Search Results
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
Exploratory Trial of Ruxolitinib 1.5% Cream for Early Stage Hidradenitis Suppurativa
Explore all stages of Hidradenitis Suppurativa with a topical medication.
There will be 7 in-person visits and 1 follow-up phone call over a 33 week period. Over the course of the study, the following study procedures will take place: medical history and medication history collection, ECG, lab tests (both blood and urine), photography, skin exams, physical exams, questionnaires, and skin biopsies.
Up to $350
Must have active HS in at least 1 area
Must have negative TB screening assessment
Certain medications can be continued if on stable dose; study coordinator will discuss further.
Pregnant (or considering becoming pregnant) or lactating females
Does not have reliable internet access for weekly electronic surveys
Implementation of a Transcutaneous CO2 Monitoring (ITCOM) Study in ALS
Amyotrophic lateral sclerosis (ALS) leads to respiratory failure due to chronic hypoventilation. The gold standard for measuring hypoventilationrequires an arterial blood gas, which is impractical in the outpatient setting due to invasiveness, pain, and need for specialized equipment. Recently, the Penn State Health Hershey ALS Clinic has implemented transcutaneous CO2 (TCO2) monitoring as standard of care clinical assessment. The overall goals of this study are to gather critical preliminary data for stakeholder-driven refinement of a TCO2 monitoring protocol within a busy ALS clinic and identify how TCO2 may enhance our understanding of standard respiratory measurements.
Participants will complete a survey related to their experience having their CO2 reading performed in the ALS Clinic.
$20 will be paid for every survey completed, for a maximum possible payment of $80 per person.
18 years of age or older.
Seated forced vital capacity (FVC) of less than 100% predicted normal.
Use of any type of non-invasive ventilation, except in the case of continuous positive airway pressure (CPAP) for obstructive sleep apnea
Use of diaphragm pacer
Use of a tracheostomy
In hospice or in active transition to hospice
Young Children’s Representations of Parent-Child Negotiation
The goal of this study is to learn how young children think and tell stories about challenges between parents and children. Children will play games and tell stories using toys while caregivers fill out surveys and talk to researchers. This will occur twice, about 6 months apart. Qualities of children's stories, their language and regulation skills, demographic information about children and caregivers, and parenting behaviors will be examined.
At least one caregiver of a child between ages 5 and 7
English-speaking
Middle income
Caregiver at least 18 years old
Children that are not fluent in English
Children who are unable to tell stories with a researcher due to developmental disability or language delay
Children who are younger than 5 or older than 7
Low or high income
The HEALthy Brain and Child Development Study (HBCD)
This multi-site consortium research study, entitled the HEALthy Brain and Child Development (HBCD) study, willprospectively examine human brain, cognitive, behavioral, social, and emotional development beginning prenatallythrough age 10 years. The study will determine the short- and long-term impacts of a variety of potentially harmfulas well as protective environmental factors. These include prenatal substance use, mental health, stress,sociodemographics, biological and genetic factors, and parent/child interaction. The overall goal of this study is tounderstand the neurodevelopmental trajectories of children growing up in diverse environments. A sample of~7,500 pregnant women will be recruited from 25 sites across the U.S. and they and their liveborn children will befollowed for 10 years.
If you agree for you and your child to participate, we will ask you to take part in completing visits from pregnancy through the first 10 years of your child’s life. These visits will take place both in-person and remotely. The length of visits will vary and may last between approximately one to nine hours per visit (which can be broken up into multiple visits). Over the first four years of the study, all study visits will require about 33-37 hours total. This will include interviews, questionnaires and other tests about yourself and your child. We will ask you and your child to wear small devices for a few days to measure heart rate and or movement. We will ask you and your child to provide some biological samples. Because this study is looking at how a child’s brain develops in the first years of life, we will ask that you allow your child to have brain scans and other measures of how your child’s brain is developing. This study is being offered in both State College, PA at the University Park campus and in Hershey, PA at the College of Medicine campus. You may choose to complete this study at either site.
$1,350
Speaks English or Spanish
Does not speak English or Spanish
Testing the Risk Preferences of Engineering Students under Conditions of Limited Information, Sleep, Optimism, and Time Constraints
This is a study that will examine how engineers make decisions under certain conditions and the factors that drive these decisions. The game will be used to simulate different engineering scenarios. All you need to do is play an online game with 3 different scenarios and choose what you feel is the better design based on the available information.
Over 18 years old
Speaks English
Graduate Students
Non-Engineering Majors
A Second Intermediate Expanded Access Protocol for AmyotrophicLateral Sclerosis with CNM-Au8
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 300 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 48-week periods until the treatment plan is discontinued. Participants will have one last visit 4 weeks after their last dose of the investigational medicine.
Able to understand and give written informed consent.
Male or female participants aged 18 years or greater (inclusive) at the time of ALS diagnosis.
Participants with a confirmed diagnosis of ALS per Gold Coast criteria as determined by a neurologist specializing in ALS (e.g., the site principal investigator or sub-investigator for this study).
Participant is able to daily consume up to 240 mL of the investigational drug suspension without substantial dysphagia, OR can intake the investigational product through a gastrostomy tube.
Participant has a history of any clinically significant or unstable medical condition (other than ALS) 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).
Phase 1/2 Multicenter Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of APL-101 in Subjects with Non-Small Cell Lung Cancer with c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
This Phase 1 and 2 study is to determine the safety of APL-101 in subjects with NSCLC with specific mutations. It is also to determine the dose that is tolerable for oral administration of APL-101. And to see if there is a clinical benefit to subjects for the amount of time to progression, or progression free survival and overall survival.
We are asking you to give permission for your doctor to send your stored tumor tissue sample for cancer genetic analysis. As part of your cancer care, your doctor may have already collected a tumor tissue biopsy sample (of your cancer tissue) in the past, recently, or being planned as part of standard medical care. Your doctor will ask for any of your stored or available tumor tissue sample collected elsewhere from previous doctors you may have seen in the past. We will not ask you to undergo a new tissue biopsy procedure for this testing however your treating physician may decide to do so as part of your standard of care.There is no required visit for this testing. Once you have signed this consent, your available tumor tissue sample from a prior biopsy or surgery along with the pathology report will be sent to an accredited and certified external genetic laboratory (such as Caris Life Sciences or Interpace Pharma Solutions) to test and understand your cancer’s genetic make-up. The use of your tumor tissue samples as described in this form is necessary for the genetic testing. Without your consent to test your samples, the genetic testing cannot be performed. Once you agree to provide your samples, they cannot be returned to your doctor’s clinic. If the genetic testing of your samples show you have c-MET genetic dysregulations in your cancer, your doctor will discuss your treatment options including clinical trials, such as the APL-101-01 SPARTA trial, with you. If you are interested in participating, you will be asked to review and sign another participant information and informed consent form for the clinical trial before undergoing further screening tests to confirm if you are eligible to participate. The genetic results could also be used to help your clinic doctor decide on an approved therapy, or other investigational therapies that may be right for your specific cancer genetic alterations.
Women of child-bearing potential (WOCBP) must have a negative serum or β-human chorionic gonadotropin (β-hCG) at screening or evidence of surgical sterility or evidence of postmenopausal status.
Abnormal c-Met dysregulation, by tissue and/or plasma, defined as the following from local/archival molecular pre-screening evaluations.
Measurable disease according to RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0–1
Known mutation/gene rearrangement of EGFR (except for Cohort C), ALK, ROS1, RET, NTRK, KRAS, and BRAF.
Active uncontrolled systemic bacterial, viral, or fungal infection or clinically significant, active disease process
History of, or currently, or at risk for, cardiac disease (e.g., long QT syndrome [> 450 msec QTcF or concurrent treatment with any medication that prolongs QT interval).
Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter drug absorption (e.g., Crohn’s, ulcerative colitis, active inflammatory bowel disease, uncontrolled nausea, vomiting, diarrhea, or malabsorption sydrome).
PSCI 23-145 Effective Quadruplet Utilization After Treatment Evaluation (EQUATE): A Randomized Phase 3 Trial for Newly Diagnosed Multiple Myeloma Not Intended for Early Autologous Transplantation
This trial is comparing two different therapies for the treatment of newly diagnosed multiple myeloma who are not having a bone marrow transplant.
Subjects will be required to keep all research visits, take medications as directed, report any new medication of side effects to the study team,
Patient must be considered ineligible for autologous stem cell transplantation by the treating physician, or willing to delay stem cell transplantion until first relapse or later.
Patient must agree to register to the mandatory Celgene Revlimid REMS program and be willing and able to comply with the requirements of the Revlimid REMS program.
Patient must have standard risk MM as defined by the Revised International Staging System (R-ISS) Stage I or II.31
Patient must be able to undergo diagnostic bone marrow aspirate following preregistration if not performed previously.
Patient must not be pregnant or breast-feeding due to the potential harm and teratogenic effects to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.
Patient must not have moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification.
Patient may have a history of current or previous deep vein thrombosis (DVT) or pulmonary embolism (PE) but must be willing to take some form of anti-coagulation as prophylaxis if they are not currently on full-dose anticoagulation.
Patient must not have peripheral neuropathy ≥ Grade 2 on clinical examination or grade 1 with pain
Testing the effect of ENDS flavors on Neurotransmission
Tobacco users will be randomized to use electronic cigarettes containing varying levels of nicotine and flavor during laboratory protocols to investigate the effects on the brain and behavior. Subjects will complete surveys, functional magnetic resonance imaging scans, and complete computerized tasks. Eligible participants include daily users of inhaled tobacco products who are at least 21 years old, able to read and write in English, and not planning to quit tobacco use within the next month. Exclusion criteria include: current substance use impairing participation, unstable or significant medical conditions, current use of smoking cessation medication, uncontrolled serious mental illness, and MRI safety or neurological contraindications.
Subjects will taste test a variety of e-cigarette flavorings, answer questions and complete a single MRI.
50
No plan to quit tobacco use in the next month
Age 21 or older
Able to read and write in English
Unstable or Significant Medical Conditions
Uncontrolled serious mental illness
Current substance abuse