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Discover 8,657 clinical trials near Colorado. Find research studies in your area.
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NCT05064553
The primary objective is to assess overall sensitivity and specificity of Oncoguard™ Liver for hepatocellular cancer (HCC) detection in a surveillance population.
NCT03887455
This study will be conducted to evaluate the efficacy of lecanemab in participants with early Alzheimer's disease (EAD) by determining the superiority of lecanemab compared with placebo on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months of treatment in the Core Study. This study will also evaluate the long-term safety and tolerability of lecanemab in participants with EAD in the Extension Phase and whether the long-term effects of lecanemab as measured by the CDR-SB at the end of the Core Study is maintained over time in the Extension Phase. Extension Phase Part B will continue dosing with lecanemab in countries where lecanemab may not be commercially available.
NCT03836105
The objectives of the study are: * To describe the effectiveness of cemiplimab 350 mg administered every 3 weeks (Q3W) for treatment of patients with advanced (defined as locally advanced or metastatic \[nodal or distant\]) cutaneous squamous cell carcinoma (CSCC) and patients with advanced (defined as locally advanced or metastatic \[nodal or distant\]) basal cell carcinoma (BCC) in real-world clinical settings * To evaluate the safety of cemiplimab based on incidence of treatment related immune-related adverse events (irAEs), infusion related reactions (IRRs), and treatment related serious adverse reactions (TSARs) in patients with advanced CSCC and patients with advanced BCC receiving cemiplimab treatment in real world clinical settings * To describe patient experience, including patient reported quality of life (QOL) and functional status, and clinician reported performance status in a real-world setting for patients with advanced CSCC and patients with advanced BCC * To describe baseline characteristics that could potentially be associated with health-related outcomes for patients with advanced CSCC and patients with advanced BCC undergoing treatment with cemiplimab * To describe patients who receive cemiplimab as treatment for CSCC or BCC in a real-world setting * To describe real-world use patterns of cemiplimab for CSCC and BCC * To investigate the long-term effects and effectiveness of cemiplimab in patients with advanced CSCC or advanced BCC * To describe the effectiveness of cemiplimab in immunosuppressed and immunocompetent patients with advanced CSCC or advanced BCC, regardless of etiology, per available data * To describe the effectiveness of cemiplimab after prior exposure to radiation therapy for CSCC per available data * To describe the effectiveness of cemiplimab as a first-line (1L) or later systemic treatment in patients with advanced CSCC, regardless of etiology, per available data * To describe the effectiveness of cemiplimab in patients with advanced BCC based on treatment patterns (reason for discontinuation, treatment exposure, etc) of prior Hedgehog inhibitor (HHI) usage
NCT05381948
This is a phase 2 randomized, double -masked study comparing the efficacy of EYP-1901 at 2 dose levels: 2060 microgram (mcg) and 3090 mcg against aflibercept.
NCT02446132
This was an extension study of the Phase 3 Studies 15-AVP-786-301, 15-AVP-786-302, and 17-AVP-786-305.
NCT04103892
The clinical trial is a Phase 2, double-blind, randomized, placebo controlled study in Major Depressive Disorder (MDD) participants currently treated with antidepressant therapy. The objective of the study is to assess CLE-100 for the treatment of MDD in participants currently treated with standard antidepressant therapy.
NCT00345553
Little is known about the factors that cause biliary atresia nor the factors that influence disease progression. The purpose of this study is to collect the pertinent clinical information, genetic material and body fluid samples to enable investigators to address the following aims: To identify the gene or genes implicated in the etiology of BA; To characterize the natural history of the older, non-transplanted child with BA.
NCT07065331
The purpose of this study is to evaluate the pharmacokinetic (PK) profile, safety, tolerability, and immunogenicity of single inhaled dose of AZD8630 administered in adolescent participants with asthma as well as the safety and performance of the dry powder inhaler.
NCT06381674
Current clinical assessment tools are often not sensitive enough to detect and treat some subtle (yet troubling) problems after mTBI. In this study, the investigators will use wearable sensors to both assess and treat people with mTBI. Specifically, the investigators will provide immediate feedback, with visual and/or auditory, on movement quality during physical therapy. This immediate feedback on performance may improve outcomes as the investigators will measure multiple body segments including head movements simultaneously with balance and walking exercises. Such complex movements are needed for safe return to high level activity and military duty. The investigators will test this approach against a standard vestibular rehabilitation program. There are few potential risks to this study such as increasing symptoms and a small fall risk. Benefits include physical therapy for balance problems regardless of therapy with or without biofeedback. An indirect benefit is to have data on correct dosage of physical therapy. The investigators will also distinguish which concussion subtype profiles benefit most from physical therapy. This will help healthcare providers and patients by providing more information to help establish clinical guidelines and new tools for physical therapy.
NCT04638660
The objectives of this study are: * To evaluate the efficacy of Nyxol to improve mesopic low contrast visual acuity (mLCVA) in subjects with Dim Light Vision Disturbances (DLD) * To evaluate efficacy of Nyxol to improve visual performance * To evaluate the safety of Nyxol
NCT06791122
This study is open to people aged 18 years or older with schizophrenia. People can join the study if they are willing to use a smartphone app called CT-155. This app is being developed to help people with schizophrenia manage their negative symptoms. The purpose of this study is to gather new information on CT-155. Researchers want to see how well it works, how well participants use the study app, and how it affects the use of health care services. Participants use the app for 16 weeks. They may continue using it for another 16 weeks. During the study, participants continue with their normal treatment for schizophrenia. Participants are in the study for about a year. During this time, they visit the study site every 2 months. During this study, doctors regularly check participants' schizophrenia symptoms and overall quality of life. Researchers may also compare the healthcare data of study participants with a similar group of people with schizophrenia who are not part of the study. The doctors also regularly check participants' health and take note of any unwanted effects.
NCT06050122
The aim of this clinical study is to find out how well Patidegib Gel 2% works in preventing new basal cell carcinomas (BCCs) developing on the face of adults with Gorlin syndrome, and how safe Patidegib Gel 2% is to use. People who take part will apply either Patidegib Gel 2% or a Vehicle Gel (with no active drug substance) to their face twice a day for a year (12 months). The number of new BCCs on the face will be compared between those who used Patidegib Gel 2% or Vehicle Gel after 12 months.
NCT05328934
A trial to compare the performance of the SoftHand Pro (SHP) and Ossur i-Limb in people with transradial limb loss over an 8-week period.
NCT07216521
This multicenter retrospective observational cohort study seeks to: 1. Classify surgical intent in patients with resected Intraductal Papillary Mucinous Neoplasms (IPMN) and quantify the proportion of IPMN-associated cancers diagnosed as overt pancreatic cancer with incidental IPMN association on pathology. 2. Compare clinicopathologic features and outcomes between surveillance-detected and incidentally detected IPMN-derived pancreatic cancers. 3. Revise and redefine risk features limited to patients undergoing surgery for IPMN-related indications, identifying optimal predictors of malignant IPMN (high-grade dysplasia or invasive cancer).
NCT06699212
The goal of this clinical trial is to learn if ASP-1929 photoimmunotherapy (PIT) in combination with pembrolizumab works to treat recurrent squamous cell cancer of the head and neck (HNSCC) with no distant metastases. It will also learn about the safety of ASP-1929 PIT in combination with pembrolizumab. Researchers will compare ASP-1929 PIT in combination with pembrolizumab to pembrolizumab alone or pembrolizumab plus chemotherapy (carboplatin or cisplatin, plus 5-fluorouracil or paclitaxel or docetaxel) according to physician's choice (control arm). The overall primary study hypothesis being tested is whether ASP-1929 PIT plus pembrolizumab combination treatment improves the overall survival (OS) of the population defined by the inclusion/exclusion criteria over the control arm.
NCT05768932
This study is a multiple cohort, multicenter, open-label Phase 1 study with dose-escalation substudies investigating intravenous (IV) BAL0891 as monotherapy, and in combination with tislelizumab or paclitaxel, to determine the safety and tolerability of increasing doses of BAL0891 in patients with advanced solid tumors or relapsed or refractory acute myeloid leukemia. An adaptive model-based design will be used to guide the dose escalation. Subject assignment to Substudy 1, 2, 3 and 4 will be finalized following approval from the investigator and sponsor. The dose-expansion stage will be conducted with the RP2D to further evaluate the preliminary anti-tumor activity, safety, and tolerability in metastatic TNBC and GC.
NCT03412773
This Phase 3 study was a global, multicenter trial that randomly assigned participants to either tislelizumab or sorafenib as a first-line treatment for adults with advanced liver cancer (hepatocellular carcinoma) that could not be surgically removed. Before enrolling Japanese participants in the main Phase 3 study, a preliminary assessment of safety and tolerability (the Safety Run-In Sub-study) was conducted in Japan.
NCT06176768
The main purpose of this study is to determine the efficacy and safety of LY3972406 in adult participants with moderate-to-severe plaque psoriasis.
NCT06947928
This Phase 2/3, multicenter, randomized, double-blind, placebo-controlled trial will evaluate the Objective Response Rate (ORR) of IFx-Hu2.0 as an adjunctive therapy to pembrolizumab in adult participants (≥18 years) with advanced or metastatic Merkel Cell Carcinoma. A total of 118 participants will be randomized to receive either IFx-Hu2.0 or placebo via intralesional injection in a single lesion, followed by pembrolizumab.
NCT04330365
The overarching goal of this Pain Management Collaboratory Demonstration project is to test a new Whole Health paradigm for chronic pain care, emphasizing non-pharmacological pain self-management that is hypothesized to reduce pain symptoms and improve overall functioning and quality of life in Veterans. In UH3 Aim 1, the investigators will conduct a 12-month pragmatic effectiveness trial at 5 VA sites across the country to test whether veterans with moderate to severe chronic pain randomized to receive the Whole Health Team (WHT) intervention are more likely than those receiving Primary Care Group Education (PC-GE) to: Hypothesis 1: Experience improved pain interference (primary outcome), pain intensity, functioning and quality of life (secondary outcomes); Hypothesis 2: Decrease use of higher-risk pain medications, including opioids, or high-risk combinations; Hypothesis 3: Engage in a greater number of non-pharmacological pain management activities; and Hypothesis 4: Experience improved mental health-related symptoms, including sleep problems and suicidality. In addition, both the WHT and PC-GE arms will be compared to a third group of veterans randomized to Usual Primary Care (UPC, Control) on the same primary and secondary outcomes above. After the baseline assessment, masked telephone assessments will be administered to participants at 3, 6, 9, and 12 months. UH3 Aim 2 is to conduct a process evaluation of the two active interventions (WHT and PC-GE) and a budget impact analysis that includes costs to implement and execute the two active interventions as well as the control condition (UPC) to inform the development of an implementation toolkit for scaling and dissemination. Eligible participants are veterans reporting moderate to severe chronic pain present every day or nearly every day for ≥ 6 months. The total sample size for the population is based on our main study aim/hypothesis and is N=745. This breaks down to n=341 in each of the active interventions (WHT and PC-GE) and N=63 in the Usual Primary Care arm (Control). Results of this UG3/UH3 Pain Management Collaboratory Demonstration project will contribute to the overall mission of the NIH/VA/DoD initiative to build national-level infrastructure that supports non-pharmacologic pain management in veterans and military service personnel.
