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

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

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

$1200.00 You will only be compensated for completed visits.

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT07291037
STUDY00027769
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Inclusion Criteria:
Participant must be ≥ 18 years old
Has pathologically documented Stage IIIB, IIIC, or Stage IV non-squamous NSCLC
Participants must have documentation of radiographic disease progression

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

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

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

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

Yes
 

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

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

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

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

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

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

Yes
 

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

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

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

Examining language use across the lifespan in English

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

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

$20.00

Yes
 

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

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

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

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

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

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

Yes
 

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

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

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

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

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

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

$500.00 if substudy completed

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT07016971
STUDY00027245
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Inclusion Criteria:
Adults aged 21 years or older
Patients with grade 1 or greater CIPN symptoms, such as neuropathic pain, paresthesia, or muscle weakness, persisting for more than 2 weeks
Patients who have completed platinum-based chemotherapy for colorectal carcinoma, biliary tract carcinoma, pancreatic carcinoma, esophageal carcinoma, gastric carcinoma, or small intestinal carcinoma within the past 2 years
Patients from Penn State Health
Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 1 months after the last dose of protocol therapy

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

Investigating memory decisions in younger and older adults

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

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

$10/hour

Yes
 

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

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

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

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

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

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

$3,122

Yes
 

Kofi Clarke
Zvjezdana (Stella) Sever Chroneos - at zchroneos1@pennstatehealth.psu.edu or 717-531-8259
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT07196722
STUDY00027773
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Inclusion Criteria:
Adult, >18 years of age
Able to sign informed consent and understand the study requirements
Diagnosed with IBD-Crohn's disease at least 12 weeks prior
Receiving active treatment for IBD that is not working
Must agree to the contraception requirements

Exclusion Criteria:
Less than 18 years of age
Pregnant
Not able to complete the questionnaires
Not able to take pills
Any planned major surgery
Digestive Systems & Liver Disease
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

A Phase 3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol in Adults with an Open Label Study in Adolescents to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with Icotrokinra in Participants with Moderately to Severely Active Ulcerative Colitis

The study will evaluate the safety and effectiveness of ICOTROKINRA treatment compared to placebo in participants with moderately to severely active ulcerative colitis. For the induction treatment (12 -weeks), the participants will be randomized to one of the two doses of drug icotrokinra or the placebo (2:1). At week 12 of induction, the participants will be evaluated, and clinical responders will be rerandomized to the drug treatment or placebo. Non-responders will not be randomized but could continue to the maintenance treatment (40-weeks). The study participants will have response to the treatment evaluated by blood draws to test for biomarkers and PK, study symptoms questionnaires (e.g. stool frequency and pain), and colonoscopy with biopsies. They will also have the physical evaluations, ECG, suicidality assessment, pregnancy testing and monitoring of hypersensitivity reactions, along with test for tuberculosis and other infections. The potential participants will enter screening process after they sign the informed consent. The screening for eligibility lasts six weeks and included at least two visits, the clinic visit, and the endoscopy with biopsies. If eligible for the treatment induction, five in-person visits will be held on day 0, week 2, week 4, week 8 and week 12. Except on the visit days, patients will dose at home per the team's instructions. The safety follow-up visit will be held four weeks after the last dose for eligible participants. If eligible to continue treatment after the 40-weeks of maintenance (eleven in-person visit), participants could receive treatment for another four years with in-person visits every eight weeks in the long-term extension. Endoscopy exam will be done at screening, week 12 (end of induction), week 40 (end of maintenance). or disease evaluation (ED)

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

$3000

Yes
 

Kofi Clarke
Zvjezdana Stella Sever Chroneos - at zchroneos1@pennstatehealth.psu.edu or 717-531-8259
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT07196748
STUDY00027795
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Inclusion Criteria:
Adult, >18 years of age
Able to sign informed consent and understand the study requirements
Diagnosed with ulcerative colitis
Received treatment for ulcerative colitis that did not work or stopped working
Must agree to the contraception requirements

Exclusion Criteria:
Complications of UC with fulminanting colitis, toxic megacolon, anything requiring surgery
presence of stoma
presence of history of fistula
Reseaction of colon within last six months or plans for resection
Evidence of high- or low- grade dysplasia in the area of colitis, or adenomatous polyps outside of area of known colitis
Digestive Systems & Liver Disease
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Developmental Differences in Physical and Psychosocial Outcomes in Children and AYAs with Cancer and Survivors: The Pediatric Adjustment to Treatment and Healing (PATH) Study

This study examines how physical health and emotional well-being differ across ages in children, adolescents, and young adults with cancer, cancer survivors, and individuals without a history of cancer. The goal of the study is to better understand how experiences such as fatigue, pain, sleep, physical activity, mood, anxiety, and quality of life vary at different ages and at different points in the cancer journey (during treatment versus after treatment), and how factors like treatment intensity and family resources may influence these experiences. Participants will be asked to complete a set of online questionnaires about their physical health, daily functioning, and emotional well-being. No medical procedures or treatments are involved.

Participants will be asked to complete a set of online questionnaires about their physical health, daily functioning, and emotional well-being. No medical procedures or treatments are involved. The questionnaires will take approximately 45 minutes to complete. - For children aged between 2 and 7 years old, we ask that parents report on behalf of their child. - For children/adolescents aged between 8 and 17 years old, we ask that they complete the survey themselves. Parents may also report on behalf of their child if the child is unwilling or unable to complete the survey themselves. - For young adults aged between 18 and 24 years old, we ask that they complete the survey themselves. Parents may not complete the survey on their behalf.

No
 

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

All
All
This study is also accepting healthy volunteers
STUDY00028747
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Inclusion Criteria:
Be aged or have a child aged ≥2 and <25 years old at the time of assessment
Fluent in English

Exclusion Criteria:
Having a severe cognitive impairment preventing completion of questionnaire, unless parent/legal guardian proxy is available for participants aged <18 years old
Having a non-oncologic primary diagnosis if in the children/AYAs with cancer group (the child or young adult’s main medical diagnosis is not a cancer or tumor)
For healthy volunteers, having a chronic medical condition diagnosed by a healthcare professional
Children's Health, Mental & Behavioral Health, Cancer
Not applicable
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An Open-Label Study of Donidalorsen in Pediatric Patients Age 2 to Less than 12 Years Old with Hereditary Angioedema [Donidalorsen Treatment in Children with Hereditary Angioedema]

This research study is being done to see how well the Study Drug, also called donidalorsen (ISIS 721744), works and if it is safe for children with HAE age 2 to less than 12 years old. Donidalorsen is approved in the United States to prevent HAE attacks in adolescent and adult patients 12 years of age or older. The Study Drug is designed to lower the amount of a protein, known as prekallikrein (PKK), which is made by the liver. When PKK is made by the liver and released into the blood stream, it can lead to HAE attacks. Therefore, the purpose of this study is to assess if reducing the amount of PKK can reduce your child’s HAE attacks and to assess the safety of donidalorsen for children with HAE age 2 to less than 12 years old. This study is an open-label study which means that your child and all participants enrolled in the study will receive active Study Drug. Study participants will receive a subcutaneous (under the skin) injection of donidalorsen once every 4 weeks. The Study Drug dose (10, 40 or 80 mg) will be determined by your child’s body weight and may change during the study. Following screening, you and your child will be asked to come to the study site for 14 visits over about 1 year during the initial treatment period. There is also a Post-Treatment Period your child may choose to enter, which requires 2 phone calls and 1 final visit over 13 additional weeks.

This study is an open-label study which means that your child and all participants enrolled in the study will receive active Study Drug. Study participants will receive a subcutaneous (under the skin) injection of donidalorsen once every 4 weeks. The Study Drug dose (10, 40 or 80 mg) will be determined by your child’s body weight and may change during the study. Following screening, you and your child will be asked to come to the study site for 14 visits over about 1 year during the initial treatment period. There is also a Post-Treatment Period your child may choose to enter, which requires 2 phone calls and 1 final visit over 13 additional weeks. During the Study Treatment and Post-Study Treatment Periods, there is also the option to have some of your child’s visits done by a home health care nurse. At each study visit, height and weight will be collected. A physical exam will be performed. An ECG and vital signs will be collected, paper questionnaires will need to be completed, you and/or child will be asked questions about your child's health, medications and medical history. Any HAE attacks will need to be reported to the study staff.

Yes
 

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

All
Younger than 18 years old
This study is NOT accepting healthy volunteers
NCT07298447
STUDY00028451
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Inclusion Criteria:
Participant’s parents or legally accepted representative is capable of providing informed consent (signed and dated) and able to attend all scheduled study visits and provide feedback regarding the participant’s symptoms and performance
Must be able to comply with all study procedures.
Must be between the ages of 2 and less than 12 years, inclusive, at the time of informed consent and, as applicable, assent.
Must weigh at least 9 kg at the time of informed consent and, as applicable, assent.
Documented diagnosis of HAE-1/HAE-2

Exclusion Criteria:
Must not have any clinically significant abnormalities in medical history (e.g., major surgery within 3 months of Screening), or on physical examination.
Any clinically significant renal or hepatic diseases.
Malignancy within 5 years.
Allergies
Prefer not to display
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Hershey, PA ,

PSCI #25-129: NRG-GY037: A Phase III Study of Induction Pembrolizumab and Chemotherapy Followed By Chemoradiation and Pembrolizumab Vs Chemoradiation and Pembrolizumab Both Followed By Pembrolizumab For High Risk Locally Advanced Cervical Cancer

To determine whether induction IO and chemotherapy prior to CCRT+IO improves progression-free survival (PFS) compared to CCRT+IO alone.

The patient will either get induction therapy, chemoradiation with pembrolizumab, and pembrolizumab maintenance therapy for up to 2 years, or chemoradiation and pembrolizumab followed by pembrolizumab maintenance therapy for up to 2 years. Induction therapy means they will receive chemotherapy with cisplatin and paclitaxel once a week for 6 weeks, plus pembrolizumab every 3 weeks for 2 doses, before starting chemoradiation and pembrolizumab. After the patient finishes treatment, they will check the patient every 3 months for the first 2 years after treatment. After that, they will check every 6 months for 3 years. This means the patient will keep seeing their doctor for 5 years after treatment.

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT07061977
STUDY00028374
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Inclusion Criteria:
Adequate hematologic function
Adequate renal function
Adequate hepatic function
Adequate cardiac function
ECOG Performance Status of ≤ 2

Exclusion Criteria:
Pregnant and Nursing
Prior definitive surgical, radiation, or systemic therapy for cervical cancer.
Prior immunotherapy
Prior pelvic radiation therapy for any disease
History of allergic reaction to the study agent(s) or compounds of similar chemical or biologic composition to the study agent(s)
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

Melanopic lighting and cognitive functions

The study aims to quantify the effects of blue-enriched white light on cognitive performance.

There will be only one visit where participants will complete cognitive tasks and subjective evaluations of the indoor experimental space.

15

Yes
 

Olivia Knoechel
Olivia Knoechel - at okk5100@psu.edu
Architectural Engineering (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00028247
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Inclusion Criteria:
over the age of 18
normal or corrected-to-normal vision

Exclusion Criteria:
over the age of 50 years old
severe eye disease, color deficiency, visual acuity problems (low vision)
psychiatric disorders (schizophrenia, personality disorder) or learning disabilities that affect performance (dyslexia, dysgraphia, dyscalculia, etc)
sleep disorders (narcolepsy, shift work sleep disorder, jet lag, etc)
professional or educational background in lighting and circadian photobiology
Vision & Eyes
Survey(s)
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State College, PA ,

A Phase 3 Randomized, Open-label Study of Pasritamig (JNJ-78278343), a T-cell redirecting Agent Targeting Human Kallikrein 2, With Docetaxel Versus Docetaxel for Metastatic Castration-resistant Prostate Cancer

The purpose of this study is to understand if an investigational treatment (pasritamig) added to docetaxel for progressive metastatic hormone resistant prostate cancer will work better than docetaxel alone.

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.

Yes
 

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

Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT07225946
STUDY00028191
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Inclusion Criteria:
Be ≥18 years of age at the time of informed consent or at least the legal age of majority in the jurisdiction in which the study is taking place.
Have histologically confirmed adenocarcinoma of the prostate.
Have disease that is metastatic at the time of the screening as determined by the investigator.
PSA level ≥2 ng/mL that has increased on at least 2 successive occasions at least 1 week apart.
Progressive disease or new lesion(s) in the lymph nodes, bones, or viscera as defined by RECIST v1.1 and/or in bone scan per PCWG3 while on medical or surgical castration.

Exclusion Criteria:
Known history of either brain or leptomeningeal prostate cancer metastases.
Patients with known BRCA 1/2 mutations (germline or somatic) who have not received treatment with a PARP inhibitor, unless not available or contraindicated.
Suspected or known allergies, hypersensitivity, or intolerance to pasritamig excipients or docetaxel excipients
Not recovered from recent surgery.
Solid organ or bone marrow transplantation.
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

How the brain supports semantics in younger and older adults

The goal of this project is to understand how the brain supports semantics and how this changes as we grow older.

There will be one, in-person, 90-minute session that will include computer tasks and an MRI. All activities will be at the University Park Campus.

$40 and free parking

Yes
 

Michele Diaz
Michele Diaz - at mtd143@psu.edu
Psychology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00028801
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Inclusion Criteria:
Right Handed
Monolingual
Adults ages 18-35 or 60-89

Exclusion Criteria:
No history of brain disorders
No implanted electrical devices
Language & Linguistics
Not applicable
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State College, PA ,

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
NCT07612696
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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Hershey, PA ,

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
Show full eligibility criteria
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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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Hershey, PA ,

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
Show full eligibility criteria
Hide eligibility criteria
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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See this study on ClinicalTrials.gov
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Study Locations

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Location Contacts
Hershey, PA ,