Search Results
Defining the cellular and molecular signatures that are associated with the clinical heterogeneity of hidradenitis suppurativa
Patients with the clinical diagnosis of mild, moderate to severe Hidradenditis Suppurativa or normal healthy volunteers ages 18 and older to participate in a 1 time study visit. There is no treatment provided but we may gain information for the treatment of HS.
Eligible participants will attend a one time in person visit. During the visit, the study team will ask you to participate in the following activities: collect skin sample, blood sample and cheek swab. Take photographs of your HS lesions.
study coordinator will discuss.
Hidradentitis Suppurativa diagnosis for 3 months
Normal skin participants
Normal skin participants do not have an autoimmune disease
Participants who do not want to have any of the lesion sampling performed
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.
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab in Patients with Chronic Spontaneous Urticaria Who Remain Symptomatic Despite H1 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
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.
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 tasks All 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
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
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
How do cues from the environment affect sound perception?
This study is about investigating how certain elements of urban configuration affects people's subjective perception of noise in urban environments. This section of the study assesses participants' subjective reactions to noise 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
21-60 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-Au8 for 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
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
The HEALthy Brain and Child Development Study (HBCD)
This multi-site consortium research study, entitled the HEALthy Brain and Child Development (HBCD) study, will prospectively examine human brain, cognitive, behavioral, social, and emotional development beginning prenatally through age 10 years. The study will determine the short- and long-term impacts of a variety of potentially harmful as 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 to understand 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 be followed 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
A Second Intermediate Expanded Access Protocol for Amyotrophic Lateral 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
PSCI# 18-127 EA6174 Adjuvant MK-3475 to SOC
The purpose of this Phase III study is to compare Overall Survival (OS) and Recurrence Free Survival (RFS) across the two arms: MK3475 (Pembrolizumab) to Standard of Care Observation. Patients will undergo standard clinical procedures including physical, labs, vitals, ecg's, and imaging.
We are asking you to take part in a research study. We do research studies to try to answer questions about how to prevent, diagnose, and treat diseases like cancer.
Patient must have a histological confirmation of diagnosis of Merkel cell carcinoma (MCC), pathologic stages (AJCC version 8) I-IIIb.
completely resected by surgery within 8 weeks before enrollment.
All patients must have disease-free status documented by a complete physical examination and conventional imaging studies within 4 weeks prior to randomization.
Patients must not be on active immunosuppression, have a history of life threating virus, have had other cancer diagnoses in the last two years
present metastases
previous systemic therapy or radiation therapy for Merkel cell carcinoma.
inoperable disease who have received radiation are not eligible.
history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
PSCI 23-035 A Phase 3 Randomized Study Comparing Talquetamab in Combination with Pomalidomide (Tal-P),Talquetamab in Combination with Teclistamab (Tal-Tec), and Investigator’s Choice of Either Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pomalidomide, Bortezomib, and Dexamethasone (PVd) in Participants with Relapsed or Refractory Myeloma who Have Received 1 to 4 Prior Lines of Therapy Including an Anti-CD38 Antibody and Lenalidomide
This trial will compare two different drug combinations known for treating multiple myeloma by adding two new drugs to those existing combinations (talquetamab and Teclistamab)for multiple myeloma patients
Participation will be at least three months or until the medication stops working. You will need to come to the clinic every week for the first cycle of medication for lab work, a physical exam, EKG and vital signs and for the study doctor to see how you are feeling. After that you will come in every other week for treatment. You will see the study doctor and have a physical exam, blood tests and other evaluations to make sure that you are okay,.
$57.00 per completed visit. $14.00 for a caregiver to come with you.
have a diagnosis of Multiple myeloma
Measurable disease at screening
Relapsed or refractory disease
Negative serum or urine pregnancy test within 24 hours prior to the start of study treatment
A participant must agree not to plan to father a child while enrolled in this study or within 6months after the last dose of study treatment.
Major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of study treatment
Stroke, transient ischemic attack, or seizure within 6 months prior to signing ICF
Alzheimer’s Network for Treatment and Diagnostics (ALZ-NET)
ALZ-NET will follow and record information about people’s health, safety, brain scans, and long-term health outcomes during their regular memory care.
At specific time points throughout your participation in ALZ-NET, your memory care provider or designated staff will transfer data about your health, diagnosis, treatment, and brain imaging that are related to your memory concerns to the ALZ-NET operations center. These time points include at a 6-month, 12-month, 18-month, and 24-month timepoint, and once per year after that until your participation ends.
Patient or patient’s legally authorized representative (LAR) (e.g., spouse or legal guardian) has the ability to understand and provide signed and dated informed consent
Patient has a diagnosis of MCI or dementia with clinical suspicion of Alzheimer’s disease (AD)
If treatment is initiated at time of consent, the patient meets appropriate label requirements and treatment follows appropriate use recommendations for novel FDA-approved AD therapy/therapies
Patient’s treating clinician has made the decision to provide clinical care or treatment prior to patient consent and independently of the purpose of ALZ-NET
Impact of fermented pulses on inflammation and the gut microbiota
The purpose of this study is to investigate whether fermenting pulse foods (e.g. beans, chickpeas, lentils, peas, etc.) changes their effects on the gut microbiome and inflammation. Participants will eat provided meals of either fermented or unfermented pulses, providing blood and fecal samples at the beginning of the study and after two weeks of eating meals containing each of the pulse types.
The study lasts 8 weeks. 2 weeks where you do not consume any of the test food (pulses such as chickpeas, lentils, peas or beans), 2 weeks of consuming the first type of the provided meals, 2 weeks without consuming any of the test foods, 2 weeks consuming the second type of provided meals. There will be five in person visits, one at the beginning to provide consent and then one at the end of each 2 week section. At three of these visits a fecal sample will be collected, blood will be drawn and a dietary survey completed.
300
18-65
BMI >24.9
Taking any medication for diabetes or weight management
Pregnant
Allergies to meal components
Augmented Reality: Perceptions, Performance, and Language Enhancement
This is a single-center feasibility study assessing the Apple Vision Pro as a device for augmentative and alternative communication in patients with Amyotrophic Lateral Sclerosis who are experiencing impaired communication. Participants in this study will visit the study site once for approximately 1.5 hours. During the session, participants will complete questionnaires about their medical history, undergo an eye exam, and use an augmented reality headset that tracks the motion of the eyes to communicate.
Participants and their caregivers will complete a single visit lasting approximately 1.5 hours. During this time, they will undergo an eye exam, answer a set of questionnaires, and use an augmented reality (AR) headset that tracks eye-gaze to communicate.
$25
Use of augmentative and alternative communication device device (including but not limited to: eye tracking, switch control, scanning interface, written or typed communication).
Score of 1 or 0 on the ALS Functional Rating Scale (ALSFRS-R, Cedarbaum1999) speech sub-score and/or score of 2, 1, or 0 ALSFRS-R handwriting sub-score.
Continuous use of face-mask noninvasive ventilator that would impair comfortable wearing of AVP headset for at least 60 minutes
History of visual impairment incompatible with device use
History of medical diagnoses that could be exacerbated by use of the augmented reality headset: uncontrolled migraines or chronic headache, dizziness, vertigo, or other inner ear conditions, dry eyes, skin allergies, seizures
Diagnosis of frontotemporal dementia or other severe cognitive impairment that is sufficient, in the opinion of the study neurologist, to interfere with the subject’s ability to provide informed consent and reliably complete questionnaires
Motion in action: Integrating multisensory inputs for posture stabilization and complex action acquisition
This study looks at how people use their eyes and body to interact with moving objects while standing up. Participants will stand at a robotic device and try to stop virtual objects moving at different speeds on a screen, similar to catching or blocking a ball. The research will help us understand how the brain coordinates sensory information to maintain balance.
Participants will be required to stand and interact with virtual objects by grasping a robotic manipulandum. A session will last approximately 120 minutes.
$30 per session
Right-hand dominant
Normal or corrected-to-normal vision (20/20)
Able to stand for up to 2 hours
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 such that informed consent cannot be obtained, or that participant would not be safe with the protocol
Medication that could make the participant drowsy or tired during the experiment
PSCI 23-023 A PHASE III, MULTICENTER, RANDOMIZED, OPEN‑LABEL STUDY COMPARING THE EFFICACY AND SAFETY OF GLOFITAMAB (RO7082859) IN COMBINATION WITH POLATUZUMAB VEDOTIN PLUS RITUXIMAB, CYCLOPHOSPHAMIDE, DOXORUBICIN, AND PREDNISONE (POLA-R-CHP) VERSUS POLA‑R‑CHP IN PREVIOUSLY UNTREATED PATIENTS WITH LARGE B-CELL LYMPHOMA
To see if using glofitamab added to chemotherapy is better than chemotherapy alone.
Participants will be required to come to all study visits, report any new medications, prescription or over the counter that they are taking, make sure to tell the study doctor of any new symptoms you may be having.
$180/visit, $130 follow up visit
Previously untreated participants with CD20-positive LBCL
IPI score 2-5
ECOG Performance Status of 0, 1, or 2
Life expectancy >/= 6 months
Current Grade > 1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease
receiving systemic immunosuppressive agents
Significant or extensive history of cardiovascular disease