Search Results
Music Appreciation of Pediatric and Adult Hearing Aid Users over Time
The purpose of this study is to survey hearing aid users over a 6 month time period to see if their music perception improves over time.
Study participants will complete surveys about their music experience four times: first at your initial clinic visit and then sent to your email at 1, 3, and 6 months following your visit. This survey will include questions about the participants experience with music as well as name, age, gender, and duration of hearing aid use.
Hearing aid use
Auditory implants including bone anchored hearing aids
Poor compliance with the use of hearing aids
Age 12 years old or younger
Women and Infants' Stress and Health
The goal of this study is to understand how babies and their mothers learn to respond to stress during the early years of the baby's life. Participating women complete questionnaires and do a mildly stressful task alone (during pregnancy) or with their babies (at four different times over the first two years of the baby's life) and collect saliva samples that tell us about stress responses, either at home or at one of our lab sites. We aim to use what we learn to better support expecting parents who may be at risk for stress-related health problems and improve their children's resilience to stress throughout life.
Women are asked to participate in six sessions over Zoom and/or at the PACT Center between their 28th week of pregnancy and when their child is 2 years old. During these sessions, which last up to 2 hours each, mothers and babies will1.participate in mildly stressful tasks (like having the mother leave the room for up to 3 minutes and then return) and games to assess the baby’s emotional and cognitive development2.provide saliva samples by drooling into a tube (for the mother) or holding a cotton swab in their baby’s mouth to get it wet3.fill out questionnaires about themselves and their baby4.take part in clinical interviews that ask about mood and other markers of psychological ill-being
$220
18 or older
English speaking
Slips of Action in Adolescents and Young Adults
Adolescence is a critical period during which many important healthhttps://irb.psu.edu/IRB/sd/ResourceAdministration/Project/ProjectEditor?Project=com.webridge.entity.Entity[OID[058ACDEB3E43384D816C7E390C2B83F6]]&Mode=smartform&WizardPageOID=com.webridge.entity.Entity[OID[E4552FC57E491543A6B7FD8268E23FD7]] habits form in humans. However, animal models provide mixed information about habit formation across development and there are relatively few human studies that address differences between habit formation in adolescents and adults. To address this gap, the proposed study will assess differences in habit formation in adolescents and adults as measured by the "Slips of Action" task, which seeks to discriminate between habitual and goal-directed learning of visual stimuli pairings.
There will be one in-person visit lasting about one hour. Visits will begin with informed consent. Participants will complete a computer task where they are asked to learn associations between pictures and then will be tested on the associated pairings. They will also complete questionnaires and cognitive tasks.
$20
Healthy adults between the ages of 25 to 40
No learning disabilities (e.g., ADHD) or diagnosed psychological conditions (e.g. anxiety)
Right handed
Not on any medications known to influence behavior
Diagnosed neurological or psychological condition including severe anxiety and/or depression, schizophrenia, learning disability, ADD/ADHD, or autism
Significant family history of neurological or psychological disorders
Left handed
Participant is on any medication that may influence behavior
NMTRC012: PEDS-PLAN – Pediatric Precision Laboratory Advanced Neuroblastoma Therapy
A study of the safety and feasibility of using molecularly guided therapy in combination with standard therapy followed by maintenance therapy with DFMO in patients with newly diagnosed high risk neuroblastoma.
Participating in this study requires that you visit the study hospital Penn State Hershey Medical Center multiple times over the course of the full study for evaluations (physical exam, blood draw, urine analysis, etc.) and scans (MRI/CT, MIBG). Weekly visits may occur at your home institution with your home treating oncologist. As a subject in this clinical trial you are expected to receive treatment on this phase of the study for a total of about 2 ½ years if you complete all portions. After treatment, you will have follow-up examinations and medical tests.
Must be 21 years of age or younger when diagnosed.
No prior systemic therapy with some exceptions.
Tumor samples will be obtained only in a non-significant risk manner and not solely for the purpose of the study.
Female patients who are lactating are not eligible unless they agree not toe breast feed.
NUTRI-Beta Study: A Pilot Clinical Trial for Children with New Diagnosis of Stage 3 Type 1 Diabetes
This will be a 12-week single blinded, randomized, nutrition clinical trial for children with new diagnosis of stage 3 type 1 diabetes (clinical diagnosis of T1D). Beta cell function will be measured after 3 and 6 months.
Study participants in the intervention group will be required to follow the intake of specific foods and adhere to specific nutrition guidelines in addition to follow with a registered dietitian for 12 weeks (4 in person visits and 3 virtual visits). All these visits will be compensated. All study visits will be seen for a screening visit, an enrollment visit, 12-week visit and a 24-week visit. During the study visits, participants will undergo the following: physical exam/ demographic/social evaluation, clinical nutrition evaluation, nutrition counseling, dietary intake assessment, blood test collection, 2-hour Mixed Meal Tolerance Test (MMTT) and anthropometry.
$345
Age 6-17 years old, any gender
Attendance to the Pediatric diabetes clinic at Penn State Health in Hershey, PA
Positive antibodies for type 1 diabetes
History of seafood allergies and/or milk/dairy related allergies
Type 2 diabetes
Food sensory disorders
Pubertal children
A Multicenter, Open-Label, Single Group Clinical Trial to Assess the Pharmacokinetics, Safety and Efficacy of Nemolizumab (CD14152) in Pediatric Subjects (aged 2 to 11 years) with Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis: Open Label, 64 weeks study. Injectable medicine. Males/Females 2-11 years with moderate to severe atopic dermatitis. The goal of the study is assess the uptake of the drug by the body and safety of nemolizumab administered with topical corticosteroids.
Participants will attend in person visit at the Dermatology Clinical Trial office. Dr. Zaenglein is the pediatric dermatologist in charge of this research study and will do all skin evaluations. In addition at different time points there will be blood that is drawn, questionnaires to be completed, and ECGs will be performed.
Study coordinator will discuss.
Diagnosed with Moderate to Severe Atopic Dermatitis
Willing to attend all study visits and follow directions
Had a documented asthma exacerbation requiring hospitalization in the past 12 months.
Weigh less than 22 pounds
A multicenter safety study of unlicensed, investigational cryopreserved cord blood units (CBUs) manufactured by the National Cord Blood Program (NCBP) and provided for unrelated hematopoietic stem cell transplantation of pediatric and adult patients
Study of the safety of unlicensed cord blood units for stem cell transplant of children and adults.
For the treatment arm of this study you will no receive the total body radiation (TBI) as typically given before transplant. In this study you will have various research procedures such as a Blast sample at the screening part of the study, and MRD testing of your bone marrow and blood at screening and through the course of the study. Participation in the treatment arm (Non-TBI) of the study will last up to 5 years.
You are receiving unlicensed CB products from other CB banks
SELVA: A Multicenter, Phase 3 Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX-022 in the Treatment of Microcystic Lymphatic Malformations
Microcystic lymphatic malformations (mLMs) are masses of spongy tissue that may have small fluid-filled cysts. They are made of abnormally large or misshapen lymph vessels that do not work correctly. They are usually present at birth and get worse over time. Complications of mLMs include infection, bleeding, leaking of lymphatic fluid, disfigurement, and impaired mobility. The purpose of this study is to find out if the study medicine, sirolimus 3.9% topical gel, can help with the treatment of mLMs.
Total duration of the study is approximately 14 months, with up to 8 visits (approximately 1 visit per month). 5 visits will occur in person and 3 visits will be phone call visits. You will also complete 2 interviews. After the first 14 months, you will have phone call visits every 84 days until either the study is discontinued, or you decide to no longer participate. Procedures involved in the study include: medical history collection, physical exams, skin assessments, patient interviews, photographs, blood draws (at 3 visits), urine tests, and questionnaires.
At least 6 years old
Willing to follow all study guidelines
History of HIV or other immunodeficiency
PARPAML: A Phase 1 Protocol for Relapsed Pediatric AML to Determine the Safety and Efficacy of the PARP Inhibitor Talazoparib in Combination with Chemotherapy
The purpose of this study is to find out what effects, good and/or bad, study treatment with talazoparib in combination with the chemotherapy drugs topotecan and gemcitabine has on pediatric patients with acute myeloid leukemia (AML) that has returned or has not responded to treatment. The study drug talazoparib has been chosen because there is evidence that is can reduce tumor activity in a more specific way than chemotherapy.
If you join the study, you will given a certain dose of the study drug talazoparib, and of the chemotherapy drugs topotecan and gemcitabine. You may be asked to provide biological samples (such as blood or bone marrow) and undergo procedures that might be different from a regular medical examination. This study will involve screening, treatment, and follow up period. During screening, the study doctor will determine whether you are eligible for the study. If you are eligible and are enrolled into the study, you will have 2-3 months of active participation, including collection of information from you, admission to the hospital for a minimum of 5-7 days, and at least weekly visits to the study center.
BCC015: Phase II Trial of Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma
This is a study of the drug DFMO (difluoromethylornithine) for neuroblastoma that has returned or not responded to treatment. DFMO is an oral drug that inhibits a certain enzyme (protein) in blood which is associated with a bad outcome in neuroblastoma cases. Cancer cells have pathways that drive the cancer to grow and DFMO targets the specific pathway of this enzyme to turn these cells off.
You will have exams, tests, and procedures while on the study to evaluate whether you can participate in the study and how you are doing while on the study. These include physical exams, blood tests, urine tests, bone marrow aspirate and biopsies, heart tests, hearing tests, and imaging evaluations such as CT scans and MIBG or PET scans. You will receive treatment on this study for a total of about 2 years. After treatment, you will have follow-up examinations and medical tests. We would like to continue to find out about your health for about 5 years after you complete the study.
Completed upfront therapy with at least 4 cycles of aggressive multi-drug chemotherapy
Currently receiving another investigational drug
BCC022: Phase II Trial of Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma
The purpose of this research is to evaluate the investigational drug, tipifarnib (a pill taken by mouth), in combination with the FDA approved drug, naxitamab, administered intravenously (IV; a liquid that continuously goes into your body through a tube that has been placed during a surgery into one of your veins).
You will be asked to come in for screening and at the start of each cycle (every 28 days), and at the end of study treatment to have tests done (these may include a physical exam, blood tests, and electrocardiogram [ECG]). During the first cycle you will need to have blood tests done weekly. You will also need to come in during Days 1-5 of each cycle to receive the study treatment. You will also have scans and a bone marrow biopsy (tissue sample) and aspirate (fluid and cells) done at the start of study, every 2 cycles, and at the end of study.
Age >12 months of age at enrollment
Age 6 years or older for safety run in
Currently receiving another investigational drug
Lexical and sentence processing in novice L2 learners: Psycholinguistic and neurocognitive investigations
We are studying how children and adults learn second languages in the classroom. To do this, we ask children and adults to read words or sentences in English and in Spanish while we record brainwaves using noninvasive sensors. The participant wears a cap that looks like a swimmers cap with the sensors attached to it.
Middle school students enrolled in first year Spanish
Monolingual English speaker
Right-handed
Normal or corrected-to-normal vision
History of neurological disorders
Uncorrected vision
ATHN 10: Rare Coagulation Disorders Project
This is a multi-center project in which the American Thrombosis & Hemostasis Network (ATHN) will offer free genotyping to individuals with Rare Coagulation Disorders (RCD).
One tube of blood will be collected during a routine clinic visit.
Must currently receive or have received care at and ATHN affiliated HTC
Subject must have opted into the ATHNdataset
Attention and Emotional Development in Children
Children with attention problems often feel anxious or worried, and likewise, children who are anxious or worried often have problems with attention. We are looking for children aged 8-12 who may or may not have problems with attention or anxiety to help us understand what happens in the brain that could explain why. You will receive up to $100 gift card for your participation, and informal clinical feedback on your child.
Two in person visits of 2 hours each to the University Park campus, scheduled at the participant(s) convenience
$100
History of seizures or photosensitive epilepsy
Advanced fMRI Study on the Functional Abnormality of BNST in Anorexia Nervosa Restricting-type
This research is being done to better understand how certain parts of the brain may react differently in people who have a particular eating disorder, anorexia nervosa, which may help us understand why they respond to food in the way they do. This may help us design more effective treatments for people with anorexia nervosa.
You will complete a package of surveys for personality, psychopathology, an evaluation of taste functions, and an MRI/fMRI examination.
Up to a total of $100.
Anorexia nervosa restricting type patients
Healthy volunteer with normal body weight
Right-handed
Fluent in written and spoken English
Pregnancy or breastfeeding
History of diabetes, substance abuse, head trauma
Allergy to milk and milk products
Cannot have MRI due to claustrophobia or specific implants
Drawing and Anxiety Study Phase 2
This study will test the efficacy of novel guided drawing activities for reducing anxiety in young adults
For this study, your teen will be asked to in a 90 minute in-person lab visit. Cardiac data will be recorded as your teen engages in a drawing activity. Your teen will also answer questionnaires during the visit and again approximately one week later, online via Qualtrics. This final questionnaire will take approximately 30 minutes to complete.
$25
Youth must be able to speak, understand and read English.
2.Youth who cannot speak, understand, and read English.
The Ecology of Infant Emotion-Regulation
This study aims to understand how emotion regulation in infants develops within the context of family and community support. We're particularly interested in the relation between mother-infant synchrony, facilitated by family and community support, and infant emotion regulation. We will use a multi-method approach to collect simultaneous brain activation in mothers and infants, infant's physiological responses, and information about family and community support.
Participants complete an online survey, then come in for 1 in-person visit. This research aims to find out how patterns of brain activation in infants and mothers and infant physiological responses relate to the real life, face-to-face interactions that mothers and babies usually engage in.
50
Infants born 3 weeks within their due date.
Infants of a birth weight > 2500 g.
Infants with NO serious medical complications.
English-speaking families.
Infants who experienced any serious medical complications.
Infants who were born > 3 weeks before the indicated gestational period.
Families who do not understand and do not speak English
Investigation of Digital Media Use, Anxiety, and Biobehavioral Emotion Regulation in Adolescents
Over the past few decades, the social world of teens has been transformed by the use of digital technology. This study will examine associations between digital media use and emotions in adolescents' daily lives.Youth and their parent will complete questionnaires and semi-structured clinical interviews regarding the youth’s emotions, social experiences, and possible anxiety symptoms. For 10 consecutive days, youth will complete one computerized task once per day and four mini questionnaires via the Wear-It app on the youth's mobile device.Some youth will also participate in a lab visit that will last approximately two hours. Six months later, all youth will be asked to repeat one computerized task once per day and four mini questionnaires via the Wear-It App on the youth's mobile device.One year after enrollment, participants will complete final questionnaires, interviews, one computerized task once per day and four mini questionnaires via the Wear-It App on the youth's mobile device. Some youth will also participate in a lab visit that will last approximately two hours.
Over the past few decades, the social world of teens has been transformed by the use of digital technology. This study will examine associations between digital media use and emotions in adolescents' daily lives.Youth and their parent will complete questionnaires and semi-structured clinical interviews regarding the youth’s emotions, social experiences, and possible anxiety symptoms. For 10 consecutive days, youth will complete one computerized task once per day and four mini questionnaires via the Wear-It app on the youth's mobile device.Some youth will also participate in a lab visit that will last approximately two hours. Six months later, all youth will be asked to repeat one computerized task once per day and four mini questionnaires via the Wear-It App on the youth's mobile device.One year after enrollment, participants will complete final questionnaires, interviews, one computerized task once per day and four mini questionnaires via the Wear-It App on the youth's mobile device. Some youth will also participate in a lab visit that will last approximately two hours.
$495
Speak, write and read English
Must reside and participate from the US
Neurological disorders (ie, Autism, seizures)
Youth of parent not between 14-16.9 years of age
Those not residing in or participating from the US
Normalizing preteen HPV vaccination with practice-based communication strategies (Protect Them)
This study seeks to adapt and test a culturally-relevant, web-based game intervention to motivate Spanish-speaking preteens to initiate and complete human papillomavirus (HPV) vaccination. The present study will adapt an existing web-based game developed as an educational tool on HPV vaccination for English-speaking preteens in North Carolina. The study includes the recruitment of paired dyads (Spanish-speaking preteens and parents) to focus groups to evaluate the acceptability of cultural adaptations to the existing web-based game intervention. We will recruit up to 25 parents and preteens ages 11-12 who will receive a link to the Spanish game to play for 7-10 days in advance of the focus group discussions. The focus groups will ask participants about cultural and language adaptations to the existing game and how they react to a game that will serve as an interactive, educational tool on HPV vaccination. The focus groups will take place in Harrisburg, PA between January and March of 2018. No health information will be collected as part of this study.
Not vaccinated with the HPV vaccine
Have computer, tablet, or smartphone
Children’s reaction to multimodal cues in instructional materials
We aim to study how minoritized students perceive multimodal cues in instructional materials to improve STEM teaching for their STEM identity development.
To participate in the study at Penn State, students will be accompanied with their parent or a legal guardian. During the 40-minute session, participants will be asked to complete a brief survey and take part in an interview.
$50
English is understood by prospective subjects or representatives
English is not understood by prospective subjects or representatives
Prevalence of Avoidant Restrictive Food Intake Disorder (ARFID) traits among children and adolescents with Food Allergy
This study looks at understanding eating behaviors and attitudes toward food in children/adolescents. More specifically the study's goal is to compare those with and without food allergies to gain a better understanding of a possible underlying factor towards certain behaviors. Children and their caregivers will complete a survey composed of a short section on the child's medical history regarding allergies followed with questions in commonly used clinical assessments.
Age 18 years or older
Intellectual disability preventing comprehension of questions
Child and/or caregiver unable to respond to English-language questionnaire
Parent-to-child anxiety transmission in early childhood: Capturing in-the-moment mechanisms through emotion modeling and biological synchrony
Anxiety can emerge as early as pre-school age (4-7) and is often linked to anxiety in the parent. This study will examine patterns of brain and behavioral synchrony in parent-child pairs as they complete puzzles together and other social activities.
Participation requires three steps; a remote video session with the primary parent, an in-lab visit scheduled with the primary parent and child, and then an additional set of questionnaires given to the secondary caregiver.The remote session consists of obtaining consent, 2 questionnaires, and a clinical interview. The in-lab visit typically lasts about 2-3 hours, consisting of two parent-child activities and several child-only activities. Participants will be asked to wear mobile eye-tracking glasses and special caps used to measures brain activity during some of the tasks.
$125, $100 for the primary parent/or child and $25 for secondary parent
Children ages 4 to 6
Children less than age 4 or over age 6
Mechanisms of New-Onset Autoimmunity-Longitudinal Immune Systems Analysis
The purpose of this study is to investigate why some individuals who have a few findings of autoimmunity eventually develop a condition such as systemic lupus erythematosus (SLE). In addition to stored biosamples from the SMILE clinical trial, new samples will be collected from persons with findings such as lab tests that are suggestive of lupus with an emphasis on recruitment of individuals ofnon-European ancestry, who were under-represented in the previous clinical trial.
Participants in this study will answer questions about their health and have a short physical exam performed on them. They will provide a blood and urine sample. These procedures will be repeated every twelve months for three years (a total of four times). Both routine and experimental tests will be performed on the blood and urine samples. Genetic studies will be done to help understand the risk of developing lupus.
positive ANA test of at least 1:80
Have one or more additional features of lupus
Able to give assent or consent.
Current or past use of immunosuppressants
Have a diagnosis of another autoimmune disease, other than autoimmune thyroid disease.
The Role of Parental Emotion Regulation in Parent-Child Conflicts
This study seeks to examine parenting skills in responses to child misbehavior. Parents complete rating scales about their child's symptoms and behaviors and also participate in computer tasks to measure brain wave activity through EEG. There is an optional section where parent and child will be video recorded while completing activities together. Following the testing sessions are 8 weeks of counseling sessions for parents to help better manage their child's attention and behavior symptoms.
Participants will complete C-DISC while caregiver will complete rating scales around ADHD, ODD, and CD symptoms during initial visit. On the second visit, participants will complete emotion regulation tasks while EEG data is collected. Caregivers will also complete a monetary task while connected to EEG equipment. Parents will use LifeData to report inattentiveness, hyperactivity, and oppositional behaviors over 14 days. Optional parent child interaction and 8-week parenting intervention are offered to participating families.
$50
Child must have mild to moderate symptoms of ODD
Non-English speaking
Child with ADHD has diagnosis of mental retardation or prominent traits of autism
No additional child in the family can be enrolled simultaneously in this study
Interoception, the 8th Sensory System, Is it measurable?
Sensory processing is often affected in children and adolescents with ASD (autism). The 8th sensory system, coined interoception, is under studied in how it affects children with autism. Our study will compare children with and without autism (ages 11-18 years) using a tool we are developing. Our study hopes to develop psychometric properties of a tool to measure this new sensory sense.
Reading at 5th grade level in English
Healthy controls OR high functioning Autism
Under age 11 or over age 18
Cannot read English
A Phase 4, Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety ofSPN-812 in Preschool-Age Children (4 to 5 years old) with Attention-Deficit/Hyperactivity Disorder (ADHD)
The purpose of this study is to learn more about the use of an investigational drug for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in preschool-aged (4-5 years old) children.
If after Visit 1 (Screening) your child is found to be eligible to take the study drug, he/she will need to come to the study center for 7 additional visits (Visits# 2-8; 6 weeks) and you will receive a follow-up phone call one week after your child’s last study visit (or after your child takes the last capsule of study drug). Most visits will be scheduled 1 week apart. Every participant will take 1 capsule each day for 6 weeks. Your child will either take one SPN-812 capsule every day for 6 weeks or a Placebo capsule every day for 6 weeks.
$650
Subject’s parent(s) or legal guardian(s)/representative(s) is (are) willing and able to provide written informed consent, including a signed Informed Consent Form
Has a primary diagnosis of ADHD
Is participating in a structured group activity (e.g., preschool, kindergarten, sports, Sunday school or child care program)
Is not currently receiving a behavioral intervention for ADHD at the time of screening nor plans to receiving a behavioral intervention for ADHD throughout their study
Has a current diagnosis of a major neurological disorder.
History of Bipolar Disorder diagnosed in a first degree relative.
Has global development delay or intellectual disability by medical history.
Has body mass index > 95th percentile for the subject’s age and gender.
The Penn State Personalized Research for Innovation, Discovery, and Education (PRIDE) Program.
The Penn State Personalized Research for Innovation, Discovery, and Education (PRIDE) Program.The aims of the PRIDE Program are to:1. Create a centralized Biorepository using extra blood obtained from a clinically-ordered, or another IRB approved research protocol initiated blood draw, leftover biospecimens that are removed during medically indicated procedures or a saliva sample from consented participants that do not have clinically ordered blood draws or a medical procedure.2. Construct a dynamic database of health and related data (via both manual and electronic abstraction) from consented participants.3. Establish a mechanism for approving use of the banked biospecimens for future research.
The participant will meet with PRIDE Program team member in person to join the study.The participant with supply a saliva sample for the program.There is no compensation for joining the PRIDE Program.
Ability of patient, child and/or parent to understand or complete the consent process
Livestreaming, Content Creation, and Playing and Learning Online
This study surveys how different viewers, livestreamers and content creators learn and engage online. We are recruiting people who view or create content on livestreaming platforms such as Twitch, YouTube or Mixer (past or present). This study involves filling out a survey which should take 15-20 minutes to complete. Participants will be entered into a drawing to win one of 20 $75 e-gift cards for their participation.
people who watch livestreams
aged 13 or older (if not yet legally adults, with parental/guardian permission)
online content creators
gamers or esports viewers
cannot read, communicate or provide consent in English
does not livestream or watch livestreams or create content online
if a minor, does not have parental/legal guardian permission
BCC018: A Phase II Study of Naxitamab Added to Induction Therapy for Subjects with Newly Diagnosed High-Risk Neuroblastoma
This study is being done to learn if it is safe to add naxitamab to standard therapy during the Induction phase of care for patients with newly diagnosed high-risk neuroblastoma. Naxitmab is an immunotherapy agent which trains your immune system to target your tumor in a more specific way than chemotherapy does.
This study has 3 phases- screening, treatment, and follow up. If you join the study, during screening we will test a sample of your tumor along with your blood. The tumor sample will be obtained at the same time as you are having surgery or a biopsy. Other testing will be done to make sure you are eligible to receive treatment. If you are eligible for treatment, you will receive five 21 day cycles of anti-cancer medication (induction chemotherapy) along with naxitamab. You will have to stay in the hospital to receive this treatment for at least 6 days of each 21 day cycle. If your screening testing also shows a certain genetic change in your tumor, we may also add a medication that is targeted at that change. If your tumor does not respond adequately to the initial cycles, we may give up to three additional 21 day cycles of chemotherapy with naxitamab. You will also have procedures at certain timepoints during induction that are standard of care for your tumor. These include collecting stem cells for use later in your therapy after Cycle 2. After Cycle 4, you will have surgery to remove as much of the tumor as possible. The treatment phase will last about 8 months, after which you will be in follow up. During your time on the study, we will ask to collect research samples of blood, bone marrow, and tumor. We will be monitoring your progress and health throughout your time on treatment and in follow up.
≤ 21 years of age at initial diagnosis and > 12 months of age at time of enrollment
Receiving any investigational drug
Hidradenitis Suppurativa: Evaluation of Upadacitinib in Adult and Adolescent Subjects
Phase 3, global, randomized, double-blind, placebo-controlled, multi-center study that will evaluate upadacitinib in the treatment of moderate to severe HS in adult and adolescent subjects who have failed to respond to or are intolerant of ant-TNF therapy and/or 1 approved non-anti-TNF-biologic therapy for HS.This study is comprised of a 35-day screening period, a 16 week placebo-controlled, double-blinded treatment period (Period 1), a 20-week re-randomized extension treatment period (Period 2), a 68-week long-term extension treatment period (Period 3) and a 30-day follow-up period.
You will completed 3 study periods over approximately 104 weeks. During that time at different time points you will have your skin examined, ECG, complete questionnaires, and have your labs drawn. In addition you will take the study medication as directed by the research study coordinators.
2 active HS areas
History of previous use ≥ 1 TNF inhibitor for at least 12 weeks and/or 1 approved non-anti-TNF biologic therapy for HS for at least 16 weeks - study coordinator will discuss
Must agree to use daily wash