Broomfield

Researchers are evaluating a personalized management strategy for people with symptoms suggesting coronary artery disease (CAD). The study compares this strategy, which uses AI-based software to analyze coronary plaque from CT scans, against the usual care based on current guidelines. The goal is to see if this new approach improves diagnosis certainty, risk factor control, and referral efficiency for invasive coronary angiography with appropriate percutaneous coronary intervention (PCI). This is a prospective, randomized, open-label trial focusing on symptomatic patients suspected of having CAD. Participants assigned to the personalized management group will undergo a coronary CT angiography (CCTA) at the start. The images from these scans are processed using Cleerly Labs and Cleerly ISCHEMIA software to assess coronary plaque. This information is used to guide medical and interventional treatment decisions. The usual care group will receive standard diagnostic and treatment approaches based on American Heart Association/American College of Cardiology guidelines. During the study, which lasts about one year, researchers will monitor participants to evaluate the effectiveness and efficiency of these management strategies. They will measure outcomes such as improved diagnosis certainty, better control of CAD risk factors, and more appropriate use of invasive procedures like PCI. Safety and adherence will also be followed throughout the study period to understand the overall impact of the personalized approach compared to usual care.

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.

Researchers are evaluating two platelet-based treatments for painful lumbar degenerative disc disease in adults aged 25 to 65. This single-blind, randomized, placebo-controlled study compares these treatments given 4 weeks apart against sham procedures. The study aims to observe improvements in pain and function up to 12 months after treatment, with a primary focus on changes reported 3 months after the second treatment.

Researchers are investigating a treatment for craniocervical junction (CCJ) instability caused by injuries to the alar, accessory, and transverse ligaments. The study compares the safety and effectiveness of using an anterior injection approach through the posterior oropharynx with bone marrow concentrate (BMC) against a sham procedure. This method aims to offer an alternative to invasive surgery for patients experiencing symptoms such as headaches, dizziness, and imbalance related to upper cervical ligament injuries. The study involves two groups: one receiving two treatments of bone marrow concentrate injections three months apart, and the other receiving two sham procedures at the same intervals. For the treatment group, bone marrow is collected from the patient's pelvis, processed to extract platelet-rich plasma and other components, then injected into the damaged ligaments under anesthesia using fluoroscopy and endoscopic guidance. The sham group undergoes similar anesthesia and bone marrow aspiration but receives only skin punctures to mimic treatment without active injections. Participants will be monitored through clinical questionnaires and digital motion x-rays three months after their second procedure. The main outcome measured is the change in Headache Impact Test scores from baseline. Patients who initially receive the sham procedure may choose to crossover to the treatment group after unblinding at three months. The study includes safety monitoring and thorough follow-up evaluations to assess treatment impact and patient recovery over this period.

This research aims to learn how incentives affect anxiety and cooperation in children aged 6 to 17 undergoing stressful medical procedures. It focuses on whether incentives can reduce distress during procedures and explores the best way to offer incentives, either conditionally based on behavior or unconditionally. The study also looks at patient anxiety levels and satisfaction with their visit. Participants will receive support and preparation from a Certified Child Life Specialist before and during their medical procedure. They may be assigned to one of three groups: standard support without incentives, support plus an incentive given only if they meet a coping goal during the procedure, or support plus an incentive given unconditionally after the procedure. During the study, researchers will observe participants' distress and ask them to rate their anxiety using validated scales immediately after the procedure. They will compare anxiety levels between those who did and did not receive incentives to understand the impact of incentives on procedural anxiety. Participants will be closely supported throughout the process, and their responses will help evaluate the effectiveness of incentive use in this setting.