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Clinical Study on the Impact of Electronic Cigarette Temperature and Solvent on Biomarkers of Oxidant Exposure

This project seeks to determine how e-cigarette (EC) physical design features, including those that allow the user to manipulate the quality and quantity of aerosols, affect exposure and toxicity from oxidants and other aerosol constituents.

Subjects will attend 8 study visits over the course of 14 weeks to collect various biological samples (such as blood draws, exhaled breath samples, saliva samples). They will be given a study provided e-cigarette that they will use during and between the study visits. There will also be surveys to complete throughout the study.

900

Yes
 

Zachary Bitzer
smokingresearch@pennstatehealth.psu.edu
Public Health Sciences (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00028240
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Inclusion Criteria:
21 years or older
E-cigarette use for more than 12 months
Normal pulmonary function

Exclusion Criteria:
Respiratory diseases
Uncontrolled substance abuse
Pregnant or nursing
Smoking, Vaping, Nicotine and Tobacco, Addiction & Substance Abuse
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Hershey, PA ,

STOP-HAE: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of siRNA Targeting of Prekallikrein With ADX-324 in Participants With Hereditary Angioedema

We are testing an experimental drug, ADX-324, as a potential new treatment to help prevent HAE attacks. We are doing this study to find out if an injection of ADX-324 once every 3 months or every 6 months under the skin (subcutaneous) is safe, and if it can reduce the severity and number of HAE attacks.

The total study duration is up to 8 months (up to 2 months for screening before the first dose of ADX-324 or placebo, one dose of ADX-324 or placebo at Day 1 and again 3 months later (Week 13), and follow-up visits for up to 6 months after the first dose). You will need to answer questions about your health/HAE attacks, provide blood samples, undergo routine urine laboratory tests, receive the trial drug, undergo electrocardiogram (ECG), complete questionnaires about the quality of your life, undergo physical exams, and provide HAE attack information.

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06960213
STUDY00027293
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Inclusion Criteria:
Age ≥18 years at the time of signing informed consent
Have a documented diagnosis of HAE-1/HAE-2 (Type I or II)
Experienced ≥1 Investigator-confirmed HAE attack in the first 4 weeks of Screening or ≥2 Investigator-confirmed HAE attacks in 8 weeks of Screening.
Women of childbearing potential must have a negative serum pregnancy test during Screening and a negative urine pregnancy test on Study Day 1

Exclusion Criteria:
Concurrent diagnosis of another form of recurrent angioedema.
History of alcohol or drug abuse within the previous year prior to Screening
Participant is breastfeeding.
Any clinically significant renal disease, including chronic kidney disease (CKD) Stage 3 or higher
Infectious Diseases & Immune System, Allergies
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Tilt Testing in Endometriosis

Endometriosis is a common condition that can sometimes affect the nerves and may also impact heart and blood‑vessel health. In this study, we will use routine medical tests that show how the nervous system and cardiovascular system work together. Women with and without endometriosis will go through standard tilt testing - laying still on a table while the head of the table is tilted upward. Blood pressure and heart rate are measured. Participants then wear a blood pressure monitor for 24 hours.

Participants will go through standard tilt testing (laying down on a table that is tilted head up) and 24-hour blood pressure monitoring (wearing a portable blood pressure monitor while going about their day for one day).

100

Yes
 

Lacy Alexander
Auni Williams - at abw5795@psu.edu
Kinesiology (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00028763
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Inclusion Criteria:
Born with a uterus
At least one intact ovary
Aged 18-49
With and without endometriosis

Exclusion Criteria:
Currently pregnant
Diagnosed cardiovascular, neurological, or endocrine disease
Current or recent nicotine use
Hypertension
Heart & Vascular, Neurology, Women's Health
Not applicable
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State College, PA ,

Transdiagnostic Sleep and Circadian Treatment for Autistic Adults

Sleep and circadian problems are associated with deleterious social, emotional, and cognitive outcomes, yet are modifiable. This prospective study will adapt, optimize, and test an empirically supported behavioral intervention that addresses common sleep and circadian problems of autistic adults, who are at increased risk for mental health disorders, using a transdiagnostic approach. The knowledge gained from this study will address a critical need for accessible transdiagnostic sleep interventions for autistic adults, who experience a broad range of sleep and circadian problems at high rates and often lack access to specialty care treatment.

You will need to complete self-report assessments at baseline and post-treatment, as well as collect data at home for 2 weeks by wearing a physical activity monitor on your wrist, and completing sleep diaries (short questionnaires) each day. You will also need to complete 6 weekly 50 minute sessions delivered individually by trained clinicians. You will also complete a 30-minute semi-structured interview at post-treatment with the study coordinator.

$75.00

Yes
 

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

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT07461844
STUDY00028767
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Inclusion Criteria:
Adult diagnosed with Autism
Between the ages of 18 and 65 years
English-speaking
Sufficient verbal communication skills to participate in interviews, surveys, or tasks
One or more sleep or circadian problem(s)

Exclusion Criteria:
A history of intellectual and developmental disability (IDD)
A history of psychotic, bipolar or seizure disorders
Untreated sleep apnea, a history of narcolepsy, or restless legs syndrome
Sleep Management, Mental & Behavioral Health
Not applicable
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Hershey, PA ,

PSCI 25-075: A Phase 2, Single-Arm Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression

This Study is being done to understand how well INCB123667 works, how safe it is, and how well it is tolerated in people with platinum-resistant ovarian cancer whose tumors have high levels of cyclin E1.

On certain visit days, subject will need to take Study Drug tablets at the Study Site instead of at home. On those days you must fast (no food or drinks) for 8 hours before your visit, so that certain blood tests can be done before you take your Study Drug.

Yes
 

Shaina Bruce
Kelly Sentz - at ksentzbrenneman@pennstatehealth.psu.edu or 717-531-7417
Obstetrics and Gynecology (HERSHEY)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
NCT07023627
STUDY00027972
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Inclusion Criteria:
Ability to comprehend and willingness to sign a written ICF for the study
Female participants aged 18 years or older at the time of signing the ICF
Histological diagnosis of a high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Willingness to undergo pretreatment biopsy.
Received at least 1 and no more than 4 prior lines of systemic therapy following the initial diagnosis, after which single-agent therapy is considered an appropriate next therapeutic option.

Exclusion Criteria:
Have endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of these histologies, or low-grade/borderline ovarian cancer.
The tumor tests positive for FRα but the participant has not received mirvetuximab soravtansine due to it being unavailable.
History or presence of an ECG abnormality that, in the investigator's opinion, is clinically meaningful.
Known active CNS metastases and/or carcinomatous meningitis.
Significant concurrent, uncontrolled medical condition.
Cancer
Not applicable
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PSCI # 25-036 A PHASE 3 STUDY OF FIXED DOSE COMBINATIONS OF FIANLIMAB AND CEMIPLIMAB VERSUS RELATLIMAB AND NIVOLUMAB IN PARTICIPANTS WITH UNRESECTABLE OR METASTATIC MELANOMA

This study is comparing two treatments for the treatment of melanoma.

You will need to come to the clinic twice before start study treatment. The first time is to sign permission to send your tumor to be tested for specific changes. If those changes are in the tumor you will be brought back to the clinic and invited to participate in the study. After testing and scans are done to make sure it is safe for you to take part in the study, you will begin treatment. You will come to the clinic every 3-4 weeks for treatment. You will continue treatment until it no longer works, you no longer wish to receive treatment, or the study doctor feels it is not safe for you to continue.

$60.00 for each completed visit

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
NCT06246916
STUDY00028308
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Inclusion Criteria:
Age ≥18 years
unresectable stage III and stage IV (metastatic) melanoma
must not have received prior systemic therapy

Exclusion Criteria:
Uveal, acral or mucosal melanoma.
Uveal, acral or mucosal melanoma.
Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C virus (HCV) infection
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

Cognitive and perceptual responses to low outdoor lighting

The purpose of this study is to explore outdoor lighting and its environmental impact, focusing on human perception of these factors. Participants will undergo various tests to evaluate their subjective and objective responses to different light levels and chromaticities.

Participants will complete a demographic survey, will undergo screening tests to assess their visual acuity. If eligible, they will evaluate various lighting environments through a questionnaire and complete an object detection test before and after a brief training session. The total duration of the experiment will be approximately 1 hours.

$20

Yes
 

Zora LIU
Yue Liu - at ybl5822@psu.edu or 814-769-1215
Architectural Engineering (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00027606
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Inclusion Criteria:
Adults aged between 18 and 50
Normal or corrected-to-normal vision
Available to attend all scheduled training and experiment
Able to provide informed consent
Able to identify color

Exclusion Criteria:
Participants with visual impairments (e.g., low vision, color deficiency)
Participants with expertise in lighting or color science
Vulnerable populations
Age above 50
Age under 18
Vision & Eyes
Not applicable
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State College, PA ,

Studying speech perception with different acoustic playback methods

The purpose of this study is to examine how different acoustic playback methods affect the understanding of speech.

There will be one in person session in the Hammond building on University Park Campus. The session will last approximately 1 - 1.5 hours. During this session you will listen to audio recordings over headphones and loudspeakers and will complete a speech intelligibility task - you will need to listen for a certain talker and indicate what the talker said. You will receive training before completing the task. You will wear a sensor on one of you fingers that measures your physiological response including heart rate, body temperature, and perspiration for the duration of the session. When wearing the headphones, your head motion will be tracked. A hearing screening will be done at the start of your scheduled time to confirm eligibility for the study. If you don't meet the requirements, you will receive $5 in cash. If you do meet the requirements and complete the study, you will receive $25 in cash.

$25

Yes
 

Michelle Vigeant-Haas
Paula Sedlacek - at pbs5654@psu.edu
Acoustics (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00028910
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Inclusion Criteria:
Have hearing thresholds of 25 dB or lower in the following frequencies: 250, 500, 1000, 2000, 4000 and 8000 Hz. A threshold of 30 dB in one frequency in each ear is also acceptable.
A native speaker of American English.
Does not have any diagnosed speech, language, or hearing disorders.
Must be able/willing to have physiological devices placed on their head and wrist for accurate data collection.
Have normal or corrected-to-normal vision

Exclusion Criteria:
Not have hearing thresholds of 25 dB or lower in the following frequencies: 250, 500, 1000, 2000, 4000 and 8000 Hz. A threshold of 30 dB in one frequency in each ear is also acceptable.
Not a native speaker of American English.
Have any diagnosed speech, language, or hearing disorders.
Not able/willing to have physiological devices placed on their head and wrist for accurate data collection.
Not have normal or corrected-to-normal vision
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State College, PA ,

REGIMEN-SPECIFIC APPENDIX I FOR NUZ-001

NUZ-001 ((S)-monepantel) is a synthetic drug that aims to stimulate a natural cleaning mechanism called autophagy that removes the build-up of waste products in cells. In patients with ALS, autophagy can be impaired, leading to the toxic build-up of waste products, causing the motor neuron to die.

If you qualify for this regimen, you will be randomly assigned to take either active study drug or placebo. This is a double-blind, placebo-controlled study. This means that participants are selected by chance (like tossing a coin) to be in 1 of 2 groups – this is called “randomization.” “Double-blind” means that neither you, the study doctor, nor any of the study staff will know whether you are receiving active drug or placebo. However, your study doctor can find out in case of an emergency. The placebo looks and feels exactly like the study drug but contains no active drug.

$700

Yes
 

Zachary Simmons
Nervemuscle@pennstatehealth.psu.edu
Neurology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04297683
STUDY00028665
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Inclusion Criteria:
must meet the Master Protocol eligibility criteria

Exclusion Criteria:
Clinically significant liver disease (e.g., chronic hepatitis B, untreated hepatitis C)
Prior history of drug-induced liver injury (DILI)
Family history of SOD1 or VCP-associated ALS or known SOD1 or VCP mutation via genetic testing or self-report
Use of any prohibited medications as outlined in Section 5.9 within 30 days prior to Baseline or anticipated use during the study treatment period
Participants who are taking Nuedexta® and have a prolonged Fridericia-corrected QT (QTcF) interval (QTcF > 450 ms (males) or > 470 ms (females)) at Master Protocol Screening
Neurology
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Fanship, Leisure, and Loneliness: Exploring Social Connection in Sports Fan Communities

This study examines how participation in sports fandom as a leisure activity shapes social connection and experiences of belonging. Through interviews and optional reflective diaries, the research explores how fans interact with others, build relationships around shared team identities, and understand the role of fandom in their everyday social lives. The goal is to better understand how leisure-based fan communities may help reduce feelings of loneliness and social isolation.

Participants will complete a 60–90 minute interview about their experiences as fans of the Philadelphia Eagles and/or Philadelphia Phillies to explore how fandom relates to their social interactions and leisure activities. Participants may also choose to complete an optional 4–6 week fan experience log, where they briefly note fandom-related activities or interactions (for example watching games with others, attending events, or participating in fan discussions).

No
 

Liselle Milazzo
Liselle Milazzo - at lmm6871@psu.edu
Recreation, Park and Tourism Management (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00026258
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Inclusion Criteria:
Be between the ages of 18–30.
Self-identify as a fan of the Philadelphia Eagles and/or Philadelphia Phillies.
Engage in fandom-related activities (e.g., watching games, discussing sports with others, attending games, following teams online, or participating in fan communities).
Be able to participate in an interview conducted in English.

Exclusion Criteria:
Be able to participate in an interview conducted in English.
Are under the age of 18 or over the age of 30.
Do not identify as a fan of the Philadelphia Eagles or Philadelphia Phillies.
Are unable to complete the interview in English.
Education, Mental & Behavioral Health
Not applicable
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A Phase III, multisite, randomized, double-blind trial of BNT327 in combination with chemotherapy versus placebo with chemotherapy in patients with previously untreated locally recurrent inoperable or metastatic TNBC determined ineligible for PD(L)1 therapy based on PD-L1 negative disease

The purpose of this voluntary research study is to evaluate the effects of pumitamig compared with placebo in combination with chemotherapy.

Participants must come to all study visits, take the medication as instructed, tell the study how you are feeling and tell the study team about any medications you are taking, especially over the counter medications.

$50.00 per visit

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT07173751
STUDY00028147
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Inclusion Criteria:
Adults, ≥18 years of age at the time of giving informed consent. Local laws will be followed if the age of consent is older.
Are considered ineligible for combination treatment with a monospecific PD(L)1 targeting immunotherapy plus chemotherapy as per their tumor PD-L1 expression status.
Have confirmed locally recurrent inoperable or metastatic TNBC, or ER-low, HER2-negative breast cancer documented prior to trial screening as part of standard of care.
Have at least one measurable lesion as the targeted lesion based on RECIST v1.1.
Have provided a tissue sample, archival or fresh, during the screening period

Exclusion Criteria:
Have received prior systemic anticancer therapy for advanced disease.
Have received prior treatment with a PD(L)-1/VEGF bispecific antibody.
Are pregnant or breastfeeding or are planning pregnancy or planning to father children during the trial or within 6 months after the last dose of pumitamig or placebo.
Have a medical, psychological, or social condition which, in the opinion of the investigator, could compromise their wellbeing if they participate in the trial,
Have received allogeneic hematopoietic stem cell transplantation or organ transplantation.
Cancer
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

ALTE2321: Walking Juntos: Developing and Testing a Culturally-Tailored Mobile Health and Social Media Physical Activity Intervention Among Adolescent and Young Adult Childhood Cancer Survivors

This study is being done to answer the following question: How can a home-based physical activity program best meet the unique language and cultural preferences of Hispanic or Latino/a AYA survivors of cancer? In order to develop a culturally-tailored physical activity program that works well, we know we must address the unique language and cultural needs of Hispanic or Latino/a AYA survivors of childhood cancer. We are doing this study because we want to find out what ideas work best to encourage Hispanic or Latino/a childhood cancer survivors to stay physically active after receiving cancer treatment.

complete participant contact forms, surveys and questionnaires, social media interaction with participant group, wearing an exercise tracker (FitBit).

($30 per each qualitative interview completed

No
 

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

All
All
This study is NOT accepting healthy volunteers
NCT06410209
STUDY00026537
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Inclusion Criteria:
Patient must be ≥ 15 years and < 21 years at the time of enrollmen
First diagnosis of malignant neoplasm in first and continuous remission at the time of enrollment.
Self-identify as Hispanic, Latino/Latina/Latinx
Completed all chemotherapy and/or radiation therapy in the last 3–36 months. This includes completion of all oral (e.g., tyrosine kinase inhibitors) and/or maintenance chemotherapy.
Able to read and write Spanish or English.

Exclusion Criteria:
Patients with previous allogeneic Hematopoietic Stem Cell Transplant (HSCT) are excluded.
Post-menarchal female patients who are pregnant or planning to become pregnant in the next year are excluded.
Participants who were enrolled in ALTE2031 (Step by Step) cannot enroll in ALTE2321. Participants who were enrolled in ALTE2321 Stage 1 (cultural tailoring) cannot enroll to participate in Stage 2 (RCT)
Children's Health, Cancer
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MOMENTUM-1: A MULTICENTER, RANDOMIZED, OPEN-LABEL, PHASE II STUDY OF [177LU]LU-DOTATATE IN ADULTS WITH PROGRESSIVE INTRACRANIAL GRADE 1-3 MENINGIOMA

We are doing this study because we want to find out if this study therapy is better or worse than the usual drug therapy for your meningioma. The usual is defined as the standard of care most people get for meningiomas that have come back after treatment.

Your participation in this study will last a maximum of 4 years. If you are randomized to Group 1, your study doctor will discuss the usual drug treatment options with you and you will be followed for up to 24 months. Your total participation could be up to 14 research visits which includes up to 6 months of treatment and 18 months of follow up. If your meningioma progresses within the first 12 months, you may switch to Group 2 and the 24 month follow-up clock restarts. If you are randomized to Group 2, you will receive the study drug once every 4 weeks for up to 4 times (total duration of 3 months). If after 4 doses your meningioma has not grown and you are tolerating the study treatment, you may receive 2 more doses of study drug. Your total participation for Group 2 could be up to 14 research visits which includes up to 6 months of treatment and 18 months of follow up.

Yes
 

Raymond Hohl
Sara Craig - at scraig@pennstatehealth.psu.edu or 717-531-0003, ext=285799
Cancer Institute (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06955169
STUDY00027569
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Inclusion Criteria:
Histologically confirmed diagnosis of WHO grade 1-3 meningioma
Presence of measurable contrast-enhancing disease on gadolinium-enhanced MRI brain scan
Progression of disease determined by local radiology review
Patients must be willing and able to undergo regular MRI scans of the brain and [68Ga]Ga-DOTATATE PET-CT imaging during the study.
Adequate organ and bone marrow function

Exclusion Criteria:
Patients with a clinical diagnosis of NF2-related schwannomatosis
Patients with radiation-associated meningiomas.
Patients with known intraspinal meningiomas or meningioma metastases outside the skull/spinal column.
Prior SSTR2-targeted therapy, e.g. Somatostatin LAR or short-acting Octreotide.
An active malignancy ≤ 3 years.
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

A Phase 2, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Mibavademab in Adult Women with Functional Hypothalamic Amenorrhea

The study is researching an experimental drug called mibavademab. The study is focused on patients with a condition called Functional Hypothalamic Amenorrhea (FHA). FHA is a condition where a woman stops menstruating because the brain is not sending the correct hormonal signals to the ovaries, which then are not able to cycle and ovulate properly. The aim of the study is to see how well the study drug helps the body make the hormones necessary for ovulation and reproduction, and to assess its safety.

Subjects will have 18 in person visits, 1 EKG, 8 blood draws, pregnancy tests, 2 Dexa scans, transvaginal ultrasound, menstrual monitoring, optional blood sample for DNA isolation. Participation will last approximately 11 months.

Yes
 

Stephanie Estes
Dodi Schaak - at dschaak@pennstatehealth.psu.edu or 717-531-3692
Medicine: Endocrinology, Diabetes and Metabolism (HERSHEY)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
NCT07235917
STUDY00028278
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Inclusion Criteria:
Age: 18 to 40 years old at screening
BMI between 18.5 (18.5 included) and <25 kg/m2 at screening. OR BMI 25 (included) to < 30 kg/m2 with a serum leptin level < 8.0 ng/mL at screening.
Diagnosis of Functional Hypothalamic Amenorrhea as defined by the Endo Society Practice Guidelines
No menstrual bleeding episode within 3 months prior to Day 1
Willing and able to comply with clinic visits and study-related procedures.

Exclusion Criteria:
Presence of primary amenorrhea (failure to reach menarche (i.e., the first menstrual cycle)
Pregnant, breastfeeding, or lactating
Blood estradiol ≥ 50 pg/ml or blood progesterone ≥ 1ng/ml at screening
Uterine (e.g. absence of uterus, prior endometrial ablation, endometriosis outflow tract disorders) or ovarian (e.g. absence of an ovary, presence of polycystic ovaries) conditions that impact assessment of menses or of the HPO axis
Use of medications affecting bone metabolism and/or HPO axis (e.g. bisphosphonates, teriparatide, denosumab, estrogen, progesterone, anabolic steroids, GnRH agonists or antagonists, gonadotropins or analogues
Women's Health
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PSCI# 26-013 A Randomized Phase II Study of Amivantamab (JNJ-61186372) and hyaluronidase (rHuPH20) versus Cetuximab in Immunocompromised Participants with Recurrent Inoperable or Metastatic Cutaneous Squamous Cell Carcinoma

To see how well amivantamab works in immunosuppressed patients with cutaneous squamous cell cancer.

Participants will need to come to the clinic every week for the first four weeks of treatment while you are getting the amivantamab. After that you will come in monthly for treatment. You will continue treatment until it stops working, you no longer want to participate in the trial or the doctor\ thinks it is no safe for you to participate. Make sure to tell the study team how you are feeling and any medications that you er taking.

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
NCT07042295
STUDY00028946
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Inclusion Criteria:
must have pathologically proven diagnosis of cutaneous squamous cell carcinoma
Participants must have CLL, acute leukemia, lymphoma, multiple meyloma, recent organ transplant, autoimmune disease
Participant must be ≥ 18 years old

Exclusion Criteria:
Participants must not have an uncontrolled illness
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

The Genome Integrity and Epigenome of Sperm from Men with Recurrent Pregnancy Loss

Semen sperm samples will be collected from the male partner of couples that experience recurrent pregnancy loss. DNA analysis will be performed on the samples to investigate potential male factor causes of recurrent pregnancy loss.

Male partners of couples with recurrent pregnancy loss will be asked to provide two semen samples. The male partner will also be asked to complete the Charleston Co-Morbidity index at the time of the patient visit.

Yes
 

Samantha Butts
Robinn Moyer - at rmoyer3@pennstatehealth.psu.edu or 717-531-6272
Obstetrics and Gynecology (HERSHEY)
 

Male
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00028434
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Inclusion Criteria:
Male partners of couples with two or more pregnancy losses
Paternal age 18-40 years old at losses
Maternal age 18-40 years old at losses
A couple undergoing ASRM evidenced based work-up or work-up already performed
Actively trying to conceive

Exclusion Criteria:
Known causes of recurrent pregnancy loss
Co-morbidities in female partner including diabetes, autoimmune diseases, and BMI >40
Pregnancy & Infertility
Not applicable
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Hershey, PA ,

Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) and Interstitial Lung Disease Prospective Outcomes (ILD-PRO) Registry

This is an observational registry with the goal of collecting data and biological samples that will support future research studies for Idiopathic Pulmonary Fibrosis (IPF) and other chronic fibrosing ILDs.

Participants will be required to answer questionnaires and have blood drawn every 6 months at their routine pulmonary clinic visits. Participants' de-identified health information will be entered into the a registry database by the study team every 6 months.

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
STUDY00028427
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Inclusion Criteria:
Established diagnosis of IPF within the last 12 months
Age >/= 21 years

Exclusion Criteria:
Malignancy, treated or untreated, other than skin or early-stage prostate cancer, within the past 5 years
Currently listed for lung transplantation at the time of enrollment
Currently enrolled in an interventional clinical trial at the time of enrollment in this registry
Lung Disease & Asthma
Not applicable
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Hershey, PA ,

.PSCI# 25-163 The NEO-RT Trial: A Phase 3 Randomized Trial of Neoadjuvant Chemotherapy, Excision and Observation Versus Chemotherapy For Early Rectal Cancer

This is an international multi-centre, phase 3 randomized non-inferiority trial comparing induction FOLFOX/CAPOX chemotherapy followed by transanal endoscopic surgery (TES) to chemoradiation (chemoRT) followed by transanal endoscopic surgery (TES) in patients with cT1-T3ab*/N0 pMMR rectal adenocarcinoma.

Participants will receive chemotherapy with or without radiation for approximately 12 weeks. Once treatment is completed, they will have tests to see if the cancer is gone. Depending upon the scan results, the participant may have surgery or watch and wait. Total participant ime would be five years.

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06205485
STUDY00028547
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Inclusion Criteria:
Histologically confirmed invasive, well-moderately differentiated rectal adenocarcinoma, mismatch repair proficient.
cN0 stage based on pelvic MRI – including absence of radiographic evidence of mesorectal nodal metastasis, tumour deposits or extramural venous invasion (EMVI).
M0 stage based on no evidence of metastatic disease by CT imaging of chest, abdomen and pelvis.
Mid to low-lying tumour eligible for transanal excision in the opinion of the treating surgeon.
Medically fit to undergo radical TME surgery as per treating surgeon’s decision.

Exclusion Criteria:
Pathologic high-risk factors on diagnostic biopsy: high histologic grade (poorly differentiated), mucinous or signet ring histology.
Patients with visible pelvic sidewall nodes on MRI.
Patients with unequivocal determination of nodal disease that, in the opinion of the investigator, would prohibit protocol therapy administration.
Prior treatment for rectal cancer.
Any contra-indications to undergo MRI imaging.
Cancer
Approved drug(s)
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Hershey, PA ,

PSCI # 25-077 A Phase III, Randomized, Open-Label, Multicenter, Global Study of Puxitatug Samrotecan (AZD8205) Monotherapy versus Physician’s Choice of Chemotherapy in Participants with B7-H4-Selected Advanced/Metastatic Endometrial Cancer Who Progressed On or After Platinum-Based Chemotherapy and Anti-PD-1/Anti-PD-L1 Therapy (BLUESTAR-Endometrial01)

This study will compare Puxitatug Samrotecan vs. standard of care in the tretment of advanced endometrial cancer.

Participants will have two screening visits. One to sign a consent for testing of tumor tissue for B7-H4 mutation. If they have this mutation, you will come back to the clinic to sign a second consent to participate in the trial. At that time, you will have scans scheduled and blood work drawn to make sure it is safe for you to participate. After you have started study medication, you will be expected to keep all your study appointments, tell the study team how you are feeling and report on any medications you are taking.

Yes
 

Shaina Bruce
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Obstetrics and Gynecology (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT07044336
STUDY00028212
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Inclusion Criteria:
Diagnosis of endometrial carcinoma or carcinosarcoma
≥ 18 years

Exclusion Criteria:
The participant had uterine sarcomas
Has had a recurrence of endometrial carcinoma or carcinosarcoma more than > 12 months after completing platinum-based therapy
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

Effects of Reduced Vision and Light Touch on Walking Balance

This study will assess how healthy adults use vision and light touch at their fingertips (for example, as you might lightly touch a handrail) to help them maintain balance while they walk.

If you agree to participate, we will ask you to come to the lab in Rec Hall on Penn State's campus. First, we will ask you to complete a health history questionnaire, visual assessments, and physical assessments. We will also make measurements of your height, weight, and blood pressure. These assessments will help us determine if you are eligible to continue in the remainder of the study. After screening, if you meet the eligibility criteria, we will ask you to walk on various paths on a virtual reality treadmill under various conditions. Your task will be to walk normally and look forward in each condition. Treadmill walking will take less than an hour and breaks will be given as needed.

$20.00

Yes
 

Jonathan Dingwell
Ashley Faller - at ajf6804@psu.edu
Kinesiology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00028383
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Inclusion Criteria:
Age 18-35
Normal vision without or with glasses/contacts
Able to walk unassisted at least 5 minutes

Exclusion Criteria:
High blood pressure (> 140 systolic or > 90 diastolic)
Body mass index (BMI) > 30 kg/m^2
Health conditions or medications that might impair your balance
Not applicable
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State College, PA ,

The Effects of Acute Hyperglycemia on Cardiovascular Responses to Exercise in Healthy Adults and Individuals with Prediabetes and Type 2 Diabetes

Blood sugar spikes (i.e., acute hyperglycemia) are a common occurrence in individuals with metabolic dysfunction (i.e., prediabetes and type 2 diabetes). Previous research has shown that blood sugar spikes can temporarily worsen blood vessel health and function in healthy adults and individuals with metabolic dysfunction. Additionally, previous research suggests that blood sugar spikes can lead to elevated exercise blood pressure responses in healthy, college-aged adults. However, little is known about the impact of blood sugar spikes on cardiovascular responses to exercise (i.e., blood pressure and blood flow) in healthy middle-aged adults and individuals with metabolic dysfunction. The purpose of this study is to determine the impact of blood sugar spikes on cardiovascular responses during handgrip exercise. Participants will report to the lab for 3 sessions. Session 1 will be a baseline/control session. During sessions 2 and 3, participants will be randomly assigned to consume either a high-glucose beverage (75 g), or a high-fructose beverage (75 g). Glucose causes blood sugar spikes whereas fructose does not. Both before and after the consumption of either beverage, blood pressure, blood flow, and muscle oxygenation responses to handgrip exercise will be measured.

The study will include 3 sessions. Participants will report to the lab for 3 sessions. Session 1 will be a control session. During sessions 2 and 3, participants will be randomly assigned to drink a high-glucose beverage, or a high-fructose beverage. The measurements for this study will include body composition measurements, questionnaires, finger prick blood sampling to measure blood sugar levels, heart rate and blood pressure measurements, measurements of blood vessel health, and handgrip exercise with the measurement of blood pressure, blood flow, and muscle oxygen levels.

$75

Yes
 

Blaine Arney
Blaine Arney - at bqa5352@psu.edu
Education, Human Development and Social Sciences (ALTOONA)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00028698
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Inclusion Criteria:
Individuals 40 years and older
Individuals with normal blood sugar levels
Individuals with prediabetes
Individuals with type 2 diabetes

Exclusion Criteria:
Diagnosed cardiovascular disease
Insulin medication use
Diabetic neuropathy
Women who are pregnant
Diagnosed type 1 diabetes
Food & Nutrition, Sports Medicine, Diabetes & Hormones
Not applicable
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Altoona, PA ,
State College, PA ,

A Phase 3, Multi-regional, Open-label, Randomized Study of Tirabrutinib vs Rituximab and Temozolomide in Participants With Relapsed/Refractory Primary Central Nervous System Lymphoma

The study is being done to learn how well tirabrutinib (investigational drug) works against cancer as compared to the combination of rituximab and temozolomide (comparator) in participants with PCNSL. We will also learn more about the safety of tirabrutinib and look at how tirabrutinib may affect the body.

To be in this study: o You must have confirmed PCNSL that has come back after treatment (relapsed) or has not improved with prior treatment (refractory) o You must have received methotrexate previously. You will be required to only take the assigned study drug to treat your cancer while on this study. If you believe that you will want to receive other therapy for your cancer, you should not participate in this study. You must agree to not participate in any other study while participating in this study or take any other therapy for your cancer while participating in this study.

Yes
 

Dawit Aregawi
mgrien@pennstatehealth.psu.edu
Neurosurgery (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT07104032
STUDY00028192
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Inclusion Criteria:
Written informed consent by the participant or legal authorized representative prior to Screening
Participants aged ≥18 years on the day of consenting to the study
Relapsed or refractory B-cell PCNSL with at least 1 prior HD-MTX–based therapy for PCNSL
Pathology report confirming the diagnosis of B-cell PCNSL
Life expectancy of at least 3 months

Exclusion Criteria:
Isolated intraocular PCNSL or spinal PCNSL with no brain lesions
Participants who have contraindications to MRI or use of MRI contrast
Participants with non-B cell PCNSL
Participants with systemic presence of lymphoma
Refractory to temozolomide with or without rituximab containing regimens (eg, methotrexate-temozolomide-rituximab) in the last PCNSL treatment
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

PSCI 25-150 A Phase III, randomized, multi-site, open-label trial of BNT323/DB-1303 versus investigator’s choice of chemotherapy in previously treated patients with HER2- expressing recurrent endometrial cancer

This trial will be comparing a new drug against investigator's choice of therapy in the treatment of endometrial cancer that is HER 2 in addition to using a new assay to measure Her2

After the determination is made that it is safe for the patient to participate, the consent form will be signed, and the patient will have scans and blood work taken. The subject is expected to come to all study visits, report to the study team how they feel and let them know about any changes in medication. The study treatments will be given once a week for 21 or 28 days until the medication no longer works, you no longer want to take the medications, or the study doctor feels it is not safe for you to continue. After you complete treatment, you will be seen by the study team monthly for three months then followed for survival for 5 years.

$125 for every completed visit.

Yes
 

Mark Shahin
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Obstetrics and Gynecology (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06340568
STUDY00028943
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Inclusion Criteria:
Are female adults (defined as ≥18 years of age or acceptable age according to local regulations at the time of voluntarily giving informed consent).
Have histologically confirmed recurrent endometrial cancer that:
Have measurable disease

Exclusion Criteria:
Have a history of small bowel obstruction requiring hospitalization within the past 3 months
Have clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, or peritoneal shunt within 2 wks prior to the first dose of trial treatment.
Have uncontrolled or significant cardiovascular disease,
Uncontrolled hypertension
Cancer
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Hershey, PA ,

Phase 1 of GAME-ONc (Gaming for Adolescent Mental Health and Empowerment in Oncology): A Qualitative Focus Group Study to Inform the Development of a Video Game Intervention for Adolescents and Young Adults with Cancer

The GAME-ONc Study aims to explore how video games can support teens and young adults going through cancer treatment. We will talk with adolescents and young adults with cancer, their parents, and healthcare providers to better understand what emotional, social, and practical challenges young people face during treatment, and how a video game intervention might help. The study will also ask participants what kinds of game features they’d like to see, such as whether the game should be single-player or involve someone else, what topics it should include (like coping strategies, health behaviors, or ways to connect with others), and how to make it easy and enjoyable to use. Ultimately, the feedback from this project will guide the design of a video game prototype tailored for teenagers and young adults with cancer, setting the stage for future testing and development.

Participants will complete a brief demographic and gameplay preferences questionnaire and then take part in a one-time focus group session (approximately 1-1.5 hours) conducted via Microsoft Teams or in person. During the focus group, participants will discuss psychosocial needs of adolescents and young adults with cancer and share their opinions on desired features, content, and usability of a proposed video game intervention. The session will be audio and video recorded for research purposes.

100

No
 

Ariane Levesque
Ariane Levesque - at alevesque@pennstatehealth.psu.edu
Pediatrics: General Pediatrics (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
STUDY00028889
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Inclusion Criteria:
Adolescents and young adults aged 13-17 currently receiving cancer treatment.
Any type of cancer diagnosis
Parents/legal guardians of eligible AYA patients are also invited to participate.
Pediatric oncology healthcare providers who work with in-treatment AYAs
Fluency in English

Exclusion Criteria:
Having a severe cognitive impairment preventing oral communication.
Be an AYA or the parent of an AYA who has a non-oncologic primary diagnosis (i.e., the child or AYA’s main medical diagnosis is not a cancer or tumor, their primary condition is something other than an oncologic disease.
Children's Health, Mental & Behavioral Health, Cancer
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AALL2131: An International Phase 2 Study of Chemotherapy and Tyrosine Kinase Inhibitors with Blinatumomab in Patients with Newly-Diagnosed Philadelphia Chromosome-Positive or ABL-class Philadelphia Chromosome-Like B-cell Acute Lymphoblastic Leukemia

The overall goal of this study is to determine the effects, good and/or bad, of a new treatment regimen that combines dasatinib or imatinib to chemotherapy with blinatumomab in patients with Ph+ and ABL-class Ph-like B-ALL. In this study, you will receive blinatumomab with chemotherapy and dasatinib or imatinib.

The overall goal of this study is to determine the effects, good and/or bad, of a new treatment regimen that combines dasatinib or imatinib to chemotherapy with blinatumomab in patients with Ph+ and ABL-class Ph-like B-ALL. In this study, you will receive blinatumomab with chemotherapy and dasatinib or imatinib. All patients on this study will receive the immunotherapy medicine blinatumomab in addition to chemotherapy plus dasatinib or imatinib. The treatment on this study takes about 2 years. It is divided into 7-8 phases of therapy. Participants will be asked to do some optional tests that will help to learn more about their immune system. To do these tests, we would like to take about 2 teaspoons (6-10 ml) of peripheral blood and about 1 teaspoon (3-5 ml) of bone marrow (at the time of standard procedures) at different time points. These tests will not require additional needle sticks or additional procedures. There will also be optional collection of bone marrow and/or blood for banking for future research.

Yes
 

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

All
All
This study is NOT accepting healthy volunteers
NCT06124157
STUDY00028399
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Inclusion Criteria:
Patients must be >365 days and < 18 years (
Newly-diagnosed Ph+ or ABL-class Ph-like B-ALL
Patients with Ph+ B-ALL must have previously started Induction therapy

Exclusion Criteria:
Known history of chronic myeloid leukemia (CML)
ABL-class Ph-like B-ALL who are CNS2 or CNS3 at end of Induction phase
ALL developing after a previous cancer treated with cytotoxic chemotherapy
Children's Health, Cancer
Approved drug(s)
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Hershey, PA ,

Automated Detection of Cognitive Distortions in Acute Mild Traumatic Brain Injury (mTBI) Recovery via Natural Language Processing.

Current concussion testing tracks physical symptoms like headaches but often misses psychological factors that can slow down healing. This study asks patients to respond to prompts regarding their injury in three timepoints: acute, sub-acute, and post-acute phases of injury. We will use artificial intelligence to look for specific patterns in their language that might predict a longer recovery. The goal is to create a simple screening tool that helps doctors identify patients who need extra support earlier."

There will be three surveys over the course of one month. Each survey will take around 10-15 minutes.

No
 

Zach Napora
Zach Napora - at zjn5087@psu.edu or 513-720-6960
Kinesiology (UNIVERSITY PARK)
 

Male
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00028568
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Inclusion Criteria:
Have had a concussion in the last 72 hours
adult (18 and up)
No other neurological disorder besides concussion

Exclusion Criteria:
under 18 years old
A previous neurological condition besides concussion
No diagnosed concussion in the last 72 hours
Neurology, Sports Medicine
Not applicable
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Smoothie Program for Achieving and Resilient Kids (SPARK) Study

This is a dietary treatment study that looks into the effects of the consumption of yogurt on child brain activity, behavioral control, memory, and gut health. This knowledge may help us better understand the health benefits of fermented dairy like yogurt. 60 children, ages 8-10 years-old, will complete 2 in-lab sessions that include problem-solving games, learning tasks, and IQ tests. This study also uses child-friendly brain scanning technology that uses light to record brain activity. Between the two sessions, children will consume either 1-2 yogurt or juice beverages per day for 4-weeks and also collect a stool sample before each session. Throughout the study, parents and children will complete a series of surveys that assess child behaviors, behavioral control, sleep habits, and more.

We are looking for children to help us learn about how different beverages can affect brain and gut health. The study consists of 2 visits to our facility in Chandlee Lab, located on the University Park Campus. In both visits, your child will play problem-solving games, take an IQ test, and wear a functional near-infrared spectroscopy (fNIRS) cap which uses light to measure your child's brain activity while playing a computer game. You and your child will also fill out questionnaires. We will provide you with supplies of a beverage to take home that your child will drink each day between the 2 visits (about 4 weeks). We also ask that you collect two stool samples from your child using our provided stool sample collection kits.

$300.00-380.00

Yes
 

Kathleen Keller
Cara Meehan - at childeatingbehaviorlab@psu.edu or 814-753-1005
Nutritional Sciences (UNIVERSITY PARK)
 

All
Younger than 18 years old
This study is also accepting healthy volunteers
NCT07195474
STUDY00027677
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Inclusion Criteria:
They must be of good health based on parental-report.
They must be 8-10 year-old at enrollment.
They must not be taking medications that impact appetite or cognitive function.
They must not have medical problems that affect the digestive system or ability to eat yogurt (e.g., lactose intolerance, food allergies, Crohn's disease, Celiac disease).
They must be willing to consume and report liking the provided yogurt smoothie.

Exclusion Criteria:
They are not within the age requirements (< than 8 years-old or > than 10 years-old at enrollment.
They have known emotional or cognitive delays that may impact their understanding of procedures.
They have parent-reported medical problems that can affect the digestive system or ability to eat yogurt, and/or are taking a prescription medication that may affect appetite (e.g., Ritalin, methylphenidate, Adderall XR, Concerta, Vyvanse, etc.).
Their parent is unable to attend the study visits.
If they do not speak English.
Children's Health, Food & Nutrition, Prevention
Not applicable
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State College, PA ,