Search Results
A Phase 3, Randomized, Double-blind, Placebo-controlled, Cross-over Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Attacks in Adolescents and Adults with Hereditary Angioedema
The purpose of this clinical research study is to learn more about the use of the investigational drug, deucrictibant, for the treatment of HAE. Deucrictibant is designed to block the effects of bradykinin to avoid progression of attacks and lead to the resolution of attacks. In this study, the investigational drug is a soft capsule containing 20 mg of deucrictibant that you will take by mouth. There are already medicines available to treat the manifestations of HAE attacks, but these are injected either into a vein or under the skin. If you are currently on a stable dose of prophylactic treatment to prevent HAE attacks, you will be asked to continue using this at the same dose throughout the duration of the study.
You will need to come to the study site approximately four times. At two of these visits, you will have blood and urine collected. You will have vital signs collected, physical exams, vital signs, and EKG’s performed. You will need to treat two HAE attacks with the study drug, complete questionnaires on an electronic diary, and participate in telephone interviews with the study team.
Diagnosis of HAE-1/2
History of at least 2 HAE attacks in the last 3 months before screening.
Experience with using standard-of-care treatment to effectively manage on-demand treatment for HAE attacks.
Capable of recording, without assistance, electronic HAE diary using an electronic device, as evidenced by the competency assessment conducted during the screening phase.
Any diagnosis of angioedema other than HAE-1/2.
History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse.
Use of attenuated androgens for short-term prophylaxis within the last 30 days before the time of randomization.
Prior gene therapy for any indication at any time.
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
Young Children’s Representations of Parent-Child Negotiation
The goal of this study is to learn how young children think and tell stories about challenges between parents and children. Children will play games and tell stories using toys while caregivers fill out surveys and talk to researchers. This will occur twice, about 6 months apart. Qualities of children's stories, their language and regulation skills, demographic information about children and caregivers, and parenting behaviors will be examined.
At least one caregiver of a child between ages 5 and 7
English-speaking
Middle income
Caregiver at least 18 years old
Children that are not fluent in English
Children who are unable to tell stories with a researcher due to developmental disability or language delay
Children who are younger than 5 or older than 7
Low or high income
The HEALthy Brain and Child Development Study (HBCD)
This multi-site consortium research study, entitled the HEALthy Brain and Child Development (HBCD) study, willprospectively examine human brain, cognitive, behavioral, social, and emotional development beginning prenatallythrough age 10 years. The study will determine the short- and long-term impacts of a variety of potentially harmfulas well as protective environmental factors. These include prenatal substance use, mental health, stress,sociodemographics, biological and genetic factors, and parent/child interaction. The overall goal of this study is tounderstand the neurodevelopmental trajectories of children growing up in diverse environments. A sample of~7,500 pregnant women will be recruited from 25 sites across the U.S. and they and their liveborn children will befollowed for 10 years.
If you agree for you and your child to participate, we will ask you to take part in completing visits from pregnancy through the first 10 years of your child’s life. These visits will take place both in-person and remotely. The length of visits will vary and may last between approximately one to nine hours per visit (which can be broken up into multiple visits). Over the first four years of the study, all study visits will require about 33-37 hours total. This will include interviews, questionnaires and other tests about yourself and your child. We will ask you and your child to wear small devices for a few days to measure heart rate and or movement. We will ask you and your child to provide some biological samples. Because this study is looking at how a child’s brain develops in the first years of life, we will ask that you allow your child to have brain scans and other measures of how your child’s brain is developing. This study is being offered in both State College, PA at the University Park campus and in Hershey, PA at the College of Medicine campus. You may choose to complete this study at either site.
$1,350
Speaks English or Spanish
Does not speak English or Spanish
Cognitive Debriefing: Developing and instrument to measure Internalized Weight Bias among Adolescents
For many years, overweight and obesity has been highly stigmatized in society, and children are often bullied or teased for their weight. Over time, these experiences can cause adolescents to feel badly about themselves and view themselves as society views them. We call this process the internalization of weight bias or IWB. IWB can increase feelings of depression and anxiety and is associated with unhealthy eating behaviors. For this project, we wanted to create a questionnaire to measure this important topic, and get feedback from adolescents and professionals to make sure the questions are correct and easy to understand. We want to recruit 20 adolescents age 12-17 and medical professionals to review some questions and provide their feedback on these questions by participating in an interview. Participants will be compensated for their time.
We would like to interview teens and health professionals to review some survey questions and make sure that the questions we use to measure this concept are appropriate. These interviews will take 60-90 minutes over ZOOM.
30.00
Access to internet
Access to video conference
Permission from Parents
No internet or video conference
Adults
An Open-label Study to Evaluate the Long-term Safety and Efficacy of CSL312(Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema
This phase 3b study will evaluate long-term safety and efficacy ofCSL312 (also known as garadacimab) when administeredsubcutaneously (SC) once monthly for at least 12 months.Subjects entering CSL312_3002 will be from 3 sources:• Subjects who participated in Study CSL312_2001• Subjects who participated in Study CSL312_3001• CSL312-naïve HAE subjects who have not participated ineither of the above studies
During the study, you will be expected to self-administer the study medication by injection under the skin once a month, complete a daily diary, provide blood and urine samples, complete questionnaires, undergo physical exams and have your vital signs recorded.You will visit the site 12 times.
$80.00 plus travel reimbursement
Male or female
Diagnosed with clinically confirmed C1-INH HAE
Experienced ≥ 3 HAE attacks during the 3 months before Screening, as documented in the subject's medical record.
Aged ≥ 12 at the time of providing written informed consent or assent for minors
Use of C1-INH products, androgens, antifibrinolytics or other small molecule medications for routine prophylaxis against HAE attacks at least 2 weeks before the first day of the Run-in Period.
Use of mAbs such as lanadelumab (Takhzyro®) 3 months before the first day of the Run-in Period.
Female subjects’ use of estrogen-containing medications with systemic absorption (eg, oral contraceptive or hormonal replacement therapy within 4 weeks prior to the Run-in Period).
Female or male subjects who are fertile and sexually active not using or not willing to use an acceptable method of contraception to avoid pregnancy during the study and for 3 months after receipt of the last dose of CSL312.
Concussion-Prognosis
Using micro-RNA in saliva coupled with survey data as a prognostic tool with the ability to guide clinical management of concussions
During their baseline visit participants will complete a saliva swab, surveys, balance test and brief neurocognitive test.Day 7, participants will complete a saliva swab and 2 surveys.Day 30, participants will complete a saliva swab and 4 surveys.The baseline visit is the only in-person visit, day 7 and day 30 are done remotely.All surveys are completed online and day 7 and day 30 saliva swabs are sent home with the participants and sent back in a prepaid mailer on day 30.
$40
Diagnosis of concussion
Pennsylvania Adoptees Longitudinal Study (PALS)
This study will examine various factors within the home of children adopted from the child welfare system between the ages of 4 and 10 that may impact their development. The first visit will occur remotely via Penn State Health Microsoft Teams; the second visit is optional and will occur within 4 weeks of the first visit at the Transforming Lives of Children Center in Harrisburg, PA; and the third visit will occur one year after the first visit, when research staff will travel to participants' homes. This research will help understand the factors that impact the development of children adopted from the child welfare system and how we may better serve these children and their families.
The child and parent will be asked to complete interviews, questionnaires and various tasks. Parents may also be asked to complete questionnaires online.Participation will last for one year and include the following:-One visit occurring remotely via PSH Microsoft Teams-One visit at the Transforming the Lives of Children Center in Harrisburg, PA, four weeks after Zoom visit (optional)-Final visit at home will occur one year after the first Zoom visit
$225
Child legally adopted by the caregiver
The same caregiver will participate in each of the visits
A biological parent resides in the same home as the child
Emotion Regulation and Mother-Infant Synchrony
The aim of this study is to better understand emotion regulation in infants by measuring brain, behavior, and mother-infant relational mechanisms. We plan to collect simultaneous brain activation in mothers and infants while they engage in a face-to-face interaction. We will then test associations between individual brain activation, mother-infant brain synchrony, and infant emotion regulation behaviors.
Participants complete questionnaires online, then come in for 1 in-person visit. Mother and baby complete a play and a neutral task while fNIRS is collected from them simultaneously.
40
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
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
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