Search Results
BCC015: Phase II Trial of Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma
This is a study of the drug DFMO (difluoromethylornithine) for neuroblastoma that has returned or not responded to treatment. DFMO is an oral drug that inhibits a certain enzyme (protein) in blood which is associated with a bad outcome in neuroblastoma cases. Cancer cells have pathways that drive the cancer to grow and DFMO targets the specific pathway of this enzyme to turn these cells off.
You will have exams, tests, and procedures while on the study to evaluate whether you can participate in the study and how you are doing while on the study. These include physical exams, blood tests, urine tests, bone marrow aspirate and biopsies, heart tests, hearing tests, and imaging evaluations such as CT scans and MIBG or PET scans. You will receive treatment on this study for a total of about 2 years. After treatment, you will have follow-up examinations and medical tests. We would like to continue to find out about your health for about 5 years after you complete the study.
Completed upfront therapy with at least 4 cycles of aggressive multi-drug chemotherapy
Currently receiving another investigational drug
Using grip force as a measure of fear in humans during a robot guided haunted house scenario
The objectives of the study are to determine whether grip force is related to participants’ fear and whether touch feedback from a robot can effectively communicate risk in a simulated high stress environment. We hypothesize that grip force increases in stressful situations like walking through a haunted house. Like in a real haunted house, people often find comfort in holding hands with someone as they walk through. In this study, a participant walks through a virtual haunted house.
There will be one in person visit. Participant will wear VR equipment and chest heart rate monitor. They will hold a virtual robot's hand and walk through a VR haunted house environment until it is over. They will then answer a brief survey.
15
Must not be suffering from anxiety disorders and/or panic attacks.
Must not be suffering from any known heart conditions.
Must not, to your knowledge, be prone to nausea when experiencing VR
Motion sickness caused by VR
Heart problems
Anxiety disorder
prone to nausea in VR
Investigating the effect of restaurant environment on food intake using mixed reality application.
This study investigates the influence of different rest design of restaurant on participants’ food consumption behavior. More specifically, visually pleasant versus visually unpleasant design elements are included in two cafe settings to study their influence on participant liking, and emotion response. To accomplish this, we will conduct an experiment where participants will be eating a meal while immersed in a virtual café interior with two different designs using a VR headset. Their food intake will be measured.
Participants will visit the lab for 3 sessions to eat a meal each time while wearing an immersive virtual reality headset.
$30 amazon gift card
Fluent in English
Free of self-reported food allergies
No diagnosis of cognitive or physical disabilities that may affect appetite or eating behaviors
No diagnosis of disabilities that may affect sensory proprioception related to virtual reality
Not fluent in English
Have self-reported food allergies
Have a diagnosis of cognitive or physical disabilities that may affect appetite or eating behaviors
Have a diagnosis of disabilities that may affect sensory proprioception related to virtual reality
PSCI 24-127 EXActDNA-003: Breast Cancer Clinical Validation Study to Predict Recurrence of High-Risk Early Breast Cancer Treated with Neoadjuvant Therapy Using a Bespoke Circulating Tumor DNA Assay to Detect Molecular Residual Disease (NSABP B-64)
This study will be using a test called Oncodetect to identify specific gene mutations. These may help in predicting the risk of the cancer coming back.
Subjects will need to agree to come to the hospital for 14 visits to have blood drawn.
$375.00
ECOG performance status 0 or 1.
Histologically confirmed invasive carcinoma of the breast.
Planned neoadjuvant therapy which includes cytotoxic chemotherapy.
Tumor size ≥ 2.1 cm in greatest diameter.
Initiated neoadjuvant therapy for current breast cancer diagnosis.
diagnosis of another invasive cancer
Known pregnancy at time of enrollment.
BCC022: Phase II Trial of Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma
The purpose of this research is to evaluate the investigational drug, tipifarnib (a pill taken by mouth), in combination with the FDA approved drug, naxitamab, administered intravenously (IV; a liquid that continuously goes into your body through a tube that has been placed during a surgery into one of your veins).
You will be asked to come in for screening and at the start of each cycle (every 28 days), and at the end of study treatment to have tests done (these may include a physical exam, blood tests, and electrocardiogram [ECG]). During the first cycle you will need to have blood tests done weekly. You will also need to come in during Days 1-5 of each cycle to receive the study treatment. You will also have scans and a bone marrow biopsy (tissue sample) and aspirate (fluid and cells) done at the start of study, every 2 cycles, and at the end of study.
Age >12 months of age at enrollment
Age 6 years or older for safety run in
Currently receiving another investigational drug
Parallel Phase III Randomized Trials For High Risk Prostate Cancer Evaluating De-Intensification For Lower Genomic Risk and Intensification for Higher Genomic Risk with Radiation (NRG-GU009) (PSCI# 20-141)
This study is being done to answer the following questions: If you have high risk prostate cancer, a low gene risk score and plan to receive radiation therapy, is a shorter hormone therapy treatment as effective at controlling your cancer compared to the usual 24 month hormone therapy treatment? If you have high risk prostate cancer, a high gene risk score and plan to receive radiation therapy, does adding two new hormone therapy drugs to the usual treatment increase the length of time without your prostate cancer spreading as compared to the usual treatment? We are doing this study because we want to find out if these approaches are better, similar, or worse than the usual approach for your type of prostate cancer. The usual treatment is defined as the care most people get for prostate cancer.
This study is being done to answer the following questions: If you have high risk prostate cancer, a low gene risk score and plan to receive radiation therapy, is a shorter hormone therapy treatment as effective at controlling your cancer compared to the usual 24 month hormone therapy treatment? If you have high risk prostate cancer, a high gene risk score and plan to receive radiation therapy, does adding two new hormone therapy drugs to the usual treatment increase the length of time without your prostate cancer spreading as compared to the usual treatment? We are doing this study because we want to find out if these approaches are better, similar, or worse than the usual approach for your type of prostate cancer. The usual treatment is defined as the care most people get for prostate cance
High-risk disease
ECOG Performance Status of 0-2 within 120 days prior to registration
Adequate hematologic function within 120 days prior to registration
Adequate hepatic function within 120 days prior to registration
Prior systemic chemotherapy within ≤3 years prior to registration
Current use of 5-alpha reductase inhibitor
Didanosine (DDI) antiretroviral therapy is not permitted
History of seizure disorder or current severe or unstable angina
Lexical and sentence processing in novice L2 learners: Psycholinguistic and neurocognitive investigations
We are studying how children and adults learn second languages in the classroom. To do this, we ask children and adults to read words or sentences in English and in Spanish while we record brainwaves using noninvasive sensors. The participant wears a cap that looks like a swimmers cap with the sensors attached to it.
Middle school students enrolled in first year Spanish
Monolingual English speaker
Right-handed
Normal or corrected-to-normal vision
History of neurological disorders
Uncorrected vision
The Blended4Blues Study
An intervention using an internet-based platform for coping and mood difficulties. Participants will be able to use cognitive-behavioral therapy (CBT) based online self-help modules over the course of a 10-week program.
Participants will engage with online materials on a weekly basis for 10 weeks.
$25
U.S. resident currently residing in the United States
Fluent in the English language in terms of speaking, listening, reading, and writing.
Aged 18-19 years
Presence of depressive symptoms as measured by a score ≥ 10 on the QIDS-17-SR
Unable to speak, read, listen, and write English fluently.
Do not meet inclusion criteria for clinical depression on the QIDS-17-SR, i.e., score ≥ 10
Does not fulfill DSM-5 Criteria for MDE on the MINI Clinical Interview.
Expressed suicidal ideation defined as score >1 on the suicide ideation item on the PHQ-9, and/or on the MINI.
Using Apple Watches to Assess Substance Co-use in Young Adults (Project SPARC Pre-Pilot): a Feasibility Study
In this study, we aim to investigate the feasibility and usability of using Apple Watches to collect substance co-use data, as well as contextual data that could potentially be associated with substance co-use data (location, social context, mood, health, etc.)
Currently owns and uses an iPhone with iOS version 15 or newer
Currently owns and uses an Apple Watch with watchOS version 8 or newer
Determined eligible through screener
PSCI 23-020: EA8212 A Randomized Phase III Trial of Intravesical BCG veRsus Intravesical Docetaxel and GEmcitabine Treatment in BCG Naïve High Grade Non-Muscle Invasive Bladder Cancer (BRIDGE)
If you decide to take part in this study, you will either get Gemcitabine and Docetaxel instilled through a catheter weekly in your bladder for up to 6 weeks, or you will get BCG instilled weekly in your bladder for up to 6 weeks. Your initial therapy may be followed with maintenance therapy.
If you decide to take part in this study, you will either get Gemcitabine and Docetaxel instilled through a catheter weekly in your bladder for up to 6 weeks, or you will get BCG instilled weekly in your bladder for up to 6 weeks. Your initial therapy may be followed with maintenance therapy. After you finish your treatment, your doctor will continue to follow your condition for 5 years with a combination of cystoscopies (inserting a telescope in your bladder) and CT scans (to take images of your body) in order to detect cancer recurrence.
Patient must have histologically confirmed high-grade non-muscle invasive urothelial carcinoma of the bladder (HgTa, HGT1, CIS, HgTa + CIS, or HGT1 + CIS stage)
Patient must have ECOG Performance Status 0-2.
Patient must have all visible papillary tumor resected by the treating urologist at the site registering the patient to this protocol prior to randomization.
Patient may have received prior systemic gemcitabine or docetaxel use if it was for a non-bladder malignancy
Patient must have not received prior intravesical therapy for bladder cancer, with the exception of perioperative chemotherapy at the time of TURBT.
Patient must not have pure squamous cell carcinoma or adenocarcinoma.
Patient must not have any component of neuroendocrine carcinoma (i.e., small cell or large cell).
Patient must not have any component of sarcomatoid, micropapillary, or plasmacytoid variant histology.
Early Identification in Older Adults of Risks to Sleep Health, Movement, and Cognition Using Ecological Methods
This proposal is a prospective study in which we will collect both subjective and objective quantitative data from older adults residing in independent living retirement communities, microlongitudinally (~1wk). Comprehensive measures of sleep health, cognition, and movement will be collected at community residences. The first phase of this project will recruit local, State College area adults over 70 residing in independent living facilities (e.g., Foxdale Village and The Village at Penn State). A second phase of data collection will extend to community-based older adults in rural parts of Centre and nearby counties. With this prospective, microlongitudinal information we will evaluate the characteristics of sleep predictive of daytime cognitive and neurobehavioral function and use those conclusions to inform nonpharmacologic, preventative interventions for older adults.
After consent, there will be 6 study visits at either Penn State University Park campus or at the participant's personal residence. Study participation lasts about 1 week. Participants wear non-invasive ambulatory watch-like activity monitors throughout (both day and night) the week. Participants complete electronic surveys and cognitive tests 6 times daily, with additional surveys at study conclusion. Sleep and daytime brain and heart activity are recorded (without video) using non-invasive clinical-type wire sensors applied to the face, head, and chest. Wires are worn on the face, head, and chest throughout the first two study nights. Wires are worn on the head and chest throughout the first two study days. There is not a sleep intervention in this study. We are collecting data about the typical sleep health of older adults and its relation to cognitive health.
$350
Resident of PA, Centre County region
Living without functional assistance
Able to walk unassisted for at least 5min
Evidence of cognitive impairment (will be tested)
The influence of estrogen on the thermoregulatory responses to heat stress in pre and postmenopausal women
The frequency and severity of heat waves has increased in the last decades. Women over 65 are at the most vulnerable to adverse events during these events. This sex difference only occurs in middle aged and older adults suggesting that menopause could play a role in increased risk in the heat for women. It is important to identify the role that the menopause transition plays in the ability to regulate body temperature in aging women. In this study, we will identify the role of estrogen levels in pre and post menopausal women on their ability to tolerate heat.
For this study, you will visit the lab for a screening visit, a maximal exercise test, and 6 experimental sessions. Before each experimental visit, you will swallow a temperature-sensing capsule 1-2 hours prior to arriving. In one type of experiment (passive heat stress), conducted during 2 visits, you will wear a suit with tubing running hot water to warm your body. A small catheter will be placed in your forearm to measure skin blood flow. In the other type of experiment (active heat stress), conducted during 4 visits, you will perform light exercise in heat and humidity on at least two separate days with different heat and humidity conditions. Participants will receive estrogen treatment for a portion of the study.
430
using hormonal contraceptives
History of Crohn's disease, diverticulitis, or other similar gastrointestinal disease
Medications that could alter cardiovascular responses or body temperature regulation during exercise (blood pressure reducers, fever reducers, anti-depressants, etc.)
Understanding experiences of international students with healthcare and antibiotics
This study examines the experiences of international students with regard to upper respiratory illnesses, healthcare, and use of antibiotics in their home countries and in the United States. The findings of the study will inform the development of training to improve healthcare providers’ communication skills for discussing antibiotics with international students.
Complete one online survey, which takes approximately 20 minutes.
10.00
College/university undergraduate or graduate student at a U.S. university
born and raised in and is currently a citizen of China, India, or South Korea
English speaking
lived in the United States for less than 7 years
Not a college or university student at a U.S. university
Not born or raised in and currently citizen of China, India, or South Korea
Not English speaking
Lived in the United States more than 7 years
Penn State SELF - Student Engagement, Learning and Flourishing
Substance misuse is a leading national problem, with young adults at high risk. We aim to develop a university resource that elucidates biobehavioral underpinnings of problematic student substance use at University Park campus. This initiative would inform services needed, provide engaged learning opportunities, connect with faculty, and catalyze high-impact, interdisciplinary research. In addition to this primary rationale, this study will allow us to capture detailed information about other critical student experiences such as food and housing insecurity, experiences of discrimination, and daily health practices to prevent the transmission of COVID-19. Participants will be asked to take a baseline survey followed by a 21- daily diary protocol (brief 5 minute survey each day for 21 days. For more information or to register interest in participating please see: https://projectself.psu.edu/register-your-interest/
Enrolled at UP
18-24 years old
Part-time students
Students located in the EEA
Older than 24
No graduate students
Understanding University Students' Daily Interaction with ChatGPT through the Lens of Self-Determination Theory
This study aims to learn about how university students interact with ChatGPT and how ChatGPT's support of autonomy, competence, and relatedness could either help or hinder students' ability to learn. We will interview students to understand how ChatGPT supports student learning and identify any challenges that may arise.
There will be a 60-minute interview.
$10
Use ChatGPT for their daily lives
Over 18 years old
Speak English
Students from non-EU countries
Under 18 years old
Do not use ChatGPT for their daily lives
Non-english speaker
Students from EU countries
Driver Training on the Advanced Driving Assistant System
This research aims to study the training knowledge that is essential for drivers to use Advanced Driving Assistant Systems safely and properly and identify the optimal training approaches.
If you participate in the first experiment, you will receive training of the in-vehicle system via videos and manuals, complete a driving task on the driving simulator, and answer questions from questionnaires. If you participate in the second experiment, there will be two visits. In the first visit, you will receive training via watching and interacting with online videos, watching an experimenter operating ADAS at the test track, or practicing the functions of ADAS in a vehicle at the test track. The functions in the training include adaptive cruise control, lane-keeping assistance, and Highway Driving Assist. In the second visit, you will complete a driving task on the driving simulator and answer questions from questionnaires.
$15 for experiment1 $60 for experiment2
Being fluent in English
Have a valid driver license for at least one year
have normal vision or corrected vision only wearing contact lenses
Defining the role of slow eye movements on limb motor control in younger and older adults
The purpose of this study is to define how eye movements contribute to eye-hand coordination in individuals of the age group 18-50 (young adults) and 65-80 (older adults). Specifically, the aim of the study is to understand how slow eye movements affect arm and hand movements. All procedures to be used in our study will be non-invasive. The task during the study will be performed with a robotic handle that participants will grasp with their right hand. They will interact with visual stimuli by moving the robotic handle. The robotic environment will attempt to simulate real-world mechanical interactions, such as those experienced during catching a ball.
During this study, we will ask you to come to our laboratory located in 23 Recreation Building, Pennsylvania State University, on two days separated by a maximum of 48 hours. Both sessions will last approximately 90-120 minutes. During the first session, we will review the procedures with you and if you agree to participate, you will sign this form and then proceed to perform the study. You will perform about 20-25 blocks of hand movements. Each block will consist of 24-30 trials and each trial will last between 3-5 seconds.The second day will be identical to the first day but the order of trials within a block will be changed.
$10/hour
Participants will be right-hand dominant individuals.
They will have normal or corrected-to-normal vision.
Participants should be able to sit upright in a chair for long periods (up to 2 and a half hours) with rest.
Participants should be able to grasp and move objects with both hands.
Any history of musculoskeletal disorders
Eye or vision problems (e.g., cataracts, glaucoma, a detached retina or macular degeneration).
Cognitive impairment
Medication that could make the participant drowsy or tired during the experiment.
Identifying views of Military Veterans Regarding Contemporary War and Conflict Reporting
This study will involve surveying and interviewing US military veterans and non-veterans regarding their perceptions of the quality, accuracy, and themes of contemporary war and conflict reporting.
Military Veteran
Current Member of the Military
Non-Military Civilians
Daily Thought Monitoring Study for Anxiety and Depression
This study aims to assess the relations among our daily thought patterns, positive emotions, everyday experiences, and cognitive functioning abilities. Eligible participants will complete a series of online questionnaires, a short 15- to 25-minute psychological interview, and brief cognitive functioning tests at Day 1 and Day 16. All visits will occur via Zoom. In between study visits on Day 1 and Day 16, they will be prompted to complete smartphone-delivered assessments of cognitive functioning, symptoms, and experiences for 14 days, 5 times a day. This is important to inform clinicians and researchers on how best to develop effective digital mental health therapies.
During Day 1, participants will undergo a brief 15- to 25-minute clinical interview over Zoom. After the clinical interview, if participants meet the study eligibility criteria, we will continue with the procedures outlined below. Otherwise, if they are ineligible for the study, we will mention that this study is not suitable for them and provide the contact of mental health treatment services. Eligible participants will then conduct a series of self-report questionnaires and performance-based cognitive functioning tests for the next 35 minutes. Participants will then complete a series of 14-day brief ecological momentary assessments administered on their smartphone five times a day, for 14 days. Last, participants will return for a 35- to 45-minute visit on Day 15 to complete a series of self-report questionnaires and performance-based cognitive functioning tests.
15
Owns an Android or iPhone
Fluent in the English language
Scores on self-report questionnaires suggest person does or does not struggle with depression and/or anxiety
Pregnant women will be allowed to participate
Unable to consent
Younger than 18 years of age
Reports struggling with suicidal thoughts
Judged to have alcohol, substance use, and/or eating disorder
Understanding Information Needs and Challenges faced by International Spouses during Adjustment
The study examines ways in which technology can be designed to provide support and services to international spouses during their adjustment to a new host environment. In particular, we would like to investigate the needs of spouse’s communities, the challenges faced by this population during adjustment, and propose design implications for developing systems and services to improve their access to social services and to promote community development and civic engagement.
Individuals who hold a dependent (F-2/J-2) visa status
Age under 18
Non-dependents (F-2/J-2) visa status
Anyone who cannot consent to participate in this study
A randomised, double-blind, placebo-controlled, multicentre, Phase III trial evaluating long-term efficacy and safety of survodutide weekly injections in adult participants with noncirrhotic non-alcoholic steatohepatitis/metabolic dysfunction-associated steatohepatitis (NASH/MASH) and (F2) - (F3) stage of liver fibrosis
This is Phase III study to test whether survodutide (BI 456906) helps people with a liver disease called NASH/MASH who have moderate or advanced liver fibrosis. The purpose of the study is to find out whether the study drug works and how safe it is in participants diagnosed with MASH and liver fibrosis over a long-term treatment. To answer these questions, the study drug will be compared with a placebo. The overall study duration will be up to 7 years.
If you enroll in this study, you will undergo a series of testing. You will be asked to complete an initial assessment that includes a physical exam, vital signs, waist circumference, height, and weight measurements, questionnaires, a liver biopsy, blood draws, ECG, fibroscan, eye examination, and pregnancy test, if applicable. You will be randomized to either Survodutide once weekly or placebo (an inactive substance of no medical value). For treatment, you will be trained to inject yourself once a week with the study medicine. There will be 12 in person visits over the first year, and then - every 3 months within next 6 years - to re-supply the study drug and do safety testing. There will be up to 28 phone calls with the study staff.
$3,550 over 7 years
MASH/NASH diagnosis
Stage 2 or 3 fibrosis
able to provide consent
Chronic alcohol or drug abuse
Cirrhosis
Attention and Emotional Development in Children
Children with attention problems often feel anxious or worried, and likewise, children who are anxious or worried often have problems with attention. We are looking for children aged 8-12 who may or may not have problems with attention or anxiety to help us understand what happens in the brain that could explain why. You will receive up to $100 gift card for your participation, and informal clinical feedback on your child.
Two in person visits of 2 hours each to the University Park campus, scheduled at the participant(s) convenience
$100
History of seizures or photosensitive epilepsy
PSCI# 18-049 A PHASE II, DOUBLE-BLINDED, PLACEBO-CONTROLLED RANDOMIZED TRIAL OF SALVAGE RADIOTHERAPY WITH OR WITHOUT ENHANCED ANTI-ANDROGEN THERAPY WITH APALUTAMIDE IN RECURRENT PROSTATE CANCER
To determine whether, in men with post-prostatectomy PSA recurrences, salvage radiation (SRT) with enhanced anti-androgen therapy with apalutamide will improve biochemical progression-free survival (bPFS) compared to SRT alone.
To determine whether, in men with post-prostatectomy PSA recurrences, salvage radiation (SRT) with enhanced anti-androgen therapy with apalutamide will improve biochemical progression-free survival (bPFS) compared to SRT alone.
Post-prostatectomy patients with a detectable serum PSA (≥0.1, but ≤1.0 ng/mL) at study entry (within 90 days of Step 1 registration) a
pN0 or pNx
History/physical examination within 90 days prior to Step 1 registration
Karnofsky performance status of 70-100 within 90 days prior to Step 1 registration
Prior invasive malignancy (except non-melanomatous skin cancer, carcinoma in situ of the male breast, penis, oral cavity, or stage Ta of the bladder, or stage I completely resected melanoma) unless disease free for a minimum of 2 years
Prior systemic chemotherapy for the study cancer
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
Prior whole gland ablative therapy
Study Driver Characteristics in Mixed Traffic with a Driving Simulator
This is a driving simulator behavioral study. This study aims to investigate drivers' subjective feelings and driving performance in mixed traffic shared by automated vehicles and human-driven vehicles.
This study aims to investigate the effects of drivers’ driving style and automated vehicle penetration rate on drivers’ subjective feelings and driving performance in mixed traffic shared by automated vehicles and human-driven vehicles. There will be one in-person visit for the experiment. This experiment involves driving on a driving simulator and filling out several questionnaires.
$15/hour
Have a valid US driver license for at least one year
Have normal vision or corrected vision only wearing contact lenses
Second Language Learners’ Language Development in Different Modes: Focusing on Complexity, Accuracy, and Fluency
The current study aims to investigate the development of English as a Second Language (ESL) learners' language skills over time, focusing on the interplay between the mode of production (i.e., speech versus written mode) and linguistic features related to complexity, accuracy, and fluency. To address this question, the study will collect spoken and written data from ESL learners in the U.S. at five measurement points throughout an academic year (FA23 to SP24), analyzing their production data using various complexity, accuracy, and fluency measures. The objective is to contribute to the existing body of second language (L2) development research by examining whether the interaction among time, production mode, and proficiency, as well as the varying relationships among the measures, significantly influence the observed outcomes.
Over the course of an academic year (FA23 to SP24), participants will attend five in-person visits, spaced at 7-week intervals. During each visit, they will be asked to write an essay for 20 minutes and deliver a 5-minute spoken monologue in response to prompts similar to those found in the TOEFL speaking section.
$75 ($15 per visit)
non-native English speakers
first-year undergraduate students or students in Intensive English Communication Program
native English speakers
not living in the US
PSCI# 24-014 OPTIMICE-PCR: DE-ESCALATION OF THERAPY IN EARLY-STAGE TNBC PATIENTS WHO ACHIEVE PCR AFTER NEOADJUVANT CHEMOTHERAPY WITH CHECKPOINT INHIBITOR THERAPY
this trial is examining what happens if a less toxic therapy is given to triple negative breast cancer subjects who's tumor is completely gone after receiving pre surgery chemotherapy.
Participants will need to come to all research visits, reports any side effects of medication, if they are taking any over the counter medications.
ECOG Performance Status 0-2
Triple Negative Breast Cancer
Patients must have received neoadjuvant chemotherapy in combination with pembrolizumab for a minimum of 6 cycles. All systemic chemotherapy must have been completed preoperatively.
An interval of no more than 12 weeks between the completion date of the final surgery and the date of randomization.
No history of any prior (ipsi- or contralateral) invasive breast cancer. Prior DCIS is allowed.
No evidence of recurrent disease following preoperative therapy and surgery.
No known active liver disease, e.g. due to HBV, HCV, autoimmune hepatic disorders, or sclerosing cholangitis
Advanced fMRI Study on the Functional Abnormality of BNST in Anorexia Nervosa Restricting-type
This research is being done to better understand how certain parts of the brain may react differently in people who have a particular eating disorder, anorexia nervosa, which may help us understand why they respond to food in the way they do. This may help us design more effective treatments for people with anorexia nervosa.
You will complete a package of surveys for personality, psychopathology, an evaluation of taste functions, and an MRI/fMRI examination.
Up to a total of $150.
Anorexia nervosa restricting type patients
Healthy volunteer with normal body weight
Fluent in written and spoken English
Pregnancy or breastfeeding
Allergy to milk and milk products
Cannot have MRI due to claustrophobia or specific implants
SHIELD
This trial will address the safety of withdrawing hydroxychloroquine (HCQ) in patients with systemic lupus erythematous who are 60 years of age or older. In this older population the benefits of HCQ are expected to decrease since disease activity decreases with advancing age. The study will test whether HCQ can be safely discontinued in stable/quiescent patients.
Participants will be in this study for about 1 year, during which time they will come to 7 visits in the research clinic. The first visit will take up to 2 hours and will include blood and urine sampling and completion of self-assessment questionnaires. Subsequent visits will take up to 1 hour. Participants will be randomized to receive either the active drug hydroxychloroquine or placebo. The treatment will be blinded to both the participant and the investigator. Diaries will be requested in which the participant keeps track of dosing of the study medication.
Be treated with hydroxychloroquine for at least 7 years
60 years of age or older
stable disease without recent flares
taking more than 5 mg/day prednisone
any signs of active lupus disease.
Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer (PSCI# 21-217) (NRG-GU010)
The purpose of this study is to use the Decipher risk score to guide intensification (for higher Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment to better match therapies to an individual patient’s cancer aggressiveness. The study will test your tumor tissue for many different genes that all together indicate the risk of your cancer spreading; this is called the Decipher risk score. If you have a higher Decipher risk score, you will be assigned to the part of the study that compares the use of 6 months of hormone therapy and radiation treatment (usual treatment) to the use of darolutamide (BAY 1841788) plus the usual treatment. The purpose of this study is to determine whether the additional drug can reduce the chance that your cancer will come back and spread.
The purpose of this study is to use the Decipher risk score to guide intensification (for higher Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment to better match therapies to an individual patient’s cancer aggressiveness. The study will test your tumor tissue for many different genes that all together indicate the risk of your cancer spreading; this is called the Decipher risk score. If you have a higher Decipher risk score, you will be assigned to the part of the study that compares the use of 6 months of hormone therapy and radiation treatment (usual treatment) to the use of darolutamide (BAY 1841788) plus the usual treatment. The purpose of this study is to determine whether the additional drug can reduce the chance that your cancer will come back and spread.
ECOG Performance Status of 0-2 within 120 days prior to registration;
For patients with a history of hepatitis C virus (HCV) infection must have been treated and cured.
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months
Previous bilateral orchiectomy
Prior radiotherapy to the prostate/pelvis region that would result in overlap of radiation therapy fields.
Active testosterone replacement therapy; any replacement therapy must be stopped at least 30 days prior to registration
Inability to swallow oral pills.
A PHASE III, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF ADJUVANT GIREDESTRANT COMPARED WITH PHYSICIAN'S CHOICE OF ADJUVANT ENDOCRINE MONOTHERAPY IN PATIENTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE EARLY BREAST CANCER (PSCI# 20-133) (GO42784)
The purpose of this study is to compare the effects, good or bad, of giredestrant versus an approved endocrine therapy (a treatment that blocks or removes hormones), on patients with breast cancer. In this study, subjects will get either giredestrant or a drug chosen specifically by the study doctor. Subjects can participate in this study based on breast cancer characteristics, current condition, and how well previous anti-cancer therapies were tolerated.
• You should not join another research study. • For women: If you can become pregnant, you must use a reliable non-hormonal birth control method during the study and for 9 days after your final dose of giredestrant or, if you are in the group receiving approved endocrine therapy prescribed by the study doctor, a period of time that your study doctor will discuss with you. This will be 21 days after if you are prescribed letrozole or anastrozole, 30 days after if you are prescribed exemestane, and 60 days after if you are prescribed tamoxifen. Talk with your study doctor about what birth control method may be best for you. Depending on the study treatment you receive, you might be restricted from donating eggs during this same period. Tell your study doctor right away if you get pregnant during this period. If you get pregnant, the study doctor will want to follow up with you on the outcome of the pregnancy and collect information on the baby. • For men: you must agree to take precautions as outlined below for each treatment arm: –If you are in the group receiving approved endocrine therapy prescribed by the study doctor, you study doctor will discuss with you what precautions you will need to take. –If you are in the group receiving giredestrant, and your partner is pregnant or able to become pregnant, you must use a condom during the study and for 9 days after your final dose of giredestrant. This will be 21 days after if you are prescribed letrozole or anastrozole, 30 days after if you are prescribed exemestane, and 90 days after if you are prescribed tamoxifen. You must not donate sperm during this same period. Tell your study doctor right away if your partner becomes pregnant during these periods. The study doctor or research staff will advise you of the possible risks to your unborn child and will make an effort to contact your partner to get her permission to collect information about the pregnancy and the baby. No matter what your partner decides, you can continue to take part in this study. • You should not use certain medications during this study. Your study doctor will talk to you about these medications.
Participants who have documented ER+ tumor by immunohistochemistry, as assessed locally on a primary disease specimen and defined as 1% of tumor cells stained positive according to the ASCO/College of American Pathologists (CAP) guidelines
Participants who have documented HER2- tumor, as assessed locally on a primary disease specimen and defined according to ASCO/CAP guidelines
Participants must have undergone definitive surgery of the primary breast tumor(s)
Participants who received or will be receiving adjuvant chemotherapy must have completed adjuvant chemotherapy prior to randomization
Participants who have received treatment with investigational therapy within 28 days prior to initiation of study treatment or is currently enrolled in any other type of medical research
Participants receiving or planning to receive a CDK4/6i as adjuvant therapy
Participants who have active cardiac disease or history of cardiac dysfunction
Participants who have been diagnosed with Stage IV breast cancer