Fair Lawn

This study aims to collect prospective safety and effectiveness data for the C-Brace System, a microprocessor-controlled knee ankle foot orthosis, following standard care practices. The research focuses on patients with lower extremity pareses who are fitted with the C-Brace device. The goal is to better understand how the C-Brace influences walking speed, balance, risk of falling, and confidence in balance over time. The C-Brace is a custom-made device with thigh, calf, and foot components connected by an ankle joint or spring element. It uses sensors to continuously monitor knee joint movement and walking phases, adjusting hydraulic resistance and knee motion accordingly. Patients enrolled in the registry will undergo baseline evaluation, fitting, training or therapy sessions, and follow-up visits at 6, 12, 24, and 36 months after fitting. Participants will be assessed through various tests including timed walk tests, balance confidence scores, and mobility assessments at different intervals. The study also tracks falls related to device use and changes in activity levels with an activity tracker. Data collected will help characterize the safety and functional impact of the C-Brace over three years of follow-up.

Researchers are evaluating ARQ-234, a subcutaneous injectable biological drug, in a first-in-human, Phase 1, double-blind, randomized, placebo-controlled, dose-escalation study. The study aims to assess the safety, tolerability, how the body processes the drug (pharmacokinetics), and its biological effects (pharmacodynamics) in healthy volunteers and participants with moderate to severe atopic dermatitis. The study includes healthy volunteers and participants diagnosed with moderate to severe atopic dermatitis, a condition also known as eczema. The trial has three parts: Part A involves single ascending doses (SAD) of ARQ-234 in both healthy volunteers and participants with atopic dermatitis; Part B studies multiple ascending doses (MAD) in participants with atopic dermatitis; and Part C is a proof-of-concept expansion evaluating ARQ-234 in participants with atopic dermatitis. Participants may receive ARQ-234 or a placebo, with doses increasing over time to assess safety and effects. Participants will be involved from screening through follow-up visits lasting up to 16 weeks for Part A and up to 30 weeks for Parts B and C. Assessments include monitoring adverse events, changes in the Eczema Area and Severity Index (EASI), body surface area affected, itch severity, and other eczema severity scores. Blood tests will measure drug levels, and safety evaluations will include medical exams, vitals, ECGs, and lab tests. This comprehensive monitoring helps researchers understand the drug's impact and safety in both healthy individuals and those with atopic dermatitis.

Researchers are conducting a Phase 1 clinical trial to study the safety, tolerability, pharmacokinetics, and pharmacodynamics of CAY001, a drug given intravenously. This first-in-human, randomized, double-blind, placebo-controlled study involves healthy male and female volunteers aged 18 to 50 years. The goal is to better understand how CAY001 behaves in the body and how safe it is at different dose levels. Participants will be randomly assigned to receive either CAY001 or a placebo. The study will test three different dose levels of CAY001 given as a single ascending dose to groups of subjects. Approximately 24 healthy volunteers will take part in this study. Each participant will be closely monitored during and after dosing to evaluate the effects and how the drug is processed in the body. During the study, researchers will perform physical exams, vital sign checks, electrocardiograms (ECGs), blood and urine tests, and other laboratory assessments to track changes from the start of the study through 28 days after dosing. Safety will be carefully monitored by recording any adverse events and changes in various health parameters. Pharmacokinetic measurements will also be taken up to 24 hours after dosing to understand the drug's behavior. Participants will be involved in scheduled visits and assessments throughout the study period to ensure their well-being and to collect necessary data.