Search Results
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.
Participants must have active HS in at least 2 different body areas
Contraceptive/Barrier Requirements for participation will be discussed
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
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
Right Handed
12 years of education or GED equivalent
Language Disorders
Major Medical disorders (e.g., cancer)
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.
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
Certain medical history conditions are excluded from participation; study coordinator will discuss
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
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
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
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
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
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.
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.
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.
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.
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.
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.
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
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.
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.
Patients with persistent cardiac dysfunction prior to enrollment
Pregnancy and Breastfeeding
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.
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
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
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.
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%.
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.
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.
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)
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.
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
ACNS2021 - A Phase 2 Trial of Chemotherapy followed by Response-Based Whole Ventricular &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.
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
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
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.
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
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
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.
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.
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
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.
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
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.
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
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.
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
Right-handed
18-50 years old
Corrected to normal or normal vision
Ability to grasp objects like handle with right hand
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
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.
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.
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.
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.
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.
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
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.
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.
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.
AALL1732: A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#:772518) for Newly Diagnosed High‐Risk B‐ALL; Risk Adapted Post‐Induction Therapy for High‐Risk B‐ALL, Mixed Phenotype Acute Leukemia, and Disseminated B‐LLy
This phase III trial studies how well inotuzumab ozogamicin and post-induction chemotherapy work in treating patients with high-risk B-cell lymphoblastic lymphoma (B-ALL), mixed phenotype acute leukemia, and B-lymphoblastic lymphoma (B-LLy). Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called calicheamicin. Inotuzumab attaches to cancer cells in a targeted way and delivers calicheamicin to kill them. Drugs used in chemotherapy, such as cyclophosphamide, cytarabine, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, thioguanine, vincristine, and pegaspargase, 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. The overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The goal of the part 1 of the study is to collect information about leukemia and the effects of the first two phases of treatment, called Induction and Consolidation on this cancer. Additionally, this study aims to investigate whether treating both males and females with the same duration of chemotherapy maintains outcomes for males who have previously been treated for 3 years from the start of Interim Maintenance in patient with High Risk Favorable (HR-Fav) and HR B-ALL. Another aim is to understand the outcomes of subjects with disseminated B-cell Lymphoblastic Leukemia (B LLy) receiving HR B-ALL therapy. Finally, another goal of this study is to determine the outcomes of subjects with Mixed Phenotype Acute Leukemia (MPAL) with a favorable early response to treatment using High Risk B-cell Acute Lymphoblastic Leukemia therapy.
Consent to treatment, required labs, sample collections, and imaging.
B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to Eligibility studies (Part A) prior to treatment and enrollment on AALL1732.
White Blood Cell Count (WBC) Criteria
Patient has newly diagnosed B-ALL or MPAL (by WHO2016 criteria) with ≥25% blasts on a bone marrow (BM) aspirate
A complete blood count (CBC) documenting the presence of at least 1,000/µL circulating leukemic cells if a bone marrow aspirate or biopsy cannot be performed
Patients who have received > 72 hours of hydroxyurea within one week prior to start of systemic protocol therapy.
Patients with Acute Undifferentiated Leukemia (AUL) are not eligible
Patients requiring radiation at diagnosis.
AHEP1531 - Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)
This partially randomized phase II/III trial studies how well cisplatin and combination chemotherapy works in treating children and young adults with hepatoblastoma or liver cancer after surgery. Drugs used in chemotherapy, such as cisplatin, doxorubicin, fluorouracil, vincristine sulfate, carboplatin, etoposide, irinotecan, sorafenib, gemcitabine and oxaliplatin, 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. Giving combination chemotherapy after surgery may kill more tumor cells.
Consent to treatment, required labs, sample collections, and completion of research study tests.
Patients in Group F must have a BSA ≥ 0.6 m2 .
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.
Patients newly diagnosed with histologically-proven primary pediatric hepatic malignancies including hepatoblastoma or hepatocellular carcinoma
Patients who are currently receiving another investigational drug
Patients who are currently receiving other anticancer agents
Patients with uncontrolled infection.
Patients who previously received a solid organ transplant, other than those who previously received an orthotopic liver transplantation (OLT) as primary treatment of their hepatocellular carcinoma.
AGCT1531 - A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplaitin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors
This partially randomized phase III trial studies how well active surveillance, bleomycin, carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients with germ cell tumors. Active surveillance may help doctors to monitor subjects with low risk germ cell tumors after their tumor is removed. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and cisplatin, 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.
Consent to treatment, required labs, sample collections, and completion of research study tests and surveys and/or questionnaires.
Standard Risk 1 Patients must be < 11 years of age at enrollmen
Standard Risk 2 Patients must be ≥ 11 and < 25 years of age at enrollment
Patients enrolling on one of the Low Risk arms must be newly diagnosed with a Stage I germ cell tumor. For the Standard Risk arms, patients must be newly diagnosed with metastatic germ cell tumor (Stage II or higher).
Patients must have a performance status corresponding to ECOG scores of 0, 1, 2 or 3. Use Karnofsky for patients > 16 years of age and Lansky for patients 16 years of age
Pure dysgerminoma
Pure mature teratoma
ARST2032: A Prospective Phase 3 Study of Patients with Newly Diagnosed Very Low-risk and Low-risk Fusion Negative Rhabdomyosarcoma
This phase III trial aims to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized molecular risk stratification in the treatment of rhabdomyosarcoma. To determine the feasibility of adding cabozantinib S-malate (cabozantinib) to standard MAP (high dose methotrexate, doxorubicin hydrochloride [doxorubicin], and cisplatin) chemotherapy in patients with newly diagnosed metastatic osteosarcoma with a resectable primary tumor.
Consent to treatment, required labs, sample collections, and imaging.
Patients must be ≤ 21 years at the time of enrollment
Patients must have newly diagnosed embryonal rhabdomyosarcoma (ERMS), spindle cell/sclerosing RMS, or FOXO1 fusion negative alveolar rhabdomyosarcoma (ARMS) (institutional FOXO1 fusion results are acceptable).
Patients who have received chemotherapy or radiation for non-malignant conditions (e.g., autoimmune diseases) are eligible. Patients must discontinue chemotherapy for non-malignant conditions prior to starting protocol therapy
Vincristine is sensitive substrate of the CYP450 3A4 isozyme. Patients must not have received drugs that are moderate to strong CYP3A4 inhibitors and inducers within 7 days prior to study enrollment
Patients unable to undergo radiation therapy, if necessary, as specified in the protocol
Evidence of uncontrolled infection
The Ethics of the Influence of Beauty-Focused Social Media Content on Cosmetic Procedure Intentions and Utilization Among Women Aged 21-25
This mixed-methods study examines the relationship between engagement with beauty-focused social media content created by young female influencers and intentions to pursue cosmetic procedures among women aged 21-25. The research employs both quantitative survey methods and qualitative interviews to understand this relationship and its ethical implications.
1 online survey (5-10 min) Some participants may be asked to partake in a 15 min qualitative interview
social media use of at least 3 hrs/week
ability to provide informed consent
under 21
diagnosed body dysmorphia
PSCI #25-020 NRG-CC013: A Randomized, Masked, Placebo Controlled, Phase II Trial of Concurrent Chemoradiation with BMX-001 in Patients with Head and Neck Squamous Cell Carcinoma Receiving Concurrent Chemoradiation
This trial will examine the usual symptom management chemoradiation with or without BMX-001.
Participants must agree to come to all study visits. Participants will be coming to the clinic at least twice a month for treatment. After treatment is finished, you will be followed every three months to see how you are doing
Zubrod Performance Status of 0-2
Patients must have adequate health that permits completion of the study
Patients must be planned to receive radiation and concurrent cisplatin chemotherapy as definitive therapy.
Pathologically confirmed (histologically or cytologically) squamous cell carcinoma of the oropharynx, larynx, hypopharynx, nasopharynx, or oral cavity.
definitive clinical or radiologic evidence of metastatic (M1) disease related to current diagnosis.
Age < 18
prior radiotherapy that would result in overlap of radiation treatment fields with planned treatment for study cancer
current treatment of adjuvant post-op chemoradiation
Effects of substitutionary somatosensory haptic feedback on the control of myoelectrically driven virtual joint.
This study will examine the impact of natural and artificial feedback about joint position in a prosthetic driven by muscle activity.
Participants will be asked to come to the lab and contract their upper arm muscles in order to control the movement of a motor driving a virtual prosthetic to reach a set of targets either with feedback about their joint angle or without feedback.
15 dollars
healthy and able-bodied
right-handed
english speaking
2. All vulnerable populations are excluded from participating
A Multi-Site, Parallel-Group, Randomized Clinical Trial Comparing a Brief Tele-Cognitive Behavioral Therapy Intervention (BRIGHT) with Attention Control for the Reduction of Body Image-Related Distress Among Head and Neck Cancer Survivors
In this multi-site, parallel-group, randomized clinical trial, we will evaluate the efficacy of BRIGHT, a novel psychological intervention for cancer survivors, compared with attention control (AC) for managing body image distress (BID) among head and neck cancer survivors (HNC) survivors, examine BRIGHT’s underlying mechanisms, and characterize factors affecting the future adoption of BRIGHT into clinical care.
1. The researchers will check your medical records to gather information about your diagnosis and treatment. 2. You will meet with the study coordinator to fill out baseline questionnaires. 3. You will be randomly assigned to one of two groups. This means that you have a 50/50 chance (like flipping a coin) of being in either group. Neither the researchers nor you will make the choice to which group you are assigned. 4. Cognitive behavioral therapy involves meeting with a study psychologist to identify and address unhelpful automatic thoughts that may contribute to unwanted behaviors. The cognitive behavioral therapy group will meet with one-on-one with the study psychologist once per week for six weeks, using a video telemedicine platform. Each visit with the psychologist will take one hour. An attention control group is one that receives the same amount of attention as the intervention group but without the potential active ingredient. The attention control group will meet with one-on-one with a head and neck cancer clinician once per week for six weeks, using a video telemedicine platform to receive survivorship education. Each visit with will take one hour. These sessions will be video-recorded to help ensure that the interventionist delivers each intervention as intended. 5. Regardless of whether you are in the cognitive behavioral therapy or attention control group, you will meet with the study coordinator at the end of the study to complete questionnaires to measure changes compared to baseline and describe your experience in the study.
125
Completion of cancer treatment within 12 months of study enrollment
Cancer-free at time of accrual
No planned significant head and neck surgery
Willingness to complete 6 weekly educational or therapeutic sessions
Currently receiving ongoing psychotherapy services
Initiation or adjustment of psychotropic medications within the last 3 months
Mental illness diagnosis that would prevent trial participation
First-Generation Undergraduate Women in Engineering Majors: Pathways to Doctoral Study in STEM
This qualitative case study will explore the experiences of 10-15 First-Generation Undergraduate Women (FGUW) in engineering majors at PSU that led them to apply to STEM PhD programs, and also how they overcame any barriers they encountered to then still apply. The method for data collection will include 1-2 individual semi-structured participant interviews, as well as 1-2 focus group interviews with the full participant group. During the interview process, opportunities for artifact analysis or direct observation may arise. With the permission and agreement of the participant, if these opportunities arise, I will plan to do no more than one direct observation or artifact analysis per participant.
1-2 Individual Zoom Interviews, lasting about 1 hour each. 1-2 Focus Group Interviews, lasting about 1 hour each.
$30 Amazon Gift Card
Undergraduate Student at Penn State
Majoring in a College of Engineering Program Major
Intend to apply to a Science, Technology, Engineering, or Math PhD Program
A First-Generation College Student (no parent or guardian has obtained a 4-year college degree)
Male