This study is being conducted in women who are at least 22 years old,+ and will be undergoing either a unilateral or bilateral mastectomy with immediate two-stage post-mastectomy alloplastic prepectoral breast reconstruction (initial insertion of a tissue expander on top of the chest wall muscle followed by change-over to a breast implant after a period of tissue expander inflation).
The purpose of this research study is to evaluate the safety and effectiveness of the Melodi Matrix. .
The Melodi Matrix is an absorbable mesh that contains antibacterial agents (medicines that fight infections caused by bacteria) and is wrapped around tissue expanders before being implanted. After approximately 9 weeks, the mesh will fully absorb into the body.
For this pilot study, children diagnosed with ADHD starting stimulant treatment for the first time, or have not received stimulant treatment in the prior 6 months, in rural settings will be the focus of efforts to improve time to optimal symptom control, in an effort to maximize the treatment benefit for the academic year. We anticipate that more frequent provision of information by families and teachers to medical providers, enabled by technology and remote monitoring tools, will encourage more rapid improvement in symptom burden. This would be achieved through timely, even weekly, titration of medication per the current treatment guidelines, which is only possible with symptom reports.
The goals of this pilot study are 2-fold:
• Evaluate caregiver and teacher utilization of the RAMP platform early in the treatment course of ADHD
• Evaluate provider utilization of the RAMP platform in everyday practice and management of children early in the treatment course of ADHD
This is a randomized, single-blind controlled, two group, multicenter trial
preceded by a safety run-in, in patients with Hepatorenal Syndrome (HRS) –
Acute Kidney Injury (HRS-AKI) to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of the Relaxin Agonist R2R01 Plus Terlipressin Versus Terlipressin Alone in Patients.
This is a Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group, 3-arm, multiple dose level study to investigate the efficacy and safety of subcutaneous injections of amlitelimab in participants aged 12 years and older with moderate-to-severe AD who are on background topical corticosteroids or calcineurin inhibitors and have had an inadequate response to prior biologic or oral JAKi therapy. There will be up to 13 visits including up to a 4-week screening period, a 36 week treatment period, and a post-treatment safety follow up period or a long-term Safety Study for 16 weeks. Subjects will be randomized in a 1:1:1 ratio to the following study arms: amlitelimab Q4W, amlitelimab Q12W, and placebo Q4W.
This study is for subjects that are premenopausal and have a higher-than-average risk of developing breast cancer. The main purpose of this study is to determine if using change in breast density to guide personalized tamoxifen dosing is better or worse than the usual approach for premenopausal women with dense breast tissue at higher-than-average risk of developing breast cancer. Subjects can expect to be in this study for up to XX months.
If a person has symptoms of an upper respiratory infection, the sponsor is developing a blood test to help decide if it is bacterial or viral infection. Using a blood sample, the test will give a score of 0-100 to help decide along with your symptoms if antibiotics are necessary for treatment.
Substudy: Subjects with suspected infection will give a blood sample for the evaluation of certain biomarkers to help determine if the biomarkers can predict the disease progression to severe disease.
If a person has symptoms of an upper respiratory infection, the sponsor is developing a blood test to help decide if it is bacterial or viral infection. Using a blood sample, the test will give a score of 0-100 to help decide along with your symptoms if antibiotics are necessary for treatment.
Substudy: Subjects with suspected infection will give a blood sample for the evaluation of certain biomarkers to help determine if the biomarkers can predict the disease progression to severe disease.
Millions of children are victims of maltreatment each year in the United States. Research on home visiting programs show that child maltreatment can be prevented; however, these programs struggle to reach families in need and provide high quality care. SafeCare is a sustainable and effective home visiting child maltreatment prevention program, serving over 8,000 families each year. This study will examine the feasibility and implementation of a hybrid in-person/virtual delivery model for SafeCare with 12 home visiting providers and 40 caregivers to inform how home visiting programs are delivered to maximize reach to families, improve family outcomes, and decrease harm to children.
This study is for women with inflammatory breast cancer. This study is being done to see if by adding the drug olaparib to the usual radiation therapy will lower the chance of their cancer returning.
The COVID and Diabetes Assessment (CODA) study is for adults who have been diagnosed with type 1 diabetes or type 2 diabetes within the last 90 days. This study will examine if having a recent COVID-19 infection may impact the course of diabetes. We will gather information about both diabetes and COVID-19 infection. Participants will be followed for 2 years and asked to complete surveys and provide blood samples. No treatment or medications are involved in the study.