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Midlife Vascular Health Study

Several easy methods will be used to study how blood vessels change in middle-aged people. These methods include heating a small spot on the arm, using a small TENS unit, using an ultrasound with a blood pressure cuff on the arm, and taking a blood sample.

There will be 2 in-person visits, one will be ~1 hour, the other will be ~2. We will take a blood sample at each visit. The second visit will require you to be seated and resting the entire time.

75

Yes
 

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

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00026695
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Inclusion Criteria:
Aged 45-60

Exclusion Criteria:
diagnosed cardiovascular disease
nicotine use
current or recent hormone replacement therapy
bleeding disorders
beta-blockers or alpha-blockers
Heart & Vascular, Prevention, Neurology
Not applicable
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State College, PA ,

The Perceived Barriers for the Digital Healthcare Divide Among the Minority Elderly Population: A Mixed Method Approach

This research study aims to address a gap in the current literature by focusing on technology acceptance and usage factors among minority elderly individuals. The overall goal of this study is to find the perceived barriers and reasons for the digital healthcare divide within the minority elderly population in respects to patient portals.

All participants will be required to review an informed consent form prior to starting the survey or interview. Participants will be screened for eligibility criteria via questions on their age, race, and if they reside in the United States. If they meet the study's inclusion criteria, they will be able to complete the survey and/or interview focusing on electronic patient portals and demographic questions, along with data privacy, security, and data governance questions regarding patient portals.

No
 

Tanusree Sharma
Gwendolyn Powell - at gep5270@psu.edu
Information Sciences and Technology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00027290
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Inclusion Criteria:
Anyone who can speak or read English
Anyone who is 55 years of age or older
Anyone who identifies as a minority in regards to their race
Anyone who is residing inside of the United States

Exclusion Criteria:
Anyone who does not speak or read English
Anyone who is younger than 55 years old
. Anyone who does not identify as a minority in regards to their race
Anyone who is residing outside of the United States
Men's Health, Education, Women's Health
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A Mixed Methods Study to Explore the Diagnostic Delay of Endometriosis Patients

This is an exploratory sequential mixed methods study that will explore the extent to which the barriers of diagnostic delay in Black women with endometriosis are generalizable to the general endometriosis population. There will be two phases of this study: a qualitative phase followed by a quantitative phase. The qualitative phase will involve semi-structured interviews with Black women who have a confirmed endometriosis diagnosis. The findings from the qualitative phase will be used to modify a questionnaire for the quantitative phase of the study. The quantitative phase will be a short questionnaire, taken by endometriosis patients of any racial/ethnic background with a confirmed diagnosis.

Participants will be asked to complete a 15 minute online questionnaire about their experiences with receiving an endometriosis diagnosis. Questions will include demographic information, endometriosis history, and perceptions of barriers that contributed to a delayed diagnosis.

$10

No
 

Victoria Francois
Victoria Francois - at vvf5041@psu.edu or 609-955-0571
Student Affairs (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00027227
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Inclusion Criteria:
Over the age of 18
Confirmed endometriosis diagnosis (through laparoscopy)
Can read, write and understand English
Lives in the United States

Exclusion Criteria:
Under the age of 18
Unconfirmed endometriosis diagnosis (did not get a diagnosis from surgery)
Cannot read, write, and understand English
Does not live in the United States
Women's Health
Not applicable
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The impact of structural racism and discrimination on chronic pain in Black or African American older adults: Biopsychosocial mechanisms

This study is trying to understand more about factors that cause pain in people who have had experiences of discrimination.

2 in-person visits 3-4 hours each plus at-home online questionnaires In-person visits will involve: 1. Sensory and pain testing 2. Physical function testing 3. Blood draw 4. MRI scan 5. Questionnaires

Up to $250

Yes
 

Elizabeth Losin
Katelyn Richter - at pain_study@psu.edu or 717-896-1564
Biobehavioral Health (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
SITE00001393
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Inclusion Criteria:
Age 45 and older
Identify as Black or African American
Chronic pain in knee or lower back

Exclusion Criteria:
Daily opioid use
High blood pressure NOT controlled with medication
Unable to have an MRI scan
Pain Management
Not applicable
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Harrisburg, PA ,
Hershey, PA ,

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Navenibart in Participants with Hereditary Angioedema – ALPHA-ORBIT

The purpose of this study is to evaluate the effectiveness and safety of navenibart as a preventative treatment for people with Type I or Type II Hereditary Angioedema (HAE).

You will need to come to Penn State Health Milton S. Hershey Medical Center 8 times. You will answer questions about your health/HAE attacks, provide blood samples, undergo routine urine laboratory tests, receive the trial drug, undergo electrocardiogram (ECG), complete questionnaires, undergo physical exams, and provide HAE attack information.

Yes
 

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

All
All
This study is NOT accepting healthy volunteers
NCT06842823
STUDY00026533
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Inclusion Criteria:
At least 12 years of age
Diagnosis of hereditary angioedema Type 1 or Type 2
Agree not to receive a dose of any vaccine within 7 days before or after trial medication administration.

Exclusion Criteria:
Use of therapies prescribed for the prevention of HAE attacks before the first day of the Run-In Period
History of chronic viral infection with positive test for HIV or hepatitis B surface antigen; history of hepatitis C virus that has not been adequately cured
Active liver disease
History of drug or alcohol abuse in the 12 months before Screening.
Allergies
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

A sample repository for the examination of biomarkers for Amyotrophic Lateral Sclerosis (ALS) and other Motor Neuron Diseases

A sample repository for the examination of biomarkers for Amyotrophic Lateral Sclerosis (ALS) and other Motor Neuron Diseases

Participants will be asked to donate blood one or more times and provide age, sex and general history of neurological disease. ALS/motor neuron disease patients will be asked to release information from the medical record about their neurological disorder, strength, function, treatments, known pathogenic ALS-related gene variants, quality of life, and results of breathing tests.

Yes
 

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

All
18 year(s) or older
This study is also accepting healthy volunteers
PRAMS043763EP
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Inclusion Criteria:
At least 18 years of age

Exclusion Criteria:
Controls cannot have ALS or motor neuron disease diagnosis
Neurology
Not applicable
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Hershey, PA ,

NRG-BN011: A Phase III Trial of Lomustine-Temozolomide Combination Therapy Versus Standard Temozolomide in Patients with Methylated MGMT Promoter Glioblastoma

The purpose of this study is to compare the usual radiation therapy and usual chemotherapy, temozolomide, to using the usual radiation therapy and usual chemotherapy plus the chemotherapy drug lomustine (Gleostine). Lomustine (Gleostine) is already approved by the FDA for use in brain tumors but it is usually used alone and is not the first-line choice for methylated MGMT tumors.

• Group 1 If you are in this group, you will get the usual approach used to treat this type of cancer (radiation plus temozolomide, followed by temozolomide alone). You will receive radiation plus temozolomide for about 6 weeks. During this time, you will receive radiation 5 days per week and temozolomide every day. Beginning about 1 month after you finish radiation, you will receive temozolomide for 5 days in a row every 4 weeks for up to 6 months. You will get temozolomide as a pill you take by mouth. After radiation, you may receive the Optune device if you and your treating physician decide it is best for you. There will be about 153 people in this group. • Group 2 If you are in this group, you will get the usual treatment of radiation 5 days per week for 6 weeks with the chemotherapy drugs lomustine (Gleostine) and temozolomide.. You will get both lomustine (Gleostine) and temozolomide as pills you take by mouth. After radiation, you may receive the Optune device if you and your treating physician decide it is best for you. There will be about 153 people in this group.

Yes
 

Dawit Aregawi
Micaiah Grien - at mgrien@pennstatehealth.psu.edu
Neurosurgery (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05095376
STUDY00026792
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Inclusion Criteria:
No known IDH mutation.
Availability of FFPE tumor tissue block and H&E stained slide to be sent for central pathology review for confirmation of histology and MGMT promoter methylation status
Willing to use highly effective method of contraception for participants of childbearing potential
Histopathologically proven diagnosis of glioblastoma
Age 18-70 years

Exclusion Criteria:
Current or planned treatment with any other investigational agents for the study cancer
Definitive clinical or radiologic evidence of metastatic disease outside the brain
History of pulmonary fibrosis.
Prior radiotherapy to the head or neck that would result in overlap of radiation therapy fields
Prior invasive malignancy (except non-melanomatous skin cancer, cervical cancer in situ and melanoma in situ) unless disease free for a minimum of 2 years
Cancer
Approved drug(s)
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Hershey, PA ,

PSCI 24-132 A Phase 3 Randomized Double-Blind Multicenter Study of Sonrotoclax Plus Zanubrutinib Versus Placebo Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma

This trial will examine the outcome of comparing Sonrotoclax Plus Zanubrutinib vs. Zanubrutinib alone in the treatment of mantle cell lymphoma

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

Yes
 

Seema Naik
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
NCT06742996
STUDY00026759
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Inclusion Criteria:
Histologically confirmed diagnosis of MCL
Received 1 to 5 prior lines of systemic therapy
Relapsed or refractory disease after the last line of therapy
Age ≥ 18 years.

Exclusion Criteria:
Prior ASCT or chimeric antigen receptor T-cell therapy
Prior allogeneic stem cell transplant within 6 months of the first dose of the study treatment
Known central nervous system involvement by lymphoma
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

A Multicenter Observational Study of GammaTile™ Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms

This study is for participants who have a brain tumor and decide with their doctor to use GammaTile radiation therapy to treat their brain tumor. This treatment is FDA approved. The purpose of this study is to collect data on how this treatment impacts your health and wellbeing.

There are no required visits or treatments for this study. At your regularly scheduled doctor visits, your study doctor or staff will enter relevant health and medical information into the study database. You will also be asked to complete questionnaires about the quality of your life during your routine medical appointments.

Yes
 

Sean Mahase
Micaiah or Sara at mgrien@pennstatehealth.psu.edu or scraig2@pennstatehealth.psu.edu
Radiation Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04427384
STUDY00026657
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Inclusion Criteria:
Patients who undergo maximum safe resection of intracranial neoplasm(s) AND implantation of GammaTiles.
Willing and able to provide informed consent and to participate in all evaluations.

Exclusion Criteria:
Inability to undergo pre-operative and post-operative imaging for disease and implant assessment.
Major medical or psychiatric illness, which, in the investigator’s opinion would prevent completion of treatment, ability to complete assessments at the time of enrollment, and/or interfere with follow ups.
Lack of English or Spanish language fluency sufficient to allow for providing informed consent and for completion of QOL tests all of which are available in English and Spanish.
Cancer
Approved drug(s)
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Hershey, PA ,

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Brensocatib in Adults with Moderate to Severe Hidradenitis Suppurativa - The CEDAR Study

Each participant will have a maximum study participation of 61 weeks, which includes a total duration of study treatment approximately 52 weeks: Period 1 (double-blind, placebo-controlled treatment; 16 weeks) and Period 2 (double-blind, active treatment; 36 weeks). At different timepoints throughout the study subjects will have their skin examined, have labs drawn, have an ECG perfomed, as well as answer questionnaires.

Study participation will last approximately 56 weeks. During the study, participants will attend 20 in person visits in the research office. At different timepoints the participant will have their skin examined, blood drawn, have an ECG done, answer questionnaires and take study medication as directed by the study team.

Yes
 

Bryan Anderson
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
NCT06685835
STUDY00025997
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Inclusion Criteria:
Participants must have a clinical diagnosis with a history of signs and symptoms consistent with HS for at least 6 months before the Screening Visit.
Participants must have active HS in at least 2 different body areas
Contraceptive/Barrier Requirements for participation will be discussed

Exclusion Criteria:
Other active skin diseases or conditions that could interfere with HS assessments
Known history of HIV infection (HBV & HCV diagnosis will be discussed during screening process)
Certain dental conditions are not allowed; study coordinator will discuss
Certain HS medications are not allowed; study coordinator will discuss
Skin Conditions
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

ERPs examining comprehension in younger and older adults

Older and younger adults may differ in how they comprehend language. Here we plan to EEG of word and sentence processing to understand differences in how older and younger adults use context to form predictions.

There will be a single, 2-hour visit in which your 'brain waves' are recorded while you read words. We will also ask you to complete pencil and paper tasks and computer tasks to learn more about how your brain works.

$30

Yes
 

Michele Diaz
Michele Diaz - at mtd143@psu.edu or 814-863-1726
Psychology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00027454
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Inclusion Criteria:
Native English Speaker
Right Handed
12 years of education or GED equivalent

Exclusion Criteria:
Neurological Conditions
Language Disorders
Major Medical disorders (e.g., cancer)
Language & Linguistics
Not applicable
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State College, PA ,

A PHASE 3 RANDOMIZED STUDY OF INTRALESIONAL CEMIPLIMAB VERSUS PRIM ARY SURGERY IN PARTICIPANTS WITH EARLY STAGE CUTANEOUS SQUAMOUS CELL CARCINOMA (CSCC)

The purpose of this study is to measure Event Free Survival (EFS) with IL cemiplimab (investigational intervention) compared with primary surgery for participants who have an eligible CSCC (cutaneous squamous cell carcinoma) that is great than or equal to 1 to less than or equal to 2 cm in the longest diameter. The maximum length that a participant will be on study is approximately 3 years. Participants will be assigned 2 to 1 to either the experimental arm or the control arm.

The maximum length that a participant will be on study is approximately 3 years. Visit Frequency: - Experimental Arm: Every week for 6 treatment visits. There is a clinical visit for TL assessment on Week 8. Assessment of response at the TL site occurs at week 13. -Control Arm: 1 day for surgery, with post-surgical visits at week 3 and week 13 -Both Arms: Week 19, then every 3 months for years 1 and 2, and every 4 months for year 3. Additional visits may occur for clinical issues that may arise, per standard of care. At different timepoints throughout the study participants will have their skin examined and photographed, answers questionnaires/interview, have blood drawn, and have a biopsy.

Yes
 

Elizabeth Billingsley
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
NCT06585410
STUDY00026428
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Inclusion Criteria:
Participants must have a histology confirmed invasive CSCC TL.
Willing and able to comply with clinic visits and study-related procedures.
Labs will be drawn; must have adequate hepatic function, renal function, and bone arrow function.
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:
Certain medications are not allowed to be used during the study; study coordinator will discuss.
Certain medical history conditions are excluded from participation; study coordinator will discuss
Skin Conditions
Not applicable
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Hershey, PA ,

Monitoring Eating Across Locations (MEAL) – Timing, Intake, and Mealtime Evaluation (TIME)

We know that both what (e.g., apples, pizza) and how (e.g., large vs small bites, fast vs slow) can contribute to overeating. The study will be focused on how children eat. We want to see if children eat the same way in the lab as they eat at home. We will assess laboratory and home eating styles (e.g., bite rate) in 100 prepubertal 6-9-year-old children. Children will be video-recorded while consuming identical study-provided meals at home and in the laboratory in addition to a ‘typical’ meal at home.

Healthy 6-9 year-olds and their parents are needed for the MEAL-TIME Study at Penn State University. We are looking for children to help us learn about how kids respond to different types of foods and computer games. The study consists of 3 visits to our facilities in Noll and Chandlee Labs, located on the University Park Campus. Your child will eat a meal and complete computer game tasks at each visit. Between visits, you will be asked to record your child eating at home using a study-provided smart phone. Your child will also complete an IQ test. Some children may experience anxiety when completing clinical procedures (e.g., height, weight). You and your child will be compensated $50 per visit for a total of $150. Each visit is expected to be 1.5 hours long and at-home meal recordings are expected to take 30-45 min, for a total of 8 hours participating in our lab.

$150

Yes
 

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

All
Younger than 18 years old
This study is also accepting healthy volunteers
NCT07095166
STUDY00026981
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Inclusion Criteria:
children must be between the ages of 6-9 years-old
children are of good health with no learning disabilities (e.g., ADHD, determined by parent report)
children are not on any medications known to impact body weight, taste, food intake, behavior, or blood flow
parents report that children like and are willing to eat study foods
children are not color blind

Exclusion Criteria:
If they are taking cold or allergy medication, or other medications known to influence cognitive function, taste, appetite, or blood flow
If they don’t speak English
If they have a learning disability, ADD/ADHD, language delays, autism or other neurological or psychological conditions
If they have 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
Children's Health, Food & Nutrition
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State College, PA ,

Hand Action and Perception in Parkinson's Disease

The purpose of this research study is 1.) to determine if Parkinson’s Disease (PD) causes changes in the way that people sense the movements of and forces produced by their bodies, and to connect any of these changes in sensation to changes in the brain, and 2.) to identify how changes in movement might come from different parts of the nervous system. This study will use a combination of electromyography, via electrodes placed on the skin, and finger force recordings to infer how PD affects patients' sense of force production, and the neural mechanisms underlying this change.

Participants will complete a phone screen, then attend one in-person visit at Penn State Health. During the visit, they will perform finger-pressing tasks, have surface electrodes placed on their skin to record muscle activity, complete motor and memory assessments, and fill out questionnaires.

40

Yes
 

Sayan De
Sayan De - at sayande@psu.edu
Kinesiology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00020063
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Inclusion Criteria:
Age between 21 to 85 years (controls) and 40 to 85 years (PD or ET).
For ET patients, they must present a history of bilateral upper limb action tremor with a duration of at least 3 years.
Able to understand and follow instructions in English
Either diagnosed with early-stage Parkinson’s disease (Hoehn & Yahr Stage I or II), essential tremor (ET), or be a healthy adult with no neurological conditions
Mini Mental Status Exam (MMSE) score ≥ 24

Exclusion Criteria:
Age < 21 for controls; age < 40, or > 85, for subjects with PD or ET.
Significant medical and neurological deficits on routine medical and neurological exam.
Present carpal tunnel syndrome, cervical myelopathy, brachial plexopathy, hand pain, or another neuromusculoskeletal disorder affecting hand function.
History of alcohol and/or drug abuse.
History of specialized hand training such as professional musicianship.
Neurology
Prefer not to display
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Hershey, PA ,
State College, PA ,

PSCI 23-125 A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant compared with Physician’s Choice CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of Patients with BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH non-amplified) Advanced Breast Cancer (EvoPAR-Breast01)

This study is loking at how a new drug treats breast cancer. The breast cancer must have the following genetic mutations BRCA1, 2 or PALB2

You will need to come to all the study visits, take the study medication as prescribed, tell the study doctor about all medications you are taking, including over the counter and to tell the doctor how you are feeling.

Yes
 

Monali Vasekar
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
NCT06380751
STUDY00025999
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Inclusion Criteria:
Participants must be ≥ 18 years of age
Histologically or cytologically documented diagnosis of HR-positive, HER2-negative breast cancer
Advanced breast cancer with either locally advanced disease not amenable to curative treatment or metastatic disease.
Minimum life expectancy of 12 weeks.

Exclusion Criteria:
Participants with history of MDS/AML
Participants with any known predisposition to bleeding
any evidence of severe or uncontrolled systemic diseases or active uncontrolled infections
active and uncontrolled hepatitis B and/or hepatitis C.
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

AHOD2131: A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy with Immuno-oncology Therapy for Children and Adults with Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma

AHOD2131:A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab. This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard treatment alone in improving survival in patients with stage I and II classical Hodgkin lymphoma.

Consent to treatment, required labs and imaging, sample collections, and completion of research study tests and surveys and/or questionnaires.

Yes
 

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

All
All
This study is NOT accepting healthy volunteers
NCT05675410
STUDY00025443
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Inclusion Criteria:
Patients must be 5 to 60 years of age at the time of enrollment
Patients with newly diagnosed untreated histologically confirmed classic Hodgkin lymphoma (cHL) (nodular sclerosis, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted, or not otherwise specified (NOS)) with Stage I or II disease
Patients must have bidimensionally measurable disease (at least one lesion with longest diameter ≥ 1.5 cm)
Patients must have a whole body or limited whole body PET scan performed within 42 days prior to enrollment. PET-CT is strongly preferred. PET-MRI allowed if intravenous contrast enhanced CT is also obtained.
Pediatric patients (age 5-17 years) with known or suspected mediastinal disease must have an upright PA CXR for assessment of bulky mediastinal disease.

Exclusion Criteria:
Patients with nodular lymphocyte predominant Hodgkin Lymphoma
Patients with a history of active interstitial pneumonitis or interstitial lung disease
Patients with a diagnosis of inherited or acquired immunodeficiency that is poorly controlled or requiring active medications, such as primary immunodeficiency syndromes or organ transplant recipients
Patients with peripheral neuropathy > Grade 1 at the time of enrollment or patients with known Charcot-Marie-Tooth syndrome.
Administration of prior chemotherapy, radiation, or antibody-based treatment for cHL
Children's Health, Cancer
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Hershey, PA ,

AAML1831: A study to compare standard chemotherapy to therapy with CPX-351 and/or gilteritinib for patients with newly diagnosed AML with or without FLT3 mutations

This phase III trial compares standard chemotherapy to therapy with CPX-351 and/or gilteritinib for patients with newly diagnosed acute myeloid leukemia with or without FLT3 mutations. Drugs used in chemotherapy, such as daunorubicin, cytarabine, and gemtuzumab ozogamicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. CPX-351 is made up of daunorubicin and cytarabine and is made in a way that makes the drugs stay in the bone marrow longer and could be less likely to cause heart problems than traditional anthracycline drugs, a common class of chemotherapy drug. Some acute myeloid leukemia patients have an abnormality in the structure of a gene called FLT3. Genes are pieces of DNA (molecules that carry instructions for development, functioning, growth and reproduction) inside each cell that tell the cell what to do and when to grow and divide. FLT3 plays an important role in the normal making of blood cells. This gene can have permanent changes that cause it to function abnormally by making cancer cells grow. Gilteritinib may block the abnormal function of the FLT3 gene that makes cancer cells grow. The overall goals of this study are, 1) to compare the effects, good and/or bad, of CPX-351 with daunorubicin and cytarabine on people with newly diagnosed AML to find out which is better, 2) to study the effects, good and/or bad, of adding gilteritinib to AML therapy for patients with high amounts of FLT3/ITD or other FLT3 mutations and 3) to study changes in heart function during and after treatment for AML. Giving CPX-351 and/or gilteritinib with standard chemotherapy may work better in treating patients with acute myeloid leukemia compared to standard chemotherapy alone.

Consent to treatment, required labs, sample collections, and completion of research study tests and surveys and/or questionnaires.

Yes
 

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

All
All
This study is NOT accepting healthy volunteers
NCT04293562
SITE00000986
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Inclusion Criteria:
Patients must be less than 22 years of age at the time of study enrollment.
Patient must be newly diagnosed with de novo AML according to the 2016 WHO classification152 with or without extramedullary disease.
All patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part A) prior to enrollment and treatment on AAML1831.

Exclusion Criteria:
Administration of prior anti-cancer therapy - some exceptions
Patients with persistent cardiac dysfunction prior to enrollment
Pregnancy and Breastfeeding
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ACNS1833-A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma

This phase 3 trial compares the effect of selumetinib versus the standard of care treatment with carboplatin and vincristine (CV) in treating patients with newly diagnosed or previously untreated low-grade glioma (LGG) that does not have a genetic abnormality called BRAFV600E mutation and is not associated with systemic neurofibromatosis type 1. Selumetinib works by blocking some of the enzymes needed for cell growth and may kill tumor cells. Carboplatin and vincristine are chemotherapy drugs that work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. The overall goal of this study is to see if selumetinib works just as well as the standard treatment of CV for patients with LGG. Another goal of this study is to compare the effects of selumetinib versus CV in subjects with LGG to find out which is better. Additionally, this trial will also examine if treatment with selumetinib improves the quality of life for subjects who take it.

Consent to treatment, required labs, sample collections, and completion of research study tests and surveys and/or questionnaires.

Yes
 

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

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All
This study is NOT accepting healthy volunteers
NCT04166409
SITE00001040
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Inclusion Criteria:
Patients must be ≥ 2 years and ≤ 21 years at the time of enrollment
Patients must have a body surface area (BSA) of ≥ 0.5 m2 at enrollment.
Non-neurofibromatosis type 1 low-grade glioma without a BRAFV600E mutation confirmed by Central Pathology and Molecular Screening Reviews performed on APEC14B1, CCDI-MCI, or accepted CLIA-certified test.
Adequate renal, liver, cardiac, and bone marrow function
Patients with a known seizure disorder must be stable and must not have experienced a significant increase in seizure frequency within 2 weeks prior to enrollment

Exclusion Criteria:
Patients must not have received any prior tumor-directed therapy including chemotherapy, radiation therapy, immunotherapy, or bone marrow transplant. Prior surgical intervention (with the exclusion of laser interstitial thermal therapy is permitted
Patients with a concurrent malignancy or history of treatment (other than surgery) for another tumor within the last year are ineligible
Patients with diffuse intrinsic pontine tumors as seen on MRI (> 2/3 of pons involvement on imaging) are not eligible even if biopsy reveals Grade I/II histology
Patients may not be receiving any other investigational agents
Patients with any serious medical or psychiatric illness/condition, including substance use disorders or ophthalmological conditions, likely in the judgment of the investigator to interfere or limit compliance with study requirements/treatment
Children's Health, Cancer
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A Phase 2 Study Using Chemoimmunotherapy with Gemcitabine, Cisplatin and Nivolumab in Newly Diagnosed Nasopharyngeal Carcinoma (NPC)

To evaluate safety of combining chemotherapy (cisplatin and gemcitabine) with an anti-PD1 immune checkpoint inhibitor (nivolumab) in children, adolescents and young adults with nasopharyngeal carcinoma (NPC) by determining the rate of CTCAE Grade 3 or higher immune related adverse events (irAEs).

Consent to treatment, required labs, imaging, and sample collections.

Yes
 

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

All
All
This study is NOT accepting healthy volunteers
NCT06064097
STUDY00025755
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Inclusion Criteria:
Patients must be ≤ 21 years of age at the time of study enrollment
Newly diagnosed AJCC Stage II-IV nasopharyngeal carcinoma (NPC)
Patients must have a Lansky (for patients ≤ 16 years of age) or Karnofsky (for patients > 16 years of age) performance status score of ≥ 60%.

Exclusion Criteria:
Patients who received prior radiotherapy to the head or neck.
Patients who received prior chemotherapy or radiation for the treatment of any cancer in the last 3 years. These patients must also be in remission
Patients with a diagnosis of immunodeficiency
Patients with a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
Patients who have undergone solid organ or allogeneic hematopoietic transplant at any time.
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Hershey, PA ,

Pediatric Acute Leukemia (PedAL) Screening Trial – Developing New Therapies for Relapsed Leukemias

Primary Aims: 1. To utilize clinical and biological characteristics of acute leukemias to screen for patient eligibility for available Phase I/II PedAL sub-trials. 2. To maintain a longitudinal and comprehensive registry from relapse in children and young adults with recurrent and refractory leukemia.

Consent to enrollment, required labs and sample collections.

Yes
 

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

All
All
This study is NOT accepting healthy volunteers
NCT04726241
STUDY00025542
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Inclusion Criteria:
Patients must be less than 22 years of age at the time of study enrollment
Patient has known or suspected relapsed/refractory (including primary refractory) AML-This includes isolated myeloid sarcoma.
Patient has known or suspected relapsed/refractory (including primary refractory) myeloid leukemia of Down syndrome (ML-DS)
Patient has known or suspected relapsed ALL
Patient has known or suspected relapsed/refractory (including primary refractory) mixed phenotype acute leukemia (MPAL)

Exclusion Criteria:
There are no Exclusion Criteria for APAL2020SC.
Children's Health, Cancer
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COG APEC14B1 - Project: Every Child for Younger Patients With Cancer

The next generation of therapy for childhood cancers will be based upon in-depth molecular phenotyping that may facilitate the development of rational risk-adapted and target-based therapies. In order to support current and future molecularly-guided therapeutic trials and the basic science discovery efforts that will lead to more effective therapies, prevention, early detection and a reduction in early and late-onset toxicities, it is critical to implement universal, high-quality collection of annotated biospecimens from children with cancer. This protocol provides for the collection of biospecimens and accompanying demographic, epidemiologic, therapeutic, and outcome data from all children diagnosed with cancer at participating COG institutions, independent of the patient’s enrollment on a therapeutic clinical trial. Through this approach, the correlation of phenotypic and genotypic or other –omic data with the relevant outcomes at the individual, disease, and protocol levels will be ensured. Biospecimen requirements and handling may be disease specific and thus a detailed manual of procedures will provide disease specific information regarding sample collection and processing based on the clinical diagnosis.

Consent to enrollment, eligibility screening and sample collections.

Yes
 

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

All
All
This study is NOT accepting healthy volunteers
NCT00240224
SITE00000206
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Inclusion Criteria:
Subjects must be ≤ 25 years of age at time of original diagnosis, except for patients who are being screened specifically for eligibility onto a COG (or COG participating NCTN) therapeutic study, for which there is a higher upper age limit.
Patients with a known or suspected neoplasm that occurs in the pediatric, adolescent or young adult populations
Enrollment must occur within 6 months of initial disease presentation OR within 6 months of refractory disease, disease progression, disease recurrence, second or secondary malignancy, or post-mortem.
All cancer cases with an ICD-O histologic behavior code of one “1” (borderline), two “2” (carcinoma in situ) or three “3” (malignant).
All neoplastic lesions of the central nervous system regardless of behavior, i.e., benign, borderline or malignant

Exclusion Criteria:
Contact cra@pennstatehealth.psu.edu
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ACNS2021 - A Phase 2 Trial of Chemotherapy followed by Response-Based Whole Ventricular &amp;Spinal Canal Irradiation (WVSCI) for Patients with Localized Non-Germinomatous Central Nervous System Germ Cell Tumor

This phase II trial studies the best approach to combine chemotherapy and radiation therapy (RT) based on the patient's response to induction chemotherapy in patients with non-germinomatous germ cell tumors (NGGCT) that have not spread to other parts of the brain or body (localized). This study has 2 goals: 1) optimizing radiation for patients who respond well to induction chemotherapy to diminish spinal cord relapses, 2) utilizing higher dose chemotherapy followed by conventional RT in patients who did not respond to induction chemotherapy. Chemotherapy drugs, such as carboplatin, etoposide, ifosfamide, and thiotepa, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays or high-energy protons to kill tumor cells and shrink tumors. Studies have shown that patients with newly-diagnosed localized NGGCT, whose disease responds well to chemotherapy before receiving radiation therapy, are more likely to be free of the disease for a longer time than are patients for whom the chemotherapy does not efficiently eliminate or reduce the size of the tumor. The purpose of this study is to see how well the tumors respond to induction chemotherapy to decide what treatment to give next. Some patients will be given RT to the spine and a portion of the brain. Others will be given high dose chemotherapy and a stem cell transplant before RT to the whole brain and spine. Giving treatment based on the response to induction chemotherapy may lower the side effects of radiation in some patients and adjust the therapy to a more efficient one for other patients with localized NGGCT.

Consent to treatment, required labs, sample collections, and completion of research study tests and surveys and/or questionnaires.

Yes
 

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

All
All
This study is NOT accepting healthy volunteers
NCT04684368
SITE00001017
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Inclusion Criteria:
Patients must be ≥ 3 years and < 30 years at the time of study enrollment.
Patients must be newly diagnosed with localized primary CNS NGGCT of the suprasellar and/or pineal region by pathology
and/or serum or CSF elevation of AFP above institutional normal or > 10 ng/mL or hCGβ > 100 mIU/mL as confirmed by Rapid Central Marker Screening Review on APEC14B1-CNS.
Disease/Staging Imaging
CSF Cytology and tumor markers

Exclusion Criteria:
Patients with tumors located outside the ventricles (i.e., basal ganglia, thalamus)
Patients with only mature teratoma and non-elevated markers upon tumor sampling at diagnosis
Patients who have received any prior tumor-directed therapy for their diagnosis of NGGCT other than surgical intervention and corticosteroids
Patients with metastatic disease (i.e., MRI evaluation, lumbar CSF cytology or intraoperative evidence of dissemination)
Pregnancy and Breastfeeding
Children's Health, Cancer
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ACCL1931: A Randomized Trial of Levocarnitine Prophylaxis to Prevent Asparaginase-Associated Hepatotoxicity in Adolescents and Young Adults Receiving Acute Lymphoblastic Leukemia Therapy

The study involves taking the drug levocarnitine during standard of care chemotherapy. The overall goal of this study is to determine whether taking levocarnitine will reduce the rate of severe liver damage caused by asparaginase chemotherapy during the first month of treatment.

Consent to treatment, required labs, sample collections, and completion of surveys.

Yes
 

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

All
All
This study is NOT accepting healthy volunteers
NCT05602194
STUDY00026495
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Inclusion Criteria:
Age: ≥ 15 and < 40 years at time of diagnosis
Diagnosis: Newly Diagnosed B-ALL, T-ALL, Lymphoblastic Lymphoma (LLy), or Mixed-Phenotype Acute Leukemia/Lymphoma (MPAL) Note: PH+ and PH-like acute leukemia are eligible (use of TKI or CRLF2-targeted concomitant medication must be documented, if used)
Adequate liver function
Adequate renal function

Exclusion Criteria:
Down Syndrome
Known inherited or autoimmune liver disease impacting conjugated bilirubin (e.g., Alagille Syndrome, primary sclerosing cholangitis, other)
Known biopsy (or imaging) proven severe liver fibrosis (Batts-Ludwig ≥ Stage 3)
Unable to tolerate oral formulation of study drug at enrollment
Patients who received chemotherapy or treatment for a prior malignancy are not eligible
Children's Health, Cancer
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Hershey, PA ,

AREN1921:Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)

This phase II trial studies how well combination chemotherapy works in treating patients with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) or favorable histology Wilms tumors (FHWT) that have come back (relapsed). Drugs used in chemotherapy regimens such as UH-3 (vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, and irinotecan) and ICE/Cyclo/Topo (ifosfamide, carboplatin, etoposide, cyclophosphamide, and topotecan) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help doctors find out what effects, good and/or bad, regimen UH-3 has on patients with newly diagnosed DAWT and standard risk relapsed FHWT (those treated with only 2 drugs for the initial WT) and regimen ICE/Cyclo/Topo has on patients with high and very high risk relapsed FHWT (those treated with 3 or more drugs for the initial WT).

Consent to treatment, required labs, sample collections, and imaging.

Yes
 

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

All
All
This study is NOT accepting healthy volunteers
NCT04322318
SITE00001073
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Inclusion Criteria:
Patients must be ≤ 30 years old at study enrollment.
Enrollment on APEC14B1
Newly diagnosed Stages 2 - 4 diffuse anaplastic Wilms tumor as confirmed by central review
Favorable histology Wilms tumor at first relapse. Relapsed FHWT patients must have previously achieved remission for their initial FHWT diagnosis to be eligible for this study
Patients must have a performance status corresponding to ECOG scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age.

Exclusion Criteria:
Patients with a history of bilateral Wilms tumor (synchronous or metachronous)
Patients with any uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, or symptomatic congestive heart failure
Relapsed FHWT patients who did not receive frontline chemotherapy (e.g., very low risk FHWT initially observed without chemotherapy) or received only one chemotherapy agent for frontline therapy
Patients with Renal Tubular Acidosis (RTA) as evidenced by serum bicarbonate < 16 mmol/L and serum phosphate ≤ 2 mg/dL (or < 0.8 mmol/L) without supplementation
Children's Health, Cancer
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Hershey, PA ,

Umbrella Long Term Follow Up Protocol (COG ALTE05N1)

Umbrella Long Term Follow Up Protocol (COG ALTE05N1)

Consent to enrollment and eligibility screening and completion of surveys and/or questionnaires.

No
 

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

All
All
This study is NOT accepting healthy volunteers
NCT00736749
SITE00000071
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Inclusion Criteria:
The patient must have been enrolled on a frontline COG therapeutic trial for treatment of a primary malignancy;
or The patient must have been enrolled on a COG (or Legacy Group) therapeutic or non-therapeutic trial targeted for long-term follow-up by ALTE05N1
The patient must reside in the U.S. on the date of enrollment to ALTE05N1

Exclusion Criteria:
N/A
Children's Health, Cancer
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COG AALL1621 - A Phase 2 Study of Inotuzumab Ozogamicin (NSC# 772518, IND# 133494) in Children and Young Adults with Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL)

This Phase II trial studies how well inotuzumab ozogamicin works in treating younger patients with CD22 positive B acute lymphoblastic leukemia that has come back or does not respond to treatment. Immunotoxins, such as inotuzumab ozogamicin, are antibodies linked to a toxic substance and may help find cancer cells that express CD22 and kill them without harming normal cells.

Consent to treatment, required labs, sample collections, and completion of research study tests.

Yes
 

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

All
All
This study is NOT accepting healthy volunteers
NCT02981628
SITE00000114
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Inclusion Criteria:
Patients must be ≥1 year and < 22 years of age at the time of enrollment
Patients must have B-ALL, or previously diagnosed B-LL, with ≥ 5% (M2 or M3) bone marrow blasts with or without extramedullary disease.
Patients must have a performance status corresponding to ECOG scores of 0, 1, or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age

Exclusion Criteria:
SOS: Patients with any prior history of SOS irrespective of severit
Patients with isolated CNS, testicular, or any other extramedullary site of relapse.
Patients who have been previously treated with inotuzumab ozogamicin.
History of allergic reaction attributed to compounds of similar or biologic composition to inotuzumab ozogamicin or other agents in the study.
Patients with active optic nerve and/or retinal involvement are not eligible. Patients who are presenting with visual disturbances should have an ophthalmologic exam and, if indicated, an MRI to assess optic nerve or retinal involvement.
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Neural mechanisms of manual interception

How does the brain decide to reach one way or the other? This study will examine how movement decisions are coordinated by neural mechanisms in the brain during manual interception and reaching actions.

Participants will be required to complete a simple virtual interception task with a handle. Participants will be screened and sign informed consent upon entry of the lab. They will then be fitted with EMG sensors and an eye-tracking reference sticker. They will be seated for this task. The task requires a participant to hold their hand steady at the epicenter of a circle, and reach as quickly and accurately as possible to one of 2 moving targets that will appear.

$20

Yes
 

Tarkeshwar Singh
Angus Muttee - at apm6364@psu.edu or 570-832-0744
Kinesiology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00027510
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Inclusion Criteria:
Healthy adult
Right-handed
18-50 years old
Corrected to normal or normal vision
Ability to grasp objects like handle with right hand

Exclusion Criteria:
Any history of neurological disorders
Any history of musculoskeletal disorders
Any history of cardiovascular disease
Any increased risk for syncope
Any history of conditions or diseases of the eyes or vision
Neurology, Sports Medicine, Vision & Eyes
Not applicable
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State College, PA ,

ANBL1531 A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or ALK Inhibitor Therapy Added to Intensive Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma (NBL) (IND# 134379)

This phase III trial studies iobenguane I-131 or lorlatinib and standard therapy in treating younger patients with newly-diagnosed high-risk neuroblastoma or ganglioneuroblastoma. Radioactive drugs, such as iobenguane I-131, may carry radiation directly to tumor cells and not harm normal cells. Lorlatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving iobenguane I-131 or lorlatinib and standard therapy may work better compared to lorlatinib and standard therapy alone in treating younger patients with neuroblastoma or ganglioneuroblastoma.

Consent to treatment, required labs, sample collections, and completion of research study tests and surveys and/or questionnaires.

Yes
 

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

All
All
This study is NOT accepting healthy volunteers
NCT03126916
SITE00000119
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Inclusion Criteria:
Patients must be enrolled on ANBL00B1 or APEC14B1 prior to enrollment
Patient must be ≥ 365 days and ≤ 30 years of age at diagnosis
Patients must have a diagnosis of neuroblastoma or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites.

Exclusion Criteria:
2 Patients with bone marrow failure syndromes
Patients who have an INRG Stage L2 tumor without amplification of MYCN regardless of tumor histology (may meet criteria for may meet criteria for high risk classification but are not eligible for this trial).
Patients for whom targeted radiopharmaceutical therapy would be contraindicated due to underlying medical disorders.
Children's Health, Cancer
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AOST2031: A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients with Osteosarcoma

The overall goal of this study is to compare the effects, good and/or bad, of two different surgery methods for people with OST that has spread to the lung to find out which is better. In this study, participants will receive 1 of 2 treatment plans. Treatment with open surgery is the older standard therapy for people with OST that has spread to the lung. Treatment with VATS is a newer method that has also been shown to work when used to treat the same type of cancer

Consent to treatment, required labs, sample collections, and completion of research study tests and surveys and/or questionnaires.

Yes
 

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

All
All
This study is NOT accepting healthy volunteers
NCT05235165
STUDY00024197
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Inclusion Criteria:
Patients must be < 50 years at the time of enrollment
Patients must have ≤ 4 nodules per lung consistent with or suspicious for metastases, with at least one of which being ≥ 3 mm and all of which must be ≤ 3 cm size
Lung nodules must be considered resectable by either open thoracotomy or thoracoscopic surgery. Determination of resectability is made by the institutional surgeon
Patients must have a histological diagnosis of osteosarcoma
Patients must have evidence of metastatic lung disease at the time of initial diagnosis, or at time of 1st recurrence following completion of therapy for initially localized disease.

Exclusion Criteria:
Patients with unresectable primary tumor
Patients with chest wall or mediastinal based metastatic lesions, or with significant pleural effusion.
Patients with evidence of extrapulmonary metastatic disease
Patients who received therapeutic pulmonary surgery for lung metastasis prior to enrollment
Patients with disease progression at either the primary or pulmonary metastatic site while on initial therapy. N
Children's Health, Cancer
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ANBL1821 - A Phase 2 Randomized Study of Irinotecan/Temozolomide/Dinutuximab with or without Eflornithine (DFMO) (IND# 141913) in Children with Relapsed, Refractory, or Progressive Neuroblastoma

This phase II trial studies how well irinotecan hydrochloride (irinotecan), temozolomide, and dinutuximab work with or without eflornithine in treating patients with neuroblastoma that has come back or that isn't responding to treatment. Drugs used in chemotherapy, such as irinotecan hydrochloride and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as dinutuximab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Eflornithine blocks the production of chemicals called polyamines that are important in the growth of cancer cells. Giving eflornithine with irinotecan hydrochloride, temozolomide, and dinutuximab, may work better in treating patients with relapsed or refractory neuroblastoma.

Consent to treatment, required labs, sample collections, and completion of research study tests and surveys and/or questionnaires.

Yes
 

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

All
All
This study is NOT accepting healthy volunteers
NCT03794349
SITE00000574
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Inclusion Criteria:
Patients ≥ 1 year of age at the time of enrollment are eligible for this study
Patients must have had histologic verification of neuroblastoma or ganglioneuroblastoma or demonstration of neuroblastoma cells in the bone marrow with elevated urinary catecholamines, at the time of initial diagnosis
Patients must have a performance status corresponding to ECOG scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients  16 years of age.

Exclusion Criteria:
Pregnancy and Breastfeeding
Patients must not have received prior treatment with irinotecan and temozolomide.
Patients must not have been diagnosed with myelodysplastic syndrome or with any malignancy other than neuroblastoma
Patients with symptoms of congestive heart failure are not eligible.
Patients must not have uncontrolled infection.
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Hershey, PA ,