Search Results
Inositol Supplementation to Treat Polycystic Ovary Syndrome: A Double Blind Dose Ranging RCT (INSUPP-PCOS)
Polycystic ovary syndrome (PCOS) is the most common endocrine abnormality in women in the U.S. and is characterized by both reproductive (anovulation and androgen excess) and metabolic dysfunction (insulin resistance). PCOS lacks a simple, safe and effective treatment for women of all ages and all weights. Recentlya dietary supplement, inositol, has been used widely to treat women with PCOS. However there are no well designed trials to address the risk/benefit ratio and identify the mechanism of action. In this study we propose a 3 month double blind (of both patients and investigators) randomized controlled trial of inositol supplementation compared to placebo. We hypothesis that women with PCOS who receive inositol supplementation will have a significantly greater reduction in serum total testosterone than women on placebo as well has improvement in glucose tolerance and decrease in fasting insulin.
There will be 4 in person visitsHave a physical exam and other evaluations, including ultrasoundTake study drug as directedHave bloodwork taken throughout studyComplete questionnaires and a daily diary
$300
Diagonosed with Polycystic Ovary Sydrome
8 or less periods per year
Periods of greater than or equal to 45 days
Not seeking pregnancy
Uncorrected thyroid disease
Suspected adrenal or ovarian tumor screting androgens
Suspected Cushing's syndrome
Contraindications to the study drug or placebo
Phase III Study of Daratumumab/RHuPH20 + Lenalidomide or Lenalidomide in Patients with Multiple Myeloma Using MRD to Direct Therapy Duration (PSCI# 19-079) (S1803)
This study is being done to answer the following questions: 1.Will adding the drug daratumumab/rHuPH20 to the usual maintenance treatment with lenalidomide after stem cell transplant help multiple myeloma patients survive longer?2.For patients who have no evidence of multiple myeloma in their bone marrow (patients who do not have “minimum residual disease” [MRD-negative]), should maintenance therapy be stopped after 2 years? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your multiple myeloma. The usual approach is defined as care most people get for multiple myeloma.
Phase III Study of Daratumumab/rHuPH20 (NSC-810307) + Lenalidomide or Lenalidomide as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration
Patients with disease measurable by serum light chain assay alone are eligible (defined as ≥ 100 mg/L on involved light chain).
Patients must be ≥ 18 and ≤ 75 years of age at time of registration to Step 1.
Patients must have history and physical exam within 28 days prior to registration.
Patients must have Zubrod Performance Status ≤ 2.
Patients must not have any organ involvement by amyloidosis or evidence of amyloidosis related organ dysfunction.
Patients must not have progressive disease at any time prior to registration.
Patients must not be refractory or intolerant to either lenalidomide or daratumumab/rHuPH20.
Patients must not have moderate or severe persistent asthma within the past 2 years and must not have currently uncontrolled asthma of any classification.
The role of middle temporal and frontoparietal areas in limb motor control
The goal of this research is to understand the role of motion-processing areas on limb motor control. We will be using behavioral studies and combining that with functional brain imaging, EEG, and non-invasive brain stimulation using transcranial magnetic stimulation (TMS). TMS has been used in thousands of studies and is a very safe method to understand brain function for eye hand coordination.
There will be three visits. Participants will under go brain scanning. They will perform eye-hand coordination tasks by grabbing a robotic manipulandum. During the eye-hand coordination tasks, participants' brain activity will be measured using electroencephalography (EEG) and muscle activity using surface electromyography (EMG). Researchers will also apply transcranial magnetic stimulation (TMS) to temporarily inhibit and excite different brain areas. TMS is a noninvasive procedure that uses magnetic fields to stimulate nerve cells
50
Participants should be right-hand dominant individuals
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
Participants should be able to lie still and perform behavioral tasks inside a magnetic scanner for up to 60 minutes
Any history of musculoskeletal disorders (e.g., carpal tunnel syndrome, any form of arthritis, fibromyalgia, tendinitis, or previous injury or surgery to the bones or joints in your neck, upper back, arms or hands in the last six months)
Eye or vision problems (e.g., cataracts, glaucoma, a detached retina, or macular degeneration)
Individuals with metallic implants will be excluded from the study. The metallic implant will make participation in a magnetic scanner impossible
Medication that could make the participant drowsy or tired during the experiment
PSCI# 23-137 NRGF-001: ACTIVITY MONITORING TO IMPROVE PATIENT CARE DURING CHEMORADIOTHERAPY FOR LOCALLY ADVANCED NON-SMALL CELL LUNG CANCER (LA-NSCLC)
this trial looks at the difference in health between lung cancer subjects who do deliberate exercise measured by a fit bit and those who do not.
Participants will need to commit to all appointments. All those assigned to the fit bit arm must agree to wear it as instructed. You will wear the activity monitor for approximately 4 months. There are approximately 13 visits in total that you would need to come to the clinic.
Planned initiation (within the 30 days after study registration) of fractionated (≥15 treatments) thoracic radiotherapy with concurrent chemotherapy.
Age ≥ 18
Ambulates independently or with a cane (use of a walker not permitted)
Patients receiving concurrent treatment for another cancer that is expected to affect the toxicity profile of thoracic chemoradiotherapy
Can Twitter be the platform that leads to the rise of ’Crisis Reporters’?
Citizen journalism refers to production of journalistic content by ordinary citizens such as ‘current affairs-based blogging, photo and video sharing, and posting eyewitness commentary on current events’. In our study we try to redefine ‘citizen journalism’ to ‘crisis reporting’ that includes sharing updates and actionable news using Twitter. To this end we wish to propose a study where we interview people to understand the feasibility of the same. In addition, as supporting data, we would use historical data from Twitter. This would be done keeping in mind a particular event which would be the Texas snowstorm.
Present in Texas during the snowstorm
Have an active Twitter account
Not present in Texas during the snowstorm
Do not have an active Twitter account
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study toAssess the Efficacy and Safety of Barzolvolimab in Patients withChronic Spontaneous Urticaria Who Remain Symptomatic DespiteH1 Antihistamine Treatment (EMBARQ – CSU2)
A clinical research study called EMBARQ-CSU, which seeks to assess an investigational study medicine that has the potential to expand treatment options for Chronic Spontaneous Urticaria (CSU). CSU is a skin condition also known as chronic hives or long-term hives that is characterized by raised itchy welts on the skin that persist for six weeks or longer with no known cause.
If you decide to take part in this research study, you will have a screening phase where you will have procedures to determine if you meet the requirements to be in the study. These include a physical exam and an electrocardiogram (ECG) which will measure the electrical activity of your heart. You will also be required to give blood and urine samples. If you are a woman who can have children, you will also need to take pregnancy tests.If you qualify and agree to take part in the study, you will receive injections of barzolvolimab or placebo (the placebo contains the same ingredients but without barzolvolimab) under your skin every 4 weeks for 6 months. After 6 months, everyone will receive barzolvolimab for an additional 6 months, involving visits every 4 weeks. During the study, you will continue to have physical exams, blood taken for testing, and urine tests.You will need to complete a daily diary.
Diagnosis of CSU ≥ 6 months prior to Screening.
CSU remains despite a stable dose and regimen containing a second-generation antihistamine.
Agree to use highly effective contraception.
Willing and able to comply with all study requirements and procedures, including the completion of a daily symptom diary during screening and throughout of the study.
Diseases with possible symptoms of urticaria or angioedema.
Phototherapy with ultraviolet (UV) A or UVB within 4 weeks of Screening.
Diagnosis of idiopathic anaphylaxis or a history of anaphylaxis.
Women who are pregnant or nursing.
A Phase Ib/II Study of Venetoclax (ABT-199) in Combination with Liposomal Vincristine in Patients with Relapsed or Refractory T-cell or B-cell Acute Lymphoblastic Leukemia (EA9152) (PSCI 18-047)
This study is being done to determine what effects (good and bad) the therapy venetoclax has on your type of cancer (acute lymphoblastic leukemia, also known as ALL). This investigational therapy will be added to what is a standard, liposomal vincristine, to treat relapsed acute lymphoblastic leukemia. It is hoped that venetoclax will help liposomal vincristine work better to kill your ALL, but it has not yet been proven.
venetoclax will be given orally in a tablet formulation once daily in 3 dose arms with a fixed, standard dose of intravenous (IV) liposomal vincristine 2.25mg/m2 weekly starting after a 2 week lead-in phase of venetoclax
ECOG performance status 0-2
Creatinine clearance of at least 50 mL/min within 7 days prior to first dose of study agent
Adequate liver function with AST/ALT less than 3X upper limit of normal and total bilirubin less than 2 mg/dL within 7 days prior to first dose of study agent
Circulating WBC count must not be above 20 x10^9/L within 7 days prior to first dose of study agent
Evidence of isolated extramedullary relapse (i.e., testicular or CNS)
Serious medical or psychiatric illness that in the opinion of the primary investigator is likely to interfere with study participation may not be enrolled
Poorly controlled HIV, or CD4 < 400. HIV positive patients are allowed on this study if they have a CD4 count greater than or equal to 400, and are on a stable antiviral regimen
Patients with NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia may not be enrolled
Comparing Interactions Between Heterogeneous and Homogeneous Pairs of Building Designers
This study considers how building designers work together on a design task. During the 1-hour long study, participants will be assigned a design partner and given a design task with specific goals to address. The entire study will take place over a computer and the design process will be recorded through the computer's video and audio.
Architectural Engineering Students
4th or 5th year undergrads with internship experience
Graduate students
UroGen UR001
This study is being done is to test the safety of a drug called UGN-301 at different dose levels, either alone or with another drug called UGN-201, and to understand how these drugs interact with the bladder and body
If you decide to take part in this study and meet all of the requirements, you will receive 6 treatments, once per week for 6 weeks in a row. The medication treatments will be instilled via catheter into your bladder. There will be 11 total visits with blood draws at all of the visits. As part of screening for this study you will have to have a CT scan, a cystoscopy, and a bladder biopsy. At 3 months you will be required to return for a cystoscopy and bladder biopsy if necessary. Finally, there will be a follow up cystoscopy and bladder biopsy at 6 months.
Have confirmed recurrent NMIBC with HG Ta disease and/or CIS
Has a life expectancy > 12 months.
Be post menopausal, surgically sterile, or using a combination of 2 methods of birth control for maximally effective birth control
Have adequate organ and bone marrow function within 14 days of treatment initiation as determined by routine laboratory tests
Current or previous evidence of muscle invasive, locally advanced nonresectable, or metastatic urothelial carcinoma (ie, T2, T3, T4 and/or stage IV). High or low grade T1 disease.
Current systemic therapy for bladder cancer.
History of malignancy of other organ system within the past 5 years. Patients with genitourinary cancers other than urothelial cancer or prostate cancer that are under active surveillance
Prior therapy with an anti-CTLA-4, anti-PD-1, anti-PD-L1 agent, or with an agent directed to another co-inhibitory T-cell receptor.
Pathway to Prevention Study
This study will help us learn more about how type 1 diabetes occurs and provides monitoring to individuals at risk. In addition, the study will help us identify people who may be eligible for prevention trials. The study is divided into two parts: Screening and Monitoring. During screening, participants with a 1st degree relative who has type 1 diabetes will be tested for diabetes-related autoantibodies in the blood. Autoantibodies are proteins that are made by the body’s immune system. If autoantibodies are present, it could mean that cells in the pancreas which produce insulin are damaged. Certain kinds of autoantibodies can be found in the blood years before type 1 diabetes occurs. If the screening blood tests show that a participant has the autoantibodies, they will be asked to have an Eligibility visit to determine if you can participate in the Monitoring part of the study.
screened for Type 1 diabetes antibodies
aged 1-20 years and a niece, nephew, aunt, uncle, grandchild, cousin, or half sibling of an individual with Type 1 diabetes
willing to have blood drawn
Currently use immunosuppressive or immunomodulatory therapies
Has diabetes
Defining the role of slow eye movements on limb motor control
The purpose of the study is to examine how slow eye movements called smooth-pursuit eye movements, contribute to hand-eye coordination. Participants will grasp a robotic manipulandum and using the manipulandum interact with virtual visual stimuli in an augmented-reality environment.
Should have normal vision or corrected vision
Participants should be able to sit upright on a chair for upto 2 hours
Participants should be able to grasp and move objects with their right hand
Participants should be able to provide informed consent
History of musculoskeletal disorders (e.g., carpal tunnel syndrome, arthritis, fibromyalgia, tendinitis, trigger finger, mallet finger, fracture, or previous injury to the bones or joints in your neck, upper back, arms or hands in the last six months)
eye or vision problems (e.g., cataracts, glaucoma, a detached retina or macular degeneration)
Cognitive impairment such that informed consent cannot be obtained.
Medication that could make the participant either drowsy or tired. Individuals who get tired with 2 hours of mild to moderate exercise are also not eligible to participate.
A Phase 3, Randomized, Double-blind, Placebo-controlled, Cross-over Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Attacks in Adolescents and Adults with Hereditary Angioedema
The purpose of this clinical research study is to learn more about the use of the investigational drug, deucrictibant, for the treatment of HAE. Deucrictibant is designed to block the effects of bradykinin to avoid progression of attacks and lead to the resolution of attacks. In this study, the investigational drug is a soft capsule containing 20 mg of deucrictibant that you will take by mouth. There are already medicines available to treat the manifestations of HAE attacks, but these are injected either into a vein or under the skin. If you are currently on a stable dose of prophylactic treatment to prevent HAE attacks, you will be asked to continue using this at the same dose throughout the duration of the study.
You will need to come to the study site approximately four times. At two of these visits, you will have blood and urine collected. You will have vital signs collected, physical exams, vital signs, and EKG’s performed. You will need to treat two HAE attacks with the study drug, complete questionnaires on an electronic diary, and participate in telephone interviews with the study team.
Diagnosis of HAE-1/2
History of at least 2 HAE attacks in the last 3 months before screening.
Experience with using standard-of-care treatment to effectively manage on-demand treatment for HAE attacks.
Capable of recording, without assistance, electronic HAE diary using an electronic device, as evidenced by the competency assessment conducted during the screening phase.
Any diagnosis of angioedema other than HAE-1/2.
History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse.
Use of attenuated androgens for short-term prophylaxis within the last 30 days before the time of randomization.
Prior gene therapy for any indication at any time.
Understanding the Public Opinion about Commute Time in Automated Vehicles
The main research goal of this work is to collect drivers’ opinions on autonomous vehicles and their perceptions of time when they ride with autonomous vehicles comparing with manual-driven vehicles.
Have at least one year of driving experience
The age of driver is under 18
Testing the Effect of ENDS Flavors on Neurotransmission
This clinical trial will test the effects of common flavor chemicals in electronic nicotine delivery systems on brain reward function and nicotine use behaviors.
Subjects completing brain scans: Subjects will attend two in person visits with MRI or NIRS brain scans, where they will complete questionnaires, use e-cigarette devices and complete computer tasks.Subjects not completing brain scans: Subjects will attend two in person visits where they will complete questionnaires, use e-cigarette devices and complete computer tasksAll subjects will take a study E-cigarette device home to use for 10 days between their two in person visits.
If completing brain scans - up to $400; If not completing brain scans - up to $250
No plan to quite tobacco in the next month
Able to read or write in English
Age 21 or older
Unstable or Significant Medical Conditions
Uncontrolled serious mental illness
Current substance abuse
Examining Cortical Lateralization of Motor Learning through Transcranial Stimulation
The aim of this study is to understand how brain stimulation affects learning of a novel task on a virtual reality system. Participation involves playing virtual reality games during non-invasive brain stimulation.
Single in person visit involving the application of a non-invasive brain stimulation technique during a reaching task in a 2D virtual reality environment.
25
18-40 years old (healthy young)
18-80 years old (stroke patient)
neurological disease
movement disorder
major psychiatric diagnosis
orthopedic damage to the arms
Describing and Understanding Local Varieties of Central Pennsylvanian English
This study aims to provide original descriptions and analyses of features of the vernacular varieties of English spoken in Central Pennsylvania. Previously understudied, this project will provide new data from both spontaneous speech and controlled experiments to contribute to our understanding of language variation in Central PA, and to the larger body of knowledge on variation in American English.
from the Central PA region
native speaker of American English
did not grow up in Central PA
does not speak English as a native language
A Phase I/II Study of Neratinib in Pediatric Patients with Relapsed/Refractory Solid Tumors
Neratininb for childhood cancer that has returned or is not responding to previous therapy
Cancer that has returned or is not responding to previous therapy
Has failed at least one prior therapy
SPICE UP MyPlate - Strategy for Promoting Intake of Delicious Healthful Dietary Patterns Based on MyPlate: A Pilot Study
The aim is to conduct a pilot study to assess the feasibility, acceptability and potential effectiveness of culinary focused nutrition education to promote increased adherence to the Dietary Guidelines for Americans compared to standard low-intensity care.
You will be asked to attend two fasting clinic visits. At these visits paperwork will be completed, measures of weight, height, waist circumference, and vascular health will be taken. A blood draw and hair samples will also be taken. We will ask you to collect 12 saliva samples at home after each visit. If you are randomized to the culinary focused nutrition education group, you will receive weekly emailed links to asynchronous nutrition education sessions during the first month of the study. For months 2 and 3 emailed links will be sent bi-weekly. You will also receive emails containing videos and other resources. If you are in the standard nutrition education group, you will receive nutrition education via written study material and a phone application (app) and you will not have to attend education visits.
270
Involved in meal cooking at home and consumes a home cooked meal ≥ 1 time per week
Non-smoking
Received nutrition education for a medical condition within the past 6 months
Currently following a weight loss diet
Lost ≥ 10% body weight in the past 6 months
Unstable medical conditions requiring active intervention
COVID-19: Implications for Family Meals
The purpose of this study is to gather information about family meals, what they look like, and how they have changed over time since the COVID-19 pandemic. Participants will complete a confidential online survey last approximately 10-15 minutes.
Adults who live in a household with a child under the age of 18
Adult who are fluent in English
Individuals who can read and respond to written closed and open-ended survey questions electronically
Individuals who live in the United States
Individuals who do not reside in a household with a child under the age of 18
Individuals who are not fluent in English
Individuals with poor reading comprehension or are otherwise limited in their ability to read and respond to survey questions.
Individuals who do not currently live in the United States
A Randomized, Placebo-Controlled, Double-Blind Study of Adjuvant Cemiplimab versus Placebo after Surgery and Radiation Therapy in Patients with High Risk Cutaneous Squamous Cell Carcinoma (CSCC) (PSCI 18-112)
This study is a comparison of disease-free survival of patients with high-risk cutaneous squamous cell carcinoma (CSCC) when treated with a medication (cemiplimab) versus those treated with placebo after already having surgery and radiation therapy.
The study is conducted in 2 parts. Part 1 consists of a screening period, treatment period and a completion period including a period of long term follow up. During part 1, you will be asked to answer questions about your health, participate in a physical examination that includes vital signs,height and weight, have testing done including an electrocardiogram, blood draws, urine sampling, pregnancy test, biopsy, and medical imaging. Part 2 consists of an additional screening period, treatment period and an end of treatment period.
70.00 per visit
Post resection and curative intent post-operative Radiation Therapy within 2 to 6 weeks of randomization
Adequate hepatic, renal, and bone marrow function as defined in the protocol
Squamous cell carcinomas (SCCs) arising in non-cutaneous sites as defined in the protocol
Significant autoimmune disease that required treatment with systemic immunosuppressive treatments (including corticosteroids)
Has had prior systemic anti-cancer immunotherapy for cutaneous squamous cell carcinoma
Student Experience in New Class Modes during Covid-19
This is a survey study that will examine how the new instruction modes during COVID-19 have impacted undergraduate education experience. Participants will be asked to complete a survey to give feedback and comments on their classes. The survey will take 15 - 20 minutes.
An active undergraduate student at University Park campus
Enrolled for as least one class
Can read instruction materials written in English
Dynamic Assessment of English Vocabulary
Better understand and improving Chinese English learners' vocabulary development
•Complete seven sessions, which may take approximately 20-30 minutes of your time per session.•Read several English short texts and identify meanings of target words.•Possibly participate in a virtual interview that will be scheduled at your convenience.
Adult English learners
Currently enrolled in a college or university
A Survey to Estimate the Socio-Economic Impact of the Novel Corona Virus (COVID-19) Pandemic
We are experiencing global outbreak of coronavirus (COVID-19) recently. Millions of people are suffering and dying every day, in spite of putting our best efforts. We are doing this survey to understand people’s reaction to this situation. The survey will ask about your knowledge, practices and worries. Your response will help us to understand how to better control these situations. Your feedback is highly important to us, as we need to find out the best way to stop the disease from spreading and killing thousands of lives, and to reduce the stress among the population.
Adult
Mentally impaired
Participants from Europe or European Union (EU)
How do cues from the environment affect sound perception?
This study is about investigating how certain elements of urbanconfiguration affects people's subjective perception of noise in urbanenvironments.This section of the study assesses participants' subjective reactions tonoise intensity when the tree density changes in various spaces.
Gender: all
no visual or hearing impairments
Effects of acid sensing ion channels blockade on the exercise pressor reflex following ischemia-reperfusion stress in healthy individuals
The purpose of this voluntary research study is to test if the drug amiloride can decrease blood pressure during exercise.
This project includes 3 visits to the research lab. Each visit last approximately 3.5-4 hours (~11-12 hours altogether). In each visit, you will be asked to perform foot exercise before and after a blood pressure cuff on your leg was inflated. You will also be asked to take pills prior to visit 2 and 3. One of these pills will be a drug called amiloride (10mg), which was traditionally used to lower blood pressure. The other pill will be a placebo (no active medication).
You will receive $25 per hour for your participation in this research study
21-40 years of age
Healthy (absence of any active or chronic disease)
Pregnant or nursing women
Have a major disease (heart, lungs, kidney, diabetes, cancer)
current smoker
High blood pressure
An Intermediate Expanded Access Protocol with CNM-Au8for Amyotrophic Lateral Sclerosis for NIH Grant RFA-NS-23-012
The main purpose of this research study is to provide access to the investigational product, CNM-Au8 at a dose of 30mg per day, to up to 180 people living with ALS. The study wants to find out if CNM-Au8 is safe to take without causing too many side effects and can help people with ALS.
Participants will have a visit to see if they qualify to participate. Following this visit, they will return to the clinic for visits every 12 weeks and these visits will continue in 144-week periods until the treatment plan is discontinued. Participants will have one last visit 4 weeks after their last dose of the investigational medicine.
Male or female aged 18 years or greater at time of ALS diagnosis
Participants with a confirmed diagnosis of ALS as determined by a neurologist specializing in ALS
Participant is able to consume up to 240mL of investigational drug without substantial dsyhpagia or can take the investigational drug through a gastronomy tube
Participant has a history of clinical significant or unstable medical condition that may interfere with assessment of safety or compromise the study objectives
Based on the investigator’s judgment, participants who may have difficulty complying with the protocol and/or any study procedures.
Within the prior 90-days the participant has had clinically significant findings on standard hepatic, hematologic, or renal safety assays.
Participant is currently involved in another placebo-controlled clinical trial (note: concomitant therapy with other investigational products is permitted with certain restrictions—see concomitant medications section below).
Understanding the Experiences of College Students of Color with Psychiatric Disabilities
The purpose of this study is to develop a better understanding of the lived experiences of college students of color with psychiatric disabilities, particularly related to the formation of racial identity, disability identity, and the impact of perceived discrimination.
18 years of age or older
Capable of providing informed consent
Diagnosis of a psychiatric disability
Identify as a person of color
Individuals who are not yet legal adults
Prisoners
Unable to speak/read English Language at time of interview
Randomized Phase III Trial Incorporating Abiraterone Acetate with Prednisone and Apalutamide (NRG-GU008) (PSCI# 20-087)
The purpose of this study is to compare the use of hormone therapy and radiation therapy (usual treatment) to the use of apalutamide and abiraterone acetate with prednisone plus the usual treatment. The addition of apalutamide and abiraterone acetate with prednisone to the usual treatment could stabilize your cancer and prevent it from spreading. But it could also cause side effects, which are described in the risks section below.This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the study approach increases the time without prostate cancer spreading compared to the usual approach. The study drugs, apalutamide and abiraterone acetate with prednisone, are already approved by the FDA for use in prostate cancer. But, most of the time abiraterone acetate with prednisone is not used until hormone drugs stop working and apalutamide is not used until hormone drugs stop working and after prostate cancer has spread. There will be about 586 people taking part in this study.
The purpose of this study is to compare the use of hormone therapy and radiation therapy (usual treatment) to the use of apalutamide and abiraterone acetate with prednisone plus the usual treatment. The addition of apalutamide and abiraterone acetate with prednisone to the usual treatment could stabilize your cancer and prevent it from spreading. But it could also cause side effects, which are described in the risks section below.This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the study approach increases the time without prostate cancer spreading compared to the usual approach.The study drugs, apalutamide and abiraterone acetate with prednisone, are already approved by the FDA for use in prostate cancer. But, most of the time abiraterone acetate with prednisone is not used until hormone drugs stop working and apalutamide is not used until hormone drugs stop working and after prostate cancer has spread. There will be about 586 people taking part in this study.
History/physical examination within 90 days prior to registration
ECOG Performance Status of 0-1 within 90 days prior to registration
Any T-stage is eligible (AJCC 8th ed)
Adequate hepatic function within 90 days prior to registration
Seizure or known condition that may pre-dispose to seizure
Severe or unstable angina, myocardial infarction, arterial or venous thromboembolic events within 6 months prior to registration
Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone/prednisolone once daily
Patients with inflammatory bowel disease.
The effects of creatine supplementation on neurocognitive function of college students of differing levels and types of physical activity
This study design is a survey that collects information about students' active level and supplement use, with an emphasis on creatine. The difference between contact and non-contact athletes will be examined, in addition to people who are considered inactive/low activity. This will help provide information of how physical activity related supplementation use affects cognition in different populations, with varying amounts of neurotrauma.
All participants will complete a digital survey that provides information about their dietary supplementation and physical activity habits. As part of the survey, participants will be allowed to indicate their interest and availability to come to a laboratory setting to complete a brief batter of neurocognitive tests.
Has had concussion in last 3 months
Sex and race differences in exercise pressor reflex under blood flow restriction condition
The purpose of this voluntary research study is to test the effects of exercise on reduction in blood flow to exercising muscle.
You will be asked to participate in one visit to perform handgrip exercise and foot exercises with, and without a blood pressure cuff inflated on your arm and leg. Various physiological measurements will be recorded during this time including microneurography, blood pressure, heart rate, blood flow and muscle oxygenation.
You will receive $25 per hour for your participation in this research study
All races and ethnicities welcome
Are fluent in written and spoken English
Healthy status as defined by history and physical
blood pressure that is within a safe range (<150/100)
Pregnant or nursing woman
Current smoker
Any chronic diseases (heart, lung, neuromuscular disease or diabetes)
High blood pressure