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570 Study Matches

VIBRANT: VIB4920 for Active Lupus Nephritis

A randomized placebo-controlled study to evaluate the efficacy and safety of VIB4920 in study participants with active lupus nephritis

Patients come for in-person visits at the Penn State Hershey main hospital location. There will be blood draws, physical exams, and questionnaires spread out across 60 weeks.

Yes
 

Nancy Olsen
Peri Newman - at pnewman@pennstatehealth.psu.edu or 717-531-0003, ext=287327
Medicine: Rheumatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05201469
SITE00001277
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Inclusion Criteria:
Lupus nephritis
Systemic lupus erythematosus

Exclusion Criteria:
Pregnant
Transplant
Kidney & Urinary System, Arthritis & Rheumatic Diseases, Muscle & Bone
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

PHASE I SAFETY ASSESSMENT OF HYPOFRACTIONATED POSTOPERATIVE RADIOTHERAPY (H-PORT) FOR INTERMEDIATE-RISK HEAD AND NECK CANCER

The purpose of this study is to test the good and bad effects of using hypofractionated radiation therapy. Hypofractionated radiation therapy could shrink or stabilize your cancer, but it could also cause side effects. The study doctors hope to learn if hypofractionated radiation therapy is safe and tolerable in patients with your type of cancer. You will receive radiation therapy for 4 weeks. You may also receive chemotherapy.

Participants will be required to receive radiation therapy for 4 weeks. Participants may also receive chemotherapy with cisplatin, carboplatin, or cetuximab.

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05540899
STUDY00022103
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Inclusion Criteria:
Pathologically (histologically) proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma NOS, etc.) of the head/neck
Clinical stage II, III or IVA squamous cell carcinoma of the oral cavity, oropharynx or larynx (AJCC 8th edition), including no distant metastases.
Total resection of the patient’s cancer (i.e. no residual disease after total resection of the patient’s cancer ).
One or more indications for postoperative radiotherapy, based upon pathologic findings: • Perineural invasion; • Lymphovascular invasion;
Zubrod Performance Status 0-1

Exclusion Criteria:
Recurrence of the study cancer.
History of systemic lupus erythematosus or systemic sclerosis (scleroderma).
Pregnancy and individuals unwilling to discontinue nursing.
Feeding tube (gastric or jejuno) at the time of registration.
Anticipated need for high-dose systemic chemotherapy (e.g. high dose q3-week cisplatin), multiple systemic therapy agents or immunotherapy. Weekly single-agent systemic therapy with cisplatin, carboplatin, or cetuximab is allowable.
Cancer
Not applicable
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Hershey, PA ,

Characterizing Physical Interactions Used to Correct Robot Errors for Learning from Demonstration

The purpose of this research study is to learn about how humans provide corrections to robot movements when the robot makes mistakes while performing a task. Understanding the intent of humans can inform how we incorporate the information provided by that interaction into machine learning algorithms that improve the robot’s task performance in future.

Participants will observe the robot performing three different tasks. The robot will place a peg in a hole, pickup and pour a cup, and draw and erase an image on a whiteboard. The robot may or may not make mistakes while performing these tasks. Mistakes may be minor or may be significant such as colliding with an object or the work table. Participants will be asked to correct the robot’s mistake by moving the robot arm or stopping the task execution altogether by hitting a red stop button. After observing the robot perform each task several times, you will be asked to demonstrate a new task to the robot. The robot will then try to replicate your demonstration and you may choose to provide corrections to improve the robot’s execution of the task anytime you think it is making a mistake or not performing well enough.

20

Yes
 

Katie Fitzsimons
Junru Pang - at jvp6149@psu.edu
Mechanical and Nuclear Engineering (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00022768
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Inclusion Criteria:
Ages 18-65

Exclusion Criteria:
Under 18
Upper limb injuries
Not applicable
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State College, PA ,

Understanding the factors affecting job satisfaction and unemployment in the USA.

This study will assess the various factors that influence job satisfaction, including salary, benefits, work-life balance, work environment, job security, and opportunities for advancement. It will also aim to measure the main causes for unemployment and the impact on general well being.

Complete an electronic survey which will take about 20 minutes on average

No
 

Prabhani Kuruppumullage Don
Prabhani Kuruppumullage Don - at pxk919@psu.edu or 814-863-3193
Statistics (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00022901
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Inclusion Criteria:
18 years or older
residing in USA

Exclusion Criteria:
less than 18 years old
residing outside USA
Not applicable
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UroGen UR001

This study is being done is to test the safety of a drug called UGN-301 at different dose levels, either alone or with another drug called UGN-201, and to understand how these drugs interact with the bladder and body

If you decide to take part in this study and meet all of the requirements, you will receive 6 treatments, once per week for 6 weeks in a row. The medication treatments will be instilled via catheter into your bladder. There will be 11 total visits with blood draws at all of the visits. As part of screening for this study you will have to have a CT scan, a cystoscopy, and a bladder biopsy. At 3 months you will be required to return for a cystoscopy and bladder biopsy if necessary. Finally, there will be a follow up cystoscopy and bladder biopsy at 6 months.

Yes
 

Jay Raman
Urology Research - at urologyresearch@pennstatehealth.psu.edu
Urology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05375903
SITE00001313
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Inclusion Criteria:
Have confirmed recurrent NMIBC with HG Ta disease and/or CIS or recurrent IR LG Ta disease
Have confirmed recurrent NMIBC with HG Ta disease and/or CIS
Has a life expectancy > 12 months.
Be post menopausal, surgically sterile, or using a combination of 2 methods of birth control for maximally effective birth control
Have adequate organ and bone marrow function within 14 days of treatment initiation as determined by routine laboratory tests

Exclusion Criteria:
Intravesical therapy within 4 weeks before starting study treatment.
Current or previous evidence of muscle invasive, locally advanced nonresectable, or metastatic urothelial carcinoma (ie, T2, T3, T4 and/or stage IV). High or low grade T1 disease.
Current systemic therapy for bladder cancer.
History of malignancy of other organ system within the past 5 years. Patients with genitourinary cancers other than urothelial cancer or prostate cancer that are under active surveillance
Prior therapy with an anti-CTLA-4, anti-PD-1, anti-PD-L1 agent, or with an agent directed to another co-inhibitory T-cell receptor.
Cancer
Not applicable
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Hershey, PA ,

Drawing and Anxiety Study Phase 2

This study will test the efficacy of novel guided drawing activities for reducing anxiety in young adults

For this study, your teen will be asked to in a 90 minute in-person lab visit. Cardiac data will be recorded as your teen engages in a drawing activity. Your teen will also answer questionnaires during the visit and again approximately one week later, online via Qualtrics. This final questionnaire will take approximately 30 minutes to complete.

$25

Yes
 

Sarah Myruski
Bridget Cahill - at bqc5600@psu.edu
Psychology (UNIVERSITY PARK)
 

All
Younger than 18 years old
This study is also accepting healthy volunteers
NCT00000000
STUDY00021234
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Inclusion Criteria:
Youth must be at least 13 years of age and no more than 17 years of age at the time of recruitment
Youth must be able to speak, understand and read English.

Exclusion Criteria:
1.Youth who are not at least 13 years of age or are 18 years of age or older at the time of recruitment.
2.Youth who cannot speak, understand, and read English.
Education, Mental & Behavioral Health
Not applicable
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State College, PA ,

An Innovative Approach for Assessing Interoception: A Pilot Validation Study

The primary rationale for this study lies in addressing the identified gaps in knowledge within the field of interoception research. A comprehensive understanding of interoception and its role in emotion regulation, behavior, and appetite control is vital for the development of effective interventions and therapeutic approaches targeting various psychological and physiological conditions. By investigating the applicability and accuracy of a novel method for assessing interoception, this study aims to contribute to the existing literature on interoceptive awareness and measurement.

This study will involve a single-in person visit. During the visit to the lab, we will weigh and measure you, have you complete two tasks assessing your ability to feel your own heartbeat, and answer questionnaires. For one of these tasks, you will be asked to complete Jumping Jacks. Throughout the session you will also be asked to wear a heartbeat monitor.

$10

Yes
 

Kathleen Keller
Nicholas Neuwald - at nvn5211@psu.edu or 814-863-0920
Nutritional Sciences (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00022855
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Inclusion Criteria:
Age of 18-30
Proficient in English
Adequate cognitive abilities

Exclusion Criteria:
Anxiety Disorder
Cardiovascular Health Conditions
Substance Use
Currently Pregnant
Sensory Impairments
Heart & Vascular, Neurology, Mental & Behavioral Health
Not applicable
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State College, PA ,

PSCI 21-158 Radiopaque Hydrogel Rectal Spacer for Prostate Cancer Radiation Image Guidance

Prior to enrollment, potential subjects will be evaluated during the Screening Period to determine eligibility. The following assessments will be performed during the Screening Period:●Review of eligibility ●Placement of hydrogel spacer and fiducial marker after eligibility is determined Visit 2 or Day 2 or Post-test - Radiotherapy per standard of care.

Prior to enrollment, potential subjects will be evaluated during the Screening Period to determine eligibility. The following assessments will be performed during the Screening Period:●Review of eligibility ●Placement of hydrogel spacer and fiducial marker after eligibility is determinedVisit 2 or Day 2 or Post-test - radiotherapy per standard of care

Yes
 

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

Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05650021
STUDY00022554
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Inclusion Criteria:
Untreated cT1 – cT3 prostate cancer
N/A
N/A
N/A
N/A

Exclusion Criteria:
Extracapsular extension
Prior prostate surgery
Prior prostate radiotherapy
N/A
N/A
Cancer
Approved device(s)
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Hershey, PA ,

Incidence Rates of Hair Loss in Women Who Wear Hijab

The aim of this study is to obtain information regarding the incidence of hair-related concerns in women who wear hijab and to collect information pertaining to factors that could contribute to hair loss in women who wear the hijab.

This survey study will involve a one-time survey that will take 5-10 minutes.

No
 

Matthew Helm
Tierney Wallace - at twallace3@pennstatehealth.psu.edu or 717-531-6117
Dermatology (HERSHEY)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00023070
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Inclusion Criteria:
Wear the hijab
Women
Read and understand English
Ages 18 years and older

Exclusion Criteria:
Do not meet inclusion criteria
Skin Conditions
Not applicable
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Interpersonal contrast avoidance of anxiety and depression

This research aims to learn more about your daily thoughts, behaviors, and their impact on social relationships. We want to understand the different qualities of day-to-day thoughts, how these might affect your mood, and how this may influence how you behave in social interactions. We will first ask you to complete a set of structured questionnaires and a brief 30-minute psychological interview via Zoom. This will be followed by a training session in which you will learn how to use your smartphone to track your social interactions and related daily thoughts and behaviors eight times a day for eight days.

You will undergo an initial assessment visit conducted on Zoom, where you will provide informed consent and undergo screening through a brief 30-minute clinical interview. Based on your responses, we will know if you can participate in the study. If eligible, you will be invited to the second part of the study. If so, during the same session, you will then receive a brief half-hour training session reviewing instructions on using a mobile application to complete daily surveys and then complete a series of online questionnaires.When you leave this session, for the next eight days, you will complete eight (approximately 2-minute) questionnaires daily between 10 a.m. and 10 p.m. On the third day, you will attend a compliance check via Zoom to review your progress in the present study.

$20

Yes
 

Adam Calderon
Adam Calderon - at afc6160@psu.edu
Psychology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00022977
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Inclusion Criteria:
At least 18 years of age
Scores on self-report questionnaires suggest person does or does not struggle with anxiety and/or depression
Owns a smartphone
Fluent in the English language in terms of speaking, listening, reading, and writing.

Exclusion Criteria:
Younger than 18 years of age
Does not own a smartphone
Unable to speak, read, listen, and write English fluently.
Men's Health, Mental & Behavioral Health, Women's Health
Not applicable
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State College, PA ,

PSCI 23-012 THE JANUS RECTAL CANCER TRIAL: A RANDOMIZED PHASE II TRIAL TESTING THE EFFICACY OF TRIPLET VERSUS DOUBLET CHEMOTHERAPY TO ACHIEVE CLINICAL COMPLETE RESPONSE IN PATIENTS WITH LOCALLY ADVANCED RECTAL CANCER

This trial is using long course chemoradiation in combination with three different chemotherapy treatments to treat rectal cancer. Once therapy is completed patients will either have surgery or watch and wait. The goal is to see which therapy is better in achieving a complete response, if any.

Patients will be expected to come to the clinic for all radiation treatments and all chemotherapy treatments.

Yes
 

Mitchell Machtay
PSCI-CTO@pennstatehealth.psu.edu
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05610163
SITE00001341
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Inclusion Criteria:
Clinical stage II or III rectal adenocarcinoma defined as T4N0 or any T with node positive disease (any T, N+); also T3N0 requiring APR or coloanal anastomosis
Tumor Site: Rectum; ≤ 12cm from the anal verge
No prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer within the past 5 years is allowed.
Not pregnant and not nursing,
Age ≥ 18 years

Exclusion Criteria:
No upper rectal tumors (distal margin of tumor >12 cm from the anal verge)
No recurrent rectal cancer; prior transanal excision, prior distal sigmoid cancer with a low anastomosis
No known mismatch repair deficient rectal adenocarcinoma
Cancer
Approved drug(s)
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Hershey, PA ,

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety andEfficacy of DWN12088 in Patients With Idiopathic Pulmonary Fibrosis

A Phase 2 Clinical Trial to assess whether study drug DWN12088 is safe and effective in Patients With Idiopathic Pulmonary Fibrosis

During this study, you will be asked to come to in-person visits at the Hershey Medical Center over a period of 6 months During that time you will visit the study center 8 times and have various tests done including: signing informed consent, providing demographics, having a chest CT scan, reviewing medical history, having a physical exam done, having vital signs and an ECG taken, having bloodwork done, receiving study drug, receiving patient diaries, having study drug administered, performing lung function tests (spirometry, DLCO and 6-minute walk test), and completing questionnaires.

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05389215
STUDY00020774
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Inclusion Criteria:
At least 40 years of age
Diagnosed with idiopathic pulmonary fibrosis in the past 5 years
Able to walk 150 meters (492 feet) in 6 minutes

Exclusion Criteria:
Unwilling to refrain from smoking
Lower respiratory tract infections requiring antibiotics in the last 4 weeks
Female participants who are pregnant or nursing
Use of investigational drugs for idiopathic pulmonary fibrosis in the last 4 weeks
Lung Disease & Asthma
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Use of the Frequen-ZZZ Sleep Pad to Increase Restorative Sleep: A Proof-of-Concept Study

This research is a small, 8wk clinical trial testing the potential effects of an investigational device, Frequen-ZZZ/Sleepergize Sleep Pad, on the sleep of adults 40-65 years old. We aim to determine whether sleeping with the Sleep Pad, which creates an electromagnetic field around the sleeper, has an improving effect on sleep. Sleep will be primarily measured using a non-invasive clinical standard method, called polysomnography (PSG), for 6 separate nights in the personal residence of participants. Sleep will also be measured both day and night with a watch-like device that measures activity, and with surveys. We will look for changes in sleep quality, in sleep duration, and in the way that sleep is organized by the body. We will also measure changes in inflammation, which is related to sleep, from 3 blood samples collected during the study. There are 15-17 in-person appointments across the course of the study. With the data, we hope to also evaluate the feasibility and effect sizes of this non-pharmacological intervention to inform future research, and we plan to use data in support of a future FDA application for the device.

Participation involves sleeping with the investigational device, 6 separate nights of sleep monitoring in your home with standard equipment that is used in clinical settings, 3 blood draws, surveys, and wearing an activity watch, all over the course of an ~8wk participation period. There are 15-17 in-person appointments and about 15 active hours of engagement involved in the study.

$3,000.

Yes
 

Anne-Marie Chang
Anne-Marie Chang - at sleeppad@psu.edu
Biobehavioral Health (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT05908344
STUDY00020435
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Inclusion Criteria:
40-65 years of age (inclusive)
At least some Insomnia symptoms
Living without assistance and able to sign own informed consent
Not a nocturnal shift or rotating shift-worker
English speaker/reader

Exclusion Criteria:
Current smoker
Diagnosed with a sleep disorder
Pacemaker
Pregnant, breast-feeding, or planning to become pregnant
Taking prescribed medication or therapy for sleep
Men's Health, Sleep Management, Women's Health
Experimental device
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State College, PA ,

PSCI 22-114: A PHASE 2/3, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF NKTR-255VS PLACEBO FOLLOWINGCD-19 DIRECTED CAR-T THERAPYIN PATIENTS WITH RELAPSED/REFRACTORY LARGE B-CELL LYMPHOMA.

This is a drug study that will evaluate how well the investigational drug works compared to a placebo following CAR-T cell therapy. Participants will be required to keep all your scheduled visits, receive drug treatment, blood draws, imaging, and possibly a tumor biopsy.

Participants will be required to receive the study treatments including CAR-T infusion, blook tests, imaging, tumor biopsy, and study medications.

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05664217
SITE00001327
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Inclusion Criteria:
Male or female ≥ 18 years of age at the time of consent.
Received standard of care therapy with axi-cel or liso-cel (Stage 1 and Stage 2), or tisa-cel (Stage 2 only)
Received lymphodepleting chemotherapy regimen according to the respective FDA (or SmPC) label for CAR-T cell therapy.
Fluorodeoxyglucose (FDG)-avid disease on PET imaging within 30 days prior to CAR-T cell infusion
FDG avid lesion(s) on PET/CT scan following bridging therapy and prior to lymphodepletion, where applicable.

Exclusion Criteria:
Use of therapeutic doses of corticosteroids (≥ 5mg/day prednisone or equivalent) or other systemic immunosuppression within 7 days prior to leukapheresis or within 72 hours prior to CAR-T cell infusion. Topical and/or inhaled steroids are permitted
Prior treatment with any CD19-directed CAR-T cell therapy other than the treatment planned per Inclusion Criterion 2.
For allogeneic hematopoietic cell transplant recipients, active graft versus host disease (GVHD) and/or systemic GVHD therapy during screening or up to 30 days prior to leukapheresis.
Known active hepatitis B (detectable hepatitis B DNA) or hepatitis C (detectable hepatitis C RNA).
Known human immunodeficiency virus (HIV) infection
Cancer
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Can more sleep improve pain responses, symptomatology, and regulation in college students?

This study is being done to find out how whether sleep duration is associated with pain responses and if a sleep intervention predicts a higher tolerance and a higher threshold for pain. This is a 21-day study. Participants will be asked to wear sleep-monitoring watches. Pressure pain and cold pain will be measured at study visits.

There will be four in-person visits. Height, weight, and blood pressure will be measured during each study visit. Participants will also be asked to complete surveys during each study visit.Pain will be measured during visits 2-4. Blood will be drawn during visits 2-4. Retinal images will be captured during visits 2-4. A Trail making test (a test for executive functioning) will be administered during visit 2-4. Participants will also be asked to provide screen shots of their phone screen use at visits 2-4.

$150

Yes
 

Anne-Marie Chang
yms5393@psu.edu 814-867-1653
Biobehavioral Health (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT05816434
STUDY00022196
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Inclusion Criteria:
18 to 24 (inclusive) years of age at enrollment
Fluent English speaker and reader
Willing to refrain from initiating new therapeutic interventions (e.g., medication; behavioral) designed to target sleep or pain for the duration of study participation

Exclusion Criteria:
Diagnosed with a sleep disorder
Diagnosed with a pain disorder
Has experienced a cold-related injury or has any other nerve damage to the feet
Has a history of injury to any of the muscular measurement sites for pain (I.e. shoulder, jaw, forearm)
Diagnosed with hypertension or cardiovascular disease
Prevention
Not applicable
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State College, PA ,

An Intermediate Expanded Use Trial of DFMO(eflornithine HCl)

This research study is to provide expanded access to a new investigational drug DFMO (difluoromethylornithine) for patients with neuroblastoma, medulloblastoma, and certain rare tumors that have no other curative options. DFMO is an oral drug that inhibits a certain enzyme (protein) in blood which is associated with a bad outcome in neuroblastoma cases. Cancer cells have pathways that drive the cancer to grow and DFMO targets the specific pathway of this enzyme to turn these cells off.

If you are enrolled on this study, DFMO will be started in clinic on Day 1. After this first day you will be seen in clinic approximately once every 30 days for the first 6 months of study and once every 90 days for the last 18 months of study. These visits will last about 2 hours, and involve a physical exam, blood tests, and other testing.

Yes
 

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

All
All
This study is NOT accepting healthy volunteers
NCT03581240
STUDY00023046
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Inclusion Criteria:
0-30 years of age at the time of initial diagnosis
Not eligible for DFMO studies NMTRC014, BCC015, or BCC016

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

PSCI 23-020: EA8212 A Randomized Phase III Trial of Intravesical BCG veRsus Intravesical Docetaxel and GEmcitabine Treatment in BCG Naïve High Grade Non-Muscle Invasive Bladder Cancer (BRIDGE)

If you decide to take part in this study, you will either get Gemcitabine and Docetaxel instilled through a catheter weekly in your bladder for up to 6 weeks, or you will get BCG instilled weekly in your bladder for up to 6 weeks. Your initial therapy may be followed with maintenance therapy.

If you decide to take part in this study, you will either get Gemcitabine and Docetaxel instilled through a catheter weekly in your bladder for up to 6 weeks, or you will get BCG instilled weekly in your bladder for up to 6 weeks. Your initial therapy may be followed with maintenance therapy.After you finish your treatment, your doctor will continue to follow your condition for 5 years with a combination of cystoscopies (inserting a telescope in your bladder) and CT scans (to take images of your body) in order to detect cancer recurrence.

Yes
 

Matthew Kaag
PSCI CTO Office at psci-cto@pennstatehealth.psu.edu or 717-531-5471
Urology (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT05538663
SITE00001374
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Inclusion Criteria:
Patient must be > 18 years of age.
Patient must have histologically confirmed high-grade non-muscle invasive urothelial carcinoma of the bladder (HgTa, HGT1, CIS, HgTa + CIS, or HGT1 + CIS stage)
Patient must have ECOG Performance Status 0-2.
Patient must have all visible papillary tumor resected by the treating urologist at the site registering the patient to this protocol prior to randomization.
Patient may have received prior systemic gemcitabine or docetaxel use if it was for a non-bladder malignancy

Exclusion Criteria:
Patients must not have prostatic urethral involvement
Patient must have not received prior intravesical therapy for bladder cancer, with the exception of perioperative chemotherapy at the time of TURBT.
Patient must not have pure squamous cell carcinoma or adenocarcinoma.
Patient must not have any component of neuroendocrine carcinoma (i.e., small cell or large cell).
Patient must not have any component of sarcomatoid, micropapillary, or plasmacytoid variant histology.
Kidney & Urinary System
Experimental drug compared to an approved drug
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Hershey, PA ,

One Talk at a Time - Anti-Racism

This is a psychological study to examine the effect of a new intervention that provides parents with tools to speak with their kids about race, racism, and privilege.Participants will complete a 2-3 hour long program and answer questionnaires over the course of 6-8 weeks. The total time required for this study is approximately 4.5 hours for parents and 2 hours for children. Parents can earn up to $165 and children can earn up to $50.

Parents and children will both be asked to participate, and all participation will be remote.Over the course of 6-8 weeks, parents will answer 3 sets of questionnaires in addition to completing 2-3 hour long interactive program. Parents will also be asked to participate in a recorded discussion task with their child, and will be invited back for a short interview as the final task.Children will answer 2 sets of questionnaires at the beginning and end of the study, and will also participate in the recorded discussion task with their parents.

215

No
 

Chardee Galan
Chardee Galan - at dreamlab@psu.edu or 626-205-5563
Psychology (UNIVERSITY PARK)
 

All
All
This study is also accepting healthy volunteers
STUDY00023214
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Inclusion Criteria:
Non-Hispanic, White parent and child
Child between the ages of 10-14 years old
Child in 5th through 8th grade
Parent and youth are fluent in English
Parent and youth have access to devices with WiFi

Exclusion Criteria:
Parent or youth identify as any race/ethnicity other than non-Hispanic White, including multiracial individuals that identify as White
Family does not have reliable internet access or access to a device that can appropriately display the virtual program.
Parent or children does not speak or read sufficient English
Youth or parent/caregiver has an intellectual disability, autism spectrum disorder, or other disorder that may limit ability to complete study (surveys and interviews require sustained attention, mental processing, and comprehension)
Children's Health, Education, Mental & Behavioral Health
Not applicable
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Modifiable Prevention and Early Intervention Targets for Unhealthy Eating Behaviors: A Study in First Year Undergraduates

This is a research study investigating the prevalence and manifestation of unhealthy eating behaviors and the relationships of energetic status, cognitive function, and reproductive health in a population of first year college students.

Phase 1 will involve a minimum of 1-2 visits, and completion of surveys about your general health, exercise and nutrition history, eating behaviors and attitudes, stress, and reproductive health, as well as cognitive testing and hair sampling. For those who qualify, Phase 2 will involve approximately 4 additional visits. Each visit will be about 2 hours. The visits include completion of surveys about general health, exercise and nutrition history, eating behaviors and attitudes, stress, and reproductive health, as well as cognitive testing and physiological measurements including blood and hair sampling, and tests of metabolism. Study participation will last at minimum about 1 week, and at maximum completion of Phase 1 and Phase 2 will occur over the course of a full academic year.

$25 per visit, up to $75

Yes
 

Nancy Williams
Jaime Rodden - at whel@psu.edu
Kinesiology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00022878
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Inclusion Criteria:
First Year College Student
Age 18-25 Years
BMI 16.5-30 kg/m2
No apparent metabolic, endocrine, or musculoskeletal disease.

Exclusion Criteria:
Pregnancy or intention to become pregnant in the next 9 months
Serious or chronic health condition (including thyroid illness, metabolic disease)
Unwilling to adhere to study protocol
Lactating
Does not speak English or are unable to give consent
Men's Health, Mental & Behavioral Health, Women's Health
Not applicable
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State College, PA ,

A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Safety and Efficacy of IGV-001, an Autologous Cell Immunotherapy With Antisense Oligonucleotide (IMV-001) Targeting IGF 1R, in Newly Diagnosed Patients With Glioblastoma

The purpose of this study is to see how safe the study medicine, IGV-001 plus standard of care (SOC), is and to compare IGV-001 with placebo (only standard of care) to see if it works in slowing GBM tumor regrowth.SOC refers to the usual medicine(s) or procedures used to treat this cancer.

You will be randomly assigned by chance, like rolling a pair of dice - to receive either IGV-001 or placebo (inactive substance) that will be placed into biodiffusion chambers [dime-sized containers] and surgically implanted in your belly area for approximately 48 hours and then removed. You will have a 66.6% (2 in 3) chance of receiving IGV-001 and a 33.3% (1 in 3) chance of receiving placebo. There is a small chance that you may not receive treatment with IGV-001 or placebo after the abdominal incisions have been made.

Yes
 

Brad Zacharia
Micaiah Grien - at mgrien@pennstatehealth.psu.edu or 717-531-0003, ext=283063
Neurosurgery (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04485949
STUDY00016975
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Inclusion Criteria:
Is willing and able to give written informed consent for participation in the study
Is between 18 and 70 years of age at screening
Has a diagnosis of malignant glioma based on the treating neurosurgeon’s best clinical judgement defined using the patient’s symptomology, MRI scan results, and intraoperative frozen section verbal confirmation of malignant glioma.
Has adequate bone marrow and organ function at screening

Exclusion Criteria:
Has bi-hemispheric disease, multicentric disease, or disease burden involving the brain stem or cerebellum based on MRI post-gadolinium enhancement
Has received any previous surgery for tumor removal of GBM
Has recurrent glioma, a concurrent malignancy
Has any severe immunocompromised condition
Is receiving any other investigational agent(s) or has received an investigational agent within 30 days prior to screening
Cancer
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Defining the role of slow eye movements on limb motor control

The purpose of this study is to define how eye movements contribute to eye-hand coordination. All procedures to be used in our study will be non-invasive. The task during the study will be performed with a robotic handle that participants will grasp with their right hand. They will interact with visual stimuli by moving the robotic handle. The robotic environment will attempt to simulate real-world mechanical interactions, such as those experienced during catching a ball. Our objective is to understand how the nervous system processes visual sensory information of moving objects through slow eye movements called smooth pursuit eye movements.

During this study, we will ask you to come to our laboratory located in 23 Recreation Building, Penn State University, on two days separated by a maximum of 48 hours. Both sessions will last approximately 90-120 minutes.We will ask you to perform an eye-hand coordination task using a robot. You will sit in a modified chair and grasp a handle that permits you to move your hand leftward, rightward, towards and away from your body. A display system will project visual targets into the same plane as your hands, which will allow you to interact virtually with the visual targets. These targets will move in the workspace. When the target comes in contact with your arm, the robot will apply a gentle force to mimic what you would typically experience when you catch a ball.

40

Yes
 

Tarkeshwar Singh
Oindrila Sinha - at osinha@psu.edu or 814-206-6260
Kinesiology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00023321
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Inclusion Criteria:
Participants should be between 18-65 years old.
Male and female participants who volunteer for the study and provide informed consent.
Participants will be right-hand dominant individuals.
They will have normal or corrected-to-normal vision.
Participants should be able to sit upright in a chair for long periods (up to 2 and a half hours) with rest.

Exclusion Criteria:
Any history of neurological disorders
Any history of musculoskeletal disorders.
Eye or vision problems.
Cognitive impairment such that informed consent cannot be obtained, or that participant would not be safe with the protocol.
Medication that could make the participant drowsy or tired during the experiment.
Neurology
Not applicable
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State College, PA ,

Exploring the Needs and Challenges of Care Partners to Support Financial Management of Individuals with AD/ADRD

The project focuses on gathering initial evidence about the opportunities and challenges of designing tailored financial technology (fintech) to support the care partners of persons living with Alzheimer’s disease (AD) and AD-related dementia (ADRD) to help them with collaborative and longitudinal financial management. To accomplish this goal, we will conduct 20 min survey study and optional follow-up interview activities with care partners.

We are recruiting care partners of individuals living with Alzheimer's Disease and Alzheimer's Disease Related Dementias. There will be two phases in the study. The first phase is a 20-min survey that will ask participants about their financial management behavior. The second phase is optional, and it is a 40-min follow-up interview with similar questions.

For the first phase, each participant may choose to enter a drawing for a chance to win a $50 Amazon eGift card. For the second phase, each participant will receive a $30 Amazon eGift card for their time.

No
 

Ling Qiu
Ling Qiu - at lzq5034@psu.edu or 402-416-5975
Information Sciences and Technology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00023385
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Inclusion Criteria:
Care partners of individuals living with Alzheimer's Disease and Alzheimer's Disease Related Dementias
Ability to understand or speak English
Age range: over 21 years and less than 89 years.

Exclusion Criteria:
Minors, under age 21
Non-English-speaking respondents
Those who are NOT care partners of individuals living with Alzheimer's Disease and Alzheimer's Disease Related Dementias
Mental & Behavioral Health
Survey(s)
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The role of thromboxane A2 and its receptor in vascular regulation in women with endometriosis

Women with endometriosis have more thromboxane being produced in their platelets. Thromboxane affects blood vessels, making them constrict, and sensory nerves, making them more sensitive. This study will determine if women with endometriosis are negatively effected by the excess thromboxane.

There will be three in-person visits: one screening and two experimental visits. Participants will take aspirin before one visit and a placebo before the other then will undergo brief tests of nerve sensitivity and a blood draw.

$150

Yes
 

Lacy Alexander
Sue Slimak - at sks31@psu.edu or 814-863-8556
Kinesiology (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
NCT05962034
STUDY00021851
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Inclusion Criteria:
18-48 years
born with a uterus
with and without endometriosis

Exclusion Criteria:
diagnosed cardiovascular disease
hormone replacement therapy within previous 2 months
nicotine use
pregnant or breastfeeding
aspirin allergy or hypersensitivity
Heart & Vascular, Pain Management, Women's Health
Approved drug(s)
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Hershey, PA ,
State College, PA ,

Dynamic Assessment of Vocabulary Learning Strategies

To provide better understanding of Chinese students' vocabulary learning Strategies and help develop better learning strategies

Complete seven sessions, which may take approximately 20-30 minutes of your time per session.Read several English short texts and identify meanings of target words.Possibly participate in a virtual interview that will be scheduled at your convenience.

No
 

Yuwei Xia
Yuwei Xia - at yxx5304@psu.edu or 626-999-1712
Division of Graduate Studies (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00021134
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Inclusion Criteria:
Of Chinese origin or descent
Adult English learners
Currently enrolled in a college or university

Exclusion Criteria:
English as Native Language
Not Chinese
Education
Not applicable
I'm interested
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Dynamic Assessment of English Vocabulary

Better understand and improving Chinese English learners' vocabulary development

•Complete seven sessions, which may take approximately 20-30 minutes of your time per session.•Read several English short texts and identify meanings of target words.•Possibly participate in a virtual interview that will be scheduled at your convenience.

No
 

Yuwei Xia
Yuwei Xia - at yxx5304@psu.edu
Division of Graduate Studies (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00023081
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Inclusion Criteria:
Of Chinese origin or descent
Adult English learners
Currently enrolled in a college or university

Exclusion Criteria:
English as native language
Education
Not applicable
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Mechanisms of New-Onset Autoimmunity-Longitudinal Immune Systems Analysis

The purpose of this study is to investigate why some individuals who have a few findings of autoimmunity eventually develop a condition such as systemic lupus erythematosus (SLE). In addition to stored biosamples from the SMILE clinical trial, new samples will be collected from persons with findings such as lab tests that are suggestive of lupus with an emphasis on recruitment of individuals ofnon-European ancestry, who were under-represented in the previous clinical trial.

Participants in this study will answer questions about their health and have a short physical exam performed on them. They will provide a blood and urine sample. These procedures will be repeated every twelve months for three years (a total of four times). Both routine and experimental tests will be performed on the blood and urine samples. Genetic studies will be done to help understand the risk of developing lupus.

Yes
 

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

All
All
This study is NOT accepting healthy volunteers
SITE00001350
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Inclusion Criteria:
age 15 to 49 years inclusive
positive ANA test of at least 1:80
Have one or more additional features of lupus
Able to give assent or consent.

Exclusion Criteria:
Current or past use of hydroxychloroquine.
Current or past use of immunosuppressants
Have a diagnosis of another autoimmune disease, other than autoimmune thyroid disease.
Arthritis & Rheumatic Diseases
Not applicable
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Hershey, PA ,

PARPAML: A Phase 1 Protocol for Relapsed Pediatric AML to Determine the Safety and Efficacy of the PARP Inhibitor Talazoparib in Combination with Chemotherapy

The purpose of this study is to find out what effects, good and/or bad, study treatment with talazoparib in combination with the chemotherapy drugs topotecan and gemcitabine has on pediatric patients with acute myeloid leukemia (AML) that has returned or has not responded to treatment. The study drug talazoparib has been chosen because there is evidence that is can reduce tumor activity in a more specific way than chemotherapy.

If you join the study, you will given a certain dose of the study drug talazoparib, and of the chemotherapy drugs topotecan and gemcitabine. You may be asked to provide biological samples (such as blood or bone marrow) and undergo procedures that might be different from a regular medical examination. This study will involve screening, treatment, and follow up period. During screening, the study doctor will determine whether you are eligible for the study. If you are eligible and are enrolled into the study, you will have 2-3 months of active participation, including collection of information from you, admission to the hospital for a minimum of 5-7 days, and at least weekly visits to the study center.

Yes
 

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

All
All
This study is NOT accepting healthy volunteers
NCT05101551
SITE00001417
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Inclusion Criteria:
Ages ≥ 21

Exclusion Criteria:
Patients with down syndrome
Cancer
Prefer not to display
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Hershey, PA ,

A Phase II Study of Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer (RaPhLRR Study)

Participants in this study will receive a drug called ribociclib with the endocrine therapy of your physician’s choice. Ribociclib is taken as a pill. Endocrine therapy is taken as a pill or given as a shot. You will have tests, exams and procedures that are part of your regular care and for study purposes. Also, as part of routine care, you will be checked every 4 to 12 weeks to make sure your cancer hasn’t come back. You will receive ribociclib combined with endocrine therapy for up to 3 years. After that you will continue endocrine therapy alone for another 2 years (5 years total) as part of your regular care.

Participants will be required to: - receive ribociclib along with standard endocrine therapy drugs - have blood drawn - imaging scans (CT, PET-CT, bone scans, mammograms, MRI) - keep a medication diary - optional biopsy - ECG-a test that looks at the way your heart beats - ECHO-a test that looks at the way your heart pumps

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05467891
STUDY00022070
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Inclusion Criteria:
Written informed consent and HIPAA authorization for release of personal health information obtained prior to performing any study-specific screening procedures.
Male or female age ≥ 18 years at the time of consent.
ECOG Performance Status of 0-1 within 28 days prior to registration.
If patient is receiving tamoxifen or toremifene, a washout period of 28 days prior to registration is required.
Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer based on the most recently analyzed tissue sample and all tested by local laboratory.

Exclusion Criteria:
Patient with a known hypersensitivity to any of the excipients of ribociclib.
Patient who has received prior CDK4/6 inhibitor for recurrent disease. Patients who received a CDK4/6 inhibitor in the adjuvant setting may participate if they have been off therapy for at least 1 year prior to diagnosis of recurrent disease.
Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects.
Pregnant or breastfeeding or planning to become pregnant during the trial
Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

Home Observation of Meals and Environment (HOME) Bytes

This study aims to measure child eating behavior at home. Parents will video record their child eat 3 meals at home using a smart phone device and then take pictures of food storage locations (e.g., fridge, pantry). Videos will be coded for child eating behaviors. Parents will complete baseline and follow-up questionnaires. Children will wear an activity watch (like a Fitbit) for 1 week. In addition to these study procedures, there is an optional urine sample collection for children in order to study urinary metabolites as a marker of diet.

You will be asked to video record your child eating 3 meals at home and to take photos of food storage locations in your home (e.g., fridge, pantry).

$75 and an optional $25 for completing the urine sample collection

No
 

Alaina Pearce
Alaina Pearce - at homebytes@psu.edu
Nutritional Sciences (UNIVERSITY PARK)
 

All
Younger than 18 years old
This study is also accepting healthy volunteers
STUDY00023102
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Inclusion Criteria:
Child must be of good health
Child must have no neurodevelopmental disorder (e.g., ADHD) or learning disabilities (e.g., dyslexia)
Child must not be taking any medications known to influence body weight, taste, food intake, behavior, or blood flow.
Child must be 7-10 years-old at enrollment
The child must speak English

Exclusion Criteria:
Child is not within the age requirements (< than 7 years old or > than 10 years-old at baseline).
Child is taking cold or allergy medication, or other medications known to influence cognitive function, taste, appetite, or blood flow.
Child has a learning disability, ADD/ADHD, language delays, autism or other neurological or psychological conditions.
Child has a pre-existing medical condition such as type I or type II diabetes, rheumatoid arthritis, Cushing’s syndrome, Down’s syndrome, severe lactose intolerance, Prader-Willi syndrome, HIV, cancer, renal failure, or cerebral palsy.
Child has a highly restrictive diet limiting their ability to consume typical meals due to disordered eating (anorexia, RFID) or severe allergies.
Children's Health, Food & Nutrition
Not applicable
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A Phase 3 Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects with Relapsed/Refractory Follicular Lymphoma

The purpose of this study is to determine how effective and safe axi-cel is compared to standard of care, specifically chemo-immunotherapies, and use this information to determine the best choice of treatment in Subjects with Relapsed/Refractory Follicular Lymphoma

Attend all study visits receive study drug or SOChave blood drawn for various testsECHO or MUGA, ECG, PET/CT, and MRI if neededbone marrow biopsy if neededComplete questionnaires

Yes
 

Shin Mineishi
PSCI-CTO ONeal - at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471, ext=343429
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05371093
SITE00001300
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Inclusion Criteria:
Histologically-confirmed FL (Grade 1, 2, or 3a) per local diagnosis.
R/r disease as defined as one of the following options: a) First-line systemic chemoimmunotherapy and high-risk disease, defined as relapse or progression within 24 months of initiation of the initial course of chemoimmunotherapy (ie, POD24)
Clinical indication for treatment local symptoms due to progressive or bulky disease, systemic B symptoms, compromised organ function due to disease progression, cytopenias due to marrow involvement, or symptomatic extranodal disease.
At least 1 measurable lesion per the Lugano Classification
No known history or suspicion of central nervous system (CNS) lymphoma involvement

Exclusion Criteria:
History of large B cell lymphoma or history of transformed FL at any time during the subject’s lifetime including at the time of screening
FL Grade 3b
Small lymphocytic lymphoma
Lymphoplasmacytic lymphoma
Full-thickness involvement of the gastric wall by lymphoma
Cancer
Experimental drug compared to an approved drug
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Study Locations

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Location Contacts
Hershey, PA ,