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Discover 15,604 clinical trials near Denver, Colorado. Find research studies in your area.
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NCT05050942
The purpose of this study is to compare the effectiveness and safety of CAM2029 to octreotide LAR or lanreotide ATG in patients with advanced, well-differentiated GEP-NET. Patients who experience progressive disease in the randomized part of the study may proceed to an open-label extension part with intensified treatment with CAM2029.
NCT03972657
The main purpose of this study is to determine the safety, tolerability (how the body reacts to the drug\[s\]) and effectiveness (ability to treat the cancer) of REGN5678 (Nezastomig) alone, or in combination with cemiplimab. The study has 2 parts. The goal of Part 1 (dose escalation) is to determine a safe dose(s) of REGN5678 when it is given alone or in combination with cemiplimab. The goal of Part 2 (dose expansion) is to use the REGN5678 drug dose(s) found in Part 1 to see how well REGN5678 alone or in combination with cemiplimab works to shrink tumors. This study is looking at several other research questions, including: 1. Side effects that may be experienced by taking REGN5678 alone or in combination with cemiplimab 2. How REGN5678 alone or in combination with cemiplimab works in the body 3. How much REGN5678 and/or cemiplimab are present in the blood 4. To see if REGN5678 alone or in combination with cemiplimab works to reduce the size of the tumor by helping the immune system destroy the tumor
NCT05669664
This phase II trial tests how well darolutamide and leuprolide acetate work in treating patients with androgen receptor positive salivary cancer that has spread from where it first started (primary site) to other places in the body (metastatic), cannot be removed by surgery (unresectable) or that has come back after a period of responding to prior therapy (recurrent). Darolutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of cancer cells. Leuprolide acetate is in a class of medications called gonadotropin-releasing hormone (GnRH) agonists. It works by decreasing the amount of certain hormones in the body. Giving darolutamide in combination with leuprolide acetate may help to stop the growth of tumor cells that need androgens to grow or shrink them.
NCT03715335
Sexually transmitted infections (STIs) are highly prevalent among adolescents. Clinical practices related to screening, diagnosis, treatment, and prevention of STIs among adolescents are suboptimal. There is a need to expand our screening programs to nontraditional healthcare settings such as emergency departments (ED) and to determine the most efficient and cost-effective method for providing this screening. The goal of this study is to leverage our recent insights obtained from single center ED-based adolescent GC/CT screening research and apply them across a national pediatric ED research network to determine the most clinically effective and cost-effective screening approach for adolescents when implemented into a real-world clinical setting through a pragmatic trial. This will be accomplished through a network of children's hospital EDs with a track record of robust research collaboration (Pediatric Emergency Care Applied Research Network or PECARN). This intervention will rely on an innovative approach that electronically integrates patient-reported data to guide clinical decision support. The investigators will apply human factors modeling methods to perform ED workflow evaluations at each participating pediatric ED to determine the most efficient way to integrate the screening process into clinical care. The investigators will then conduct a comparative effectiveness pragmatic trial of targeted STI screening versus universally offered STI screening through electronic integration of patient reported data for provision of clinical decision support. The investigators will develop decision analytic models to evaluate the cost-effectiveness of targeted screening compared to universally offered screening.
NCT03734653
This is an open-labeled, single-arm, interventional pilot study. It is being done to determine the feasibility of the administration of transdermal testosterone alternating with enzalutamide, as well as the safety and efficacy.
NCT04558138
The main objective of this study is to evaluate patients undergoing mastectomy with immediate implant-based breast reconstruction and compare the outcomes of patients who are discharged the day of surgery versus patients who are discharged on post-operative day one. The primary aim of the study will be to compare the postoperative outcomes and complications between the two study groups within 30 days of discharge. The secondary aims of the study will be to compare patient satisfaction, quality of life and discharge perceptions.
NCT04809363
CDPATH™ is a tool to help predict the potential for developing Crohn's disease related complications in certain adult participants within 3 years. The main aim of the study is to explore the use of CDPATH™ to describe a participant's risk profile and to have discussions with their doctor about the potential path of their Crohn's disease. The number of visits will be decided by the study clinic according to their standard practice.
NCT05899816
The primary objectives of this study are to: * estimate vaccine response in rocatinlimab group vs placebo group, assessed using antibody anti-tetanus response at Week 24 * estimate vaccine response in rocatinlimab group vs placebo group, assessed using antibody anti-meningococcal response at Week 24
NCT02977780
This research study is studying several investigational drugs as a possible treatment for Glioblastoma (GBM). The drugs involved in this study are : * Abemaciclib (arm is currently closed to accrual) * Temozolomide (temodar) * Neratinib (arm is currently closed to accrual) * CC115 (arm is currently closed to accrual) * QBS10072S
NCT04475926
This study will follow participants who are screened and confirmed with a genetic diagnosis of Limb-girdle muscular dystrophy type 2E (LGMD2E/R4), Limb-girdle muscular dystrophy type 2D (LGMD2D/R3), Limb-girdle muscular dystrophy type 2C (LGMD2C/R5), or Limb-girdle muscular dystrophy type 2A (LGMD2A/R1). These enrolled participants will be followed to evaluate mobility and pulmonary function for up to 5 years after enrollment for participants with LGMD2C/R5, LGMD2D/R3, and LGMD2E/R4 with a North Star Assessment for Dysferlinopathy (NSAD) ≥ 25 at Baseline, up to 3 years for participants with LGMD2C/R5, LGMD2D/R3, and LGMD2E/R4 with a NSAD \< 25 at Baseline, and up to 3 years for participants with LGMD2A/R1. Additional participant data will be collected from the time the individual began experiencing LGMD symptoms to the present.
NCT06527365
This study will evaluate the safety and efficacy of VDPHL01 in male and female subjects with Androgenetic Alopecia (AGA). AGA (or pattern of hair loss) is a genetic disorder caused by an excessive (too much) hair follicle response to androgens (hormone) that causes hair loss. VDPHL01 8.5 mg Tablets for males and VDPHL01 4.5 mg Tablets for females are an investigational oral drug to treat male and female pattern baldness. This multiple center, open-label, study will last about 13 months and includes 11 study visits (screening, baseline (day 1), week 2, month 1, month 2, month 4, month 6, month 8, month 10, month 12, month 13). Male subjects that meet the study eligibility criteria will be administered VDPHL01 once daily for 12 months. Female subjects that meet the study eligibility criteria will be administered VDPHL01 either once or twice daily for 12 months.
NCT06742281
The purpose of this trial is to assess the safety and relative efficacy of CVXGA (CVXGA50), a KP.2 containing vaccine, compared to COMIRNATY® (COVID-19 Vaccine, mRNA; 2024-2025 Formula), a currently approved COVID-19 vaccine in the prevention of symptomatic, RT-PCR-confirmed SARS-CoV-2 infection. The trial will enroll up to 434 healthy participants.
NCT06431256
This study will evaluate the efficacy, safety and pharmacokinetics of HLD200 (20 mg and 40 mg) in children aged 4 to 5 years with ADHD.
NCT02242942
This open-label, multicenter, randomized Phase III study is designed to compare the efficacy and safety of a combined regimen of obinutuzumab and venetoclax versus obinutuzumab + chlorambucil in participants with chronic lymphocytic leukemia (CLL) and coexisting medical conditions. The time on study treatment was approximately one year and the follow-up period will be up to 9 years
NCT05819398
This study is open to adults with moderate to severe hidradenitis suppurativa (HS). The purpose of this study is to find out whether a medicine called spesolimab helps people with HS. People who have previously taken specific medicines such as immunosuppressive biologics other than Tumor necrosis factor (TNF) inhibitors cannot take part. This study has 2 parts. In Part 1, participants are divided into 4 groups of almost equal size. 3 groups get different doses of spesolimab, 1 group gets placebo. All participants get injections into a vein or under the skin. Placebo injections look like spesolimab injections, but do not contain any medicine. Every participant has an equal chance of being in each group. In the beginning, participants get the study medicine every week and later every 2 weeks. After 4 months, participants in the placebo group switch to spesolimab treatment. In Part 2, participants are divided into 2 groups. One group gets a suitable dose of spesolimab that was found in Part 1 of the study. The other group gets placebo. After 4 months, participants in the placebo group switch to spesolimab treatment. Participants join only one of the two parts. They are in the study for about 1 year. During this time, they visit the study site in the beginning every week and later every 2 weeks. Some of the visits can be done at the participant's home instead of the study site. The doctors regularly check participants' HS symptoms. The results are compared between the groups to see whether spesolimab works. The doctors also regularly check participants' general health and take note of any unwanted effects.
NCT06854952
This is a Phase 2a multicenter, randomized, double-blind, placebo-controlled clinical trial studying the efficacy, safety, and tolerability of orally administered TERN-601 in adults with overweight or obesity.
NCT07225387
This is a Phase IV, open-label, randomized trial to determine whether the combination of Belimumab (BEL) and Voclosporin (VCS), plus background therapy with Mycophenolate Mofetil (MMF), improves the proportion of patients with proliferative lupus nephritis achieving complete renal response (CRR) compared to proportion of patients achieving CRR from recent clinical trials. This protocol will additionally determine whether combination therapy using Belimumab (BEL) and Voclosporin (VCS) facilitates rapid discontinuation of MMF.
NCT03631225
The goal of treating patients diagnosed with rheumatoid arthritis (RA) is to achieve remission or low disease activity and thereby prevent joint damage, loss of physical function, and disability. Optimal management requires regular assessment of disease activity, with treatment changes made as needed for optimal efficacy. Vectra is a blood serum test that looks at 12 biomarkers and produces a score on a scale of 1 to 100. The Vectra score has been shown to be the strongest predictor of risk for progression of disease. There is opportunity to gain more information about the utility of Vectra in a real-world clinical setting. This study will, therefore, evaluate the utility of Vectra for guiding treatment decisions and improving RA-related outcomes in comparison with usual care, which will not include Vectra testing. This study will enable a direct evaluation of the clinical benefit associated with using Vectra to guide treatment decisions in patients with RA.
NCT01512888
SCID-X1 is a genetic disorder of blood cells caused by DNA changes in a gene that is required for the normal development of the human immune system. The purpose of this study is to determine if a new method, called lentiviral gene transfer, can be used to treat SCID-X1. This method involves transferring a normal copy of the common gamma chain gene into the participant's bone marrow stem cells. The investigators want to determine if the procedure is safe, whether it can be done according to the methods they have developed, and whether the procedure will provide a normal immune system for the patient. It is hoped that this type of gene transfer may offer a new way to treat children with SCID-X1 that do not have a brother or sister who can be used as a donor for stem cell transplantation.
NCT05117242
The goal of this clinical trial is to compare the safety and efficacy (how well the drug works) of acasunlimab (also known as GEN1046) when it is used alone (monotherapy) versus when it is combined with a cancer drug (pembrolizumab) for participants with relapsed/refractory (disease has returned after treatment or did not respond to treatment) non-small cell lung cancer (NSCLC; the most common type of lung cancer). This trial has 2 parts. The purpose of the first part is to find out if the combination of acasunlimab and pembrolizumab is safe and to find out the best doses to use. The purpose of the second part is to give acasunlimab and pembrolizumab to more participants to evaluate efficacy. In the second part of the trial, participants will be randomized to participate in 1 of the 3 arms of the trial. Randomized means that the participant will be randomly assigned to a treatment arm based on chance; no one chooses their treatment arm. Participants will receive either acasunlimab alone (100 followed by 500 mg into the vein) or acasunlimab with pembrolizumab (200 or 400 mg into the vein) once every 3 or 6 weeks, depending on which arm the participant is randomized into. All participants will receive active drug; no one will receive placebo. Trial details include: * The average trial duration for an individual participant will be about 10 months. * The average treatment duration for an individual participant will be about 6 months. * The visit frequency will be weekly at first and lessening over time until visits are only once every 3 weeks.
