Search Results
Olfactory tools for COVID-19 screening and surveillance
This a collaborative multisite NIH funded project to develop smell tests as a rapid low cost way to screen for Covid19 infections. The lead institution is the University of Florida, and this project is being entered into CATS to create a Reliance Agreement under the NIH single IRB rules (sIRB).
COVID19 negative
COVID19 positive
Able to Consent in English
History of known pre-existing olfactory or taste disorder
History of head trauma with loss of consciousness
History of neurodegenerative disease
Predicting Concussion Outcomes with Salivary miRNA
The purpose of this study is to identify changes in salivary micro ribosomal nucleic acid (miRNA) expression that are predictive of symptom duration and severity following mild traumatic brain injury (mTBI) in children. The primary endpoints of this study are as follows:1)Characterization of brain-related miRNA in the saliva of 250 children with mTBI and 200 age- and gender-matched controls between the ages of five and twenty-three years.2)Identification of a set of salivary miRNAs that is predictive of duration and severity of mTBI symptoms.
Saliva collection and surveys at baseline, 7 days, and 30 Days
$20
Seen in the Penn State Pediatric Concussion Clinic within 2 weeks of most recent concussion
Periodontal disease
Ongoing seizure disorder, or other neurologic disorder
Drug or alcohol dependency
clinical diagnosis of severe TBI
Observations of Family Mealtime Routines
The purpose of this study is to gather information about what family mealtimes look like for families with children between the ages of 3 and 8. Families will be asked to video record their family mealtime, in addition to answer some questions and to complete some questionnaires, some about body image and dieting.
On one occasion, your family's mealtime will be recorded via Zoom. You and your family will be asked some questions and to complete some questionnaires online.
$20
Adults age 18 and older
Children, ages 3-8
Individuals fluent in English
Caregivers who are under the age of 18
Individuals who are not fluent in English
Families without at least one child age 3 to 8
Behavior, Voice, and Sex Hormones Study
Hormones are molecules that deliver signals throughout the body. They influence behavior, sleep, hunger, stress, and virtually all other aspects of life. This study seeks to better understand several of these functions, specifically how hormones affect specific aspects of human behavior and psychology, as well as speech production. Following an initial lab visit, subjects will participate in the remainder of the study (~5 weeks) at home via the internet. On a daily basis, they will collect urine samples for hormone analysis, saliva samples for analysis of oral micro-organisms, and will submit voice samples for analysis of speech (e.g. measuring voice pitch and loudness). They will then complete an online survey designed to collect information about their behavior, and attitudes over the previous 24 hours. Subjects receive compensation for their participation.
- Compensation $330 at maximum- Pre-sampling lab visit to sign a consent form and receive training- A series of ~42 daily at-home sample (urine, saliva) collection & online surveys- Weekly lab visits for sample drop-off
$330
Normal menstrual cycles
Available for daily at-home session for approximately 5 weeks
Female/Identifying as a woman
Predominantly or exclusively heterosexual sexual orientation
Uncorrected severe defects of hearing, speech, or vision
Bisexual or predominantly homosexual sexual orientation
Very heavy smoking or alchohol consumption
Medications that affect levels of ovarian hormones (e.g. anti-depressants, anti-psychotics)
PSCI-22-063: NRG-GU011 NRG Promethean
This trial is comparing radiation therapy with or without hormone therapy in men with prostate cancer.
Patients must come in for all radiation treatments. Patients must take their androgen therapy as prescribed.
Age ≥ 18 years.
ECOG Performance Status 0-2 within 120 days prior to registration.
External beam and/or brachytherapy to: Prostate alone, prostate and seminal vesicles, prostate and pelvic nodes, or radiation to all three sites.
Radical prostatectomy alone, radical prostatectomy plus postoperative radiotherapy to the prostate bed, or radical prostatectomy plus postoperative radiotherapy to the pelvic nodes.
Currently on androgen deprivation or anti-androgen therapy.
Osseous metastasis on 99mTc radionuclide bone scan
Extra pelvic nodal/soft tissue disease (> 1.5cm in short axis) on CT or MRI pelvis +/- abdomen
Spinal cord compression, or spinal intramedullary, brain, and/or visceral (for example liver, lung, etc.) metastasis
A Prospective, Multicenter, Randomized, Pivotal Study of the May Health System in Transvaginal Ablation of Ovarian Tissue Under Ultrasound Guidance in Women with Infertility Due to Polycystic Ovary Syndrome
This is a randomized trial whereby a study device will be used to remove tissue from the ovary via a transvaginal ultrasound procedure in order to promote/restore ovulation in women with infertility due to PCOS. Weekly serum blood draws will also be obtained to determine ovulation rates during the first 12 weeks of study enrollment. Those randomized to the control arm will have the option of crossing over to the device arm after 3 months.
Preliminary visit to assess eligibility followed by randomization into the Device or Control Arm. Device Arm requires May Health procedure (approximately 1 hour long, similar to ovarian drilling) followed by 12 weekly blood tests and 6 follow up clinic visits and follow up calls for up to 36 months after the procedur4e. Control Arm requires 12 weekly blood tests and the option to cross-over to the device arm after 3 months. If no cross-over occurs, the control arm will have one follow up visit at 3 months and can then exit the study. Both arms will complete questionnaires and log menstruation dates in an e-diary.
1220
Infertility associated with oligo or anovulation and ultrsonographic evidence of PCOS or evidence of hyperandrogenemia
At least one ovary with volume greater or equal to 10.0ml
Ovarian accessibility by transvaginal ultrasound transducer
Has not responded to first-line ovulation induction treatment
BMI greater than 40
Marked hyperandrogenism
Poor glycemic level control (greater than 6.5%)
Bleeding disorders
PSCI 24-079 THE PHASE III ‘HIGH FIVE TRIAL’ FIVE FRACTIONRADIATION FOR HIGH-RISK PROSTATE CANCER
This trial is comparing disease free survival using standard radiation versus higher doses of radiation to the prostate to prevent the cancer from spreading.
Participants will be chosen to enroll into one of two types of radiation to treat their prostate cancer. they must agree to keep all appointments over the 5 years period and agree to be contacted every year for follow up.
High-risk disease
Prostate gland volume less than 100 cc prior to initiation of ADT
o definitive clinical or radiologic evidence of metastatic disease
Age ≥ 18
No prior radical prostatectomy;
Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both LHRH agonist and oral anti-androgen) is ≤ 185 days prior to registration;
Understanding Prenatal Hydration Behaviors
To examine women’s self-reported pregnancy hydration behaviors, especially during a global pandemic. This study will also examine other lifestyle behaviors (e.g., weight gain, exercise, eating behaviors, sleep, pain management). It is hypothesized that hydration behaviors will decrease due to lifestyle changes related to the pandemic. Secondary outcomes will also be influenced by hydration behaviors and pandemic lifestyle changes.
Women
18-45
English speaking
Men
Younger than 18
Non-English speaking
A Phase 2, Randomized, Double-Blind, Placebo-Controlled,Multicenter, Dose-Ranging Study Evaluating the Efficacy andSafety of GS-1427 in Adult Participants With Moderately toSeverely Active Ulcerative Colitis (UC)
The study will test GS-1427 for treatment of ulcerative colitis (UC). Adults diagnosed with UC can participate if otherwise eligible.The study has two parts; the first part lasts 12 weeks. Participants will be randomly assigned to either a treatment or a placebo arm. At 12-week evaluation the participants can be further assigned to an active treatment lasting 40 weeks. The study procedures include blood tests, endoscopy with biopsies, vitals, and physical exam, EKG testing, providing urine and stool samples, and completion of symptom-related diary questionnaires.
Participants will be required to sign the informed consent and show that they understand the study requirements. They will be required to complete in-person clinic visits. During the visits, the participants will have their vitals checked, and we will ask them about any problems they may have or adverse events. During the screening periods, participants undergo endoscopy with biopsies and provide stool and urine samples. Blood draws will also be done, and we will teach them to complete the questionnaires about the disease symptoms. If eligible for the study, screened subjects will be randomized for either one of four groups: three-drug treatment doses or a placebo treatment (blinded). They will attend clinic visits every four weeks. The endoscopy evaluation will be done at screening, week 12, week 52, and week 76 or at the end of the study. After week 12, participants will either continue to receive the drug treatment or, if they complete the placebo group, they will be randomized to one of the drug doses.
Part 1 total $1765 ($75 per visit, $20 meal cards v2 and v12); Part 2 TBD
diagnosed UC at least three months prior
active disease inspite of one of the standard therapies
loss of response, or intolerant to not more than one therapy
negative TB test and HIV at screening
history of ileostomy, colostomy or stenosis
history of extensive colonic resection
past treatment with vedolizumab
past treatment with ustekinumab
Understanding the effect of drivers’ profile information on riders’ feedback in ride-sharing context
This study aims to understand ways to affect how riders perceive and provide feedback to drivers through technology intervention. Particularly, we investigate how presenting drivers’ personal profile under different trip conditions may lead to differences in the ways riders may provide feedback. We hypothesize that riders will provide positive feedback when provided drivers’ personal information when the trip goes well, and that riders will provide less negative feedback when provided drivers’ personal information when the trip goes bad due to uncontrollable reasons.
You are willing to share several of your past Uber/Lyft trip records in the app with us.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants with Moderately to Severely Active Crohn’s Disease
This protocol has two independent parts. In Part 1, participants will be randomized to one of three Tulisokibart arms of treatment or placebo. Tretment will include induction, maintenance, and extension. When the maximum number of participants with prior exposure to advanced therapies has been reached, Part 2 will open for enrollment. In Part 2, the participants will be randomized to one of two dosing arms of Tulisokibart or a placebo.
The participants will be required to sign the inform consent and understand the requirements. They must have in person visits, comply with the procedures (blood test), colonoscopy, and to complete daily dairy about their symptoms. They must provide specimens such as blood, stool, and urine.
$100 per completed visit, $250 per endoscopy
Individual of any sex/gender from 18 years to 75 years of age inclusive,
Has had disease more than 3 months and has moderately active disease with one of the standard therapies
Average daily very soft or liquid SF ≥4 and/or average daily APS ≥2 at Baseline.
Demostrates loss of response, intolerance or inadequate response to standard therapy
Has CD without colonic involvement
Has known colonic stricture or colonic stenosis
Has current stoma
Is missing more than two colonic segments or has short bowel syndrome
PSCI# 25-018 Randomized Phase III Trial of Neoadjuvant Immunotherapy with Response-Adapted Treatment Versus Standard of Care Treatment for Resectable State II/IV Cutaneous Squamous Cell Carcinoma
This study is comparing standard of care surgery and after surgery radiation against pre-surgery immunotherapy, followed by surgery, followed by radiation and immunotherapy to determine which combination prevents cancer reoccurrence.
Participants must come to all scheduled study visits, all medications they are taking including over the counter and tell the study doctor how you are feeling. 7 visits; 3 blood draws; QOLs to be completed 5 times for Group 1 and 7 times for Group 2
Previously untreated or recurrent CSCC
Age ≥ 18
ECOG Performance Status of 0-2
Not Pregnant and Not Nursing
No active infection requiring systemic antibiotics, antiviral, or antifungal treatments
No history of allogeneic stem cell transplantation, or autologous stem cell transplantation.
No prior systemic therapy for the study cancer
A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults with Cutaneous Sarcoidosis
The purpose of this research is to measure clinical safety and efficacy (effectiveness) of oral brepocitinib in adults with cutaneous sarcoidosis. Participation in this study is expected to last for up to 24 weeks (about 6 months). During treatment period, visits will be scheduled about every 4 weeks. Participants will be assigned to 1 of 3 treatments, there is a chance of receiving a placebo (non active ingredient treatment) however, you will not know nor will the study team know what treatment you have been assigned too. In addition, throughout the study at different time points you will answer questions, take the study treatment as directed by the study team, have your skin examined (biopsy), have labs drawn, have an ECG, and a chest x-ray.
Participants will attend a total of 7 in person visits throughout the study and visits will be scheduled about every 4 weeks during the Treatment Period. During the study you will be asked to answer questions to gather information on your health as well have you complete questionnaires. In addition, you will have the following assessments at different time points throughout the study: skin exam, ECG, Chest X-Ray, Skin photography, Skin punch biopsy, Pulmonary function testing, and blood tests.
Skin biopsy required along with presentation of cutaneous sacroidosis symptoms for 6 months or longer
Weight requirements apply for participation, study coordinator will discuss
Must be willing to understand and comply with the study requirements
Certain medications are allowed at a maximum stable dose, study coordinator will discuss further
Women who are breastfeeding, pregnant, or planning to become pregnant, or WOCBP who are unwilling to apply a highly effect birth control method for the time specified during study participation
Making Second Language Learning More Inclusive in the Elementary Classroom: A Metalinguistic and Multimodal Approach
This study aims to find out whether learning German can help children with language difficulties improve their English skills. Children will learn German grammar using colors, shapes, and simple explanations to help them understand how language works.
Participants will complete 20 one-hour Zoom sessions over 10 weeks. During these sessions, they will learn German using a visual and interactive approach that highlights both similarities and differences between German and English. Some sessions will involve fun learning activities, while others will include assessments of language, cognitive, and metalinguistic skills.
$300
Aged 7-11
Have English as their first language
Have significant difficulties understanding and/or expressing themselves in English
Are suspected of having another neurodevelopmental disorder, based on parent report or observed behavior
Have a hearing impairment
Intersectionality and Mental Health: Developing a Culturally Sensitive Yoga Intervention for Black and Minoritized Young Adult Substance Users
The project aims to increase awareness and understanding of yoga's benefits for mental health, including substance use, and stress reduction among marginalized Black communities and to empower minoritized individuals with critical tools and techniques for managing stress. By addressing the multifaceted relationship between intersectionality, race-related stress, and mental health, including substance use, this study seeks to provide a comprehensive approach to improving health outcomes for marginalized Black young adults. Participants will engage in either a 1:1 semi-structured interview or a focus group discussion, both hosted by the principal investigator, to hear their perspectives on the accessibility and feasibility of engaging in yoga-based interventions for mental health and substance use. From this study, the researcher seeks to contribute to the development of effective yoga prevention and treatments strategies that provide coping mechanisms to deal with race-related stress, reduce substance use and related negative health outcomes, and promote resilience among affected populations.
The study will last over the course of one day and will take about two hours of your time. Participants in this study will take part in a focus group or a one-on-one interview to share their experiences, perspectives, and insights related to yoga, mental health, stress management, and substance use.
For interview participants, each individual will receive a $25.00 gift card and for focus group participants, each individual will receive a $40.00 gift card for their participation.
For focus groups: Participants must identify as Black or African American.
For focus groups: Participants must be open to discussing their past/present substance use, mental health, coping strategies, and perceptions of yoga as an intervention.
For interviews: Must be a licensed or otherwise qualified mental health professional (e.g., counselor, therapist, social worker, psychologist, psychiatrist, or substance use counselor).
For interviews: At least two years of professional experience working with marginalized populations, particularly young adults from racial/ethnic minority backgrounds, who are dealing with mental health issues, specifically substance use.
For focus groups: Individuals who do not identify as Black or African American, or who do not meet the specified racial/ethnic categories, will not be eligible for participation in the focus groups.
For focus groups: Experiencing acute substance use or psychiatric issues that require immediate medical attention
For interviews: Professionals with fewer than two years of experience working with marginalized populations, particularly young adults facing racial/ethnic stress, mental health issues, or substance use, will be excluded.
For interviews: Individuals who do not hold a recognized mental health professional role (e.g., counselors, therapists, social workers, psychologists, or substance use counselors) will not be eligible to participate.
A Phase 2, Open-label, Multicenter Study to Assess the Efficacy and Safety of BW-20805 in Adult Subjects with Hereditary Angioedema
This is a voluntary clinical research study to investigate BW-20805 a injectable treatment for hereditary angioedema (HAE). The purposes of the study are to evaluate the safety and efficacy of the study drug for the treatment of HAE, the effectiveness of the study drug for preventing HAE attacks, and how the study drug works in the body and the relationship between the amount of the study drug taken and the effect on the body.
You will answer questions about your health, provide blood samples, undergo routine urine laboratory tests, receive the study drug, undergo electrocardiogram (ECG), complete questionnaires, undergo physical exams, and provide HAE attack information. There are a total of 13 visits.
Males or females 18 to 70 years of age at the time signing informed consent
Access to rescue treatment for Hereditary Angioedema
Active or history of cancer within 5 years prior to screening
A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBEXELIMAB IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS
Study to look at the safety and effectiveness of Obexelimab in patients with active Lupus who are currently receiving standard of care medications
There will be 13 in person visit over nine months, blood and urine will be obtained at 12 of these visits.
up to $650
over 70 years old
PSCI 24-138 NRG-CC011: Cognitive Training For Cancer Related Cognitive Impairment In Breast Cancer Survivors: A Multi-Center Randomized Double- Blinded Controlled Trial
If the participant decide to take part in this study, they will join one of two computerized cognitive training groups for 10 weeks and complete assessments before and up to at least six months after training. The computerized cognitive training will be delivered remotely online. Trained research staff will help the participant learn how to use the computerized training program. The participant will also be asked to complete questionnaires via mailed surveys or electronically online and a cognitive assessment over the telephone. A cognitive assessment checks for how the brain processes thoughts, such as concentrating, learning new things, remembering, and making decisions. The total participation in this study will be about 9 months.
Participants will join one of two computerized cognitive training groups. The computerized cognitive training will involve up to 40 hours of the assigned activity over a 10-week period. The 4 questionnaires and assessment times are as follows:•at the beginning of the study (prior to the first computerized training)•12, 24, and 36 weeks after joining the study.Participants will be asked to complete questionnaires via mailed surveys or electronically online and a cognitive assessment over the telephone.
$100.00
The participant must have a first-time diagnosis of non-metastatic breast cancer which is Stage I-III.
The participant must have a score of < 12 on the PROMIS Adult v2.0 - Cognitive Function 4a.
Participants must be at least 6 months and no more than 5 years after completion of initial surgery +/- adjuvant chemotherapy/radiation therapy, and targeted therapies (e.g., PARP inhibitors, CDK4/6, or immunotherapy).
The participant must be able to understand, speak, read, and write in English or Spanish.
Patient Health Questionnaire-2 item (PHQ-2) score of ≥ 3.
Definitive clinical or radiologic evidence of metastatic disease
Current or past history of another cancer. Patients with history of only non-melanoma skin cancer or in situ cervical cancer without chemotherapy treatment would be eligible.
Previous exposure to chemotherapy treatment for another cancer or due to other medical condition (e.g., methotrexate exposure for treatment of rheumatoid arthritis).
Voice Assistant to Provide Cognitive Stimulation Therapy at Scale
This project focuses on establishing a preliminary evidence base regarding the feasibility and acceptability of using smart speakers to deliver individual cognitive stimulation therapy (iCST) to persons living with dementia (PLwDs)
Fifteen dyads of persons living with dementia and their care partners will be recruited. Participants will engage with an Alexa-based Virtual Assistant (VA), and data will be collected via surveys and Zoom interviews.
$45 per hour
Ability to speak and understand English
See and hear well enough to participate
No major physical illness or disability affecting their participation
Personal in-home Wi-Fi access and personal device capable of participating in Zoom calls
PSCI# 25-028 LoTAM: A RANDOMIZED, PHASE III CLINICAL TRIAL OF LOW-DOSE TAMOXIFEN FOR SELECTED PATIENTS WITH MOLECULAR LOW-RISK EARLY-STAGE BREAST CANCER
This study is comparing standard of care endocrine therapy for 5 years versus low dose tamoxifen for 5 years in patients with resected invasive breast cancer.
Participants must come to all scheduled study visits, all medications they are taking including over the counter and tell the study doctor how you are feeling.
No tumors that are considered pT4
No definitive clinical or radiologic evidence of metastatic disease
Age ≥ 18 years and female ___
ECOG Performance Status ≤ 2
Any patient with known atypia or endometrial pathology that the opinion of the treating investigator would place the patient at undue risk of endometrial cancer with tamoxifen
Any patient with a known hypercoagulable state that in the opinion of the treating investigator would put the patient at undue risk of venous thromboembolism with tamoxifen.
No synchronous or previous contralateral invasive or non-invasive breast
No previous history of ipsilateral invasive breast cancer or ipsilateral DCIS, regardless of the disease-free interval.
PSCI 24-106 A: A Randomized Phase II Study of Venetoclax and HMA-based Therapies for the Treatment of Older and Unfit Adults with Newly Diagnosed FLT3-mutated Acute Myeloid Leukemia (AML): A MyeloMATCH Treatment Trial
As part of the myeloMATCH Older Adult AML basket, a comprehensive geriatric assessment will be implemented across intensive and non-intensive treatment studies to validate measures of fitness and frailty that predict for treatment-related morbidity and mortality. The overall goal of the geriatric assessment will be to validate measures to be incorporated in future older adult AML myeloMATCH studies to prospectively define “fitness” for intensive chemotherapy.
Subject will either get Azacitidine through a vein in their arm or subcutaneously and Venetoclax by mouth for up to 2 years, or will get Azacitidine through a vein in your arm or subcutaneously, Venetoclax and Gilteritinib as tablets that you take by mouth for up to 2 years.After you finish your study treatment, doctor will continue to follow condition for 10 years.
Patient must have no prior therapy for AML with the exception of hydroxyurea and all-trans retinoic acid (ATRA), or leukapheresis. Patients with cytarabine-based emergency therapy prior to the start of therapy on this trial are eligible.
Patient must be assigned to this protocol by the myeloMATCH MSRP.
Patient must have the ability to understand and the willingness to sign a written informed consent document.
Creatinine clearance of ≥ 30 mL/min/1.73m2
Patient is pregnant or breast-feeding
Patients with a history of hepatitis C virus (HCV) infection have not been treated and cured.
Patient has the medical necessity for ongoing treatment with a strong CYP3A4 inducing drug.
PSCI 24-129 Open-Label, Multicenter, Phase 1 Study to Assess the Safety of P-CD19CD20-ALLO1 in Subjects with Selected Relapsed/Refractory B cell Malignancies
This trial will examine the use of "off the shelf" CAR T in the treatment of cancers that have relapsed or do not respond to treatment.
Participants must keep all study visits, tell the study doctor how you are feeling and all medications you are taking including over the counter medications.
Must have prior biopsy proven confirmed diagnosis of DLBCL NOS (including DLBCL arising from indolent lymphomas), HGBL, PMBCL, and tFL or follicular lymphoma Grade 3B.
Must have relapsed/refractory disease
Must be willing to practice birth control
Concurrent or previous other malignancy within 2 years of study entry
Has active autoimmune disease
Has a history of hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), or human T-lymphotropic virus (HTLV) infection
PSCI 24-106: Myelomatch, Master Screening And Reassessment Protocol (MSRP) For Tier Advancement In The NCI Myelomatch Clinical Trials
The purpose of the study is to see if blood and bone marrow samples can be tested in a timely manner for markers that could guide cancer treatment. The testing will look for markers that specific treatments may target. Based on test results, the subject will have the option to join a myeloMATCH treatment substudy for treatment or receive standard of care treatment from your doctor.
Participants will give bone marrow and blood samples for testing. Your samples will be tested for specific cancer biomarkers.After the study receives the results of your biomarker testing, the physician will tell you if there is a myeloMATCH treatment substudy available that matches your results.If a substudy is available the study doctor will give the subject more information about it and help the subject understand the details of the study.
Participants must be ≥ 18 years of age.
Participants must agree to have translational medicine specimens submitted per
Participants must not have a prior or concurrent malignancy that requires concurrent anti-cancer therapy.
Participants must have a Zubrod Performance Status evaluation within 28 days prior to registration
Participants are less than 18 years of age.
Participants did not agree to have translational medicine specimens submitted per
Participants have a prior or concurrent malignancy that requires concurrent anti-cancer therapy.
Participants did not have a Zubrod Performance Status evaluation within 28 days prior to registration
Cue Reactivity Responses in Alcohol and Cannabis Use
This study aims to examine how alcohol and cannabis cues (i.e. images of alcohol containing beverages or cannabis) influences brain responses in the lab and how cues in the natural environment influence self-reported craving and drug use.
Potential participants will complete a screening questionnaire over the phone, and if eligible, will also complete 3 in-person visits. These visits include an intake session in which eligibility is assessed, a MRI session, 2 weeks of smartphone based responding, and a third visit to complete a questionnaire.
$279
Able to read and write in English and complete study evaluations
Able to provide written and verbal consent
Must report regular use of alcohol and/or cannabis
Able to provide negative toxicology screenings for substances, except cannabis, nicotine, or alcohol prior to eligibility determination
Current regular illicit drug use (other than cannabis)
Any contraindications for MRI
PSCI 24-106 B: A Measurable Residual Disease (MRD) Focused, Phase II Study Of Venetoclax Plus Chemotherapy For Newly Diagnosed Younger Patients With Intermediate Risk Acute Myeloid Leukemia: A Tier 1 Myelomatch Clinical Trial
Participants take part in this research study because they have a new diagnosis of acute myeloid leukemia (AML). Study is looking at to see if treatment can be improved by adding venetoclax to the usual chemotherapy: cytarabine and daunorubicin (also known as 7+3), or azacitidine? This study wants to find out if this approach is better or worse than the usual approach for this type of cancer. The usual approach is defined as care most people get for AML.
Participants will either get cytarabine + daunorubicin + venetoclax for up to 11 days, or you will get azacitidine + venetoclax for up to two months, or you will get cytarabine + daunorubicin for up to 7 days. Subjects treatment may be extended by a few weeks if subject needs additional therapy. Doctor will continue to follow your condition for 5 years and watch subject for side effects and keep track of their health. After study treatment, subjects may also be offered another clinical trial through the myeloMATCH study. Subjects will be followed on this study even if they continue onto another study. Follow-up includes a clinic visit 28 days after subjects treatment is complete, and clinic visits every 3 months for the first year, every 6 months for the second year, and annually for years 3-5 after treatment is completed.
Participants must have been registered to Master Screening and Re-Assessment Protocol
Previously untreated, de novo AML defined by >20% myeloblasts in the peripheral blood or bone marrow
ECOG performance status ≤ 3.
WBC must be <25x109/L.
Patients who are receiving any other investigational agents.
Pregnant women are excluded
Patients with isolated myeloid sarcoma are not eligible
active, uncontrolled bacterial, fungal, or viral infection
PSCI #24-150 A Phase 3 Open-Label, Randomized Study of PDS0101 Plus Pembrolizumabvs Pembrolizumab Alone in First Line Treatment of Immune Checkpoint Inhibitor (ICI) Naïve Subjects with Unresectable Recurrent and/or Metastatic (R/M) Human Papillomavirus 16 (HPV16)-Positive Head and Neck Squamous Cell Carcinoma (HNSCC).
This study will see if pembrolizumab alone or with PDS0101 is the better treatment for head and neck cancer.
Participants will need to come to all study visits, take the study medication as prescribed, tell the study team how you are feeling and report to the study team all new medications you are tsking including over the counter medications.
Have a history of histologically- or cytologically-confirmed diagnosis of recurrent and/or metastatic squamous cell cancer of the head and neck
Subject has adequate organ function
Has had major surgery, including surgical resection of tumor, within 30 days prior
Has received radiotherapy prior
A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 inParticipants with Active Subacute Cutaneous Lupus Erythematosus(SCLE) and/or Chronic Cutaneous Lupus Erythematosus (CCLE) With or Without Systemic Manifestations
Cutaneous lupus erythematosus is an autoimmune condition that causes red, scaly plaques on the skin, often in sun-exposed areas. Complications of cutaneous lupus erythematosus (CLE) include changes in skin pigment, scarring, disfigurement, fatigue, and reduced quality of life. There are no medications currently approved for the treatment of CLE. The purpose of this study is to find out of the study medicine, IMVT-1402, can help with the treatment of CLE.
Total duration of the study is approximately 63 weeks, with up to 55 visits (approximately 1 visit per week). 16 visits will occur in person and 39 visits will be phone call visits.Procedures involved in the study include: medical history collection, physical exams, skin assessments, skin biopsy, photographs, electrocardiogram (ECG), blood draws (at up to 15 visits), urine tests, and questionnaires.
At least 18 years old
Willing to follow all study guidelines
History of HIV or other immunodeficiency
Pregnancy or breastfeeding
Whole blood from healthy volunteers
This research is being done to find out what triggers an immune response in white blood cells. For example, understanding the triggers of the individual interferon responses may lead to future therapies that are more selective for treating an exaggerated immune response.
A single visit for a whole blood sample.
$30.00
18 yrs of age or older
No skin or systemic inflammatory disease
Willing to undergo a 1-time blood collection
Subjects who are currently pregnant
Subjects who have an autoimmune or inflammatory disease
Impact of brief daily functional resistance training on lower extremity physical performance
Our research study is testing a brief exercise program designed to help older adults walk better. The exercise program is done from the comfort of the participants' home for only 5 minutes a day!
Meet with an exercise coach virtually via Microsoft TeamsCome to Penn State Hershey Medical Center 3 times for appointmentsWear a physical activity monitor 3 timesComplete surveys
115
Serious difficulty walking 3 blocks
Computer, iPad, smart phone with a camera
Participating in another research project involving physical activity, falls or weight loss
Inability to walk 10 feet without an assistive device
Pain in chest when doing physical activity
A randomized, double-blind, Phase 3 study comparing efficacy and safety of frexalimab (SAR441344) to placebo in adult participants with nonrelapsing secondary progressive multiple sclerosis.
A study that looks at the efficacy of Frexalimab compared to placebo in adults with nonrelapsing secondary progressive MS.
This study explores the efficacy and safety of Frexalimab compared to placebo in delaying disease disability progression in non-relapsing secondary progressive multiple sclerosis (nrSPMS). There will be about 53 in person visits over 4.5 years that consist of monthly IV medication administration, vitals, monthly blood draw for lab work, clinical outcome assessments, ECG, and Magnetic resonance imaging (MRI) roughly every 6 months. All study activities will be done at the Penn State Health Hershey Medical Center in the Neurology Clinic at 30 Hope Drive and Clinical Research Center (CRC) in the main hospital.
Up to $4300
Previous diagnosis of remitting relapsing multiple sclerosis (RRMS) AND absence of clinical relapses for at least 24 months
Current diagnosis of secondary progressive multiple sclerosis (SPMS) and documented evidence of disability progression observed during the 12 months before screening
Must agree to use contraception for male and female participants
Must be able to sign informed consent or have a legally authorized representative (LAR)
Treatment with lymphoid irradiation, bone marrow transplantation, mitoxantrone, alemtuzumab, cladribine, daclizumab, cyclophosphamide, other strongly immunosuppressive treatments with very long-lasting effects.
Previous exposure to frexalimab, other investigational drug trials, allergy or sensitivity to any of the study interventions.
Contraindication for MRI: pacemaker, metallic implants/presence of metallic material in high risk areas, known history of allergy to any contrast medium, or history of claustrophobia that would prevent completion of all protocol scheduled MRI scans.