Bartlett

Researchers are investigating the effects of teplizumab compared with a placebo in children and young adults aged 1 to 25 years who have recently been diagnosed with Stage 3 type 1 diabetes (T1D). This Phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to assess changes in blood sugar control and dependence on prandial insulin over one year. The study follows established criteria for Stage 3 T1D diagnosis and includes participants on standard insulin therapy. Participants will receive either teplizumab or placebo through intravenous infusion. Both treatments are given as a solution for injection. The study spans approximately 84 weeks (18 months) for each participant, with the main treatment period lasting 52 weeks. The trial compares the effects of the two treatments on diabetes management and insulin use over this time. During the study, participants will undergo evaluations of their blood sugar control, including measurements of glycated hemoglobin (HbA1c) and insulin use. For those in European Union countries aged 5 years and older, additional tests will measure insulin production response after a meal. Safety and health will be monitored through regular clinical assessments, lab tests, and antibody screening. The study tracks changes from the beginning through the 52-week treatment period to understand the impact of teplizumab on diabetes progression.

Researchers are evaluating eye health in patients with breast cancer through a multicenter study. The study aims to assess ophthalmic safety by comparing two groups of patients concurrently to account for age-related changes and worsening of existing eye conditions. The study period for ophthalmic assessments will last approximately 12 months to minimize additional burden on participants. The study includes two parallel cohorts, each with at least 60 participants. Ophthalmic examinations will be conducted at the same time points for both groups. These assessments involve tests such as visual acuity using Snellen units, slit lamp examinations, optical coherence tonometry, and fundus examinations to monitor eye health. Participants will undergo ophthalmic evaluations performed by local ophthalmologists and central readers up to 28 days after the study ends. These evaluations include eye scans and detailed eye health reviews. The study monitors changes in vision and eye structure and safety throughout the 12-month period, ensuring participants' eye health is closely observed.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Stage 2 Type 1 Diabetes (T1D) is an early phase of the disease marked by abnormal blood sugar levels but without clear clinical symptoms. Progression leads to Stage 3, where patients experience overt high blood sugar and require insulin treatment. TZIELD(teplizumab-mzwv) has been approved by the US FDA to delay the onset of Stage 3 T1D in adults and children aged 8 years and older with Stage 2 T1D. This research aims to gather general patient information and learn about the long-term effects of TZIELD when used as part of routine care in Stage 2 T1D patients. The study does not provide any treatments but observes patients receiving TZIELD as prescribed in real-world clinical practice. Participants include those starting TZIELD or treated within the last 6 months, as well as those with Stage 2 T1D who are not receiving TZIELD. TZIELD dosing follows a specific schedule from Day 1 to Day 14 with increasing doses, representing standard care. Patients are grouped into TZIELD-exposed and unexposed cohorts for observation. Participants will be followed for up to approximately 10 years to monitor safety outcomes, including adverse events in mothers, fetuses, and infants if applicable, as well as developmental outcomes in infants up to 12 months old. Researchers will assess serious and special interest adverse events throughout the study. Data collection includes long-term safety monitoring and evaluation of disease progression and treatment effects in real-world settings.

Researchers are evaluating the safety and effectiveness of a new treatment combination of lifileucel and pembrolizumab compared to pembrolizumab alone in people with untreated, unresectable, or metastatic melanoma. This Phase 3, multicenter, open-label, randomized study focuses on participants with advanced melanoma stages IIIC, IIID, or IV who have not yet received therapy for metastatic disease, although certain prior adjuvant or neoadjuvant therapies completed at least 6 months prior are allowed. Participants are assigned to one of two groups: one group receives pembrolizumab every 6 weeks along with the lifileucel regimen, which includes tumor resection, non-myeloablative lymphodepletion, lifileucel infusion, and interleukin-2 (IL-2) treatment. The other group receives pembrolizumab alone every 6 weeks until disease progression. Those in the pembrolizumab-only group who experience confirmed disease progression may opt into a crossover period to receive lifileucel monotherapy following the same preparation and treatment steps. During the study, participants will be monitored for tumor response and progression-free survival over a total duration of 5 years. Assessments include tumor measurements following RECIST 1.1 criteria, evaluation of overall health status, organ function tests, and ongoing safety monitoring. The study also tracks treatment adherence and participant well-being throughout the trial and optional crossover period.