Herzliya

Researchers are evaluating whether baricitinib can delay the onset of clinical stage 3 type 1 diabetes (T1D) in children and adults at high risk of developing the disease. This phase 3, double-blind, randomized, placebo-controlled study includes participants aged 1 to under 36 years who have early stages of T1D or multiple diabetes-related autoantibodies indicating increased risk. The study aims to measure the time from the start of the trial to diagnosis of stage 3 type 1 diabetes, with participation lasting up to approximately 5 years. Participants will be randomly assigned to receive either baricitinib or a placebo, both administered orally. The trial compares these two groups to assess the impact of baricitinib on delaying progression to stage 3 T1D. The study's design includes careful monitoring of participants over time to evaluate the effects of the medication or placebo on disease development. During the study, participants will undergo regular assessments to detect the progression of diabetes, including laboratory tests for autoantibodies and clinical evaluations. Researchers will track the time it takes for participants to develop stage 3 T1D, along with monitoring safety and any adverse effects. The total duration of participation can be up to 5 years, ensuring thorough observation of long-term outcomes related to the study interventions.

Researchers are studying whether baricitinib can help preserve beta-cell function in children and adults newly diagnosed with type 1 diabetes. This Phase 3 trial focuses on participants aged 1 to less than 36 years who have recently been diagnosed with this condition. The goal is to understand if baricitinib, compared to a placebo, can maintain insulin-producing cell activity. Participants will be randomly assigned to receive either baricitinib or a placebo, both given orally. The study is double-blind, meaning neither participants nor researchers know who receives the active drug or placebo. Treatment and observation will continue for about 60 weeks. During the study, participants will undergo evaluations including measuring C-peptide levels to assess beta-cell function at the start and after 52 weeks. Researchers will monitor health status, collect laboratory tests, and track any side effects or changes in diabetes-related markers to determine the effects of baricitinib over the study period.

This research evaluates the number of mature eggs produced during ovarian stimulation cycles using a GnRH antagonist protocol for in-vitro fertilization (IVF). It compares two approaches to deciding the timing of the trigger day for egg retrieval: decisions made by physicians versus those guided by an artificial intelligence-based algorithm. The goal is to assess whether the AI algorithm can influence IVF outcomes by optimizing the timing of egg maturity. Participants undergo ovarian stimulation cycles for either egg freezing or fertilization via intracytoplasmic sperm injection (ICSI), where egg maturity is assessed after removing surrounding cells. One group has their trigger day timing decided by their treating physician, while the other group's timing is determined by the AI algorithm. This comparison allows researchers to evaluate differences in the number of mature eggs harvested. Throughout the cycle, mature egg yield is carefully measured and compared between the two groups. The primary outcome is the number of mature oocytes collected over a two-year period. The study includes adults aged 18 to 45 undergoing ovarian stimulation with this specific protocol. Participants are monitored to ensure adherence and safety, with the main focus on egg maturity outcomes.

This research investigates a brief relationship-based intervention for mothers experiencing Post-Partum Depression (PPD) and their infants during the first year of life. Researchers aim to assess whether this dyadic psychotherapy can improve mothers' depressive symptoms, enhance the quality of the mother-child relationship, and increase oxytocin levels in both mother and infant. The study includes mothers diagnosed with PPD between 3 to 8 months postpartum and a comparison group of healthy mothers without psychiatric conditions. Participants with PPD will be randomly assigned to receive either an 8-week dyadic psychotherapy focusing on mother-infant interactions or an 8-week psycho-educational therapy about child development. The dyadic psychotherapy sessions occur once weekly at home for about 90 minutes, incorporating video feedback and cognitive-behavioral techniques. The psycho-educational therapy also takes place weekly at home, emphasizing infant developmental topics and maternal support. Healthy mothers will participate in baseline and follow-up assessments without receiving treatment. Throughout the study, mothers and infants will be assessed at home with videotaped interactions and collection of salivary oxytocin samples at baseline, during treatment sessions, and at the end of the intervention period. Researchers will use behavioral assessments and hormonal assays to measure outcomes related to depression and bonding. Healthy mothers will undergo two assessments spaced 2-3 months apart. The study monitors changes in maternal mood, parenting behaviors, infant social-emotional development, and biological markers over the course of participation.