what is a standard, liposomal vincristine, to treat relapsed acute lymphoblastic leukemia. It is hoped that venetoclax will help liposomal vincristine work better to kill your ALL, but it has not yet been proven.

venetoclax will be given orally in a tablet formulation once daily in 3 dose arms with a fixed, standard dose of intravenous (IV) liposomal vincristine 2.25mg/m2 weekly starting after a 2 week lead-in phase of venetoclax

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
NCT03504644
SITE00000009
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Inclusion Criteria:
Relapsed or refractory B-cell or T-cell ALL after multi-agent chemotherapy(≥ 5% marrow lymphoblasts, assessed by morphology and flow cytometry
ECOG performance status 0-2
Creatinine clearance of at least 50 mL/min within 7 days prior to first dose of study agent
Adequate liver function with AST/ALT less than 3X upper limit of normal and total bilirubin less than 2 mg/dL within 7 days prior to first dose of study agent
Circulating WBC count must not be above 20 x10^9/L within 7 days prior to first dose of study agent

Exclusion Criteria:
Pregnant or breast-feeding due to risk of fetal harm by the chemotherapeutic agents prescribed in this protocol
Evidence of isolated extramedullary relapse (i.e., testicular or CNS)
Serious medical or psychiatric illness that in the opinion of the primary investigator is likely to interfere with study participation may not be enrolled
Poorly controlled HIV, or CD4 < 400. HIV positive patients are allowed on this study if they have a CD4 count greater than or equal to 400, and are on a stable antiviral regimen
Patients with NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia may not be enrolled
Cancer
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Hershey, PA ,

Comparing Interactions Between Heterogeneous and Homogeneous Pairs of Building Designers

This study considers how building designers work together on a design task. During the 1-hour long study, participants will be assigned a design partner and given a design task with specific goals to address. The entire study will take place over a computer and the design process will be recorded through the computer's video and audio.

No
 

Nathan Brown
Stephanie Bunt - at s.bunt@psu.edu
Architectural Engineering (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00016546
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Inclusion Criteria:
Architecture Students
Architectural Engineering Students
4th or 5th year undergrads with internship experience
Graduate students

Exclusion Criteria:
First, Second, or Third year students
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UroGen UR001

This study is being done is to test the safety of a drug called UGN-301 at different dose levels, either alone or with another drug called UGN-201, and to understand how these drugs interact with the bladder and body

If you decide to take part in this study and meet all of the requirements, you will receive 6 treatments, once per week for 6 weeks in a row. The medication treatments will be instilled via catheter into your bladder. There will be 11 total visits with blood draws at all of the visits. As part of screening for this study you will have to have a CT scan, a cystoscopy, and a bladder biopsy. At 3 months you will be required to return for a cystoscopy and bladder biopsy if necessary. Finally, there will be a follow up cystoscopy and bladder biopsy at 6 months.

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05375903
SITE00001313
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Inclusion Criteria:
Have confirmed recurrent NMIBC with HG Ta disease and/or CIS or recurrent IR LG Ta disease
Have confirmed recurrent NMIBC with HG Ta disease and/or CIS
Has a life expectancy > 12 months.
Be post menopausal, surgically sterile, or using a combination of 2 methods of birth control for maximally effective birth control
Have adequate organ and bone marrow function within 14 days of treatment initiation as determined by routine laboratory tests

Exclusion Criteria:
Intravesical therapy within 4 weeks before starting study treatment.
Current or previous evidence of muscle invasive, locally advanced nonresectable, or metastatic urothelial carcinoma (ie, T2, T3, T4 and/or stage IV). High or low grade T1 disease.
Current systemic therapy for bladder cancer.
History of malignancy of other organ system within the past 5 years. Patients with genitourinary cancers other than urothelial cancer or prostate cancer that are under active surveillance
Prior therapy with an anti-CTLA-4, anti-PD-1, anti-PD-L1 agent, or with an agent directed to another co-inhibitory T-cell receptor.
Cancer
Not applicable
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Hershey, PA ,

Pathway to Prevention Study

This study will help us learn more about how type 1 diabetes occurs and provides monitoring to individuals at risk. In addition, the study will help us identify people who may be eligible for prevention trials. The study is divided into two parts: Screening and Monitoring. During screening, participants with a 1st degree relative who has type 1 diabetes will be tested for diabetes-related autoantibodies in the blood. Autoantibodies are proteins that are made by the body’s immune system. If autoantibodies are present, it could mean that cells in the pancreas which produce insulin are damaged. Certain kinds of autoantibodies can be found in the blood years before type 1 diabetes occurs. If the screening blood tests show that a participant has the autoantibodies, they will be asked to have an Eligibility visit to determine if you can participate in the Monitoring part of the study.

screened for Type 1 diabetes antibodies

Yes
 

Daniel Hale
Clare Robel - at crobel@pennstatehealth.psu.edu or 717-531-5656
Pediatrics: Endocrinology (HERSHEY)
 

All
All
This study is also accepting healthy volunteers
NCT00097292
SITE00000066
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Inclusion Criteria:
aged 1-45 years and a sibling, offspring, or parent of an individual with type 1 diabetes
aged 1-20 years and a niece, nephew, aunt, uncle, grandchild, cousin, or half sibling of an individual with Type 1 diabetes
willing to have blood drawn

Exclusion Criteria:
Have previous or current use of medications for the control of hyperglycemia
Currently use immunosuppressive or immunomodulatory therapies
Has diabetes
Diabetes & Hormones
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Hershey, PA ,

Defining the role of slow eye movements on limb motor control

The purpose of the study is to examine how slow eye movements called smooth-pursuit eye movements, contribute to hand-eye coordination. Participants will grasp a robotic manipulandum and using the manipulandum interact with virtual visual stimuli in an augmented-reality environment.

Yes
 

Tarkeshwar Singh
Tarkesh Singh - at tsingh@psu.edu or 814-865-7851
Kinesiology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00018339
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Inclusion Criteria:
Right-handed individuals (males and females) between 18-65 years of age
Should have normal vision or corrected vision
Participants should be able to sit upright on a chair for upto 2 hours
Participants should be able to grasp and move objects with their right hand
Participants should be able to provide informed consent

Exclusion Criteria:
History of neurological disorders (Parkinson’s or Alzheimer’s (e.g., Multiple Sclerosis, Amyotrophic Lateral Sclerosis or Lou Gehrig’s disease, Friedreich's ataxia, aneurism, brain tumor, epilepsy, suffered a concussion in the last 5 years, TBI, stroke)
History of musculoskeletal disorders (e.g., carpal tunnel syndrome, arthritis, fibromyalgia, tendinitis, trigger finger, mallet finger, fracture, or previous injury to the bones or joints in your neck, upper back, arms or hands in the last six months)
eye or vision problems (e.g., cataracts, glaucoma, a detached retina or macular degeneration)
Cognitive impairment such that informed consent cannot be obtained.
Medication that could make the participant either drowsy or tired. Individuals who get tired with 2 hours of mild to moderate exercise are also not eligible to participate.
Neurology, Vision & Eyes
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State College, PA ,

Understanding the Public Opinion about Commute Time in Automated Vehicles

The main research goal of this work is to collect drivers’ opinions on autonomous vehicles and their perceptions of time when they ride with autonomous vehicles comparing with manual-driven vehicles.

No
 

Yiqi Zhang
Cong Zhang - at ckz5120@psu.edu
Industrial and Manufacturing Engineering (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00014606
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Inclusion Criteria:
Have a valid and unrestricted US driver’s license or is allowed to drive in US
Have at least one year of driving experience

Exclusion Criteria:
Do not have a valid driving license
The age of driver is under 18
Education, Mental & Behavioral Health, Language & Linguistics
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A MULTICENTER, RANDOMIZED, DOUBLE-BLIND,PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TOEVALUATE THE EFFICACY AND SAFETY OFDAPIROLIZUMAB PEGOL IN STUDY PARTICIPANTS WITHMODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUSERYTHEMATOSUS

A randomized placebo-controlled study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus

There is up to 15 visits over the course of 54 weeks. Lab samples will be collected, medication will be administered.

amount varies based on visits completed

Yes
 

Nancy Olsen
Jamie Carter - at jcarter3@pennstatehealth.psu.edu or 717-531-0003, ext=283833
Medicine: Rheumatology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT04294667
STUDY00017186
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Inclusion Criteria:
≥16 years of age
≥40kg and ≤160kg
diagnosis of Systemic lupus erythematosus (SLE)

Exclusion Criteria:
pregnancy
history of chronic alcohol or drug abuse
known history of allergic reaction to the drug
Arthritis & Rheumatic Diseases
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Examining Cortical Lateralization of Motor Learning through Transcranial Stimulation

The aim of this study is to understand how brain stimulation affects learning of a novel task on a virtual reality system. Participation involves playing virtual reality games during non-invasive brain stimulation.

Single visit, subjection to noninvasive brain stimulation during a reaching task.

25

Yes
 

Robert Sainburg
Nick Kitchen - at nkitchen@pennstatehealth.psu.edu or 717-531-0003, ext=283146
Kinesiology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00012605
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Inclusion Criteria:
right-handed
18-40 years old (healthy young)
18-80 years old (stroke patient)

Exclusion Criteria:
left handed or ambidextrous
neurological disease
movement disorder
major psychiatric diagnosis
orthopedic damage to the arms
Neurology, Mental & Behavioral Health
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Hershey, PA ,
State College, PA ,

Describing and Understanding Local Varieties of Central Pennsylvanian English

This study aims to provide original descriptions and analyses of features of the vernacular varieties of English spoken in Central Pennsylvania. Previously understudied, this project will provide new data from both spontaneous speech and controlled experiments to contribute to our understanding of language variation in Central PA, and to the larger body of knowledge on variation in American English.

No
 

Frances Blanchette
Frances Blanchette - at fkb1@psu.edu
Psychology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00010993
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Inclusion Criteria:
18 years or older
from the Central PA region
native speaker of American English

Exclusion Criteria:
under 18
did not grow up in Central PA
does not speak English as a native language
Language & Linguistics
I'm interested
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A Phase I/II Study of Neratinib in Pediatric Patients with Relapsed/Refractory Solid Tumors

Neratininb for childhood cancer that has returned or is not responding to previous therapy

Yes
 

Valerie Brown
Suzanne Treadway, MS, RN, CCRP - at streadway@pennstatehealth.psu.edu or 717-531-3097
Pediatrics: Hematology/Oncology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT02932280
STUDY00007380
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Inclusion Criteria:
Age 3 to 21 Inclusive
Cancer that has returned or is not responding to previous therapy
Has failed at least one prior therapy

Exclusion Criteria:
Certain prior therapies
Children's Health, Cancer
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Hershey, PA ,

SPICE UP MyPlate - Strategy for Promoting Intake of Delicious Healthful Dietary Patterns Based on MyPlate: A Pilot Study

The aim is to conduct a pilot study to assess the feasibility, acceptability and potential effectiveness of culinary focused nutrition education to promote increased adherence to the Dietary Guidelines for Americans compared to standard low-intensity care.

You will be asked to attend two fasting clinic visits. At these visits paperwork will be completed, measures of weight, height, waist circumference, and vascular health will be taken. A blood draw will also be taken. If you are randomized to the culinary focused nutrition education group, you will be asked to attend weekly 1-hour face-to-face group education sessions during the first month of the study. For months 2 and 3 face-to-face sessions will be held bi-weekly for 1 hour. You will also receive emails containing videos and other resources. If you are in the standard nutrition education group, you will receive nutrition education via written study material and a phone application (app) and you will not have to attend education visits.

250

Yes
 

Kristina Petersen
Kayla Tate - at DCHLab@psu.edu
Nutritional Sciences (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00022406
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Inclusion Criteria:
Age 31-59
Involved in meal cooking at home and consumes a home cooked meal ≥ 1 time per week
Non-smoking

Exclusion Criteria:
A member of the household is already enrolled
Received nutrition education for a medical condition within the past 6 months
Currently following a weight loss diet
Lost ≥ 10% body weight in the past 6 months
Unstable medical conditions requiring active intervention
Food & Nutrition
Not applicable
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State College, PA ,

COVID-19: Implications for Family Meals

The purpose of this study is to gather information about family meals, what they look like, and how they have changed over time since the COVID-19 pandemic. Participants will complete a confidential online survey last approximately 10-15 minutes.

No
 

Hannah Mudrick
Hannah Mudrick - at hxm99@psu.edu or 717-948-6404
Behavioral Sciences and Education (HARRISBURG)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00015422
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Inclusion Criteria:
Adults age 18 and older
Adults who live in a household with a child under the age of 18
Adult who are fluent in English
Individuals who can read and respond to written closed and open-ended survey questions electronically
Individuals who live in the United States

Exclusion Criteria:
Individuals under the age of 18
Individuals who do not reside in a household with a child under the age of 18
Individuals who are not fluent in English
Individuals with poor reading comprehension or are otherwise limited in their ability to read and respond to survey questions.
Individuals who do not currently live in the United States
Food & Nutrition
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A Randomized, Placebo-Controlled, Double-Blind Study of Adjuvant Cemiplimab versus Placebo after Surgery and Radiation Therapy in Patients with High Risk Cutaneous Squamous Cell Carcinoma (CSCC) (PSCI 18-112)

This study is a comparison of disease-free survival of patients with high-risk cutaneous squamous cell carcinoma (CSCC) when treated with a medication (cemiplimab) versus those treated with placebo after already having surgery and radiation therapy.

The study is conducted in 2 parts. Part 1 consists of a screening period, treatment period and a completion period including a period of long term follow up. During part 1, you will be asked to answer questions about your health, participate in a physical examination that includes vital signs,height and weight, have testing done including an electrocardiogram, blood draws, urine sampling, pregnancy test, biopsy, and medical imaging. Part 2 consists of an additional screening period, treatment period and an end of treatment period.

70.00 per visit

Yes
 

Joseph Drabick
Irina Geier - at igeier@pennstatehealth.psu.edu
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03969004
STUDY00013965
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Inclusion Criteria:
High risk cutaneous squamous cell carcinoma
Post resection and curative intent post-operative Radiation Therapy within 2 to 6 weeks of randomization
Adequate hepatic, renal, and bone marrow function as defined in the protocol

Exclusion Criteria:
Patients with blood cancer (hematologic malignancies) or other malignancies
Squamous cell carcinomas (SCCs) arising in non-cutaneous sites as defined in the protocol
Significant autoimmune disease that required treatment with systemic immunosuppressive treatments (including corticosteroids)
Has had prior systemic anti-cancer immunotherapy for cutaneous squamous cell carcinoma
Cancer
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Hershey, PA ,

A Global, Open-Label, Adaptive Design Study to Investigate the Efficacy and Safety of SerpinPC With Severe Hemophilia A or Moderately Severe to Severe Hemophilia B

This is an open-label drug study of SerpinPC (a subcutaneously administered drug) for patients with severe hemophilia A or moderately severe to severe Hemophilia B. The study consists of 3 parts after an observation phase of 12-24 weeks: 24 week justification phase, 24 week confirmatory phase &amp; 24 week extension phase.

This is a subcutaneous drug treatment clinical trial with an observation period of up to 24 weeks, pre-dosing/dosing period of 8 visits on site or phone calls &amp; an extension period of 6 visits.

$75.00 travel reimbursement per visit

Yes
 

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

Male
All
This study is NOT accepting healthy volunteers
NCT05789524
STUDY00022327
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Inclusion Criteria:
Males ages >12 & <65 with severe hemophilia A or moderately severe to severe hemophilia B
Subjects include prophylactic dosing or on-demand dosing for factor replacement
Adequate laboratory functions

Exclusion Criteria:
Subjects with a previous factorVIII or factor IX inhibitor
Previous deep vein thrombosis, pulmonary embolism, MI or stroke.
Uncontrolled hypertension, active cancer (except basal cell)
Weight > 150kg (330 lbs.) or BMI > 40kg/m2
Blood Disorders
Not applicable
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Hershey, PA ,

Student Experience in New Class Modes during Covid-19

This is a survey study that will examine how the new instruction modes during COVID-19 have impacted undergraduate education experience. Participants will be asked to complete a survey to give feedback and comments on their classes. The survey will take 15 - 20 minutes.

No
 

Chuhao Wu
Chuhao Wu - at cjw6297@psu.edu or 765-772-8073
Information Sciences and Technology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00016364
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Inclusion Criteria:
18 years or order
An active undergraduate student at University Park campus
Enrolled for as least one class
Can read instruction materials written in English

Exclusion Criteria:
NA
Education
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Understanding the relationship of financial difficulties and mental health among a sample of American Undergraduate Students.

Aim is to explore how student's financial status and experiences influence their emotional, psychological, and social well being while being in university.

Participants, upon their consent, will be required to fill a Qualtrics survey on their personal laptop or computer.

No
 

Saeed Abdullah
Eleazar Bilewu - at ejb5857@psu.edu or 443-707-6474
Information Sciences and Technology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00022016
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Inclusion Criteria:
U.S Citizen
18 years or older
Penn State Undergraduate Student
Fluent in English

Exclusion Criteria:
Under 18 years old
Non U.S Citizen
Non Penn State Undergraduate Student
Education, Mental & Behavioral Health
Survey(s)
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Dynamic Assessment of English Vocabulary

Better understand and improving Chinese English learners' vocabulary development

•Complete seven sessions, which may take approximately 20-30 minutes of your time per session.•Read several English short texts and identify meanings of target words.•Possibly participate in a virtual interview that will be scheduled at your convenience.

No
 

Yuwei Xia
Yuwei Xia - at yxx5304@psu.edu
Division of Graduate Studies (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00023081
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Inclusion Criteria:
Of Chinese origin or descent
Adult English learners
Currently enrolled in a college or university

Exclusion Criteria:
English as native language
Education
Not applicable
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A Survey to Estimate the Socio-Economic Impact of the Novel Corona Virus (COVID-19) Pandemic

We are experiencing global outbreak of coronavirus (COVID-19) recently. Millions of people are suffering and dying every day, in spite of putting our best efforts. We are doing this survey to understand people’s reaction to this situation. The survey will ask about your knowledge, practices and worries. Your response will help us to understand how to better control these situations. Your feedback is highly important to us, as we need to find out the best way to stop the disease from spreading and killing thousands of lives, and to reduce the stress among the population.

No
 

Pritish Mondal
Pritish Mondal - at pmondal@pennstatehealth.psu.edu or 717-897-0652
Pediatrics: Allergy and Immunology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00015136
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Inclusion Criteria:
General population
Adult

Exclusion Criteria:
Age below 18 years
Mentally impaired
Participants from Europe or European Union (EU)
Infectious Diseases & Immune System, Prevention, Lung Disease & Asthma
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How do cues from the environment affect sound perception?

This study is about investigating how certain elements of urbanconfiguration affects people's subjective perception of noise in urbanenvironments.This section of the study assesses participants' subjective reactions tonoise intensity when the tree density changes in various spaces.

Yes
 

Sohail Sadroleslami
Sohail Sadroleslami - at sbs5622@psu.edu or 814-883-7773
Architecture (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00014527
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Inclusion Criteria:
Age: 18 -24
Gender: all
no visual or hearing impairments

Exclusion Criteria:
no visual or hearing impairments
Vision & Eyes
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State College, PA ,

PSCI 22-142 A Randomized, Open-label, Phase 3 Study of Sacituzumab GovitecanVersus Treatment of Physician’s Choice in Patients With HormoneReceptor-Positive (HR+)/Human Epidermal Growth Factor Receptor2 Negative (HER2−) (HER2 IHC0 or HER2-low [IHC 1+, IHC2+/ISH−]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy

This trial is to compare the effects of sacituzumab govitecan versus physician's choice in the treatment of breast cancer

Potential participants will be expected to come to all study visits, complete questionnaires, take the medication as prescribed by the study doctor, report any changes in medications of symptoms while on the trial.

Yes
 

Cristina Truica
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
NCT05840211
STUDY00023127
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Inclusion Criteria:
Assigned male or female at birth, 18 years of age or older (or minimum age according to country-specific requirements), able to understand and give written informed consent.
Must have adequate tumor tissue sample preferably from locally recurrent or metastatic site, either in a formalin-fixed, paraffin-embedded block or newly sectioned, unstained slides for HER2 status and other biomarker assessments.
Documented evidence of HR+ metastatic breast cancer (mBC)
Documented evidence of HER2− status
Documented PD by computed tomography (CT) or magnetic resonance imaging

Exclusion Criteria:
Progressive disease within 6 months of completing (neo)adjuvant chemotherapy.
Previously HER2+
Locally advanced mBC (Stage IIIc) in patients who are candidates for curative intent therapy at the time of study enrollment
Current enrollment in another clinical study
Treatment with definitive radiation within 2 weeks prior to the first dose of study drug
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

Effects of acid sensing ion channels blockade on the exercise pressor reflex following ischemia-reperfusion stress in healthy individuals

The purpose of this voluntary research study is to test if the drug amiloride can decrease blood pressure during exercise.

This project includes 3 visits to the research lab. Each visit last approximately 3.5-4 hours (~11-12 hours altogether). In each visit, you will be asked to perform foot exercise before and after a blood pressure cuff on your leg was inflated. You will also be asked to take pills prior to visit 2 and 3. One of these pills will be a drug called amiloride (10mg), which was traditionally used to lower blood pressure. The other pill will be a placebo (no active medication).

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

Yes
 

Jian Cui
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
STUDY00021886
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Inclusion Criteria:
Men and women of any race or ethnicity
21-40 years of age
Healthy (absence of any active or chronic disease)

Exclusion Criteria:
Are not between 21-40 years old
Pregnant or nursing women
Have a major disease (heart, lungs, kidney, diabetes, cancer)
current smoker
High blood pressure
Heart & Vascular
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Hershey, PA ,

Understanding the Experiences of College Students of Color with Psychiatric Disabilities

The purpose of this study is to develop a better understanding of the lived experiences of college students of color with psychiatric disabilities, particularly related to the formation of racial identity, disability identity, and the impact of perceived discrimination.

Yes
 

Amber O'Shea
Amber O'Shea - at amo5208@psu.edu or 814-867-5721
Educational Psychology, Counseling and Special Education (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00014142
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Inclusion Criteria:
Currently enrolled as a college student
18 years of age or older
Capable of providing informed consent
Diagnosis of a psychiatric disability
Identify as a person of color

Exclusion Criteria:
Adults unable to provide legal consent
Individuals who are not yet legal adults
Prisoners
Unable to speak/read English Language at time of interview
Addiction & Substance Abuse, Education, Mental & Behavioral Health
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State College, PA ,

Randomized Phase III Trial Incorporating Abiraterone Acetate with Prednisone and Apalutamide (NRG-GU008) (PSCI# 20-087)

The purpose of this study is to compare the use of hormone therapy and radiation therapy (usual treatment) to the use of apalutamide and abiraterone acetate with prednisone plus the usual treatment. The addition of apalutamide and abiraterone acetate with prednisone to the usual treatment could stabilize your cancer and prevent it from spreading. But it could also cause side effects, which are described in the risks section below.This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the study approach increases the time without prostate cancer spreading compared to the usual approach. The study drugs, apalutamide and abiraterone acetate with prednisone, are already approved by the FDA for use in prostate cancer. But, most of the time abiraterone acetate with prednisone is not used until hormone drugs stop working and apalutamide is not used until hormone drugs stop working and after prostate cancer has spread. There will be about 586 people taking part in this study.

The purpose of this study is to compare the use of hormone therapy and radiation therapy (usual treatment) to the use of apalutamide and abiraterone acetate with prednisone plus the usual treatment. The addition of apalutamide and abiraterone acetate with prednisone to the usual treatment could stabilize your cancer and prevent it from spreading. But it could also cause side effects, which are described in the risks section below.This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the study approach increases the time without prostate cancer spreading compared to the usual approach.The study drugs, apalutamide and abiraterone acetate with prednisone, are already approved by the FDA for use in prostate cancer. But, most of the time abiraterone acetate with prednisone is not used until hormone drugs stop working and apalutamide is not used until hormone drugs stop working and after prostate cancer has spread. There will be about 586 people taking part in this study.

Yes
 

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

Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04134260
SITE00000791
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Inclusion Criteria:
Pathologically (histologically) proven diagnosis of prostate adenocarcinoma
History/physical examination within 90 days prior to registration
ECOG Performance Status of 0-1 within 90 days prior to registration
Any T-stage is eligible (AJCC 8th ed)
Adequate hepatic function within 90 days prior to registration

Exclusion Criteria:
Didanosine (DDI) antiretroviral therapy is not permitted
Seizure or known condition that may pre-dispose to seizure
Severe or unstable angina, myocardial infarction, arterial or venous thromboembolic events within 6 months prior to registration
Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone/prednisolone once daily
Patients with inflammatory bowel disease.
Cancer
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Hershey, PA ,

The effects of creatine supplementation on neurocognitive function of college students of differing levels and types of physical activity

This study design is a survey that collects information about students' active level and supplement use, with an emphasis on creatine. The difference between contact and non-contact athletes will be examined, in addition to people who are considered inactive/low activity. This will help provide information of how physical activity related supplementation use affects cognition in different populations, with varying amounts of neurotrauma.

All participants will complete a digital survey that provides information about their dietary supplementation and physical activity habits. As part of the survey, participants will be allowed to indicate their interest and availability to come to a laboratory setting to complete a brief batter of neurocognitive tests.

Yes
 

Semyon Slobounov
Bogdan Ivanov - at bmi5063@psu.edu or 617-327-4064
Kinesiology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00023261
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Inclusion Criteria:
18 years or older

Exclusion Criteria:
Under 18 years of age
Has had concussion in last 3 months
Food & Nutrition, Sports Medicine
Survey(s)
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State College, PA ,

Sex and race differences in exercise pressor reflex under blood flow restriction condition

The purpose of this voluntary research study is to test the effects of exercise on reduction in blood flow to exercising muscle.

You will be asked to participate in one visit to perform handgrip exercise and foot exercises with, and without a blood pressure cuff inflated on your arm and leg. Various physiological measurements will be recorded during this time including microneurography, blood pressure, heart rate, blood flow and muscle oxygenation.

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

Yes
 

Jian Cui
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
STUDY00023505
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Inclusion Criteria:
Males and Females 21-80 years of age
All races and ethnicities welcome
Are fluent in written and spoken English
Healthy status as defined by history and physical
blood pressure that is within a safe range (<150/100)

Exclusion Criteria:
less than 21 years of age or greater than 80 years of age
Pregnant or nursing woman
Current smoker
Any chronic diseases (heart, lung, neuromuscular disease or diabetes)
High blood pressure
Heart & Vascular
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Hershey, PA ,

Exploratory Trial of Ruxolitinib 1.5% Cream for Early Stage Hidradenitis Suppurativa

Explore all stages of Hidradenitis Suppurativa with a topical medication.

There will be 7 in-person visits and 1 follow-up phone call over a 33 week period. Over the course of the study, the following study procedures will take place: medical history and medication history collection, ECG, lab tests (both blood and urine), photography, skin exams, physical exams, questionnaires, and skin biopsies.

Up to $350

Yes
 

Andrea Zaenglein
Amy Longenecker - at alongenecker@pennstatehealth.psu.edu or 717-531-5136
Dermatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04414514
STUDY00016042
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Inclusion Criteria:
Must have diagnosis of HS for at least 3 months (90 days)
Must have active HS in at least 1 area
Must have negative TB screening assessment
Certain medications can be continued if on stable dose; study coordinator will discuss further.

Exclusion Criteria:
Any other active skin disease or condition that may interfere with assessment of HS
Pregnant (or considering becoming pregnant) or lactating females
Does not have reliable internet access for weekly electronic surveys
Skin Conditions
Prefer not to display
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Hershey, PA ,

Implementation of a Transcutaneous CO2 Monitoring (ITCOM) Study in ALS

Amyotrophic lateral sclerosis (ALS) leads to respiratory failure due to chronic hypoventilation. The gold standard for measuring hypoventilationrequires an arterial blood gas, which is impractical in the outpatient setting due to invasiveness, pain, and need for specialized equipment. Recently, the Penn State Health Hershey ALS Clinic has implemented transcutaneous CO2 (TCO2) monitoring as standard of care clinical assessment. The overall goals of this study are to gather critical preliminary data for stakeholder-driven refinement of a TCO2 monitoring protocol within a busy ALS clinic and identify how TCO2 may enhance our understanding of standard respiratory measurements.

Participants will complete a survey related to their experience having their CO2 reading performed in the ALS Clinic.

$20 will be paid for every survey completed, for a maximum possible payment of $80 per person.

Yes
 

Andrew Geronimo
Cristie Crawford - at ccrawford5@pennstatehealth.psu.edu
Neurosurgery (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00022352
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Inclusion Criteria:
Diagnosis of ALS based on Gold Coast Criteria.
18 years of age or older.
Seated forced vital capacity (FVC) of less than 100% predicted normal.

Exclusion Criteria:
Inability to perform FVC due to severe bulbar weakness
Use of any type of non-invasive ventilation, except in the case of continuous positive airway pressure (CPAP) for obstructive sleep apnea
Use of diaphragm pacer
Use of a tracheostomy
In hospice or in active transition to hospice
Neurology
Survey(s)
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Hershey, PA ,

Young Children’s Representations of Parent-Child Negotiation

The goal of this study is to learn how young children think and tell stories about challenges between parents and children. Children will play games and tell stories using toys while caregivers fill out surveys and talk to researchers. This will occur twice, about 6 months apart. Qualities of children's stories, their language and regulation skills, demographic information about children and caregivers, and parenting behaviors will be examined.

Yes
 

Hannah Mudrick
Hannah Mudrick - at hxm99@psu.edu or 717-948-6404
Behavioral Sciences and Education (HARRISBURG)
 

All
All
This study is also accepting healthy volunteers
STUDY00007452
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Inclusion Criteria:
Children between the ages of 5 and 7
At least one caregiver of a child between ages 5 and 7
English-speaking
Middle income
Caregiver at least 18 years old

Exclusion Criteria:
Caregivers that are not fluent in English
Children that are not fluent in English
Children who are unable to tell stories with a researcher due to developmental disability or language delay
Children who are younger than 5 or older than 7
Low or high income
Education, Mental & Behavioral Health
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Harrisburg, PA ,