Search Results
A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) with Pembrolizumab (MK3475) in Combination with Transarterial Chemoembolization (TACE) Versus TACE in Participants with Incurable/Non-metastatic Hepatocellular Carcinoma (LEAP-012)
This is a study that will compare a study drug pembrolizumab plus a study drug lenvatinib in combination with the therapy called TACE (transarterial chemoembolization) which is a way to deliver chemotherapy locally through a procedure called embolization and how that works versus placebo (or no study medications) plus TACE and how it could lead to progression-free survival (PFS).
This is a study that will compare a study drug pembrolizumab plus a study drug lenvatinib in combination with the therapy called TACE (transarterial chemoembolization) which is a way to deliver chemotherapy locally through a procedure called embolization and how that works versus placebo (or no study medications) plus TACE and how it could lead to progression-free survival (PFS).
Has HCC localized to the liver without portal vein thrombosis, and not amenable to curative treatment such as resection, ablation, or liver transplant.
Has at least one measurable HCC lesion based on RECIST 1.1,
Has an ECOG performance score of 0 to 1
Has a predicted life expectancy of >3 months.
Has had esophageal or gastric variceal bleeding within the last 6 months.
Has clinically apparent ascites on physical examination that is not controlled with medication
Has had clinically diagnosed hepatic encephalopathy in the last 6 months unresponsive to therapy.
Has clinically significant hemoptysis from any source or tumor bleeding within 2 weeks prior
Effects of amiloride on walking ability in patients with peripheral artery disease
The purpose of the study is to determine the effects of amiloride on the blood pressure response to walking in PAD patients and healthy controls.
In each visit, you will be asked to walk on a treadmill. You will also be asked to take capsules prior to visit 2 and 3. The capsules for one visit will be a drug called amiloride (10mg, in 2 capsules with 5mg of amiloride in each capsule), which was traditionally used to lower blood pressure. The other capsules will be a placebo (no active medication). A blood sample will be drawn at each visit.
You will receive $25 per hour for your participation in this research study
Any race or ethnicity
Healthy: Free of acute medical conditions
PAD: Diagnosis of PAD, no pain at rest
Resting blood pressure of 150/100 or higher
Already taking amiloride
Recent heart attack or epilepsy
Peripheral neuropathy
Healthy Mom Zone: Control Systems Engineering for Optimizing a Prenatal Weight Gain Intervention Study 2.0
The proposed overall research aims to establish feasibility of delivering an individually-tailored, behavioral intervention to manage gestational weight gain [GWG] that adapts to the unique needs and challenges of overweight/obese pregnant women [OW/OB-PW] and will utilize control systems engineering to optimize this intervention; in other words, make this intervention manage GWG in OW/OB-PW as effectively and efficiently as possible.
You will be randomized into an intervention or attention control group from ~8 weeks gestation to ~37 weeks gestation with a BMI of 24-45 (>40 with physician consent).You will have 1 pre-intervention session that explains the study procedures and to get you ready for the study. Here you will also complete various measures of demographics, behavioral surveys, etc.Over the course of the study, you will weigh yourself each day, wear an activity monitor and complete various surveys. If you are randomized to the intervention group, you may have healthy eating demonstrations and/or physical activity sessions each week.You will have 1 post-intervention session where you will return your devices, complete a 30-60 minute interview and complete the last of the surveys.
$175
18-45 years old
8-18 gestational weeks
English speaking
BMI 24-45 (>40 with provider consent)
Men
Younger than 18
Non-English speaking
BMI <24
Music Appreciation of Pediatric and Adult Hearing Aid Users over Time
The purpose of this study is to survey hearing aid users over a 6 month time period to see if their music perception improves over time.
Study participants will complete surveys about their music experience four times: first at your initial clinic visit and then sent to your email at 1, 3, and 6 months following your visit. This survey will include questions about the participants experience with music as well as name, age, gender, and duration of hearing aid use.
Hearing aid use
Auditory implants including bone anchored hearing aids
Poor compliance with the use of hearing aids
Age 12 years old or younger
Athletes' Experiences in Sport
In this study, we are interested in learning about how male athletes think about and understand the experience and expression of emotion in competitive sports.
Competitive athlete
Penn State student
18+ years
Non-athlete
Non-student
Under 18 years
Brain Mechanisms of Overeating in Children
Reducing intake from large portions is of critical importance to preventing obesity. People consistently eat more when they are served larger portions, a phenomenon known as the portion size effect. The mechanisms of the portion size effect are not well understood, and investigating the underlying neurobiology that drives this phenomenon may inform the development of more effective obesity prevention programs. The proposed research will follow healthy weight children who vary by family risk for obesity to identify the neurobiological and appetitive traits that are implicated in overeating and weight gain during the critical pre-adolescent period. We expect results to confirm the hypothesis that reduced function of brain inhibitory pathways and increased activity in brain reward pathways in response to portion size cues contributes to excess intake with large portions and greater weight gain over time, particularly in children who have higher risk for obesity. The proposed studies will characterize the relationship between brain response to portion size and eating behavior and will allow us to determine whether brain and behavioral responses predict body fat gain during pre-adolescence. These studies will contribute essential information to our understanding of the pathways implicated in overeating and obesity and will facilitate the characterization of “at risk” phenotypes that can be targeted by prevention programs.
There will be seven in person visits with two DEXA measurements, one fMRI scan and five meals.
$350
The child must not have any food allergies to foods used in the study, learning disabilities, psychological diagnoses, red/green color blindness, or claustrophobia.
The child must not be taking any medications known to influence cognitive function, taste, appetite or blood flow
The child's BMI must be below the 90th percentile at the first visit
The biological mother and father must have a BMI between 18.5-25 kg/m2 (low-risk group) or greater than or equal to 30 kg/m2 for mothers and greater than or equal to 25 kg/m2 for fathers (high-risk group) and 1 parent must attend all visits.
Children will be excluded if they have any food allergies, learning disabilities, psychological diagnoses, red/green color blindness, or claustrophobia
Children will be excluded if they are taking cold or allergy medication, or other medications known to influence cognitive function, taste, appetite, or blood flow
Children will be excluded if their BMI is above the 90th percentile at the first visit
Families will be excluded if the biological mother or father do not fit the BMI requirements
A data and biorepository for individuals with subjective cognitive decline (SCD), mild cognitive impairment (MCI), dementia, and other individuals at increased risk for dementia
This research is being done to help us better understand the risk factors and protective factors for cognitive decline in people who are at increased risk for dementia. The goal of the study is to establish a data and biorepository for people at increased risk for dementia.
Eligible patients for the study, in addition to routine clinic visits, may undergo a series of questionnaires and blood testing.
Patient participants - Meet the criteria for subjective cognitive decline, mild cognitive impairment, dementia or at risk for any
Health controls - Normal age and education-adjusted performance on the Montreal Cognitive Assessment Test or another standardized cognitive screening test
Postmenopausal women and their endothelium: Is dietary nitrate supplementation protective?
Heart disease is the leading cause of death in the United States. The loss of estrogen from menopause puts women at a greater risk of developing heart disease. The purpose of this study is to determine the effects of drinking beetroot juice on measures of blood vessel health and blood pressure. Participants will drink beetroot juice and placebo juice each for one week followed by blood pressure measurements and ultrasound imaging of an artery in the upper arm. A sub-aim of this study is to investigate the effects of estrogen status on blood vessel function between pre- and post-menopausal women.
There are a total of 6 in-person visits to the Clinical Research Center. You will be asked to drink beetroot juice (2 oz) every day for 7 days. Participants will undergo vascular assessments, blood pressure measurements, and blood draws (11 in total for 6 visits).
$120
BMI <35
Blood pressure <130/80
LDL <170 mg/dL
Individuals with resting blood pressure > or = 130/80 mmHg
Users of any tobacco and/or nicotine products (smokers, chewing tobacco, nicotine-containing patches/gum, smokeless cigarettes)
Individuals with any overt cardiovascular, metabolic, hematologic, pulmonary, renal, musculoskeletal, and/or neurological disease(s)
Individuals with active cancer
NRG-GI008 Colon Adjuvant Chemotherapy based on Evaluation of Residual Disease (CIRCULATE-US) (22-070)
To compare time to ctDNA (+ve) status in ctDNA (-ve) cohort following resection of stage III colon cancer treated with immediate vs delayed (based on serial ctDNA surveillance) chemotherapy. Time to positive event is defined as time from randomization to the first ctDNA positive result for the immediate arm (Arm 1) and to the 2nd ctDNA positive result for the delayed arm (Arm 2) to allow for the potential effect of delayed adjuvant chemotherapy. Patients recurred without a positive ctDNA result will be considered to have ctDNA positive status at the time of recurrence for both study arms.
We are asking you to take part in this research study because you have colon cancer that has been treated with surgery but has spread to some of your lymph nodes and is known as stage III colon cancer. Or, you have stage II or stage III colon cancer with a higher risk of cancer returning, your colon cancer has been treated with surgery, and you had ctDNA testing done and are ctDNA positive. Stage II colon cancer is an early stage colon cancer that has been treated with surgery but has not spread to your lymph nodes. ctDNA, or circulating tumor DNA, is DNA that has been released from tumor cells into your bloodstream. This DNA can be measured using a blood test.
Hemoglobin must be ≥ 9 g/dL
HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months
The treating investigator must deem the patient a candidate for all potential agents used in this trial (5FU, LV, oxaliplatin and irinotecan)
The patient must have an ECOG performance status of 0 or 1
Tumor-related bowel perforation
Synchronous primary rectal and/ or colon cancers
Active seizure disorder uncontrolled by medication
Active or chronic infection requiring systemic therapy
How urban infrastructure fosters romantic relationships
The primary endpoint of this study is to identify the contributing factors in development of romantic relationships through an analysis of the real-life experiences of Penn state couples that we collect in our surveys. Our focus is to identify the spatial factors in different scales as they relate to two-person relationships. The results of this study informs architects, planners, and administrators of practical strategies to generate friendly spaces in college towns.
Live in State College area
Has visited at least 5 places with their romantic partner(s) in State College
have never engaged in a romantic relationship
My Character is...Myself? Exploring Attachment Styles, View of Self, Virtual Self-Discrepancy, & Character Attachment
The goal of this research is to confirm the relationships between virtual self-discrepancy, character attachment, view of self, attachment styles, and the potential for a moderating variable within the relationships as a starting point for future research tying in player/character relationship and gaming addiction.
Players that engage in role-play gaming using a character they have spent a significant amount of time creating.
Participants that can understand English
Players that do not engage in role-play gaming using a character they have spent a significant amount of time creating.
People who do not speak and read English.
To stretch, not strain: Impact of passive stretching on calf muscle and gait mechanics in peripheral artery disease
People with narrowed blood vessels in their legs can only walk a short distance before needing to sit down due to pain in their calf muscles. Most of these patients do not follow their heart doctor's advice to walk at home because it hurts. A therapy that does not involve painful walking would be ideal for these patients to begin to treat their disease so they can eventually walk with less discomfort. We will ask patients with peripheral artery disease (PAD) to place both feet into inflatable ankle splints 30 minutes a day for 4 weeks to passively stretch their calf muscles. Before and after this 4-week program, we will measure the health and size of their leg blood vessels, the length, and function of their calf muscles and tendons, and how long they can walk without pain. We will also closely track their joint and foot movements and calf muscle oxygen levels while they walk down a hallway. People with and without risk factors for heart disease are also eligible for this study to compare differences in vascular and muscular health to patients with PAD. Volunteers without a PAD diagnosis or poor leg circulation will not undergo the 4-week stretch and no-stretch interventions.
Peripheral artery disease (PAD) and poor leg circulation patients:-4 visits to University Park Clinical Research Center ~3 hours per visit-1 blood draw-Wear a calf muscle stretching device for 30-min a day, 5 days a week, for 4 weeks and 4 weeks of no stretching-Several muscle and vascular ultrasound measurements-Walking performance tests on and off the treadmill-Wear a smartwatch to monitor physical activity during each 4-week stretch or no stretch interventionParticipants with and without risk factors for heart disease:-2 visits to University Park Clinical Research Center within the same week lasting ~3 hours per visit-Not diagnosed with PAD or poor leg circulation-1 blood draw-Several muscle and vascular ultrasound measurements-Walking performance tests on and off the treadmill
PAD participants can receive up to $450 in compensation. Participants with and without heart disease risk factors (non-PAD participants) will receive $50 for their participation.
Participants (40-85 years) with or without risk factors for heart disease (high blood pressure, blood sugar, cholesterol, etc.) and not diagnosed with PAD
Ability to walk on or off a treadmill at 1 mile per hour
Men and women who are not pregnant or nursing
Heart attack within the past 6 months or unstable angina
Severe lung disease, rheumatoid arthritis, degenerative joint disease, critical limb ischemia
Major surgery or lower extremity revascularization surgery within the past 6 months
Recent serious ankle, Achilles tendon, or foot injuries
Women and Infants' Stress and Health
The goal of this study is to understand how babies and their mothers learn to respond to stress during the early years of the baby's life. Participating women complete questionnaires and do a mildly stressful task alone (during pregnancy) or with their babies (at four different times over the first two years of the baby's life) and collect saliva samples that tell us about stress responses, either at home or at one of our lab sites. We aim to use what we learn to better support expecting parents who may be at risk for stress-related health problems and improve their children's resilience to stress throughout life.
Women are asked to participate in six sessions over Zoom and/or at the PACT Center between their 28th week of pregnancy and when their child is 2 years old. During these sessions, which last up to 2 hours each, mothers and babies will1.participate in mildly stressful tasks (like having the mother leave the room for up to 3 minutes and then return) and games to assess the baby’s emotional and cognitive development2.provide saliva samples by drooling into a tube (for the mother) or holding a cotton swab in their baby’s mouth to get it wet3.fill out questionnaires about themselves and their baby4.take part in clinical interviews that ask about mood and other markers of psychological ill-being
$220
18 or older
English speaking
Slips of Action in Adolescents and Young Adults
Adolescence is a critical period during which many important healthhttps://irb.psu.edu/IRB/sd/ResourceAdministration/Project/ProjectEditor?Project=com.webridge.entity.Entity[OID[058ACDEB3E43384D816C7E390C2B83F6]]&Mode=smartform&WizardPageOID=com.webridge.entity.Entity[OID[E4552FC57E491543A6B7FD8268E23FD7]] habits form in humans. However, animal models provide mixed information about habit formation across development and there are relatively few human studies that address differences between habit formation in adolescents and adults. To address this gap, the proposed study will assess differences in habit formation in adolescents and adults as measured by the "Slips of Action" task, which seeks to discriminate between habitual and goal-directed learning of visual stimuli pairings.
There will be one in-person visit lasting about one hour. Visits will begin with informed consent. Participants will complete a computer task where they are asked to learn associations between pictures and then will be tested on the associated pairings. They will also complete questionnaires and cognitive tasks.
$20
Healthy adults between the ages of 25 to 40
No learning disabilities (e.g., ADHD) or diagnosed psychological conditions (e.g. anxiety)
Right handed
Not on any medications known to influence behavior
Diagnosed neurological or psychological condition including severe anxiety and/or depression, schizophrenia, learning disability, ADD/ADHD, or autism
Significant family history of neurological or psychological disorders
Left handed
Participant is on any medication that may influence behavior
The Impact of Menstrual Cup Distribution Programming on College Student Perpetuation of Period Stigma
This is a social sciences study to analyze the effect of menstrual cup introduction through the "CampusCup" free menstrual cup distribution program on the tendency of college students to perpetuate period stigma. A survey will be conducted across samples of students who participated in the CampusCup program, students who use menstrual cups independent of the CampusCup program, and students who have never used menstrual cups. The survey will address motivations behind menstrual cup usage and personal attitudes towards periods. The study seeks to investigate relationships between menstrual cup usage & CampusCup participation and impacts on community attitudes towards menstruation.
At least 18 years of age
Has experienced a menstrual period in the last calendar year
Less than 18 year of age
Has not experienced a menstrual period in the last calendar year
Penn State Hershey Sitting and Health Study
This study aims to examine the effect of pedaling a compact elliptical device at the desk on employees' work productivity. This study also aims to evaluate the effect of different types of incentives on promoting desk-based pedaling.
Overweight or obese
Spend at least 5 hours per day sitting at a desk
Have eligible overweight/obese coworker who can do study together with you
18-70 years old
Planned surgical or medical treatment that will prevent ability to complete study
Heart condition, or chest pain during physical activity
Planned travel or relocation during study period
Already have desk cycling device or treadmill at desk
S1914 Randomized Phase III Atezolizumab + SBRT vs SBRT alone in high risk, early stage NSCLC (22-025)
To compare overall survival (OS) in patients with inoperable, early stage non-small cell lung cancer (NSCLC) randomized to stereotactic body radiation therapy (SBRT) with or without atezolizumab.
Patients will need to keep all of their radiation treatment appointments and keep all appointments with the study doctor. Patients will be expected to complete questionnaires and have extra blood samples taken at specific time point throughout the study.
Age ≥ 18
ECOG performance status of 0 or 1 within 180 days prior to registration;
Pretreatment serum PSA, obtained prior to any androgen suppression therapy and within 180 days of registration.
Men of child-producing potential must be willing to consent to use effective contraception while on treatment and for at least 3 months afterwards
Definitive clinical or radiologic evidence of metastatic disease
Pathologically positive lymph nodes or nodes > 1.5 cm short axis on CT or MR imaging
HIV positive with CD4 count < 200 cells/microliter
Prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any reason
Investigation of pulse starch impact on the gut microbiome
We are investigating how the starch from pulse crops (chickpeas, lentils and dry peas) affects the gut microbiome, particularly with regards to the production of butyrate, a microbial metabolite with a number of known health benefits. We are recruiting people from two groups, those that consume a lot of these pulses and those who rarely consume them. These participants will then track their food intake for 48 hours before collecting a fecal sample which they will return to the lab. We will then use these fecal samples to conduct laboratory fermentations with pulse starches processed in a number of different ways to see what factors are important for determining the amount of butyrate that is produced. This will serve as pilot data for designing future human clinical trials.
Either consume pulses twice or more per week or consume them once a month or less. Pulses are dry legumes such as chickpeas(Garbanzo beans), lentils or other dry peas and beans
Taking a fiber supplement
Bowel problems such as IBD, IBS, chronic diarrhea or constipation
Pregnancy
Visceral Pain Sensation and Nav1.8
We wish to investigate the role of a specific gene in visceral pain sensation and perception. This gene, Nav1.8 has a known change present in 10% of the population which may affect the way we feel inflammatory pain in the gut. This is an important symptom in inflammatory bowel disease (IBD). Some patients feel high levels of pain we would like to control, other patients feel little to no pain in the presence of very active disease, which can lead to dangerously under-treated disease. In this study, we will use healthy volunteers as well as IBD patients, and test their sensitivity using rectal balloon dilation.Research subjects will be asked to fast, skipping solid foods and opaque liquids for 6 hours before the testing. Usually this means skipping 1 meal. At the beginning of the study visit. they will use an over the counter enema to clear their rectum of any stool. Healthy control subjects that have never had a colonoscopy before and all IBD patients will undergo a very brief proctoscopy to either verify rectal health or check for any IBD disease activity. Healthy controls that have had a prior colonoscopy within the last 5 years will skip that prior step. Then a trained physician on the research team will insert a thin, lubricated tube into the rectum, which will be inflated to specific pressures. Most of these tests will be designed to measure any change in sensation, then the need to use the toilet, followed by urgent need or discomfort, and lastly the lower threshold of pain. Test subjects will be able to stop testing at any time, should they become too uncomfortable. The testing takes between 1 and 1 and a half hours, and volunteers are compensated $200 for their time.
To simulate abdominal pain, we use a thin tube placed in the rectum that inflates a small balloon to very precise and safe pressures. Our bodies interpret these pressures (in ascending order) as the need to go to the bathroom; first just a little, then with increasing urgency and eventually discomfort and pain. During these experiments, we only measure the lower threshold of pain, and stop immediately when you tell us to stop. We have significant experience using this approach and we have found it consistently informative while causing the least amount of discomfort possible. The whole thing takes about an hour and we’re paying volunteers $200 for participating. We'll ask that you skip a meal before the study visit, and perform an over-the-counter enema at the start of the visit.
$200
UC and Crohn's patients: be willing to undergo a brief proctoscopy the day of the testing visit
Healthy controls: have had a colonoscopy in the last 5 years OR be willing to undergo a brief proctoscopy the day of the testing visit
Healthy control: any diagnosed lower GI disease (such as IBS or active diverticulitis) or significant abdominal pain in the last 12 months.
Any peripheral neuropathy or neuromodulating/opioid medications
Any Autoimmune disease (except Crohn's disease or ulcerative colitis)
SENTINEL LYMPH NODE BIOPSY VERSUS ELECTIVE NECK DISSECTION FOREARLY-STAGE ORAL CAVITY CANCER (NRG-HN006) (PSCI# 20-085)
The purpose of this study is to see if neck and shoulder function and pain are better after SLN biopsy surgery compared to the usual approach and to see if SLN biopsy surgery is as good as the usual approach in extending your time without cancer. SLN biopsy surgery is potentially less invasive compared to the usual approach, but it requires a radioactive imaging agent to see the lymph nodes and it could also cause side effects. These side effects are described in the risks section below. Your study doctor will choose the appropriate imaging agent, Lymphoseek or sulfur colloid, for use in your surgery.This study will help the study doctors find out if this different approach is better than the usual approach at improving neck and shoulder function. To decide if it is better, in the first part of the study, doctors will be looking to see if shoulder and neck function and quality of life are better after SLN biopsy surgery compared to the END surgery.
We are asking you to take part in a research study. This study has public funding from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH) in the United States Department of Health and Human Services. We do research studies to try to answer questions about how to prevent, diagnose, and treat diseases like cancer. We are asking you to take part in this research study because you have early-stage oral cavity cancer and are having neck dissection surgery.
Age ≥ 18
Zubrod Performance Status 0-2 within 42 days prior to registration
Only English speaking patients (able to read and understand English) are eligible to participate as the mandatory patient reported NDII tool is only available in this language
For women of child bearing potential, negative serum or urine pregnancy test within 42 days prior to registration
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
Patient with severe, active co-morbidity that would preclude an elective or completion neck dissection
Incomplete resection of oral cavity lesion with a positive margin; however, an excision biopsy is permitted
Actively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte or immunomodulatory therapy.
NMTRC012: PEDS-PLAN – Pediatric Precision Laboratory Advanced Neuroblastoma Therapy
A study of the safety and feasibility of using molecularly guided therapy in combination with standard therapy followed by maintenance therapy with DFMO in patients with newly diagnosed high risk neuroblastoma.
Participating in this study requires that you visit the study hospital Penn State Hershey Medical Center multiple times over the course of the full study for evaluations (physical exam, blood draw, urine analysis, etc.) and scans (MRI/CT, MIBG). Weekly visits may occur at your home institution with your home treating oncologist. As a subject in this clinical trial you are expected to receive treatment on this phase of the study for a total of about 2 ½ years if you complete all portions. After treatment, you will have follow-up examinations and medical tests.
Must be 21 years of age or younger when diagnosed.
No prior systemic therapy with some exceptions.
Tumor samples will be obtained only in a non-significant risk manner and not solely for the purpose of the study.
Female patients who are lactating are not eligible unless they agree not toe breast feed.
Reducing Perception Error in Diagnostic Radiology
This research is being done to find out the relationship between an individual’s mental state and how well they perform visual-perceptual tasks. This will allow us to understand the brain processes related to errors in image perception, to understand how mental states impact medical image interpretation. Overall, this research will help us develop training programs to reduce the amount of perceptual errors in diagnosing images
Healthy adults, with college or advanced degree
Normal or corrected to normal vision
Pregnant or lactating
Presence of pacemaker, aneurysm clips, or any metal in the body
A history of welding or grinding
Claustraphobia
PSCI 22-141 CCTG MA.39: “Tailor RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive and T3N0 Breast Cancer
To compare the breast cancer recurrence-free interval (BCRFI) between patients that received regional RT or not, defined as time from randomization to time of invasive recurrent disease in the ipsilateral chestwall, breast, regional nodes, distant sites or death due to BC.
Women with low risk breast cancer will be randomized to either regional radiation therapy or no regional breast radiation therapy. Patients will be expected to keep all of their radiation appointment and complete all questionnaires.
Patients must have been treated by BCS or mastectomy with clear margins of excision*.
Patients with T3N0 disease are eligible.
Patients with disease limited to nodal micrometastases are eligible.
Patients must be ER ≥ 1% and HER2 negative on local testing
Patients with pT3N1 and pT4 disease
Any prior history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated with radiation therapy
Synchronous or previous contralateral invasive breast cancer.
Patients who are pregnant.
A Randomized, Open Label Phase 3 Study Evaluating Safety and Efficacy of Venetoclax in combination with Azacitidine after allogeneic Stem Cell Transplantation in Subjects with Acute Myeloid Leukemia (AML)(M19-063)
This study is to determine the recommended Phase 3 dose of venetoclax in combination with azacitidine in Acute Myeloid Leukemia patients when given as maintenance therapy following allogeneic stem cell transplantation. It also is to determine if venetoclax can be effective in combination with azacitidine to improve Relapse Free Survival in Acute Myeloid Leukemia patients compared to Best Supportive Care (BSC) when given as maintenance therapy following allogeneic stem cell transplantation.
There are different phases of this study. The first phase is Screening, then there is the Treatment phase as well as a Follow up phase. Each phase will have testing and procedures that will require you to come to the study center.
50.00 Travel expenses
Subject must be diagnosed with Acute Myeloid Leukemia by World Health Organization (WHO) criteria (2017) and either be planning for allogeneic stem cell transplantation or have received allogeneic transplantation within the past 14 days.
Subjects that have previously been treated with venetoclax, can only be included if there was no history of disease progression during venetoclax treatment.
Grafts must be from one of the following sources: Bone marrow or peripheral blood stem cells or cord blood cells irrespective of degree of matching.
Subjects and/or their legally authorized representative (where permitted per local regulations) must voluntarily sign and date an informed consent form (and assent form for minors if required by applicable regulations)
No history of any other malignancy within 2 years prior to study entry
Subject has no known evidence indicating leukemia relapse, which may include immunophenotype, cytogenetic or molecular methods.
No psychiatric illness/social situation that would limit compliance with the study.
No evidence of other clinically significant uncontrolled systemic infection.
PSCI 22-132 A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination With Immuno-Oncology Agents in Subjects With Unresectable Advanced or Metastatic Solid Tumors
The purpose of this voluntary research study is to evaluate potential new anticancer to treat people with tumors similar to yours. This study will provide information about the safety, the ability of your body to accept the study drug(s), the amount of study drug(s) and/or break-down products in your blood, and your body’s reaction to the study drug(s). Participants will be required to take study medication, have blood drawn, and have imaging tests such as CT, MRI, ECG, MUGA, ECHO, and bone scans.
Participants in the expansion stage will receive study treatment, imaging exams (ECHO, MUGA, ECG, CT, MRI, bone scans), blood draws, tumor assessments, and tumor tissue samples.
For all Expansion Cohorts except Cohort 3 (mCRPC): Measurable disease per RECIST
For Expansion Cohorts only: Archival tumor tissue material, if available, or fresh tumor tissue if it can be safely obtained.
Recovery to baseline or ≤ Grade 1 CTCAE v5 from AE(s) related to any prior treatments unless AE(s) are deemed clinically nonsignificant by the Investigator and/or stable on supportive therapy.
Age 18 years or older on the day of consent
Cohort 2 (ccRCC 2L), Cohort 3 (mCRPC), Cohort 5 (UC), Cohort 9 (NSCLC, 2L+), and Cohort 10 (CRC, 2L+): Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.
For Cohort 3 (mCRPC): Receipt of abiraterone within 1 week; cyproterone within 10 days; or receipt of flutamide, nilutamide, bicalutamide, enzalutamide, or other androgen receptor inhibitors within 2 weeks before first dose of study treatment.
Receipt of any type of anticancer antibody (including investigational antibody) or systemic chemotherapy within 4 weeks before first dose of study treatment.
Any complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment.
A Phase III De-escalation of Breast Radiation for Stage I, Hormone Sensitive, HER2 Negative Breast Cancer (PSCI# 21-098) (NRG-BR007)
This study is being done to answer the following question:Is treatment with hormonal therapy as good as the usual treatment of radiation and hormonal therapy in women with low-risk breast cancer who have had lumpectomy? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your breast cancer. The usual approach is defined as care most people get for low-risk, early stage breast cancer that is sensitive to hormones.
Pt will either have radiation therapy to the breast and take a hormonal drug for at least five years or you will only take a hormonal drug for at least five years.
The patient must have recovered from surgery with the incision completely healed and no signs of infection
The patient must have an ECOG performance status of 0 or 1
The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination
The tumor must have been determined to be HER2-negative by current ASCO/CAP guidelines
pT2 - pT4 tumors including inflammatory breast cancer
Patient had a mastectomy
Non-epithelial breast malignancies such as sarcoma or lymphoma
Paget's disease of the nipple
A multisensory evoked potential brain-computer interface for communication in ALS
A brain-computer interface (BCI) is a device that has the potential to restore communication by direct translation of brain signals. The BCI used in this study, the P300 Speller, relies on the generation of a P300 evoked potential when a user is presented a rare and unpredictable target stimulus amidst a larger pool of non-target stimuli. This evoked potential is used to perform selections on the computer. Those with advanced ALS demonstrate decreased capacity for BCI control using the P300 speller. With this study, we aim to use a combination of eye tracking and sensory testing to quantify sensory and cognitive processes necessary for the generation of a P300 response. We will test the performance of a multisensory P300 spelling task, where brain potentials are evoked using a combination of visual, auditory, and tactile stimuli. The goal is to demonstrate the perceptual benefits of multisensory integration and generate evidence for its use in this patient group.
A brain-computer interface (BCI) is a device that has the potential to restore communication by direct translation of brain signals. The BCI used in this study, the P300 Speller, relies on the generation of a P300 evoked potential when a user is presented a rare and unpredictable target stimulus amidst a larger pool of non-target stimuli. This evoked potential is used to perform selections on the computer.With this study, we aim to use a combination of eye tracking and sensory testing to quantify sensory and cognitive processes necessary for the generation of a P300 response. We will test the performance of a multisensory P300 spelling task, where brain potentials are evoked using a combination of visual, auditory, and tactile stimuli.
$40
Fluent in written and spoken English.
Able to visit the study site in-person for the study visits
(Patient Group Only) - Diagnosis of motor neuron disease, including ALS.
(Control Group Only) Neurologically healthy individuals matching the age, gender, and education level of the patient cohort.
History of seizure disorder
Co-existing neurological or psychiatric illness that, in the opinion of the research team, exclude the subject from participation.
Neurobehavioral mechanisms of social and non-social risky decision making.
The purpose of this study is to understand the neural and behavioral mechanisms subserving social and non-social risky decision making.
There will be one in-person lab visit where you will play a decision-making game, while having an fMRI scan.
$31.25
Able to read and speak English
Normal to corrected vision in order to see a computer screen clearly
No history of head injury
No MRI contraindications
History of head injury
Had an event where loss of consciousness > 10 minutes
Weighs more than 300 pounds
Does not read and speak English
Seeking support from romantic partners
The purpose of this study is to determine whether and how people's perceptions of the power in their romantic relationships shape the messages they use to seek support from their romantic partners.
Have you sought comfort, advice, information, esteem boosts, or emotional support from your romantic partner within the last 4 weeks?
People who are not in a romantic relationship
People who did not seek support from their romantic partner in the last 4 weeks.
People who do not have access to technology to compete the survey.
Nicotine absorption, toxicant exposure, and subjective effects of a heat-not burn tobacco product
The purpose of this study is to evaluate the nicotine delivery, toxicant exposure, and subjective effects associated with the use of heat-not burn tobacco products, compared with electronic cigarettes.
Participants will attend 2 clinic visits at the Penn State Milton S. Hershey Medical Center lasting approximately 1 ½ hours each. Participants will be asked to refrain from using any tobacco or nicotine products for at least 14 hours prior to each visit. During the visit participants will try the new tobacco products in the study center while blood samples are collected through an IV catheter placed in the arm.
120
Current daily cigarette smoker (5 or more per day)
History of a seizure disorder or had a seizure in the past 12 months
History of difficulty providing or unwilling to provide blood samples
Current user of an IQOS device
Current user of an electronic cigarette device