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The HEALthy Brain and Child Development Study (HBCD)

This multi-site consortium research study, entitled the HEALthy Brain and Child Development (HBCD) study, willprospectively examine human brain, cognitive, behavioral, social, and emotional development beginning prenatallythrough age 10 years. The study will determine the short- and long-term impacts of a variety of potentially harmfulas well as protective environmental factors. These include prenatal substance use, mental health, stress,sociodemographics, biological and genetic factors, and parent/child interaction. The overall goal of this study is tounderstand the neurodevelopmental trajectories of children growing up in diverse environments. A sample of~7,500 pregnant women will be recruited from 25 sites across the U.S. and they and their liveborn children will befollowed for 10 years.

If you agree for you and your child to participate, we will ask you to take part in completing visits from pregnancy through the first 10 years of your child’s life. These visits will take place both in-person and remotely. The length of visits will vary and may last between approximately one to nine hours per visit (which can be broken up into multiple visits). Over the first four years of the study, all study visits will require about 33-37 hours total. This will include interviews, questionnaires and other tests about yourself and your child. We will ask you and your child to wear small devices for a few days to measure heart rate and or movement. We will ask you and your child to provide some biological samples. Because this study is looking at how a child’s brain develops in the first years of life, we will ask that you allow your child to have brain scans and other measures of how your child’s brain is developing. This study is being offered in both State College, PA at the University Park campus and in Hershey, PA at the College of Medicine campus. You may choose to complete this study at either site.

$1,350

Yes
 

Koraly Perez-Edgar
hbcd@psu.edu;hbcd@pennstatehealth.psu.edu 814-826-1422
Psychology (UNIVERSITY PARK)
 

All
All
This study is also accepting healthy volunteers
SITE00001129
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Inclusion Criteria:
Pregnant or recently gave birth
Speaks English or Spanish

Exclusion Criteria:
Is not pregnant or does not have newborn
Does not speak English or Spanish
Children's Health, Pregnancy & Infertility, Women's Health
Not applicable
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Hershey, PA ,
State College, PA ,

Exploring Parental Influence in Youth Disability Sport Participation

We are conducting an online survey study for parents of children with disabilities that explores their perceptions of participation in disability sport within their communities.

No
 

Courtney Jasiulevicius
Courtney Jasiulevicius - at cmj5308@psu.edu or 813-846-4145
Kinesiology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00007905
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Inclusion Criteria:
has a child with a physical disability or sensory disability
has a child that is enrolled in a disability or adapted sport program
has a child between the ages of 10 and 17

Exclusion Criteria:
does not have a child with a physical or sensory disability
does not have a child with a disability between the ages of 10 and 17
does not have a child that plays a disability or adapted sport
I'm interested
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Testing the Risk Preferences of Engineering Students under Conditions of Limited Information, Sleep, Optimism, and Time Constraints

This is a study that will examine how engineers make decisions under certain conditions and the factors that drive these decisions. The game will be used to simulate different engineering scenarios. All you need to do is play an online game with 3 different scenarios and choose what you feel is the better design based on the available information.

No
 

Uzoezi Isaac-Onwah
Uzoezi Isaac-Onwah - at uji5002@psu.edu
Energy and Mineral Engineering (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00013678
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Inclusion Criteria:
Undergraduate engineering students
Over 18 years old
Speaks English

Exclusion Criteria:
Under 18
Graduate Students
Non-Engineering Majors
Education, Sleep Management
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A Second Intermediate Expanded Access Protocol for AmyotrophicLateral Sclerosis with CNM-Au8

The main purpose of this research study is to provide access to the investigational product, CNM-Au8 at a dose of 30mg per day, to up to 300 people living with ALS. The study wants to find out if CNM-Au8 is safe to take without causing too many side effects and can help people with ALS.

Participants will have a visit to see if they qualify to participate. Following this visit, they will return to the clinic for visits every 12 weeks and these visits will continue in 48-week periods until the treatment plan is discontinued. Participants will have one last visit 4 weeks after their last dose of the investigational medicine. 

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05281484
SITE00001330
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Inclusion Criteria:
ior participation in the HEALEY Platform ALS trial (Regimen C) Open Label Extension (NCT04414345) will be considered an automatic inclusion.
Able to understand and give written informed consent.
Male or female participants aged 18 years or greater (inclusive) at the time of ALS diagnosis.
Participants with a confirmed diagnosis of ALS per Gold Coast criteria as determined by a neurologist specializing in ALS (e.g., the site principal investigator or sub-investigator for this study).
Participant is able to daily consume up to 240 mL of the investigational drug suspension without substantial dysphagia, OR can intake the investigational product through a gastrostomy tube.

Exclusion Criteria:
Participant is eligible for participation in: (i) the HEALEY ALS Platform trial (NCT04297683), or (ii) any active study investigating CNM-Au8 for the treatment of ALS.
Participant has a history of any clinically significant or unstable medical condition (other than ALS) that may interfere with assessment of safety or compromise the study objectives.
Based on the investigator’s judgment, participants who may have difficulty complying with the protocol and/or any study procedures.
Within the prior 90-days the participant has had clinically significant findings on standard hepatic, hematologic, or renal safety assays.
Participant is currently involved in another placebo-controlled clinical trial (note: concomitant therapy with other investigational products is permitted with certain restrictions—see concomitant medications section below).
Neurology
Not applicable
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Hershey, PA ,

Understanding the Well-being of Advanced Counseling Students of Color

The primary objective of this study is to increase our understanding of the ways in which perceived discrimination, coping strategies, competence, stress, social support, and self-efficacy in counselor education programs relate to overall well-being for advanced counseling students of color.

No
 

Kyesha Isadore
Kyesha Isadore - at kmi5@psu.edu or 337-326-3788
Counselor Education, Counseling Psychology, and Rehabilitation Service (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00014713
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Inclusion Criteria:
Currently enrolled as a master’s or doctoral student in a counseling education program
18 years of age or older
Capable of providing informed consent without the assistance of a legal guardian
Identify as a racial or ethnic minority
Able to understand written and spoken English at the time of the survey

Exclusion Criteria:
Adults unable to consent
Individuals who are not yet adults (infants, children, teenagers)
Education, Mental & Behavioral Health
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A Phase II, Multicenter, Double-Blind, Randomised, Placebo-Controlled Study and Open-Label Long Term Extension to Evaluate the Safety and Efficacy of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis (PSC).

this is a phase II study to evaluate the safety and tolerability of 2 doses of elafibranor in participants with Primary Sclerosing Cholangitis (PSC), and its potential effect on the change in serum alkaline phosphatase (ALP) and other hepatic markers of PSC during 12 weeks of treatment in the double-blind period (DBP) compared to placebo. This will be followed by a 96-week open-label extension (OLE) period (no placebo) to assess long-term safety and maintenance of effects of elafibranor.After the first dose of the study intervention on Day 1, the participants will have study visits every 4 weeks through Week 12 of the DBP to assess efficacy and safety. In the OLE period, the study visits for each participant will occur after 4 weeks of entering the OLE, then every 12 weeks up to Week 52, followed by every 22 weeks up to Week 96 which will be the end of treatment (EOT). All participants will have a safety follow-up 4 weeks after the last dose of study intervention.

There will be 2 screening visits followed by 4 visits during the double blind/placebo part of the trial, followed by visits every 3 months for the open label part of the study. All visits will be in person. Blood will be drawn at every visit. Urine will be collected at most visits. ECG's (recording of your heart activity) will be done on a regular basis. Additional procedures include fibroscans (scan of your liver to determine liver stiffness) and ultrasound exams of your abdomen and bladder. Multiple questionnaires will be competed throughout the trial period.

Yes
 

Karen Krok
Laurie Peiffer - at lpeiffer@pennstatehealth.psu.edu or 717-531-5226
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05627362
STUDY00021989
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Inclusion Criteria:
Diagnosis of PSC
Elevated ALP

Exclusion Criteria:
Chronic Liver Disease
percutaneous drain or bile duct stent
cholangiocarcinoma
bacterial cholangitis within 60 days
hepatic decompensation
Digestive Systems & Liver Disease
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Phase 1/2 Multicenter Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of APL-101 in Subjects with Non-Small Cell Lung Cancer with c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors

This Phase 1 and 2 study is to determine the safety of APL-101 in subjects with NSCLC with specific mutations. It is also to determine the dose that is tolerable for oral administration of APL-101. And to see if there is a clinical benefit to subjects for the amount of time to progression, or progression free survival and overall survival.

We are asking you to give permission for your doctor to send your stored tumor tissue sample for cancer genetic analysis. As part of your cancer care, your doctor may have already collected a tumor tissue biopsy sample (of your cancer tissue) in the past, recently, or being planned as part of standard medical care. Your doctor will ask for any of your stored or available tumor tissue sample collected elsewhere from previous doctors you may have seen in the past. We will not ask you to undergo a new tissue biopsy procedure for this testing however your treating physician may decide to do so as part of your standard of care.There is no required visit for this testing. Once you have signed this consent, your available tumor tissue sample from a prior biopsy or surgery along with the pathology report will be sent to an accredited and certified external genetic laboratory (such as Caris Life Sciences or Interpace Pharma Solutions) to test and understand your cancer’s genetic make-up. The use of your tumor tissue samples as described in this form is necessary for the genetic testing. Without your consent to test your samples, the genetic testing cannot be performed. Once you agree to provide your samples, they cannot be returned to your doctor’s clinic. If the genetic testing of your samples show you have c-MET genetic dysregulations in your cancer, your doctor will discuss your treatment options including clinical trials, such as the APL-101-01 SPARTA trial, with you. If you are interested in participating, you will be asked to review and sign another participant information and informed consent form for the clinical trial before undergoing further screening tests to confirm if you are eligible to participate. The genetic results could also be used to help your clinic doctor decide on an approved therapy, or other investigational therapies that may be right for your specific cancer genetic alterations.

Yes
 

Patrick Ma
Irina Geier - at igeier@pennstatehealth.psu.edu or 717-531-8678
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03175224
STUDY00014799
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Inclusion Criteria:
Phase 1, histologically and / or cytological confirmed unresectable or metastatic solid malignancy, refractory to standard therapies with no more than three prior lines of therapy
Women of child-bearing potential (WOCBP) must have a negative serum or β-human chorionic gonadotropin (β-hCG) at screening or evidence of surgical sterility or evidence of postmenopausal status.
Abnormal c-Met dysregulation, by tissue and/or plasma, defined as the following from local/archival molecular pre-screening evaluations.
Measurable disease according to RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0–1

Exclusion Criteria:
Hypersensitivity to APL-101, excipients of the drug product, or other components of the study treatment regimen.
Known mutation/gene rearrangement of EGFR (except for Cohort C), ALK, ROS1, RET, NTRK, KRAS, and BRAF.
Active uncontrolled systemic bacterial, viral, or fungal infection or clinically significant, active disease process
History of, or currently, or at risk for, cardiac disease (e.g., long QT syndrome [> 450 msec QTcF or concurrent treatment with any medication that prolongs QT interval).
Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter drug absorption (e.g., Crohn’s, ulcerative colitis, active inflammatory bowel disease, uncontrolled nausea, vomiting, diarrhea, or malabsorption sydrome).
Cancer
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Hershey, PA ,

PSCI 23-145 Effective Quadruplet Utilization After Treatment Evaluation (EQUATE): A Randomized Phase 3 Trial for Newly Diagnosed Multiple Myeloma Not Intended for Early Autologous Transplantation

This trial is comparing two different therapies for the treatment of newly diagnosed multiple myeloma who are not having a bone marrow transplant.

Subjects will be required to keep all research visits, take medications as directed, report any new medication of side effects to the study team,

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
NCT04566328
STUDY00024221
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Inclusion Criteria:
Patient must have suspected or confirmed newly diagnosed multiple myeloma (MM) by International Myeloma Working Group (IMWG) criteria and must not have received more than one cycle of treatment.
Patient must be considered ineligible for autologous stem cell transplantation by the treating physician, or willing to delay stem cell transplantion until first relapse or later.
Patient must agree to register to the mandatory Celgene Revlimid REMS program and be willing and able to comply with the requirements of the Revlimid REMS program.
Patient must have standard risk MM as defined by the Revised International Staging System (R-ISS) Stage I or II.31
Patient must be able to undergo diagnostic bone marrow aspirate following preregistration if not performed previously.

Exclusion Criteria:
Patient must not be pregnant or breast-feeding due to the potential harm and teratogenic effects to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.
Patient must not be pregnant or breast-feeding due to the potential harm and teratogenic effects to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.
Patient must not have moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification.
Patient may have a history of current or previous deep vein thrombosis (DVT) or pulmonary embolism (PE) but must be willing to take some form of anti-coagulation as prophylaxis if they are not currently on full-dose anticoagulation.
Patient must not have peripheral neuropathy ≥ Grade 2 on clinical examination or grade 1 with pain
Cancer
Approved drug(s)
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Harrisburg, PA ,
Hershey, PA ,
Reading, PA ,

Testing the effect of ENDS flavors on Neurotransmission

Tobacco users will be randomized to use electronic cigarettes containing varying levels of nicotine and flavor during laboratory protocols to investigate the effects on the brain and behavior. Subjects will complete surveys, functional magnetic resonance imaging scans, and complete computerized tasks. Eligible participants include daily users of inhaled tobacco products who are at least 21 years old, able to read and write in English, and not planning to quit tobacco use within the next month. Exclusion criteria include: current substance use impairing participation, unstable or significant medical conditions, current use of smoking cessation medication, uncontrolled serious mental illness, and MRI safety or neurological contraindications.

Subjects will taste test a variety of e-cigarette flavorings, answer questions and complete a single MRI.

50

Yes
 

Andrea Hobkirk
Kenneth Houser - at abl@pennstatehealth.psu.edu or 717-531-5473
Psychiatry and Behavioral Health (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT05836051
STUDY00019883
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Inclusion Criteria:
Daily inhaled nicotine user for over 1 year
No plan to quit tobacco use in the next month
Age 21 or older
Able to read and write in English

Exclusion Criteria:
MRI Contraindications
Unstable or Significant Medical Conditions
Uncontrolled serious mental illness
Current substance abuse
Smoking, Vaping, Nicotine and Tobacco, Addiction & Substance Abuse, Mental & Behavioral Health
Prefer not to display
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Hershey, PA ,

PSCI# 18-127 EA6174 Adjuvant MK-3475 to SOC

The purpose of this Phase III study is to compare Overall Survival (OS) and Recurrence Free Survival (RFS) across the two arms: MK3475 (Pembrolizumab) to Standard of Care Observation. Patients will undergo standard clinical procedures including physical, labs, vitals, ecg's, and imaging.

We are asking you to take part in a research study. We do research studies to try to answer questions about how to prevent, diagnose, and treat diseases like cancer.

Yes
 

Joseph Drabick
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
NCT03712605
SITE00000461
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Inclusion Criteria:
Patients must have an ECOG performance Status: 0, 1, or 2
Patient must have a histological confirmation of diagnosis of Merkel cell carcinoma (MCC), pathologic stages (AJCC version 8) I-IIIb.
completely resected by surgery within 8 weeks before enrollment.
All patients must have disease-free status documented by a complete physical examination and conventional imaging studies within 4 weeks prior to randomization.
Patients must not be on active immunosuppression, have a history of life threating virus, have had other cancer diagnoses in the last two years

Exclusion Criteria:
Women who are pregnant
present metastases
previous systemic therapy or radiation therapy for Merkel cell carcinoma.
inoperable disease who have received radiation are not eligible.
history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
Cancer
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Hershey, PA ,

The opioid epidemic among Pennsylvania immigrants: Insights from prescribers and rehabilitation professionals

We will interview prescribers and rehabilitation professionals who have provided services and treatment to immigrants in PA with a history of opioid abuse. The goal is to highlight best practices, resources needed, cultural awareness, and training needs to support the rehabilitation and recovery of this client group.

One 45-minute, recorded interview via Zoom

$50.00 Amazon gift card

No
 

Abigail Akande
Abigail Akande - at aoa29@psu.edu
Social and Behavioral Sciences (ABINGTON)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00021288
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Inclusion Criteria:
Medication Assisted Treatment Provider
Substance abuse treatment provider
Opiate pain medication prescriber
Service provider in PA
Provide services to immigrants (non-citizens)

Exclusion Criteria:
Working outside of PA
No experience with immigrant patients/clients
No experience with opioid use disorder
Addiction & Substance Abuse, Mental & Behavioral Health
Not applicable
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Impact of fermented pulses on inflammation and the gut microbiota

The purpose of this study is to investigate whether fermenting pulse foods (e.g. beans, chickpeas, lentils, peas, etc.) changes their effects on the gut microbiome and inflammation. Participants will eat provided meals of either fermented or unfermented pulses, providing blood and fecal samples at the beginning of the study and after two weeks of eating meals containing each of the pulse types.

The study lasts 8 weeks. 2 weeks where you do not consume any of the test food (pulses such as chickpeas, lentils, peas or beans), 2 weeks of consuming the first type of the provided meals, 2 weeks without consuming any of the test foods, 2 weeks consuming the second type of provided meals. There will be five in person visits, one at the beginning to provide consent and then one at the end of each 2 week section. At three of these visits a fecal sample will be collected, blood will be drawn and a dietary survey completed.

300

Yes
 

Darrell Cockburn
Darrell Cockburn - at dwc30@psu.edu or 814-863-2950
Food Science (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT06134076
STUDY00023162
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Inclusion Criteria:
healthy
18-65

Exclusion Criteria:
antibiotic use in the past month
BMI >24.9
Taking any medication for diabetes or weight management
Pregnant
Allergies to meal components
Food & Nutrition
Not applicable
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State College, PA ,

A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of PLN-74809 (bexotegrast) for the treatment of idiopathic pulmonary fibrosis (BEACON)

This is a phase 2b clinical trial looking to see if the drug PLN-74809 (bexotegrast) is effective and safe in patients diagnosed with idiopathic pulmonary fibrosis (IPF).

If you choose to participate in this study and meet all the study entry requirements, you will be randomly assigned (by chance; like the flip of a coin) to receive either bexotegrast or placebo for the whole study. Neither your study doctor nor you will know whether you are receiving bexotegrast or placebo. You will be required to visit the Hershey Medical Center on at least 8 separate occasions over an approximate 58-week period. Procedures that will be performed during your visits include, but are not limited to, physical exams, blood tests, ECGs, completing questionnaires, lung functions tests, and CT scans.

1200

Yes
 

Rebecca Bascom
Timothy Sheehan - at tsheehan@pennstatehealth.psu.edu or 717-531-2925
Medicine: Pulmonary, Allergy and Critical Care (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06097260
STUDY00023219
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Inclusion Criteria:
>/= 40 years of age
IPF diagnosis ≤ 7 years prior to screening
If on Ofev or Esbriet, must be on stable dose for >/= 12 weeks
FVC >/=45% predicted
DLCO >/= 30% predicted and </= 90% predicted

Exclusion Criteria:
Taking medication for pulmonary hypertension
Obstructive lung disease
Current smokers
Active infection
IPF exacerbation within the last 6 months
Lung Disease & Asthma
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Identifying an Alternative to the Classic Presentation of Autism: The ISM Autism Presentation

This study aims to build upon a previous study that established a different presentation of autism called the ISM presentation by using a large sample size to either confirm or dispute this presentation as an alternative to classical autism.

Participants will be required to complete a survey expected to take no longer than an hour.

No
 

Zak Kabbara
Zouheir Kabbara - at zak5195@psu.edu or 478-737-4600
Division of Graduate Studies (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00024256
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Inclusion Criteria:
Reside in the USA
At least 18 years old
Either diagnosed with autism, suspected of having autism or typically developing

Exclusion Criteria:
Is unable to read independently or complete the survey
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The effect of muscle shortening on the force-length characteristics of neighboring inactive muscles

We are trying to better understand the ways in which people contract their muscles. Specifically, we want to learn more about how connections between our muscles influence how they produce forces. Participants in this study will have their calf muscle group activated while we record the individual muscles' electrical activity and the length of the muscle fibers.This research will help us to understand the underlying mechanical function of muscles in a more realistic context. This understanding may also have profound implications for current computer models of muscles, which most often ignore the connectivity between muscles.

There will be one in-person visit. At this visit, participants will have their calf muscle group activated while we record the individual muscles' electrical activity and the length of the muscle fibers.

$50

Yes
 

Jonas Rubenson
Jonas Rubenson - at jxr75@psu.edu or 814-867-6209
Kinesiology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00019507
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Inclusion Criteria:
18-40 years old

Exclusion Criteria:
chronic or acute leg injury in last 12 months
heart condition
chest pain during exercise
balance or dizziness problems
prescribed drugs for blood pressure or heart condition
Muscle & Bone
I'm interested
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State College, PA ,

PSCI 21-191: CG-745-2-08

The purpose of this voluntary research study is to learn more about an investigational drug (also known as the “study drug”) called ivaltinostat as a possible treatment for metastatic pancreatic adenocarcinoma.

Participants will be required to attend all study visits, receive drug treatment, have blood drawn, imaging assessments and tumor biopsy if needed

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05249101
SITE00001325
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Inclusion Criteria:
Provision of informed consent prior to any study specific procedures.
Age: ≥18 years
Histologically or cytologically confirmed pancreatic adenocarcinoma
Patients with or without radiographically measurable disease per RECIST v1.1 are eligible to participate.
Patients with metastatic disease are eligible.

Exclusion Criteria:
For Phase 2, radiographic progression of tumor per RECIST 1.1 between start of first line FOLFIRINOX chemotherapy for metastatic pancreatic adenocarcinoma and randomization.
Cytotoxic chemotherapy or non-hormonal targeted therapy within 21 days of Cycle 1 Day 1 is not permitted
Exposure to an investigational agent within 30 days or 5 half-lives (whichever is longer) prior to randomization.
Any previous treatment with a histone deacetylase (HDAC) inhibitor, including ivaltinostat.
Other primary cancers.
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

Cognitive Debriefing: Developing and instrument to measure Internalized Weight Bias among Adolescents

For many years, overweight and obesity has been highly stigmatized in society, and children are often bullied or teased for their weight. Over time, these experiences can cause adolescents to feel badly about themselves and view themselves as society views them. We call this process the internalization of weight bias or IWB. IWB can increase feelings of depression and anxiety and is associated with unhealthy eating behaviors. For this project, we wanted to create a questionnaire to measure this important topic, and get feedback from adolescents and professionals to make sure the questions are correct and easy to understand. We want to recruit 20 adolescents age 12-17 and medical professionals to review some questions and provide their feedback on these questions by participating in an interview. Participants will be compensated for their time.

We would like to interview teens and health professionals to review some survey questions and make sure that the questions we use to measure this concept are appropriate. These interviews will take 60-90 minutes over ZOOM.

30.00

No
 

Melissa Butt
Melissa Butt - at mab787@psu.edu or 717-531-0003, ext=282467
Public Health Sciences (HERSHEY)
 

All
Younger than 18 years old
This study is NOT accepting healthy volunteers
STUDY00021345
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Inclusion Criteria:
Teens (age 12-17)
Access to internet
Access to video conference
Permission from Parents

Exclusion Criteria:
No parental consent
No internet or video conference
Adults
Mental & Behavioral Health
Not applicable
I'm interested
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SARS Cov-2 Nasal Pharyngeal and Oral Pharyngeal Wash (SNOW) Trial SARS Cov-2 Nasal Pharyngeal and Oral Pharyngeal Wash (SNOW) Trial

Adults recently diagnosed with SARS-CoV-2 infection who use a 4-day combined intervention of nasal washes with 1% baby shampoo solution and oral gargles with Listerine Antiseptic® will have a reduced SARS-CoV-2 viral load compared to those using nasal and oral washes with normal saline. This combined intervention should be acceptable, tolerable and safe in this population. To test this, we are conducting a trial comparing the efficacy of a number of washes in reducing the oral and nasal SARS-CoV-2 viral load amongst adults.

At their home, participants will perform three nasal and oral rinses per day for 4 days and self-swab the nose and mouth before and after each morning rinse to collect specimens under the guidance of a zoom visit. On the morning of the 5th day participants will also self swab the nose and mouth for a final collection specimen. Participants will answer questions on an app and online platform.

100

Yes
 

Rena Kass
Dee Bagshaw - at ddm108@psu.edu or 814-863-7126
Surgery: General Surgery (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04802408
STUDY00016947
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Inclusion Criteria:
18 years of age or older
A positive test for SARS-CoV-2 infection within 5 days of enrollment
Currently in isolation

Exclusion Criteria:
History of nasal or sinus surgery
Non-English speaking
Lack of electronic device (computer, mobile phone etc) on which to access an app for study data collection
Adults that need inpatient care for COVID-19 or any of its complications
Adults that give a history of being unable to tolerate gargles or nasal washes
Infectious Diseases & Immune System, COVID-19, Prevention
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Harrisburg, PA ,
Hershey, PA ,
State College, PA ,

Home telemonitoring of bulbar function by acoustic measurement of swallowing and speech sounds in ALS

Most individuals with ALS experience changes in speech and swallowing over the course of the disease. In some, these are their initial indication of ALS. Identifying these changes, which may be rapid in some individuals, is complicated by the recent acceleration of virtual care delivery. This is a longitudinal home study of ALS patients to assess speech and swallowing function through use of smartphone application. The overall hypothesis is that this monitoring protocol can be used in a way that, 1) is satisfactory to the patient, 2) performs at least as well as standard clinical measures of dysarthria and dysphagia, and 3) resolves the development of emergence of speech and swallowing pathologies in ALS. Patients enrolling in this study will participate for approximately 24 weeks, during which they will have swallowing and speech tests performed, complete surveys, and perform audio recordings of speech on their cellphone. Healthy controls will be enrolled to judge the intelligibility of speech samples provided by patients in the study.

Patients enrolling in this study will participate for approximately 24 weeks, during which they will have swallowing and speech tests performed, complete surveys, and perform audio recordings of speech on a cellphone.

340

Yes
 

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

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT04889898
STUDY00016872
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Inclusion Criteria:
At least 18 years of age
Possess a diagnosis of amyotrophic lateral sclerosis (ALS)
Have symptom onset within the last 6 years
Demonstrate changes in speech or swallowing as a result of ALS.
Possess a smartphone capable of running the study application or have home wireless internet service capable of transmitting study data from a study-issued smartphone.

Exclusion Criteria:
Possess a co-existing neurological or psychiatric illness in addition to their ALS diagnosis
Possess abnormal speech or swallowing processes due to a condition independent of their ALS diagnosis
Neurology, Language & Linguistics
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Hershey, PA ,
State College, PA ,

Collaborative Research: Enhancing Speech Science Training through Collaboration: Investigating Perception of a Variable Speech Signal

In this study, we will evaluate the factors that affect how well human listeners can perceive connected speech despite variability in the speech signal. Participants in the study will be asked to judge speech segments presented to you over headphphones. For instance, we may ask you to indicate whether the sound you hear a "pa" or "ba".

Yes
 

Navin Viswanathan
Navin Viswanathan - at navin@psu.edu
Communication Sciences and Disorders (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00018207
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Inclusion Criteria:
Over 18 and under 65
Knowledge of English (Native and non-native)
Normal or Corrected to normal Vision

Exclusion Criteria:
Under 18 or Over 65
Lack of Knowledge of English
Vision that is not normal and has not been corrected to normal.
Language & Linguistics
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State College, PA ,

Recruitment for Nicotine and Tobacco Related Research at Penn State Hershey

The purpose of this project is to screen potential participants for multiple research studies being conducted by tobacco researchers at Penn State Hershey. Since there are multiple IRB approved studies enrolling at Penn State Hershey with similar but not identical inclusion/exclusion criteria, it is more efficient for the researchers and participants to have one phone number to call initially for basic screening. After completing this, the participant can be redirected for more specific screening if they are found to be potentially eligible for one of the studies.

Participants will fill out a 5-minute survey on tobacco use in order to find out which study they may be eligible for.

Depends on study

Yes
 

Jonathan Foulds
Nicolle Krebs - at smokingresearch@pennstatehealth.psu.edu or 844-207-6392
Public Health Sciences (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00002213
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Inclusion Criteria:
Age 21 or older
Current tobacco user

Exclusion Criteria:
Age less than 21
Smoking, Vaping, Nicotine and Tobacco, Addiction & Substance Abuse, Lung Disease & Asthma
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Harrisburg, PA ,
Hershey, PA ,
York, PA ,

Effects of Vitamin B6 on the Exercise Pressor Reflex in Lower Limb Ischemia-Reperfusion

In this study, we are trying to determine whether Vitamin B6 will help improve the exercise-induced cardiovascular response in healthy participants following a procedure by restricting and recovering the blood flow to the leg.

There will be 6 in-person visits over a month long supplementation of Vitamin B6. Three visits will include a blood draw. Half of the visits will include walking a treadmill and 3 will involve foot exercise (plantar flexion)

You will receive $25/hour for in-person visits and $50 for completing the B6 supplementation

Yes
 

Lu Qin
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
NCT06369350
STUDY00020217
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Inclusion Criteria:
Males or females at least 21 - 70 years of age
All races and ethnicities welcome
Can speak and understand spoken English
Healthy status as defined by history and physical
Females may be on oral contraceptives, but will be excluded if they are pregnant or lactating

Exclusion Criteria:
Pregnant or nursing woman
Current smoker
Known allergy or hypersensitivity to Vitamin B6
Use of recreational drugs in the past 6 months
Taking any medication containing B6 (including multivitamins)
Heart & Vascular
Prefer not to display
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Hershey, PA ,

A Phase 2, double-blind, placebo-controlled, parallel-group study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and potential efficacy of multiple doses of ONO-2808 in patients with Multiple System Atrophy (MSA)

The purpose of this clinical research study is to look at how safe the study drug, ONO-2808, is and whether it works when given to people with Multiple System Atrophy (MSA). The study will look at 3 different doses of the study drug, ONO-2808, compared to a placebo.

Screening Period (up to 6 weeks):The purpose of the Screening Period is to make sure the study is right for you. The Screening Period may be done over 2 days. This is to give you plenty of time to eat, rest and navigate through the study center/hospital at your own pace. Double-blind Treatment Period (24 weeks)The treatment period will consist of approximately 14 visits. Visit 1 (Baseline Visit), Visit 10 and Visit 13 will be done at the study center/hospital. Each visit may be done over 2 days. For the remaining visits, a nurse from IQVIA’s Research Nurse and Phlebotomy Solutions (RNPS) will come to your home to perform visit procedures. It is expected that these visits will take about 2 hours. All necessary safety measures will be taken during these visits. Your study medication may also need to be delivered to your home address. In this case, you or your caregiver will need to receive and sign for the study medication.You may be asked to come to the study center/hospital for extra visits (unscheduled), if the study doctor feels it is in your best interest.You may be allowed to continue taking medications to treat your MSA symptoms. Your study doctor will discuss this with you.After you complete the 24-week treatment period, you may be eligible to receive ONO-2808 in a separate study.Follow-up Period (4 weeks after last dose of study medication):You will have a follow-up visit about 4 weeks after your last dose of study medication. This visit will be done at your home in a similar way to your home visits during the Double-blind Treatment Period. It is expected that this visit will take about 2 hours.If you are eligible and volunteer to receive ONO-2808 after the 24-week treatment period, the follow-up visit will not be required.Early Termination Visit:If you stop the study early, you will be asked to come to the study center/hospital for an Early Termination Visit. This visit may be done over 2 days.Study visits include questionnaires; physical/neurological exams; vital signs and blood pressure measurements; ECGs; blood draws, including HIV and hepatitis testing; urine tests; and brain and liver MRIs. Pregnancy testing is required for female participants.

750.00

Yes
 

Sol De Jesus
Autumn Collier - at acollier3@pennstatehealth.psu.edu or 717-531-0003, ext=281168
Neurology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05923866
STUDY00022433
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Inclusion Criteria:
Participants aged 30-80 years (inclusive) at signing of consent documents
Diagnosis of clinically-established or clinically-probable MSA-parkinsonian type or MSA-cerebellar type
Participants at the early stages of the disease, defined as a maximum of 5 years since the onset of one of the following symptoms associated with MSA: parkinsonism, ataxia, orthostatic hypotension and/or urinary dysfunction
Ability to take at least 10 steps, turn around, and walk at least another 10 steps without the assistance of another person. Assistive devices are allowed.
Ability to swallow oral medication

Exclusion Criteria:
Neurological diseases/disorders other than MSA
Regular use of neuroleptics within 6 months prior to the initial evaluation by the study team
Patients with documented liver diseases or cirrhosis
Inability to undergo MRIs
Neurology
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Understanding Shooter Dynamics with VR

We are trying to characterize the movement of a shooter in a VR environment.

The study consists of one visit lasting approximately 30-40 minutes: 10 minutes for VR setup, 15 minutes for simulated test, and 5-15 minutes for post-experiment survey. During the simulated test, participants will be asked to move around in the environment and shoot NPCs.

$20

Yes
 

Alan Wagner
Chris McClurg - at cam7498@psu.edu
Aerospace Engineering (UNIVERSITY PARK)
 

Male
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00022246
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Inclusion Criteria:
At least 18 years of age.
Male.
Not prone to nausea when experiencing VR.

Exclusion Criteria:
Under the age of 18 years.
Do not identify as male.
Prone to nausea when experiencing VR.
Education, Mental & Behavioral Health
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State College, PA ,

Non-Hispanic Black Individuals and Vascular Function

This study will examine the impact of age, sex, and racial/ethnic background on vascular function.

There will be three (3) in-person visits: one screening, one experimental visit, and one visit to return equipment. Equipment includes a 24-hour Ambulatory Blood Pressure monitor and an 8-day accelerometer (physical activity tracker). Blood will be drawn at the screening and experimental visit. Participants will undergo tests for cardiovascular measures during the experimental visit.

$100

Yes
 

Lacy Alexander
Virginia Content - at vgc5042@psu.edu or 814-863-2140
Kinesiology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00023545
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Inclusion Criteria:
18-75 years of age
Male or Female
Identify as Non-Hispanic Black or Non-Hispanic White

Exclusion Criteria:
Individuals of mixed race
Tobacco consumption (e.g., smoking) or Recreational drug use (e.g., marijuana)
Pregnant and/or breastfeeding
Taking blood pressure medication
Diagnosed with metabolic and/or cardiovascular disease(s)
Heart & Vascular
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State College, PA ,

Oxidative Stress and Harmful Constituent Levels Associated with Little Cigars

The propose of this voluntary research study is to look at the effect of little cigars on biomarkers of potential harm with a focus on oxidative stress and inflammation. The study is also interested the effect of flavors in little cigar.

Subjects will attend 7 study visits over 7 weeks. They will be sent home with a selection of little cigars to use during the first week. Starting at week 2, they will be asked to smoke a certain cigar each week for the next 6 weeks at their study visit. They will be asked to answer a series of questionnaires and to provide biosamples (Exhaled Carbon Monoxide, Exhaled Breath Condensate, Buccal Cells, Urine and Spirometry).

600

Yes
 

Joshua Muscat
smokingresearch@pennstatehealth.psu.edu
Public Health Sciences (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT06310187
STUDY00023967
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Inclusion Criteria:
Aged 21-65
Daily tobacco smoker
No serious quit attempts in previous 30 days

Exclusion Criteria:
Pregant or trying to become pregnant
Respiratory diseases
Substance Abuse
Smoking, Vaping, Nicotine and Tobacco, Addiction & Substance Abuse
Not applicable
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Hershey, PA ,

Understanding Suicide and Self-Harm Among Young Adults in Daily Life

This study explores participants mood and how it changes from day to day and how mood and other things like personality and relationships influence thoughts of suicide or self-harm. Participants will both track and be able to visualize their mood and other experiences on a daily basis from their own smartphones.

There will be a set of questionnaires to complete online that will last between 45 and 90 minutes. Then participants will complete very brief (about 2 minute) surveys a few times per day on their smartphone over 12 weeks.

$140

No
 

Kenneth Levy
Alec Trahan - at atrahan@psu.edu
Psychology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT00000000
STUDY00018404
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Inclusion Criteria:
English-speaking
Undergraduate student at Penn State
Have thoughts of suicide or self-harm in the past 12 months
Own and use an Apple iOS or Android smartphone device

Exclusion Criteria:
Does not speak English
Not a Penn State undergraduate student
Does not own an Apple iOS or Android smartphone device
Unwilling/unable to download and utilize study smartphone app
Prevention, Sleep Management, Mental & Behavioral Health
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Studying speech perception in realistic listening conditions

The purpose of this study is to examine how various factors, such as the acoustics of the environment and background noise, affect the understanding of speech.

Researchers in the Graduate Program in Acoustics are looking for participants for a study related to speech intelligibility and room acoustics. The experiment will take approximately 1.5-2 hours of your time. The experiment will consist of listening to sentences and transcribing them under different acoustic and noise conditions. Your head movement will also be measured through a motion sensor. The compensation for your voluntary participation is a $25 Amazon gift card.

$25 Amazon gift card

Yes
 

Michelle Vigeant-Haas
Olivia Heui Young Park - at hkp5188@psu.edu
Acoustics (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00024788
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Inclusion Criteria:
18 years of age or older
native speaker of American English
no diagnosed speech, language, or hearing disorders
normal or corrected-to-normal vision

Exclusion Criteria:
younger than 18 years old
not a native speaker of American English
diagnosed with speech, language, or hearing disorders
not have normal or corrected-to-normal vision
Language & Linguistics
Not applicable
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State College, PA ,

Daratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (PSCI# 21-115) (EAA173).

The purpose of this study is to determine whether patients with high-risk smoldering multiple myeloma when treated with daratumumab in addition to lenalidomide and dexamethasone live longer when compared to patients with high-risk smoldering multiple myeloma patients treated with lenalidomide and dexamethasone. We would also like to know whether the period of time in which patients are free of multiple myeloma symptoms differs between the two treatment groups.Daratumumab is already approved by the FDA for use in combination with lenalidomide and dexamethasone in people who have received at least one prior medicine to treat multiple myeloma. It is not, however, approved for treatment of smoldering multiple myeloma, either alone or when combined with the treatment regimen of lenalidomide and dexamethasone, and therefore is considered experimental. Lenalidomide and dexamethasone are approved for treatment of multiple myeloma (symptomatic) but not for the treatment of smoldering multiple myeloma and therefore is also considered an experimental treatment.

We are asking you to take part in a research study because you have high-risk smoldering multiple myeloma. We do research studies to try to answer questions about how to prevent, diagnose, and treat diseases like cancer.

Yes
 

Seema Naik
psci-CTO@pennstatehealth.psu.edu
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03937635
SITE00001112
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Inclusion Criteria:
Patient must be 18 years or older.
Patient must be diagnosed with asymptomatic high-risk smoldering multiple myeloma (SMM) within the past 12 months.
A bone marrow aspirate and/or biopsy is required to be performed within 42 days prior to randomization and must demonstrate 10-59% clonal plasma cells.
Patient must have adequate organ and marrow function.
Patient must agree to register into the mandatory REMS program and be willing and able to comply with the requirements of REMS.

Exclusion Criteria:
Known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) <50% of predicted normal or known moderate or severe persistent asthma within 2 years prior to randomization.
Concurrent use of erythropoietin is not allowed while on study therapy.
Prior or glucocorticosteroid therapy for the treatment of multiple myeloma is not permitted.
Patients with monoclonal gammopathy of undetermined significance are not eligible.
Patient must not have Grade 2 or higher peripheral neuropathy per CTCAE.
Cancer
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Hershey, PA ,

Habitual Diet and Avocado Trial

This study aims to evaluate the effect of providing one avocado per day for consumption over a six month period on established health parameters, including visceral adiposity, hepatic lipid content, markers of metabolic syndrome and high sensitivity C-reactive protein (hsCRP), compared to habitual diet.The primary aim of this study is to determine whether providing one avocado per day for consumption for six months will produce a greater decrease in visceral adiposity as measured by magnetic resonance imaging (MRI) in Americans with an increased waist circumference as compared to habitual diet.

Yes
 

Richard Legro
Erin Hammett - at ehammett@psu.edu or 717-531-1510
Obstetrics and Gynecology (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
SITE00000366
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Inclusion Criteria:
>25 years of age
not currently eating >2 avocados per month
increased waist circumference (35+ inches for women, 40+ inches for men)

Exclusion Criteria:
does not eat or is allergic to avocados
not willing to undergo MRI scans
unstable medical conditions
lost/gained 10 or more pounds in past year
Food & Nutrition
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Hershey, PA ,