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SNAC Study

This is a multi center clinical trial to test the efficacy of N-acetylcysteine for treatment of patients with active systemic lupus Erythematosus. Healthy control subjects who do not receive treatment are also recruited to serve as controls for the laboratory assays.

This is a clinical trial to be carried out in patients who have systemic lupus erythematosus. Participants will be asked to attend seven study visits over a period of 13 months. After an initial period where it will be determined that the patient can tolerate the medication, N-acetyl cysteine, then there will be a three-month double blind phase where the participant receives either the active treatment or a placebo. At each visit the participant will be asked to complete several questionnaires and blood and urine samples will be obtained. Healthy control individuals will be also enrolled for blood samples only; not for any treatment intervention.

$20 per visit completed

Yes
 

Nancy Olsen
Jamie Carter - at jcarter3@pennstatehealth.psu.edu or 717-531-4921
Medicine: Rheumatology (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT00775476
SITE00001115
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Inclusion Criteria:
Diagnosis of Systemic Lupus Erythematosus
Age 18 years or older
On stable medications
Experiencing flare of disease

Exclusion Criteria:
pregnant or lactating
regular daily use of Tylenol (acetaminophen)
active chronic infections
current treatment with cyclophosphamide or rituximab
current use of anti-oxidants
Arthritis & Rheumatic Diseases
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

AIDP

The purpose of this study is to test the performance of a web-based system for automated review of MRI images across 21 sites in the Parkinson Study Group. Each site will perform imaging, clinical scales, diagnosis, and will upload the data to the web-based software tool. The clinical diagnosis will be blinded to the diagnostic algorithm and the imaging diagnosis will be compared to the movement disorders trained neurologist diagnosis.

Participants will attend two study visits that will include questionnaires, a physical exam and motor exams and an MRI (during one of the visits).

300

Yes
 

Sol De Jesus
Autumn Collier - at acollier3@pennstatehealth.psu.edu or 717-531-5233
Neurology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
SITE00001044
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Inclusion Criteria:
40-80 years old at baseline
Diagnosed with a Parkinsonism (PD, MSA or PSP)

Exclusion Criteria:
Unable to undergo an MRI
Neurology
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Hershey, PA ,

A Survey of the Sex Differences in Taking Selfies while Driving

This study aims to understand peoples’ selfie-taking behavior and how, if at all, they relate to their driving behavior and gender difference. The participants will participate the study by completing an online survey.

No
 

Yiqi Zhang
Josh Avalos - at jqa5409@psu.edu or 610-716-7976
Industrial and Manufacturing Engineering (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00016045
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Inclusion Criteria:
Subjects who are 18 years of age or older
Subjects have a valid U.S. driver license or are allowed to drive in the US

Exclusion Criteria:
Subjects who under 18 years of age
Subjects who do not have a valid U.S. driver license or are not allowed to drive in the US
Education, Language & Linguistics
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Olfactory tools for COVID-19 screening and surveillance

This a collaborative multisite NIH funded project to develop smell tests as a rapid low cost way to screen for Covid19 infections. The lead institution is the University of Florida, and this project is being entered into CATS to create a Reliance Agreement under the NIH single IRB rules (sIRB).

No
 

John Hayes
Elisabeth Weir - at efw5195@psu.edu
Food Science (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
SITE00000951
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Inclusion Criteria:
Aged 18 to 99
COVID19 negative
COVID19 positive
Able to Consent in English

Exclusion Criteria:
Inability to provide consent
History of known pre-existing olfactory or taste disorder
History of head trauma with loss of consciousness
History of neurodegenerative disease
COVID-19
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Predicting Concussion Outcomes with Salivary miRNA

The purpose of this study is to identify changes in salivary micro ribosomal nucleic acid (miRNA) expression that are predictive of symptom duration and severity following mild traumatic brain injury (mTBI) in children. The primary endpoints of this study are as follows:1)Characterization of brain-related miRNA in the saliva of 250 children with mTBI and 200 age- and gender-matched controls between the ages of five and twenty-three years.2)Identification of a set of salivary miRNAs that is predictive of duration and severity of mTBI symptoms.

Saliva collection and surveys at baseline, 7 days, and 30 Days

$20

Yes
 

Jayson Loeffert
Brennen Harding - at bharding@pennstatehealth.psu.edu or 717-531-5656
Family and Community Medicine (HERSHEY)
 

All
All
This study is also accepting healthy volunteers
NCT02901821
STUDY00003729
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Inclusion Criteria:
5 to 23 years of age
Seen in the Penn State Pediatric Concussion Clinic within 2 weeks of most recent concussion

Exclusion Criteria:
Does not speak english
Periodontal disease
Ongoing seizure disorder, or other neurologic disorder
Drug or alcohol dependency
clinical diagnosis of severe TBI
Children's Health, Neurology, Sports Medicine
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Hershey, PA ,

Observations of Family Mealtime Routines

The purpose of this study is to gather information about what family mealtimes look like for families with children between the ages of 3 and 8. Families will be asked to video record their family mealtime, in addition to answer some questions and to complete some questionnaires, some about body image and dieting.

On one occasion, your family's mealtime will be recorded via Zoom. You and your family will be asked some questions and to complete some questionnaires online.

$20

No
 

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

All
All
This study is also accepting healthy volunteers
STUDY00015339
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Inclusion Criteria:
At least one adult who is the caregiver of at least one child between age 3 and 8 (e.g., at least one parent-child dyad)
Adults age 18 and older
Children, ages 3-8
Individuals fluent in English

Exclusion Criteria:
Non-family members, as defined individually by each family
Caregivers who are under the age of 18
Individuals who are not fluent in English
Families without at least one child age 3 to 8
Children's Health, Food & Nutrition
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Human-robot interaction study

We are interested in developing robots that can interact with humans. We hope that to develop robots that can interact with people and be used in a variety of different situations such as schools, offices, and homes. This study investigates human-robot interaction.

Yes
 

Alan Wagner
Alan Wagner - at alan.r.wagner@psu.edu or 814-865-3136
Aerospace Engineering (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00010270
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Inclusion Criteria:
Ability to read and see

Exclusion Criteria:
Under 18
Education
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State College, PA ,

Behavior, Voice, and Sex Hormones Study

Hormones are molecules that deliver signals throughout the body. They influence behavior, sleep, hunger, stress, and virtually all other aspects of life. This study seeks to better understand several of these functions, specifically how hormones affect specific aspects of human behavior and psychology, as well as speech production. Following an initial lab visit, subjects will participate in the remainder of the study (~5 weeks) at home via the internet. On a daily basis, they will collect urine samples for hormone analysis, saliva samples for analysis of oral micro-organisms, and will submit voice samples for analysis of speech (e.g. measuring voice pitch and loudness). They will then complete an online survey designed to collect information about their behavior, and attitudes over the previous 24 hours. Subjects receive compensation for their participation.

- Compensation $330 at maximum- Pre-sampling lab visit to sign a consent form and receive training- A series of ~42 daily at-home sample (urine, saliva) collection & online surveys- Weekly lab visits for sample drop-off

$330

Yes
 

David Puts
Sojung Baek - at research1871@psu.edu or 814-321-5541
Anthropology (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00013693
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Inclusion Criteria:
Between 18 and 30 years of age
Normal menstrual cycles
Available for daily at-home session for approximately 5 weeks
Female/Identifying as a woman
Predominantly or exclusively heterosexual sexual orientation

Exclusion Criteria:
On hormonal birth control
Uncorrected severe defects of hearing, speech, or vision
Bisexual or predominantly homosexual sexual orientation
Very heavy smoking or alchohol consumption
Medications that affect levels of ovarian hormones (e.g. anti-depressants, anti-psychotics)
Language & Linguistics, Diabetes & Hormones, Women's Health
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State College, PA ,

PSCI-22-063: NRG-GU011 NRG Promethean

This trial is comparing radiation therapy with or without hormone therapy in men with prostate cancer.

Patients must come in for all radiation treatments. Patients must take their androgen therapy as prescribed.

Yes
 

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

Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05053152
SITE00001224
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Inclusion Criteria:
Pathologically (histologically or cytologically) proven diagnosis of prostate adenocarcinoma at any anatomical location (for example, prostate, metastatic site), including intraductal or ductal carcinoma, at any time before registration.
Age ≥ 18 years.
ECOG Performance Status 0-2 within 120 days prior to registration.
External beam and/or brachytherapy to: Prostate alone, prostate and seminal vesicles, prostate and pelvic nodes, or radiation to all three sites.
Radical prostatectomy alone, radical prostatectomy plus postoperative radiotherapy to the prostate bed, or radical prostatectomy plus postoperative radiotherapy to the pelvic nodes.

Exclusion Criteria:
Evidence of local tumor recurrence in the prostate and/or periprostatic/seminal vesicle region after radiotherapy, or in the prostate bed after prostatectomy.
Currently on androgen deprivation or anti-androgen therapy.
Osseous metastasis on 99mTc radionuclide bone scan
Extra pelvic nodal/soft tissue disease (> 1.5cm in short axis) on CT or MRI pelvis +/- abdomen
Spinal cord compression, or spinal intramedullary, brain, and/or visceral (for example liver, lung, etc.) metastasis
Cancer
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

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

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

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

1220

Yes
 

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

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

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

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

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

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

Yes
 

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

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

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

Understanding Prenatal Hydration Behaviors

To examine women’s self-reported pregnancy hydration behaviors, especially during a global pandemic. This study will also examine other lifestyle behaviors (e.g., weight gain, exercise, eating behaviors, sleep, pain management). It is hypothesized that hydration behaviors will decrease due to lifestyle changes related to the pandemic. Secondary outcomes will also be influenced by hydration behaviors and pandemic lifestyle changes.

No
 

Danielle Downs
Abigail Pauley - at amp34@psu.edu
Kinesiology (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00016174
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Inclusion Criteria:
Pregnant
Women
18-45
English speaking

Exclusion Criteria:
Non-pregnant
Men
Younger than 18
Non-English speaking
Food & Nutrition, Mental & Behavioral Health, Women's Health
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A Phase 2, Randomized, Double-Blind, Placebo-Controlled,Multicenter, Dose-Ranging Study Evaluating the Efficacy andSafety of GS-1427 in Adult Participants With Moderately toSeverely Active Ulcerative Colitis (UC)

The study will test GS-1427 for treatment of ulcerative colitis (UC). Adults diagnosed with UC can participate if otherwise eligible.The study has two parts; the first part lasts 12 weeks. Participants will be randomly assigned to either a treatment or a placebo arm. At 12-week evaluation the participants can be further assigned to an active treatment lasting 40 weeks. The study procedures include blood tests, endoscopy with biopsies, vitals, and physical exam, EKG testing, providing urine and stool samples, and completion of symptom-related diary questionnaires.

Participants will be required to sign the informed consent and show that they understand the study requirements. They will be required to complete in-person clinic visits. During the visits, the participants will have their vitals checked, and we will ask them about any problems they may have or adverse events. During the screening periods, participants undergo endoscopy with biopsies and provide stool and urine samples. Blood draws will also be done, and we will teach them to complete the questionnaires about the disease symptoms. If eligible for the study, screened subjects will be randomized for either one of four groups: three-drug treatment doses or a placebo treatment (blinded). They will attend clinic visits every four weeks. The endoscopy evaluation will be done at screening, week 12, week 52, and week 76 or at the end of the study. After week 12, participants will either continue to receive the drug treatment or, if they complete the placebo group, they will be randomized to one of the drug doses.

Part 1 total $1765 ($75 per visit, $20 meal cards v2 and v12); Part 2 TBD

Yes
 

Kofi Clarke
Zvjezdana 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
NCT06290934
STUDY00024299
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Inclusion Criteria:
age18-75 years
diagnosed UC at least three months prior
active disease inspite of one of the standard therapies
loss of response, or intolerant to not more than one therapy
negative TB test and HIV at screening

Exclusion Criteria:
diagnosis of Crohn's disease
history of ileostomy, colostomy or stenosis
history of extensive colonic resection
past treatment with vedolizumab
past treatment with ustekinumab
Digestive Systems & Liver Disease
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Hershey, PA ,

Understanding the effect of drivers’ profile information on riders’ feedback in ride-sharing context

This study aims to understand ways to affect how riders perceive and provide feedback to drivers through technology intervention. Particularly, we investigate how presenting drivers’ personal profile under different trip conditions may lead to differences in the ways riders may provide feedback. We hypothesize that riders will provide positive feedback when provided drivers’ personal information when the trip goes well, and that riders will provide less negative feedback when provided drivers’ personal information when the trip goes bad due to uncontrollable reasons.

Yes
 

Benjamin Hanrahan
Ning Ma - at nzm37@psu.edu
Information Sciences and Technology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00013808
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Inclusion Criteria:
Taken at least 10 Uber/Lyft ride in the last 12 months.
You are willing to share several of your past Uber/Lyft trip records in the app with us.

Exclusion Criteria:
You are a current or past employee with one of the ride-sharing corporations (Uber/Lyft)
Education
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State College, PA ,

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants with Moderately to Severely Active Crohn’s Disease

This protocol has two independent parts. In Part 1, participants will be randomized to one of three Tulisokibart arms of treatment or placebo. Tretment will include induction, maintenance, and extension. When the maximum number of participants with prior exposure to advanced therapies has been reached, Part 2 will open for enrollment. In Part 2, the participants will be randomized to one of two dosing arms of Tulisokibart or a placebo.

The participants will be required to sign the inform consent and understand the requirements. They must have in person visits, comply with the procedures (blood test), colonoscopy, and to complete daily dairy about their symptoms. They must provide specimens such as blood, stool, and urine.

$100 per completed visit, $250 per endoscopy

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
NCT06430801
STUDY00025295
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Inclusion Criteria:
Read, understood, and provided written informed consent
Individual of any sex/gender from 18 years to 75 years of age inclusive,
Has had disease more than 3 months and has moderately active disease with one of the standard therapies
Average daily very soft or liquid SF ≥4 and/or average daily APS ≥2 at Baseline.
Demostrates loss of response, intolerance or inadequate response to standard therapy

Exclusion Criteria:
Has a diagnosis of UC, or indetermined colitis
Has CD without colonic involvement
Has known colonic stricture or colonic stenosis
Has current stoma
Is missing more than two colonic segments or has short bowel syndrome
Digestive Systems & Liver Disease
Experimental drug compared to a placebo/”sugar pill”
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PSCI# 25-018 Randomized Phase III Trial of Neoadjuvant Immunotherapy with Response-Adapted Treatment Versus Standard of Care Treatment for Resectable State II/IV Cutaneous Squamous Cell Carcinoma

This study is comparing standard of care surgery and after surgery radiation against pre-surgery immunotherapy, followed by surgery, followed by radiation and immunotherapy to determine which combination prevents cancer reoccurrence.

Participants must come to all scheduled study visits, all medications they are taking including over the counter and tell the study doctor how you are feeling. 7 visits; 3 blood draws; QOLs to be completed 5 times for Group 1 and 7 times for Group 2

Yes
 

Danh Pham
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
NCT06568172
STUDY00026574
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Inclusion Criteria:
Pathologically (histologically or cytologically) proven diagnosis of invasive cutaneous squamous cell carcinoma (CSCC) or regional lymph node or in-transit metastasis of CSCC.
Previously untreated or recurrent CSCC
Age ≥ 18
ECOG Performance Status of 0-2
Not Pregnant and Not Nursing

Exclusion Criteria:
No history of myocardial infarction within the last 6 months
No active infection requiring systemic antibiotics, antiviral, or antifungal treatments
No history of allogeneic stem cell transplantation, or autologous stem cell transplantation.
No prior systemic therapy for the study cancer
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults with Cutaneous Sarcoidosis

The purpose of this research is to measure clinical safety and efficacy (effectiveness) of oral brepocitinib in adults with cutaneous sarcoidosis. Participation in this study is expected to last for up to 24 weeks (about 6 months). During treatment period, visits will be scheduled about every 4 weeks. Participants will be assigned to 1 of 3 treatments, there is a chance of receiving a placebo (non active ingredient treatment) however, you will not know nor will the study team know what treatment you have been assigned too. In addition, throughout the study at different time points you will answer questions, take the study treatment as directed by the study team, have your skin examined (biopsy), have labs drawn, have an ECG, and a chest x-ray.

Participants will attend a total of 7 in person visits throughout the study and visits will be scheduled about every 4 weeks during the Treatment Period. During the study you will be asked to answer questions to gather information on your health as well have you complete questionnaires. In addition, you will have the following assessments at different time points throughout the study: skin exam, ECG, Chest X-Ray, Skin photography, Skin punch biopsy, Pulmonary function testing, and blood tests.

Yes
 

Matthew Helm
Dermatology Clinical Trials at dermatologyclinicaltrials@pennstatehealth.psu.edu or 717-531-5136
Dermatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00026360
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Inclusion Criteria:
Must be 18-75 years of age
Skin biopsy required along with presentation of cutaneous sacroidosis symptoms for 6 months or longer
Weight requirements apply for participation, study coordinator will discuss
Must be willing to understand and comply with the study requirements
Certain medications are allowed at a maximum stable dose, study coordinator will discuss further

Exclusion Criteria:
Medical History will be discussed with study coordinator.
Women who are breastfeeding, pregnant, or planning to become pregnant, or WOCBP who are unwilling to apply a highly effect birth control method for the time specified during study participation
Skin Conditions
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Making Second Language Learning More Inclusive in the Elementary Classroom: A Metalinguistic and Multimodal Approach

This study aims to find out whether learning German can help children with language difficulties improve their English skills. Children will learn German grammar using colors, shapes, and simple explanations to help them understand how language works.

Participants will complete 20 one-hour Zoom sessions over 10 weeks. During these sessions, they will learn German using a visual and interactive approach that highlights both similarities and differences between German and English. Some sessions will involve fun learning activities, while others will include assessments of language, cognitive, and metalinguistic skills.

$300

No
 

Natacha Mally
Natacha Mally - at nmally@psu.edu
Division of Graduate Studies (UNIVERSITY PARK)
 

All
Younger than 18 years old
This study is NOT accepting healthy volunteers
NCT00000000
STUDY00026229
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Inclusion Criteria:
Children who likely have developmental language disorder (DLD; SLI)
Aged 7-11
Have English as their first language
Have significant difficulties understanding and/or expressing themselves in English

Exclusion Criteria:
Have a diagnosis of a neurodevelopmental disorder other than DLD (e.g., autism, ADHD, intellectual disability)
Are suspected of having another neurodevelopmental disorder, based on parent report or observed behavior
Have a hearing impairment
Children's Health, Education, Language & Linguistics
Not applicable
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Intersectionality and Mental Health: Developing a Culturally Sensitive Yoga Intervention for Black and Minoritized Young Adult Substance Users

The project aims to increase awareness and understanding of yoga's benefits for mental health, including substance use, and stress reduction among marginalized Black communities and to empower minoritized individuals with critical tools and techniques for managing stress. By addressing the multifaceted relationship between intersectionality, race-related stress, and mental health, including substance use, this study seeks to provide a comprehensive approach to improving health outcomes for marginalized Black young adults. Participants will engage in either a 1:1 semi-structured interview or a focus group discussion, both hosted by the principal investigator, to hear their perspectives on the accessibility and feasibility of engaging in yoga-based interventions for mental health and substance use. From this study, the researcher seeks to contribute to the development of effective yoga prevention and treatments strategies that provide coping mechanisms to deal with race-related stress, reduce substance use and related negative health outcomes, and promote resilience among affected populations.

The study will last over the course of one day and will take about two hours of your time. Participants in this study will take part in a focus group or a one-on-one interview to share their experiences, perspectives, and insights related to yoga, mental health, stress management, and substance use.

For interview participants, each individual will receive a $25.00 gift card and for focus group participants, each individual will receive a $40.00 gift card for their participation.

Yes
 

Mary Mbaba
Mary Mbaba - at mkm7561@psu.edu
Prevention Research Center (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT00000000
STUDY00026251
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Inclusion Criteria:
For focus groups: Participants must be between the ages of 18 and 30.
For focus groups: Participants must identify as Black or African American.
For focus groups: Participants must be open to discussing their past/present substance use, mental health, coping strategies, and perceptions of yoga as an intervention.
For interviews: Must be a licensed or otherwise qualified mental health professional (e.g., counselor, therapist, social worker, psychologist, psychiatrist, or substance use counselor).
For interviews: At least two years of professional experience working with marginalized populations, particularly young adults from racial/ethnic minority backgrounds, who are dealing with mental health issues, specifically substance use.

Exclusion Criteria:
For focus groups: Individuals outside the age range of 18-30 will be excluded.
For focus groups: Individuals who do not identify as Black or African American, or who do not meet the specified racial/ethnic categories, will not be eligible for participation in the focus groups.
For focus groups: Experiencing acute substance use or psychiatric issues that require immediate medical attention
For interviews: Professionals with fewer than two years of experience working with marginalized populations, particularly young adults facing racial/ethnic stress, mental health issues, or substance use, will be excluded.
For interviews: Individuals who do not hold a recognized mental health professional role (e.g., counselors, therapists, social workers, psychologists, or substance use counselors) will not be eligible to participate.
Addiction & Substance Abuse, Mental & Behavioral Health
Not applicable
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A Phase 2, Open-label, Multicenter Study to Assess the Efficacy and Safety of BW-20805 in Adult Subjects with Hereditary Angioedema

This is a voluntary clinical research study to investigate BW-20805 a injectable treatment for hereditary angioedema (HAE). The purposes of the study are to evaluate the safety and efficacy of the study drug for the treatment of HAE, the effectiveness of the study drug for preventing HAE attacks, and how the study drug works in the body and the relationship between the amount of the study drug taken and the effect on the body.

You will answer questions about your health, provide blood samples, undergo routine urine laboratory tests, receive the study drug, undergo electrocardiogram (ECG), complete questionnaires, undergo physical exams, and provide HAE attack information. There are a total of 13 visits.

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06846398
STUDY00026212
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Inclusion Criteria:
Documented diagnosis of Hereditary Angioedema Type 1 or Type 2.
Males or females 18 to 70 years of age at the time signing informed consent
Access to rescue treatment for Hereditary Angioedema

Exclusion Criteria:
Diagnosis of another form of chronic angioedema
Active or history of cancer within 5 years prior to screening
Infectious Diseases & Immune System, Allergies
Experimental drug compared to an approved drug
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Hershey, PA ,

A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBEXELIMAB IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS

Study to look at the safety and effectiveness of Obexelimab in patients with active Lupus who are currently receiving standard of care medications

There will be 13 in person visit over nine months, blood and urine will be obtained at 12 of these visits.

up to $650

Yes
 

Nancy Olsen
Jamie Carter - at jcarter3@pennstatehealth.psu.edu
Medicine: Rheumatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06559163
STUDY00025867
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Inclusion Criteria:
Systemic Lupus

Exclusion Criteria:
Active Lupus Nephritis
over 70 years old
Arthritis & Rheumatic Diseases
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

PSCI 24-138 NRG-CC011: Cognitive Training For Cancer Related Cognitive Impairment In Breast Cancer Survivors: A Multi-Center Randomized Double- Blinded Controlled Trial

If the participant decide to take part in this study, they will join one of two computerized cognitive training groups for 10 weeks and complete assessments before and up to at least six months after training. The computerized cognitive training will be delivered remotely online. Trained research staff will help the participant learn how to use the computerized training program. The participant will also be asked to complete questionnaires via mailed surveys or electronically online and a cognitive assessment over the telephone. A cognitive assessment checks for how the brain processes thoughts, such as concentrating, learning new things, remembering, and making decisions. The total participation in this study will be about 9 months.

Participants will join one of two computerized cognitive training groups. The computerized cognitive training will involve up to 40 hours of the assigned activity over a 10-week period. The 4 questionnaires and assessment times are as follows:•at the beginning of the study (prior to the first computerized training)•12, 24, and 36 weeks after joining the study.Participants will be asked to complete questionnaires via mailed surveys or electronically online and a cognitive assessment over the telephone.

$100.00

Yes
 

Hyma Polimera
PSCI Clinical Trials Office at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
Penn State Hershey Medical Group (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05896189
STUDY00026015
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Inclusion Criteria:
The participant must be ≥ 18 years of age.
The participant must have a first-time diagnosis of non-metastatic breast cancer which is Stage I-III.
The participant must have a score of < 12 on the PROMIS Adult v2.0 - Cognitive Function 4a.
Participants must be at least 6 months and no more than 5 years after completion of initial surgery +/- adjuvant chemotherapy/radiation therapy, and targeted therapies (e.g., PARP inhibitors, CDK4/6, or immunotherapy).
The participant must be able to understand, speak, read, and write in English or Spanish.

Exclusion Criteria:
Scoring ≤ 3 on the 6-item cognitive screen.
Patient Health Questionnaire-2 item (PHQ-2) score of ≥ 3.
Definitive clinical or radiologic evidence of metastatic disease
Current or past history of another cancer. Patients with history of only non-melanoma skin cancer or in situ cervical cancer without chemotherapy treatment would be eligible.
Previous exposure to chemotherapy treatment for another cancer or due to other medical condition (e.g., methotrexate exposure for treatment of rheumatoid arthritis).
Cancer
Survey(s)
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Hershey, PA ,

Voice Assistant to Provide Cognitive Stimulation Therapy at Scale

This project focuses on establishing a preliminary evidence base regarding the feasibility and acceptability of using smart speakers to deliver individual cognitive stimulation therapy (iCST) to persons living with dementia (PLwDs)

Fifteen dyads of persons living with dementia and their care partners will be recruited. Participants will engage with an Alexa-based Virtual Assistant (VA), and data will be collected via surveys and Zoom interviews.

$45 per hour

No
 

Saeed Abdullah
Ita Saragih - at ixs5315@psu.edu or 582-203-8955
Information Sciences and Technology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00024129
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Inclusion Criteria:
Family care partner and their family member with mild dementia
Ability to speak and understand English
See and hear well enough to participate
No major physical illness or disability affecting their participation
Personal in-home Wi-Fi access and personal device capable of participating in Zoom calls

Exclusion Criteria:
Persons living with dementia or their care partners who are unable to provide inform consent
Neurology, Mental & Behavioral Health
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PSCI# 25-028 LoTAM: A RANDOMIZED, PHASE III CLINICAL TRIAL OF LOW-DOSE TAMOXIFEN FOR SELECTED PATIENTS WITH MOLECULAR LOW-RISK EARLY-STAGE BREAST CANCER

This study is comparing standard of care endocrine therapy for 5 years versus low dose tamoxifen for 5 years in patients with resected invasive breast cancer.

Participants must come to all scheduled study visits, all medications they are taking including over the counter and tell the study doctor how you are feeling.

Yes
 

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

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06671912
STUDY00026751
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Inclusion Criteria:
Unilateral invasive adenocarcinoma of the breast that is histologically confirmed
No tumors that are considered pT4
No definitive clinical or radiologic evidence of metastatic disease
Age ≥ 18 years and female ___
ECOG Performance Status ≤ 2

Exclusion Criteria:
Abnormal or dysfunctional uterine bleeding within 1 year prior to study enrollment
Any patient with known atypia or endometrial pathology that the opinion of the treating investigator would place the patient at undue risk of endometrial cancer with tamoxifen
Any patient with a known hypercoagulable state that in the opinion of the treating investigator would put the patient at undue risk of venous thromboembolism with tamoxifen.
No synchronous or previous contralateral invasive or non-invasive breast
No previous history of ipsilateral invasive breast cancer or ipsilateral DCIS, regardless of the disease-free interval.
Cancer
Approved drug(s)
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Hershey, PA ,

PSCI 24-106 A: A Randomized Phase II Study of Venetoclax and HMA-based Therapies for the Treatment of Older and Unfit Adults with Newly Diagnosed FLT3-mutated Acute Myeloid Leukemia (AML): A MyeloMATCH Treatment Trial

As part of the myeloMATCH Older Adult AML basket, a comprehensive geriatric assessment will be implemented across intensive and non-intensive treatment studies to validate measures of fitness and frailty that predict for treatment-related morbidity and mortality. The overall goal of the geriatric assessment will be to validate measures to be incorporated in future older adult AML myeloMATCH studies to prospectively define “fitness” for intensive chemotherapy.

Subject will either get Azacitidine through a vein in their arm or subcutaneously and Venetoclax by mouth for up to 2 years, or will get Azacitidine through a vein in your arm or subcutaneously, Venetoclax and Gilteritinib as tablets that you take by mouth for up to 2 years.After you finish your study treatment, doctor will continue to follow condition for 10 years.

Yes
 

Joseph Cioccio
PSCI CTO Office at PSCI-CTO@Pennstatehealth.psu.edu or 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06317649
STUDY00026189
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Inclusion Criteria:
Patient must have a morphologically confirmed diagnosis of AML according to the WHO 2016 classification excluding APL with PML-RARA, AML with RUNX1-RUNX1T1, or AML with CBFB-MYH11.
Patient must have no prior therapy for AML with the exception of hydroxyurea and all-trans retinoic acid (ATRA), or leukapheresis. Patients with cytarabine-based emergency therapy prior to the start of therapy on this trial are eligible.
Patient must be assigned to this protocol by the myeloMATCH MSRP.
Patient must have the ability to understand and the willingness to sign a written informed consent document.
Creatinine clearance of ≥ 30 mL/min/1.73m2

Exclusion Criteria:
Patient must have prior therapy with hypomethylating agents or FLT3 inhibitors
Patient is pregnant or breast-feeding
Patients with a history of hepatitis C virus (HCV) infection have not been treated and cured.
Patient has the medical necessity for ongoing treatment with a strong CYP3A4 inducing drug.
Cancer
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

PSCI 24-129 Open-Label, Multicenter, Phase 1 Study to Assess the Safety of P-CD19CD20-ALLO1 in Subjects with Selected Relapsed/Refractory B cell Malignancies

This trial will examine the use of "off the shelf" CAR T in the treatment of cancers that have relapsed or do not respond to treatment.

Participants must keep all study visits, tell the study doctor how you are feeling and all medications you are taking including over the counter medications.

Yes
 

Shin Mineishi
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
NCT06014762
STUDY00026280
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Inclusion Criteria:
Males or females ≥ 18 years of age.
Must have prior biopsy proven confirmed diagnosis of DLBCL NOS (including DLBCL arising from indolent lymphomas), HGBL, PMBCL, and tFL or follicular lymphoma Grade 3B.
Must have relapsed/refractory disease
Must be willing to practice birth control

Exclusion Criteria:
Is pregnant or lactating
Concurrent or previous other malignancy within 2 years of study entry
Has active autoimmune disease
Has a history of hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), or human T-lymphotropic virus (HTLV) infection
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

PSCI 24-106: Myelomatch, Master Screening And Reassessment Protocol (MSRP) For Tier Advancement In The NCI Myelomatch Clinical Trials

The purpose of the study is to see if blood and bone marrow samples can be tested in a timely manner for markers that could guide cancer treatment. The testing will look for markers that specific treatments may target. Based on test results, the subject will have the option to join a myeloMATCH treatment substudy for treatment or receive standard of care treatment from your doctor.

Participants will give bone marrow and blood samples for testing. Your samples will be tested for specific cancer biomarkers.After the study receives the results of your biomarker testing, the physician will tell you if there is a myeloMATCH treatment substudy available that matches your results.If a substudy is available the study doctor will give the subject more information about it and help the subject understand the details of the study.

Yes
 

Joseph Cioccio
Rachael Griffith - at rgriffith2@pennstatehealth.psu.edu or 717-531-7128
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT05564390
STUDY00026188
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Inclusion Criteria:
Participants must not have received prior anti-cancer therapy for AML or MDS.
Participants must be ≥ 18 years of age.
Participants must agree to have translational medicine specimens submitted per
Participants must not have a prior or concurrent malignancy that requires concurrent anti-cancer therapy.
Participants must have a Zubrod Performance Status evaluation within 28 days prior to registration

Exclusion Criteria:
Participants have received prior anti-cancer therapy for AML or MDS.
Participants are less than 18 years of age.
Participants did not agree to have translational medicine specimens submitted per
Participants have a prior or concurrent malignancy that requires concurrent anti-cancer therapy.
Participants did not have a Zubrod Performance Status evaluation within 28 days prior to registration
Blood Disorders, Cancer
Not applicable
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Hershey, PA ,

Cue Reactivity Responses in Alcohol and Cannabis Use

This study aims to examine how alcohol and cannabis cues (i.e. images of alcohol containing beverages or cannabis) influences brain responses in the lab and how cues in the natural environment influence self-reported craving and drug use.

Potential participants will complete a screening questionnaire over the phone, and if eligible, will also complete 3 in-person visits. These visits include an intake session in which eligibility is assessed, a MRI session, 2 weeks of smartphone based responding, and a third visit to complete a questionnaire.

$279

Yes
 

Eric Claus
Eric Claus - at edc5208@psu.edu or 814-865-2007
Biobehavioral Health (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00026494
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Inclusion Criteria:
Between the ages of 18-30
Able to read and write in English and complete study evaluations
Able to provide written and verbal consent
Must report regular use of alcohol and/or cannabis
Able to provide negative toxicology screenings for substances, except cannabis, nicotine, or alcohol prior to eligibility determination

Exclusion Criteria:
Women who are pregnant or lactating
Current regular illicit drug use (other than cannabis)
Any contraindications for MRI
Addiction & Substance Abuse
Not applicable
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State College, PA ,

PSCI 24-106 B: A Measurable Residual Disease (MRD) Focused, Phase II Study Of Venetoclax Plus Chemotherapy For Newly Diagnosed Younger Patients With Intermediate Risk Acute Myeloid Leukemia: A Tier 1 Myelomatch Clinical Trial

Participants take part in this research study because they have a new diagnosis of acute myeloid leukemia (AML). Study is looking at to see if treatment can be improved by adding venetoclax to the usual chemotherapy: cytarabine and daunorubicin (also known as 7+3), or azacitidine? This study wants to find out if this approach is better or worse than the usual approach for this type of cancer. The usual approach is defined as care most people get for AML.

Participants will either get cytarabine + daunorubicin + venetoclax for up to 11 days, or you will get azacitidine + venetoclax for up to two months, or you will get cytarabine + daunorubicin for up to 7 days. Subjects treatment may be extended by a few weeks if subject needs additional therapy. Doctor will continue to follow your condition for 5 years and watch subject for side effects and keep track of their health. After study treatment, subjects may also be offered another clinical trial through the myeloMATCH study. Subjects will be followed on this study even if they continue onto another study. Follow-up includes a clinic visit 28 days after subjects treatment is complete, and clinic visits every 3 months for the first year, every 6 months for the second year, and annually for years 3-5 after treatment is completed.  

Yes
 

Joseph Cioccio
Hannah O'Donnell - at hodonnell@pennstatehealth.psu.edu or 717-531-0003, ext=8199
Medicine: Hematology and Medical Oncology (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05554393
STUDY00026190
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Inclusion Criteria:
Age 18-59 years at time of induction therapy
Participants must have been registered to Master Screening and Re-Assessment Protocol
Previously untreated, de novo AML defined by >20% myeloblasts in the peripheral blood or bone marrow
ECOG performance status ≤ 3.
WBC must be <25x109/L.

Exclusion Criteria:
Prior therapy for AML except for hydroxyurea and leukapheresis to control blood counts.
Patients who are receiving any other investigational agents.
Pregnant women are excluded
Patients with isolated myeloid sarcoma are not eligible
active, uncontrolled bacterial, fungal, or viral infection
Blood Disorders
Experimental drug compared to an approved drug
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Hershey, PA ,

PSCI #24-150 A Phase 3 Open-Label, Randomized Study of PDS0101 Plus Pembrolizumabvs Pembrolizumab Alone in First Line Treatment of Immune Checkpoint Inhibitor (ICI) Naïve Subjects with Unresectable Recurrent and/or Metastatic (R/M) Human Papillomavirus 16 (HPV16)-Positive Head and Neck Squamous Cell Carcinoma (HNSCC).

This study will see if pembrolizumab alone or with PDS0101 is the better treatment for head and neck cancer.

Participants will need to come to all study visits, take the study medication as prescribed, tell the study team how you are feeling and report to the study team all new medications you are tsking including over the counter medications.

Yes
 

Danh Pham
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
NCT06790966
STUDY00026812
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Inclusion Criteria:
Subject is ≥18 years
Have a history of histologically- or cytologically-confirmed diagnosis of recurrent and/or metastatic squamous cell cancer of the head and neck
Subject has adequate organ function

Exclusion Criteria:
Primary tumor location of nasopharynx
Has had major surgery, including surgical resection of tumor, within 30 days prior
Has received radiotherapy prior
Cancer
Experimental drug compared to an approved drug
I'm interested
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Hershey, PA ,