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Stepping and Balance in Young and Older Healthy Adults Walking on Winding Paths

As we walk, we have to stay balanced to avoid falling while also being able to maneuver along various paths that are most often not straight. This study will test younger and older healthy adults walking on paths of varying complexity and difficulty to determine how they negotiate achieving these various task goals. We predict that older adults will have greater difficulty successfully completing these tasks and will use different motor control strategies to do so.

There will be one in-person visit (easy free parking is available). This visit should last no more than 2 hours total.We will ask you to complete a health history questionnaire, do some basic visual assessments, and physical assessments. Your height, weight, and blood pressure will also be taken. After screening, you will walk on a treadmill in a virtual reality environment. We will ask you to walk on various different paths. Your task will be to stay on a path that may be windy and/or difficult to see. Treadmill walking will take less than an hour and you can take rest breaks as needed.

$30.00

Yes
 

Jonathan Dingwell
Sarah Overby - at seo5285@psu.edu
Kinesiology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00025096
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Inclusion Criteria:
Age 18-35, or 65 or older
No medications or health conditions that significantly impair your walking ability.
Body Mass Index (BMI) more than 18 and less than 30
Normal corrected vision (≥ 20/40)
Able to walk un-assisted for at least 5 minutes without shortness of breath, chest pain, or joint pain in the legs, neck, or back

Exclusion Criteria:
Not meeting any of the above
Prevention
Not applicable
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State College, PA ,

Feasibility Study of a Training/Certification Program to Improve Health Care Outcomes for Individuals with Autism

This feasibility study will examine interest and attitudes in a possible training/certification program relating to health care outcomes for individuals with autism. The study will utilize a survey distributed to staff in health care settings. The survey will explore staff preferences regarding training formats and training incentives as well as current accommodations offered to patients with autism. The data from the survey answers will guide researchers to the most effective type of training modules to support health care professionals in providing health care to individuals with autism. In addition, the survey answers will provide researchers with the tools needed to offer support to medical professionals and other office staff members to provide purposeful accommodations with patients with autism.

Participants will be asked to complete an online survey.

No
 

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

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00025482
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Inclusion Criteria:
Individuals at least 18 years of age
English as primary language
Work in a licensed health care setting
Have direct contact with patients

Exclusion Criteria:
Individuals under 18 years of age
English is not the primary spoken language
Do not work in a licensed health care setting
Do not have direct contact with patients
Not applicable
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A Phase 2 Long-Term Open-Label Trial to Assess the Safety andEfficacy of Repeat Dosing of STAR-0215 in Adult Patients withHereditary Angioedema (The ALPHA-SOLAR Trial)

The purpose of this study is to collect long-term safety data and to assess the efficacy of STAR-0215 in subjects with Type I or Type II Hereditary Angioedema (HAE).

Participants will answer questions about your health, provide blood samples, undergo routine urine laboratory tests, receive the study drug, undergo electrocardiogram (ECG), complete questionnaires, undergo physical exams, and provide Hereditary Angioedema (HAE) attack information. Participants in this study will have 17, 18, or 23 in person visits and 4 or 9 remote visits (phone contacts) depending on the Dosing Regimen.

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06007677
STUDY00024410
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Inclusion Criteria:
History of HAE Type 1 or 2.
AT least 2 HAE attacks during the Run-In Period between Screening and the Treatment Period.
Agree not to receive a dose of any vaccine within 7 days before or after study medication administration.

Exclusion Criteria:
Active liver disease.
Diagnosis of another form of chronic angioedema besides HAE.
Active cancers except for basal cell skin cancer.
Allergies, Infectious Diseases & Immune System
Experimental drug compared to an approved drug
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Hershey, PA ,

Clinical Decision Making

This study investigates how clinicians (medical students) assess pain during simulated patient interactions. Participants will watch videos depicting patients with varying pain levels, while their brain activity is monitored using functional Magnetic Resonance Imaging (fMRI). The research aims to understand the neurological and behavioral responses in clinical decision making enhancing our knowledge of clinical practices and patient care.

Participants will complete pre-visit questionnaires at home, engage in simulated clinical interactions during a single lab visit fMRI session, and fill out post-visit questionnaires immediately after the MRI. This study is designed to assess their clinical decision-making in response to pain scenarios.

250-400

Yes
 

Elizabeth Losin
Maryam Amini - at maryam.amini@psu.edu or 720-243-6676
Biobehavioral Health (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00024553
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Inclusion Criteria:
1.Adults aged 18-55.
2.Currently enrolled as either 4th-year medical students at Hershey Medical Campus or University Park, or pre-medical students who have been accepted into a medical program for the 2024 academic year.
3.No reported substance abuse within the past year.
4.Capable of performing experimental tasks, including speaking and reading English, following instructions, and tolerating an fMRI scan.
5.Fluent or native English speakers.

Exclusion Criteria:
1.Under the age of 18 and over 55
2.Inability to tolerate scanning procedures, including claustrophobia.
3.Presence of metal in the body or a history of working with metal fragments that pose a risk in MRI environments.
4.Contraindications for MRI examination, such as metallic implants, pacemakers, surgical aneurysm clips, nicotine patches, or known metal fragments in the body.
5.History of neurological or systemic disorder that could impair cognitive function.
Education, Mental & Behavioral Health, Pain Management
Not applicable
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State College, PA ,

A PHASE 2, SINGLE ARM, OPEN LABEL EXTENSION STUDY, EVALUATING THE LONG-TERM SAFETY AND CLINICAL EFFICACY OF INBRX-101 IN ADULTS WITH ALPHA-1 ANTITRYPSIN DEFICIENCY (AATD) EMPHYSEMA

The study will test INBRX-101 as an experimental drug to treat patients with Alpha-1 antitrypsin deficiency. “Experimental” means the drug has not been approved by any authority that regulates new medications, including the US Food and Drug Administration. Therefore, it can only be used in a research study. INBRX 101 is an artificial form of Alpha-1 antitrypsin that has been altered to last longer in the body. This means that INBRX-101 could be given less frequently than the currently approved augmentation therapies for this condition because it works for longer in the body. Its purpose is to understand the safety and therapeutic effects of INBRX-101 over 3 years. All patients in this study will receive only INBRX-101.

You will visit the study site for blood sampling, computed tomography (CT) scan, lung function tests, electrocardiograms (ECGs), study drug administration and questionnaire completion. Some visits may be completed with assistance from a home healthcare organization. The study will last approxiately 3 years.

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05897424
STUDY00024899
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Inclusion Criteria:
Males or females 18-80 years of age and Ability to understand and the willingness to sign a written informed consent document
Diagnosis of Alpha-1 Antitrypsin Deficiency
Evidence of emphysema related to alpha-1 antitrypsin deficiency
Current non-smoking status
Alpha-1 Antitrypsin Deficiency genotype of Pi*ZZ, Pi*ZNull, Pi*MaltonZ, Pi*NullNull, or Pi*Mheerlen.

Exclusion Criteria:
PI*SZ, PI*MS, and PI*MZ genotypes are excluded.
On waiting list for lung or liver transplant
Active cancers or has a history of cancer within 5 years prior to screening
Current substance and/or alcohol abuse
Lung Disease & Asthma
Experimental drug compared to an approved drug
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Hershey, PA ,

PSCI 24-079 THE PHASE III ‘HIGH FIVE TRIAL’ FIVE FRACTIONRADIATION FOR HIGH-RISK PROSTATE CANCER

This trial is comparing disease free survival using standard radiation versus higher doses of radiation to the prostate to prevent the cancer from spreading.

Participants will be chosen to enroll into one of two types of radiation to treat their prostate cancer. they must agree to keep all appointments over the 5 years period and agree to be contacted every year for follow up.

Yes
 

Zain Siddiqui
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Radiology (HERSHEY)
 

Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05946213
STUDY00025462
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Inclusion Criteria:
Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate cancer.
High-risk disease
Prostate gland volume less than 100 cc prior to initiation of ADT
o definitive clinical or radiologic evidence of metastatic disease
Age ≥ 18

Exclusion Criteria:
No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
No prior radical prostatectomy;
Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both LHRH agonist and oral anti-androgen) is ≤ 185 days prior to registration;
Cancer
Not applicable
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Hershey, PA ,

BCC021: Phase I/II study of Silmitasertib (CX-4945) in combination with chemotherapy in children and young adults with relapsed refractory solid tumors

The purpose of this study is to evaluate the investigational drug Silmitasertib (CX-4945) (a pill taken by mouth) in combination with chemotherapy drugs standardly used for your tumor type. An investigational drug is one that has not been approved by the U.S. Food & Drug Administration (FDA), or any other regulatory authorities around the world for use alone or in combination with any drug, for the condition or illness it is being used to treat.

You will undergo a number of standard tests and research-related procedures before being able to enroll on this study.

Yes
 

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

All
All
This study is NOT accepting healthy volunteers
NCT06541262
STUDY00025626
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Inclusion Criteria:
Less than 30 years old at initial diagnosis

Exclusion Criteria:
Currently receiving another investigational drug
Cancer
Prefer not to display
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Hershey, PA ,

The Association Between Head Cooling and Cognition, EEG Patterns, Neuroinflammatory Cytokines, and Mental Health

This research is being done to find out the effects of head cooling on cognition, brain activity as seen in EEG scans, inflammation of the brain, and mood in healthy subjects. What is specifically meant by healthy subjects in the context of this study is subjects who are not currently recovering from a traumatic brain injury.

This study includes an 8-day regimen of head cooling or rest at an average of 30 minutes per day, non-invasive cheek swabs used to collect saliva samples, and non-invasive brain activity testing and questionnaires.

$40

Yes
 

Semyon Slobounov
Laura Cooney - at lmc6418@psu.edu or 267-421-2419
Kinesiology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT06542419
STUDY00025196
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Inclusion Criteria:
18-24 years
Currently NOT recovering from a brain injury

Exclusion Criteria:
Under 18 years
Currently recovering from a brain injury
Mental & Behavioral Health
Not applicable
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State College, PA ,

Open-Label Safety, Pharmacokinetic, and Efficacy Trial of Sebetralstat (KVD900) in Pediatric Patients(Ages 2-11) with Hereditary Angioedema Type I or II

The purpose of this research study is to test the safety of the study drug, sebetralstat and to see if it can treat Hereditary Angioedema (HAE) at the time of an HAE attack and to determine how children's bodies absorbs, breaks down, and remove sebetralstat.

You and your child will be expected to attend all study visits, complete the HAE attack diaries to the best of your ability, and tell the study staff about changes to your child’s health, medications, and other medical treatments. Your child is expected to take the study medication as instructed and will allow study staff to draw blood.

Yes
 

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

All
Younger than 18 years old
This study is NOT accepting healthy volunteers
NCT06467084
STUDY00025025
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Inclusion Criteria:
Aged 2 to 11 years
Diagnosis of Hereditary Angioedema (HAE) Type 1 or Type 2
At least 1 HAE attack in the last year
Caregiver must be able to appropriately store and administer the study medication
Caregiver must be able to complete a paper diary about attack information

Exclusion Criteria:
Child weighs less than 20.9 pounds
Child participated in a investigational clinical trial within 4 weeks prior to the screening visit
Infectious Diseases & Immune System
Experimental drug compared to an approved drug
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Hershey, PA ,

GLP-1R Agonist Treatment for Opioid Use Disorder - A Multi-Site Randomized Placebo-Controlled Trial

This is a multi-site, double-blind, placebo-controlled trial to determine if the study drug, semaglutide, will reduce illicit opioid use and craving in opioid-dependent patients receiving treatment for opioid use disorder. The study drug, semaglutide, is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, but it is not specifically approved for the treatment of cravings and opioid use in patients with substance use disorders. Therefore, its use in this research should be considered “investigational.”

A screening visit will take place to see if you eligible to receive the research treatment, which will include urine (for drugs and pregnancy) and blood tests as well as questionnaires about your mental health and drug use. If you are eligible to continue in the research, we will randomize you to either the study medication or the placebo, which you will receive once a week for 12 weeks. During the 12 weeks of treatment, we collect your vital signs, perform a physical examination (first visit only), collect your medical history (first visit only), do a urine drug screen and pregnancy test, give you questionnaires about your mental health and drug use, and ask you about the other medications you are taking. We will then administer the study medication or placebo, depending on what group you were randomized to. You will also complete surveys at set times on your smartphone. After your last treatment visit, you will return to the site two more times for study visits without any study medication or placebo administration. A blood draw will also occur at the washout visit. The smartphone surveys will continue at set times until your final study visit. You will attend a total of 15 study visits over 19 weeks.

Maximum of $873.00

Yes
 

Jennifer Nyland
jnyland@pennstatehealth.psu.edu
Neural and Behavioral Sciences (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06548490
STUDY00024676
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Inclusion Criteria:
Age 18 to 75 years
Body mass index (BMI) > 18
Current diagnosis of Opioid Use Disorder
Currently receiving outpatient treatment for OUD and at least 2 weeks on BUP or 4 weeks on methadone at the study site and/or at an associated clinic
Able to read and communicate in English to the level required to accept standard care and complete all study requirements

Exclusion Criteria:
Age < 18 or > 75 years
BMI <18
Individuals who are pregnant, planning pregnancy, breastfeeding, or unwilling to use adequate contraceptive measures
Current use of medications that help lower blood sugar levels and promote weight loss
Plans for travel outside of the local area over the 19 that would interfere with visits during the study period or other logistic factors that would make it difficult to commit to the entire duration of study
Addiction & Substance Abuse
Experimental drug compared to a placebo/”sugar pill”
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Harrisburg, PA ,

A Phase 3, Randomized, Double-blind, Placebo-controlled, Cross-over Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Attacks in Adolescents and Adults with Hereditary Angioedema

The purpose of this clinical research study is to learn more about the use of the investigational drug, deucrictibant, for the treatment of HAE. Deucrictibant is designed to block the effects of bradykinin to avoid progression of attacks and lead to the resolution of attacks. In this study, the investigational drug is a soft capsule containing 20 mg of deucrictibant that you will take by mouth. There are already medicines available to treat the manifestations of HAE attacks, but these are injected either into a vein or under the skin. If you are currently on a stable dose of prophylactic treatment to prevent HAE attacks, you will be asked to continue using this at the same dose throughout the duration of the study.

You will need to come to the study site approximately four times. At two of these visits, you will have blood and urine collected. You will have vital signs collected, physical exams, vital signs, and EKG’s performed. You will need to treat two HAE attacks with the study drug, complete questionnaires on an electronic diary, and participate in telephone interviews with the study team.

Yes
 

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

All
All
This study is NOT accepting healthy volunteers
NCT06343779
STUDY00024656
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Inclusion Criteria:
Aged ≥12 to ≤75 years at the time of providing written informed consent/assent.
Diagnosis of HAE-1/2
History of at least 2 HAE attacks in the last 3 months before screening.
Experience with using standard-of-care treatment to effectively manage on-demand treatment for HAE attacks.
Capable of recording, without assistance, electronic HAE diary using an electronic device, as evidenced by the competency assessment conducted during the screening phase.

Exclusion Criteria:
Any female who is pregnant, plans to become pregnant, or is breastfeeding.
Any diagnosis of angioedema other than HAE-1/2.
History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse.
Use of attenuated androgens for short-term prophylaxis within the last 30 days before the time of randomization.
Prior gene therapy for any indication at any time.
Infectious Diseases & Immune System, Allergies
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

PSCI 23-110 CA209-6K6 An open label, randomized study of neoadjuvant nivolumab and chemotherapy, with or without sub-ablative stereotactic body radiation therapy, for resectable stage IIA to IIIB non-small cell lung cancer

We are asking you to take part in this voluntary research study because you have lung cancer that will require surgery, chemotherapy, and possibly immunotherapy. The study involves chemotherapy and immunotherapy given during the 6 weeks prior to surgery.

In person visits for Screening, Treatment and Follow-up visits. Treatment is given monthly on day 1,22 &amp; 43. Special test will be conducted at these time periods such as Physical Exam, Blood Draws and CT/Pet scans.

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05500092
STUDY00025056
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Inclusion Criteria:
Age > 18 years at time of study entry
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Written informed consent and HIPAA obtained from the subject prior to performing any protocol-related procedures
Evidence of post-menopausal status or negative urinary or serum pregnancy test for female premenopausal patients.
Hemoglobin ≥ 9.0 g/dL

Exclusion Criteria:
Participation in another clinical study with an investigational product during the last 3 weeks
Current or prior use of immunosuppressive medication within 14 days before the first dose of nivolumab, with the exceptions of intranasal, inhaled, topical steroids
Patients with Grade ≥2 neuropathy
History of allogeneic organ transplant.
History of hypersensitivity to nivolumab or any excipient
Cancer
Approved drug(s)
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Hershey, PA ,

The Application of Mixed Methods and Social Network Analysis to Develop a Novel Measure of Social Connectedness for Adolescent/Young Adult Cancer Survivors (AYACS)

The purpose of this voluntary study is to evaluate adolescent and young adult cancer survivors’ (AYACS) social network changes over the first year after being diagnosed with cancer. This study is also exploring difference is AYACS’ social networks based on rurality. With this information, a better understanding on rural and non-rural AYACS’ social networks will be used to improve care and available resources.

As a study participant, you will complete two study visits—one after cancer diagnosis and the second one year after cancer diagnosis. Both visits should take up to about one hour and can be completed both in person and remotely. Each visit will entail the following activities: oA 30-minute interview over a secure video conference software (Microsoft Teams). The session will be audio and video recordedoSome of your contact and medical/demographic information will be collected via chart review and/or a survey. This includes but is not limited to phone number, email, race, gender, insurance, diagnosis, and other common demographic information.oNetwork Canvas social network analysis “interview” (the program’s term for a survey)oSurveys assessing social isolation and emotional support

$100.00

No
 

Pooja Rao
Pooja Rao - at prao2@pennstatehealth.psu.edu
Pediatrics: Hematology/Oncology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT00000000
STUDY00025425
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Inclusion Criteria:
Participant age 15-29 years old at time of cancer diagnosis
Within 120 days of cancer diagnosis
Participant receiving cancer treatment at Penn State Health
United States resident and English speaking
Access to computer or smartphone

Exclusion Criteria:
Relapsed cancer
Cognitive inability to participant in study
Mental & Behavioral Health, Cancer
Not applicable
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Play &amp; Learning Across a Year

This study will record on video mothers and infants engaged in natural activities in their homes. The videos will be coded by experts in language, physical activity, emotion, and object interaction. The data will be shared with researchers via the web-based Databrary.org data library.

There will be one home visit lasting 2-3 hours. Video will be recorded of the child up to 2 years old and mother going about their day for 1 hour, play with specific toys, and survey questions for mom.

$50

Yes
 

Rick Gilmore
Andrea Seisler - at ars17@psu.edu
Psychology (UNIVERSITY PARK)
 

All
All
This study is also accepting healthy volunteers
SITE00000646
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Inclusion Criteria:
child aged 11-25 months
primarily speak English
healthy volunteers

Exclusion Criteria:
non-English speaker
Children's Health
Not applicable
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State College, PA ,

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 STUDY OF SIRNA GENE SILENCING FOR THE TREATMENT OFNON-ALCOHOLIC STEATOHEPATITIS (NASH) IN PARTICIPANTS WITH GENETIC RISK FACTORS

This is a Phase 2 drug study, using a precision medicine approach to treat a chronic liver disease called Non-Alcoholic Steatohepatitis (NASH) in individuals at increased genetic risk for this condition. The primary objective of the study is to evaluate the effect of the study drug, ALN-HSD, on the histopathologic (liver biopsy) assessment of liver fibrosis. The study has a screening period of up to 16 weeks (day -113 to -1),a double-blind placebo-controlled treatment period of 52 weeks (day 1 to 365), and an off-drug safety follow-up period of 32 weeks (day 366 to 589). In total, the study duration is approximately 100 weeks.The study drug, or placebo, would be administered subcutaneously (through a fine needle in the belly) every 4 weeks, for a total of 13 doses. During the course of the study, there will be approximately 20 visits, which will take place in the clinical research center of our hospital. At these visits, participants will receive the injections, and be evaluated for vital signs, have regular bloodwork, receive a physical, and answer questions about their well being.

There will be up to 20 in person visits. The screening visits will include bloodwork, vitals, body measurements, and some additional scans. After randomization, each visit will occur approximately every two weeks and will include blood work and a physical at each visit, in addition to the administration of the study drug.

$2000

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05519475
STUDY00025117
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Inclusion Criteria:
Adult male or female ≥18 years and ≤75 years of age.
A diagnosis of NASH with fibrosis (F) stage 2 or 3

Exclusion Criteria:
Cirrhosis from any cause, including cirrhosis due to NASH
Alcoholic liver disease
History of Type 1 diabetes
Digestive Systems & Liver Disease
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Comparison of skin menthol and other bioactive content with different commercially available topical analgesics

Menthol is the active ingredient in topical analgesics. Some manufacturers use special encapsulation techniques in order to prolong the effects of menthol. Our goal is to use intradermal microdialysis to assess how much menthol, along with other organic bioactives, are present in the skin following topical application of various commercially available topical analgesics. We also examine the affect of a menthol-based analgesic gel on the skin blood flow.

There will be a screening visit and then up to seven experiment visits where different topical analgesics will be applied to the forearm skin. We will use intradermal microdialysis and measure skin blood flow.

240

Yes
 

Lacy Alexander
Andrew Johnson - at avj5530@psu.edu
Kinesiology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00006335
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Inclusion Criteria:
Healthy
18-30 years old
Non-smokers
No use of nicotine containing compounds
No illegal/recreational drug use

Exclusion Criteria:
Regular use of commercially available topical analgesics (e.g., menthol)
Skin rash, skin disease, or disorders of pigmentation
Sensitivity to menthol
Pregnant
Breastfeeding
Heart & Vascular, Pain Management
Not applicable
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State College, PA ,

A Phase III, Randomised, Double-blind Study to Evaluate theEffect of Balcinrenone/Dapagliflozin, Compared withDapagliflozin, on the Risk of Heart Failure Events andCardiovascular Death in Patients with Heart Failure and ImpairedKidney Function (BalanceD-HF, D6402C00012))

The study is being done to determine whether dalcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of cardiovascular death and heart failure events with and without hospitalization

Sign consent form, attend scheduled study visits, undergo an echocardiogram (if applicable) and electrocardiogram, complete pregnancy test (if applicable), undergo physical examination, vital signs, height and weight measurements, complete study questionnaires, provide urine and blood samples for the study, take study medication as directed.

up to $1,600

Yes
 

Umar Farooq
PSHVIResearchCoordinators@pennstatehealth.psu.edu 717-531-5967
Medicine: Nephrology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06307652
STUDY00024754
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Inclusion Criteria:
recent heart failure event
being treated for heart failure
undergoing treatment for decreased kidney function

Exclusion Criteria:
chest discomfort, heart attack or stroke within last 3 months
major heart surgery within the past 3 months
complicated heart defects at birth or severe uncorrected valve disease
Kidney & Urinary System, Heart & Vascular
Experimental drug compared to an approved drug
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Hershey, PA ,

Alzheimer’s Network for Treatment andDiagnostics (ALZ-NET)

ALZ-NET will follow and record information about people’s health, safety, brain scans, and long-term health outcomes during their regular memory care.

At specific time points throughout your participation in ALZ-NET, your memory care provider or designated staff will transfer data about your health, diagnosis, treatment, and brain imaging that are related to your memory concerns to the ALZ-NET operations center.These time points include at a 6-month, 12-month, 18-month, and 24-month timepoint, and once per year after that until your participation ends.

Yes
 

William Jens
Reba Chivari - at rchivari@pennstatehealth.psu.edu
Neurology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06170268
STUDY00025554
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Inclusion Criteria:
Patient is at least 18 years of age at the time of informed consent
Patient or patient’s legally authorized representative (LAR) (e.g., spouse or legal guardian) has the ability to understand and provide signed and dated informed consent
Patient has a diagnosis of MCI or dementia with clinical suspicion of Alzheimer’s disease (AD)
If treatment is initiated at time of consent, the patient meets appropriate label requirements and treatment follows appropriate use recommendations for novel FDA-approved AD therapy/therapies
Patient’s treating clinician has made the decision to provide clinical care or treatment prior to patient consent and independently of the purpose of ALZ-NET

Exclusion Criteria:
Not diagnosed with AD
Neurology
Not applicable
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Hershey, PA ,

A Prospective, Multicenter, Randomized, Pivotal Study of the May Health System in Transvaginal Ablation of Ovarian Tissue Under Ultrasound Guidance in Women with Infertility Due to Polycystic Ovary Syndrome

This is a randomized trial whereby a study device will be used to remove tissue from the ovary via a transvaginal ultrasound procedure in order to promote/restore ovulation in women with infertility due to PCOS. Weekly serum blood draws will also be obtained to determine ovulation rates during the first 12 weeks of study enrollment. Those randomized to the control arm will have the option of crossing over to the device arm after 3 months.

Preliminary visit to assess eligibility followed by randomization into the Device or Control Arm. Device Arm requires May Health procedure (approximately 1 hour long, similar to ovarian drilling) followed by 12 weekly blood tests and 6 follow up clinic visits and follow up calls for up to 36 months after the procedur4e. Control Arm requires 12 weekly blood tests and the option to cross-over to the device arm after 3 months. If no cross-over occurs, the control arm will have one follow up visit at 3 months and can then exit the study. Both arms will complete questionnaires and log menstruation dates in an e-diary.

1220

Yes
 

Stephanie Estes
Robinn Moyer - at rmoyer3@pennstatehealth.psu.edu or 717-531-6272
Medicine: Endocrinology, Diabetes and Metabolism (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06206746
STUDY00023415
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Inclusion Criteria:
18-40 years of age
Infertility associated with oligo or anovulation and ultrsonographic evidence of PCOS or evidence of hyperandrogenemia
At least one ovary with volume greater or equal to 10.0ml
Ovarian accessibility by transvaginal ultrasound transducer
Has not responded to first-line ovulation induction treatment

Exclusion Criteria:
Currently pregnant
BMI greater than 40
Marked hyperandrogenism
Poor glycemic level control (greater than 6.5%)
Bleeding disorders
Women's Health
Experimental device
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Hershey, PA ,

Interoception and eating behaviors in children

The purpose of this study is to examine how individual differences in interoception (the ability to sense, interpret, and act on bodily feelings like hunger, fullness, thirst, hot, cold, etc.) relate to eating behaviors in children ages 7-10 years. Findings will inform whether interventions targeting interoceptive awareness may be helpful for prevention of obesity and related chronic diseases.

Child and parent will attend 2 visits at the Clinical Research Center, about 1-3 weeks apart.At visit 1 (~3 hours)- Your child's height and weight will be measured- Your child's percent body fat will be measured using an x-ray based technology- Your child will wear a heart rate monitor and will complete tasks where they are asked to notice or count their heartbeat- Your child will complete questionnaires via an interview with a researcher- Your child will be asked to drink several glasses of water to measure their stomach sensations- You will complete questionnairesAt visit 2 (~2.5 hours)- We will collect 4 saliva samples from your child- Your child will eat a meal and taste snacks- Your child will play brain games on an iPad- You will complete questionnaires

$100

Yes
 

Emily Hohman
Francisca Dungula - at ieatstudy@psu.edu or 814-865-5246
Center for Childhood Obesity Research (UNIVERSITY PARK)
 

All
All
This study is also accepting healthy volunteers
NCT00650465
STUDY00024712
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Inclusion Criteria:
Age 7-10 years old
Able to understand and answer questions in English

Exclusion Criteria:
Child BMI <5th percentile
Any medical conditions impacting growth, eating, or heart function
Developmental delay
Autism/autism spectrum disorder
Taking medications that impact appetite
Children's Health, Food & Nutrition
Not applicable
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State College, PA ,

An exploratory analysis of commuting satisfaction and travel mode dissonance

The purpose of this research is to explore commuting mobility patterns and satisfaction levels among commuters in different regions and demographics. The study aims to identify barriers to current commuting practices, evaluate commuter opinions and intentions, and understand the implications of travel mode dissonance on commuter satisfaction and overall well-being. This research will also investigate how future commuting policies can incentivize sustainable commuting practices, ultimately aiming to reduce commuting emissions.

Participants will be required to complete an online survey, which will take approximately 10-15 minutes. All responses are anonymous, and participants may choose to skip any questions or exit the survey at any time without providing a reason.

No
 

Nikhil Menon
Sohail Asger - at sva6012@psu.edu or 906-231-2796
Science, Engineering and Technology (HARRISBURG)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT00000000
STUDY00025749
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Inclusion Criteria:
Resident of USA
Are over the age of 18
Are working or going to school (i.e., conducting a commute trip)
Use transportation systems

Exclusion Criteria:
Individuals that do not reside in the USA
Children under 18 years
Individuals who do not work
Not applicable
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PSCI 24-077 A Phase 1b/2 Study Assessing the Safety and Efficacy of Evexomostat (SDX-7320) in Combination with a PI3K Pathway Inhibitor plus Fulvestrant in Postmenopausal Women with Advanced Breast Cancer and PI3K Pathway Alterations Who Have Progressed on or Following Endocrine Therapy plus a CDK4/6 Inhibitor

this trial is looking at introducing a medication to control blood sugars elevations caused by CDK inhibitors.

Participants must agree to come to all study visits, report any new medications to the study team, agree to having blood work done at least 8-12 hours after eating something, take study medication as directed.

Yes
 

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

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05570253
STUDY00025502
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Inclusion Criteria:
Patient is an adult female ≥18 years old at the time of informed consent(s) and has signed informed consent(s) before any trial related activities and according to local guidelines.
Patient with histologically and/or cytologically confirmed diagnosis of HR+, HER2- breast cancer, as determined by the local laboratory.
Patient has identified PI3K pathway
Patient has locally advanced (not amenable to curative therapy or metastatic) breast cancer meeting any of the following categories:
Patient has measurable disease

Exclusion Criteria:
Patient has inflammatory breast cancer at screening.
Patient has known primary brain malignancy,
Patient has a known hypersensitivity to evexomostat, fulvestrant, alpelisib or capivasertib, or to any of their excipients.
Patient has had major surgery within 30 days
Patient has uncontrolled human immunodeficiency virus (HIV) infection.
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

Locomotor Learning in Exoskeleton-Assisted Walking

The goal of this study is to explore how different ways of practicing, as well as paying attention, affect learning to walk while using an ankle exoskeleton. This pilot study will look at whether changing the settings of the exoskeleton and walking conditions frequently or not very often helps people walk better in follow-up tests. It will also examine if asking people to focus on their body (internal focus) or on their surroundings (external focus) improves their walking.

There will be three in-person visits over two days, walking in a lower limb exoskeleton will occur at all three visits.

$40.00

Yes
 

Rachael Yanalitis
Rachael Yanalitis - at rky5073@psu.edu or 412-804-8801
Mechanical and Nuclear Engineering (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00025992
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Inclusion Criteria:
Able-bodied: Able to walk continuously for 20 minutes and able to walk at least 60 minutes in a 75-minute block of time.
Normal ankle functionality
Age: 18-40 years old
Responsiveness: Subjects must be able to follow verbal instructions
Shoe size: Fit shoes sizes 6-10 (men) or 7-11 (women)

Exclusion Criteria:
Previous or existing neuromuscular or neurological pathologies, injuries, or illnesses affecting gait
Previous or existing lower limb musculoskeletal injuries or conditions (e.g. joint replacement)
Currently using blood thinners, since this could increase the risk of bruising
Pregnant women
Subjects with femoral retroversion (duck feet posture) significant enough to cause exoskeleton collisions while walking
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State College, PA ,

PSCI 24-013 A RANDOMIZED PHASE II, DOUBLE-BLIND, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF AUTOGENE CEVUMERAN PLUS NIVOLUMAB VERSUS NIVOLUMAB AS ADJUVANT THERAPY IN PATIENTS WITH HIGH-RISK MUSCLE-INVASIVE UROTHELIAL CARCINOMA

This trial is looking at what happens to muscle invasive bladder cancer when adding cevumeran to Nivolumab

Participants will be required to keep all study appointments, tell the study doctor about all medications they are taking, report any side effects to the study doctor.

$202 for each visit completed

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06534983
STUDY00025674
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Inclusion Criteria:
muscle-invasive UC of the bladder identified based on computed tomography (CT) or magnetic resonance imaging (MRI) scan of the pelvis, abdomen, and chest as cT3-T4 or N .
Surgical resection of muscle-invasive UC of the bladder or upper tract
Cisplatin ineligible
Absence of residual disease and absence of metastasis,
ECOG performance status of 0 or 1

Exclusion Criteria:
Pregnancy or breastfeeding,
Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment
Any prior neoadjuvant immunotherapy
Adjuvant chemotherapy or radiation therapy for UC following surgical resection
Absence of spleen
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

BCC022: Phase II Trial of Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma

The purpose of this research is to evaluate the investigational drug, tipifarnib (a pill taken by mouth), in combination with the FDA approved drug, naxitamab, administered intravenously (IV; a liquid that continuously goes into your body through a tube that has been placed during a surgery into one of your veins).

You will be asked to come in for screening and at the start of each cycle (every 28 days), and at the end of study treatment to have tests done (these may include a physical exam, blood tests, and electrocardiogram [ECG]). During the first cycle you will need to have blood tests done weekly. You will also need to come in during Days 1-5 of each cycle to receive the study treatment. You will also have scans and a bone marrow biopsy (tissue sample) and aspirate (fluid and cells) done at the start of study, every 2 cycles, and at the end of study.

Yes
 

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

All
All
This study is NOT accepting healthy volunteers
NCT06540963
STUDY00025733
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Inclusion Criteria:
Age ≤ 21 years at initial diagnosis
Age >12 months of age at enrollment
Age 6 years or older for safety run in

Exclusion Criteria:
Age less than 1 year
Currently receiving another investigational drug
Cancer
Prefer not to display
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Hershey, PA ,

A Confirmatory Phase 3 Mutlicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Topical HyBryte (Hypericin Sodium) and Visible-Light Activation for the Treatment of Cutaneous T-Cell Lymphoma (CTCL).

The purpose of this trial is to evaluate the safety and efficacy of 18 weeks of HyBryte (topical gel) treatment in combination with visible light therapy in subjects with cutaneous T-cell lymphoma when compared to placebo (no active ingredient). Cutaneous T-cell lymphoma (CTCL), of which the most common early stages are also known as mycosis fungoides (MF), is the most common type of T cell lymphoma. Participants will be enrolled in this trial for 30 weeks and will follow up at the clinic site every 4 weeks following the last trial treatment for a total of 12 weeks.

Participants will attend in person visits over 30 weeks. At different timepoints throughout the study participants will have their skin evaluated and photographed, have blood drawn, have an ECG done, and apply the study medication as directed by the study team.

Yes
 

Christopher Bazewicz
Samantha Gettle - at dermatologyclinicaltrials@pennstatehealth.psu.edu or 717-531-5136
Dermatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06470451
STUDY00025614
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Inclusion Criteria:
Participants must have a clinical diagnosis of CTCL (MF)
Participants must have a minimum of 3 evaluable, discrete lesions
Participants must be willing to follow the clinical protocol and voluntarily give their written informed consent

Exclusion Criteria:
Certain medications are not allowed to be used during the study; study coordinator will discuss.
Participants with extensive skin disease may not be eligible to participate; investigator will discuss during skin evaluation
Certain medical conditions may not be eligible to participate; study coordinator will discuss further.
Skin Conditions, Cancer
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Using the Socio-ecological Model to Assess Correlates of Physical Activity Participation Among Sexual and Gender Minority Adults

The purpose of this research is to examine correlates of physical activity participation among self-identifying sexual and/or gender diverse (e.g., non-heterosexual, non-cisgender) adults, guided by the socio-ecological model for health behavior (i.e., individual, social, communal, environmental).

Eligible participants will be invited to complete an open-link online survey that should take approximately 10 - 15 minutes to complete. There will be no other research activities after this unless individuals indicate that they would like to participate in a follow-up interview by indicating their interest on a separate form at the end of the survey.  Participants who agree to take part in the interview (from the survey) will be contacted via email and an interview day/time will be scheduled. Three days before the interview, there will be an email reminder sent. Interviews will take place via Zoom at a day and time to be chosen by the participant. 

Participants will be eligible to enter a drawing for a $50 gift card once they complete the survey. If you opt in to participate in the follow-up interview portion of the study, you will receive a $25 gift card for your time.

No
 

Keegan Peterson
Keegan Peterson - at kvp5394@psu.edu
Kinesiology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00025928
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Inclusion Criteria:
Age 18 or older.
Identify as a sexual and/or gender diverse identity (i.e., non-heterosexual and/or non-cisgender).
Be able to participate in physical activities (e.g., exercise, sport).
Be able to read and write English.

Exclusion Criteria:
Under the age of 18.
Identify as heterosexual (i.e., straight).
Unable to participate in physical activities (e.g., exercise, sport)
Unable to read and write English.
Prevention, Sports Medicine, Mental & Behavioral Health
Not applicable
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PSCI 24-018 Phase 1, open label clinical trial to treat Stage IV cancer patients with multiple patient-specific mutated cell surface proteins with chimeric antibodies

This study will examine if giving patients their cells that have been modified in the lab will help control their cancer.

Subjects will be required to come to all visits. Each treatment will take 2-5 hours and there will be a total of 10 treatments over a 14 week period.

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06674538
STUDY00025562
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Inclusion Criteria:
Stage IV cancer of the following types: breast cancer, colon cancer, esophageal cancer, kidney cancer, lung cancer, lymphoma, melanoma, ovarian cancer, pancreatic cancer, bladder urothelial carcinoma, and stomach cancer.
Subjects who have refractory or progressive disease after at least 1 line of systemic treatment
Subjects must have measurable disease

Exclusion Criteria:
Insufficient tumor tissue for whole exome sequencing.
Known human immunodeficiency virus infection.
Subjects who have received any cytotoxic treatment within 3 weeks of antibody treatment.
Subjects who have received any radiotreatment to the primary sample site within the last 14 days
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

NUTRI-Beta Study: A Pilot Clinical Trial for Children with New Diagnosis of Stage 3 Type 1 Diabetes

This will be a 12-week single blinded, randomized, nutrition clinical trial for children with new diagnosis of stage 3 type 1 diabetes (clinical diagnosis of T1D). Beta cell function will be measured after 3 and 6 months.

Study participants in the intervention group will be required to follow the intake of specific foods and adhere to specific nutrition guidelines in addition to follow with a registered dietitian for 12 weeks (4 in person visits and 3 virtual visits). All these visits will be compensated. All study visits will be seen for a screening visit, an enrollment visit, 12-week visit and a 24-week visit. During the study visits, participants will undergo the following: physical exam/ demographic/social evaluation, clinical nutrition evaluation, nutrition counseling, dietary intake assessment, blood test collection, 2-hour Mixed Meal Tolerance Test (MMTT) and anthropometry.

$345

Yes
 

Lina Huerta-Saenz
Erica Miller - at emiller25@pennstatehealth.psu.edu or 717-531-5656
Pediatrics: Endocrinology (HERSHEY)
 

All
Younger than 18 years old
This study is NOT accepting healthy volunteers
NCT06640478
STUDY00020631
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Inclusion Criteria:
New diagnosis of type 1 diabetes < = 60 days
Age 6-17 years old, any gender
Attendance to the Pediatric diabetes clinic at Penn State Health in Hershey, PA
Positive antibodies for type 1 diabetes

Exclusion Criteria:
Age older than 18 years old
History of seafood allergies and/or milk/dairy related allergies
Type 2 diabetes
Food sensory disorders
Pubertal children
Children's Health, Food & Nutrition, Diabetes & Hormones
Not applicable
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Hershey, PA ,

Research on Survivorship Experiences: Disparities in cancer-related outcomes between rural and non-rural cancer survivors in the catchment areas of the Big 10 Cancer Research Consortium's Population Science Working Group

The objective of this cross sectional survey study is to describe the social and psychological outcomes of cancer survivors and characterize the disparities between rural and non-rural cancer survivors. We will collaborate will members of the Big 10 Cancer Research Consortium's Population Science Working Group to invite cancer survivors in rural and non-rural communities to complete one online survey, with each site targeting cancer survivors in their catchment areas. At Penn State, we will target recruitment to cancer survivors living in Pennsylvania. We plan to enroll 150 participants. It will take participants 30-40 minutes to complete the study and they will receive a $15 Amazon gift card for their time and effort.

If eligible, study participants will be asked to complete one online survey about their experience as a cancer survivor. Potential participants will first complete a REDCap screening form, if eligible, they will view the consent form. If they provide consent, they can complete the survey. A member of the Penn State study team will call the participant to confirm eligibility and once confirmed, will issue a $15 Amazon e-gift card. The entire study should take between 30-40 minutes to complete.

$15

No
 

Jennifer Moss
Leonard Kishel - at Casper@pennstatehealth.psu.edu or 717-531-0003, ext=321657
Family and Community Medicine (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT00000000
STUDY00025475
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Inclusion Criteria:
diagnosis of primary pathologic breast, colorectal, lung, melanoma, prostate, uterine, endometrial, or blood cancers (leukemia, lymphomas)
non-metastatic cancer
1-5 years post completion of active treatment
no current evidence of cancer
living in certain counties in south central Pennsylvania

Exclusion Criteria:
no internet access
cannot speak or read English
unable to provide informed consent
less than 18 years old at time of cancer diagnosis
Cancer
Not applicable
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