Greenwood Village

Researchers are investigating how bone mineral density changes during long-term treatment with the relugolix combination tablet in premenopausal women aged 18 to 50 who have heavy menstrual bleeding caused by uterine fibroids or moderate to severe pain related to endometriosis. This Phase 3B, single-arm, open-label study aims to assess the safety and effects of up to 48 months (4 years) of continuous treatment, followed by a 1-year post-treatment follow-up period. Participants will receive a daily fixed-dose tablet containing relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg. Bone mineral density will be monitored every 6 months using dual-energy X-ray absorptiometry during treatment. Some women who completed a prior related study may join for 3 years of treatment under this protocol. After treatment ends or if stopped early, participants will be followed for 1 year with bone density checks at 6 and 12 months. Women in the study will have regular physical, gynecological, and laboratory assessments to monitor health and treatment effects. Researchers will measure the percentage change from baseline in bone mineral density at the lumbar spine after 48 months of treatment. Safety and health status will be closely observed throughout the treatment and follow-up periods to understand the long-term impact of the relugolix combination tablet on bone health.

Researchers are conducting a Phase 2, double-blind, controlled, randomized study to evaluate the safety and preliminary effectiveness of a single dose intradiscal injection of BRTX-100 in adults diagnosed with chronic lumbar disc disease (cLDD). This condition involves back and/or radicular pain caused by degenerative changes in the spinal discs, confirmed through patient history, physical examination, and imaging tests like CT, MRI, or other accepted methods. The study aims to assess outcomes with blinded assessments over an extended period. Participants will be randomly assigned to receive either the active treatment, BRTX-100—hypoxic cultured mesenchymal stem cells from the participant's own bone marrow combined with platelet lysate—or a control treatment involving a sham intradiscal injection following bone marrow and blood harvest. The study includes a Safety Run-In phase with a 3+3 design for the first four subjects receiving BRTX-100 at a specified dose, with a 14-day safety monitoring period between doses. Participants will have scheduled visits at Weeks 2, 12, 26, 52, and 104 or upon early termination. During the study, participants will undergo various assessments including safety evaluations from baseline through Week 104 and efficacy measurements through Week 52. Monitoring includes physical exams, lab tests, and adverse event reporting reviewed by an independent Medical Monitor and possibly a Data Safety Monitoring Board. The total participation time covers up to two years to observe both safety and preliminary treatment effects in detail.

This research aims to evaluate the safety and effectiveness of NT 201 compared with a placebo in adults who have moderate to severe platysma prominence, which involves noticeable bands in the neck muscles. The study is a Phase 3 clinical trial conducted in the United States, focusing on assessing the impact of this treatment on these muscle bands using a specific rating scale. Participants will receive either NT 201, a botulinum toxin type A injection, or a placebo during the Main Period (MP) of the study. After this, there is an Open Label Extension Period (OLEX) where participants may continue to be observed or treated. The NT 201 is provided as a powder that is prepared for injection, and the study is designed as a randomized, double-blind, parallel-group trial across multiple centers. During the study, participants will be closely monitored with assessments that include both the investigator's and participant's ratings of platysma prominence using the Merz Aesthetics Platysma Scale - Dynamic (MAPS-D). The primary outcome is measured at Week 2 of the Main Period by evaluating the improvement in platysma appearance. Safety and efficacy will be carefully tracked throughout the study periods to ensure participant well-being and to gather comprehensive data on treatment effects.

Researchers are evaluating the safety and effects of two study medicines, PF-07275315 and PF-07264660, in adults with moderate to severe atopic dermatitis (AD). AD is a long-lasting itchy red rash caused by a skin reaction. The study seeks participants aged 18 or older who have had AD for at least six months, have not responded well to topical treatments, and are considered by their doctors to have moderate to severe AD. The study is divided into four stages. In Stage 1, participants received either PF-07275315, PF-07264660, or placebo; this stage is complete. In Stage 2, participants receive either PF-07275315 or placebo. In Stage 3, participants who previously received anti-inflammatory proteins will receive PF-07275315 or placebo. In Stage 4, participants will receive PF-07264660 or placebo. All treatments are given as multiple shots under the skin at the clinic during each stage. Placebo shots look like the study medicines but contain no active drug. Participants will be involved for up to 40 weeks (10 months) in Stages 1, 2, and 4, and up to 52 weeks (13 months) in Stage 3. Researchers will regularly assess their skin condition, measure improvements, and monitor for any side effects. The main outcome is the number of participants achieving at least 75% improvement in their eczema severity score at week 16. Participants will attend scheduled visits, lab tests, and follow study procedures throughout the study.

Researchers are evaluating the safety and effectiveness of the ReGelTec HYDRAFIL System in adults aged 22 to 85 who suffer from axial chronic low back pain caused by degenerative disc disease (DDD). This study focuses on individuals who continue to experience severe back pain and disability despite at least six months of conservative care. The study is a multi-center, prospective, randomized, controlled pivotal trial designed to assess this treatment approach. The study compares two approaches: the ReGelTec HYDRAFIL System, which delivers an injectable hydrogel implant designed to treat degenerative lumbar discs, and conservative care management, which may include physical therapy and pain medication. Participants have one or two symptomatic lumbar discs eligible for treatment based on imaging and diagnostic criteria. Treatments are administered according to the study protocol, with only one or two discs treated during the study period. Participants will be closely monitored for clinical success over a 12-month period, including assessments of symptoms and functionality. The study involves follow-up visits, imaging such as MRI and discography, and questionnaires to track safety and effectiveness. Researchers will measure a composite endpoint of clinical success at 12 months while ensuring adherence to the study schedule and monitoring for any adverse effects or complications.

Researchers are evaluating the Integrated Cancer Repository for Cancer Research (iCaRe2), a comprehensive multi-institutional resource developed by the Fred & Pamela Buffett Cancer Center. This resource collects and manages standardized, multi-dimensional, and longitudinal data and biospecimens from adult cancer patients, those at high risk, and normal controls. iCaRe2 includes data from a wide geographic area covering many small and rural hospitals and cancer centers, supporting studies on cancer risk factors, development, progression, and strategies for prevention, screening, early detection, and personalized treatment. iCaRe2 is a web-based, secure, HIPAA-compliant registry that integrates multiple specialized cancer collaborative registries covering a broad range of cancers such as pancreatic, breast, thyroid, thoracic, genitourinary, gastrointestinal, central nervous system, leukemia, gynecological, sarcoma, melanoma, and more. The system allows participating centers to contribute data and biospecimens like tumor samples, germ line DNA, serum, urine, and plasma. This flexible "confederation model" enables centers with different expertise and resources to collaborate on diverse research projects through a common platform. Participants include adult individuals aged 19 and older who have a cancer diagnosis or history, are at risk for cancer, have suspicious clinical findings, or have no history of cancer (normal controls). Data collection includes demographic, clinical, and biospecimen information. The registry supports multi-dimensional data mining and sharing to advance cancer research. The primary outcome is the ongoing development and implementation of this web-based cancer collaborative registry, with long-term data collection and collaboration planned over many years.

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 LUM-201 as a treatment for children with Pediatric Growth Hormone Deficiency (PGHD) who have not received prior treatment. This Phase 3 trial aims to validate a marker strategy to identify children likely to respond to daily oral LUM-201 therapy. The study includes prepubertal children with specific growth hormone deficiency characteristics and measures how well the treatment works compared to a placebo over 12 months. Participants receive either LUM-201 at a dose of 1.6 mg/kg/day or a matched placebo, both taken orally once daily. The study is randomized, double-blind, and placebo-controlled. It lasts for 12 months, during which the effects of the treatment on growth hormone response and other outcomes are closely monitored. Throughout the trial, children will undergo growth assessments and hormone level measurements. Researchers will track annualized height velocity (AHV) after 12 months to compare the effects of LUM-201 with placebo. Safety and efficacy will be evaluated regularly, with ongoing monitoring of growth, hormone levels, and related health indicators.

Researchers are evaluating the safety and effectiveness of SL1002 injectable solution compared to a placebo in treating knee pain caused by mild to moderate osteoarthritis. This Phase III randomized, double-blind, placebo-controlled study focuses on patients aged 40 and older who experience chronic knee pain from osteoarthritis. The study aims to understand how a single dose of SL1002 impacts pain levels while walking over a 12-week period. Participants will receive either a single injection of SL1002 or a placebo (normal saline). The study involves screening to confirm eligibility based on factors such as knee osteoarthritis severity and response to diagnostic nerve block. Treatments are administered once, and participants are monitored for safety and pain relief effects throughout the study. During the 12-week study, participants will have their pain intensity while walking assessed regularly to measure changes from baseline. Researchers will also monitor safety through questionnaires, physical exams, and laboratory tests. The study includes assessments to track adherence and ensure compliance with study requirements, with the total participation time spanning from initial screening through week 12 evaluations.

Researchers are conducting a global, multi-center, prospective post-market study to observe the long-term effectiveness of Boston Scientific neurostimulation systems in managing pain. The study aims to gather real-world clinical outcomes, economic value, and technical performance data of these commercially approved neurostimulation devices when used in routine clinical practice. The treatment involves an initial trial period using a Boston Scientific neurostimulation device for pain relief. Participants who experience a positive response during the trial may proceed to receive a permanent implant of the neurostimulation system. The therapy is tailored individually based on the investigator's judgment and standard care practices at each study site, following specific inclusion and exclusion criteria. Participants will be monitored throughout the trial and permanent implant phases to assess pain relief and overall treatment effectiveness. Assessments may include patient evaluations of pain and ability to complete study requirements. The study focuses on capturing comprehensive data to evaluate both clinical outcomes and device performance during regular use. Total participation duration depends on individual treatment progression from trial to permanent implant.