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Discover 11,439 clinical trials near Denver, Colorado. Find research studies in your area.
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Showing 3921-3940 of 11,439 trials
NCT04688775
The purpose of this study is to evaluate the efficacy of eptinezumab in participants with episodic Cluster Headache (eCH)
NCT03902080
This study will assess the efficacy of vibegron compared with placebo in men with overactive bladder (OAB) symptoms on pharmacological therapy for benign prostatic hyperplasia (BPH) as defined by micturition and urgency episodes.
NCT03016312
This Phase III, multicenter, randomized, open-label study will evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1 \[anti-PD-L1\] antibody) in combination with enzalutamide compared with enzalutamide alone in participants with mCRPC after failure of an androgen synthesis inhibitor (e.g., abiraterone) and failure of, ineligibility for, or refusal of a taxane regimen. Participants will be randomized to one of the two treatment arms (atezolizumab in combination with enzalutamide, and enzalutamide alone) in a 1:1 ratio (experimental to control arm) in global randomized phase. Participants will receive treatment until investigator-assessed confirmed radiographic disease progression per Prostate Cancer Working Group 3 (PCWG3) criteria or unacceptable toxicity.
NCT02713347
Chronic heart failure (CHF), chronic obstructive pulmonary disease (COPD), and interstitial lung disease (i.e., pulmonary fibrosis) are common serious illnesses. Despite disease-specific medical care, people with these illnesses often left with poor quality of life (i.e., burdensome symptoms, impaired function). Furthermore, while these illnesses are leading causes of hospitalization and mortality, few people with these illnesses engage in advance care planning, the process of considering and communicating healthcare values and goals. The investigators are conducting a randomized clinical trial to study a symptom management, psychosocial care and advance care planning intervention to improve quality of life. The study is important because it aims to improve quality of life and provision of care according to peoples' goals and preferences in common, burdensome illnesses. Furthermore, this study will generate information that supports the broader dissemination and implementation of the intervention and informs the development of future palliative care and team-based interventions in the VA.
NCT05571943
This is a Phase 3, open-label study to evaluate the long-term safety of difamilast ointment 1% in subjects ≥2 years of age with mild to moderate AD. The study will also evaluate the long-term efficacy of difamilast ointment 1%, including durability of response.
NCT05409235
This study will evaluate the safety and efficacy of OTT166 Ophthalmic solution in participants with Diabetic Retinopathy.
NCT02037893
The primary objective is to compare the effect of treatment with a combination of ear solutions on the reduction of pain symptoms at 1 hour after dosing in children with acute otitis media.
NCT01059071
The purpose of this research study is to evaluate a new investigational drug to treat neuroblastoma. This study drug is called DFMO. The objectives of this study will be to monitor for safety and to find a maximum tolerated dose in this population. A secondary objective will be to look at efficacy of DFMO. The safety of the proposed dosing regimen in this trial will be tested by an on-going risk/benefit assessment during the study. A patient benefiting from treatment, not progressing on therapy, and in the absence of any safety issues associated with DFMO and/or etoposide may continue on treatment with the expectation that there will be an overall clinical benefit. The procedures involved in this study include Medical history, Physical exam, Vital signs (blood pressure, pulse, temperature), Blood tests, Urine tests, MRI or CT scan of the tumor(s), MIBG scans, and Bone marrow aspirations. All of these tests and procedures are considered standard of care for this population. Drug administration is also part of this protocol, including an investigational new drug called DFMO, and later combined with an already approved drug, etoposide. The proposed dosing regimen is an oral dose of DFMO two times a day for each day while on study. There will be 5 cycles. Each cycle will be 21 days in length. The first cycle will be DFMO alone. In the second cycle etoposide will be added in and will be given orally once a day for the first 14 days of each cycle (cycles 2-5).
NCT01483820
The purpose of this research study is to evaluate a new investigational drug (TPI 287) for neuroblastoma and medulloblastoma. An investigational drug is one that has not yet been approved by the Food and Drug Administration. This investigational drug is called TPI 287. This study will look at the tumor's response to the study drug, TPI 287, as well as the safety and tolerability of the drug. TPI 287 was shown to be effective in stopping tumor growth and was also shown to be safe in three different animal species. TPI 287 has been tested in humans in four clinical trials, and approximately 100 subjects with various types of cancers have received the drug, including a pediatric population in our previous Phase I trial.
NCT01505608
The purpose of this research study is to evaluate a new investigational drug (TPI 287) for early relapsed neuroblastoma. An investigational drug is one that has not yet been approved by the Food and Drug Administration. This investigational drug is called TPI 287. This study will look at the tumor's response to the study drug, TPI 287, in combination with Irinotecan and Temozolomide versus the combination of Irinotecan and Temozolomide alone. This study will also evaluate the safety and tolerability of the study drug, TPI 287.
NCT05223816
Safety Run-in Cohort (cohort 1): 10 patients will be treated with IT injection of VG161 in the cohort 1 at dose level of 1.0x10E8 PFU x 3 days. Monotherapy Cohorts (Cohort 2 and 3) Cohort 2 (HCC) This part is a single-agent, single one-dose level and single-arm design. Approximately 39 subjects will be enrolled in the study to receive VG161. In the first stage, 21 subjects will be enrolled. If there is only 1 or fewer subjects has been observed with objective response and no more than 12 (\<13) subjects have PFS longer than 3 months, the trial will be stopped. Otherwise, this study will continue to enter the second stage, and 18 additional subjects will be added, and the total number of trial subjects will reach 39. Cohort 3 (ICC) This part is a single-agent, single one-dose level and single-arm design. The trial will be carried out in two periods. In the first period, a total of 20 subjects will be enrolled. If there is only 1 or fewer response case in the 20 subjects, the trial will be stopped to investigate the efficacy of the IP, otherwise, subjects will continue to enter the second period, and 13 additional subjects will be added, and the total number of trial cases will reach 33. Cohort 4 (ICC and HCC) Combination with Nivolumab Combination cohort and subjects will receive VG161 at the same schedule as the monotherapy cohorts and 240 mg of intravenous Nivolumab on days 8 and 15 of each treatment cycle. The Nivolumab dose can be changed to 480 mg every 4 weeks after cycle one based on investigator's discretion.
NCT05107882
This observational, cross-sectional study is designed to validate a novel diagnostic test for the detection of phenotypic changes in the retina that correlate with likely PET amyloid status (negative or positive), to aid in the evaluation of adult patients with cognitive impairment who are being evaluated for Alzheimer's disease and other causes of cognitive decline. The CAS test is an adjunct to other diagnostic evaluations, and is indicated for use with the Optina Diagnostics' MHRC (K200254).
NCT03879239
The study is a prospective, randomized, multicenter, adaptive design, double blinded, placebo-controlled study, to evaluate the efficacy and safety of Vibrant Capsule vs. placebo in relieving constipation in subjects with Chronic Idiopathic Constipation.
NCT03560531
This is a Phase 1/2, open-label, multicenter, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ZN-c5 administered orally in subjects with advanced estrogen receptor positive, human epidermal growth factor receptor 2 negative (ER+/HER2-) breast cancer. ZN-c5 will be evaluated both as monotherapy and in combination with palbociclib (IBRANCE®).
NCT05462639
Elranatamab is a bispecific antibody: binding of elranatamab to CD3- expressing T-cell and BCMA- expressing multiple myeloma cells causes targeted T-cell mediated cytotoxicity. This expanded access protocol will provide access to elranatamab until it becomes commercially accessible to patients who are refractory to at least one proteasome inhibitor, one immunomodulatory drug and one anti-CD38 antibody and have no access to other comparable/alternative therapy and for whom elranatamab could be a possible treatment option.
NCT00867568
The purpose of this research study is to evaluate a new investigational drug (TPI 287) for neuroblastoma and medulloblastoma both alone and in combination with temozolomide (a currently approved drug). An investigational drug is one that has not yet been approved by the Food and Drug Administration. This investigational drug is called TPI 287. This study will look at the safety and tolerability of TPI 287 both alone and in combination with temozolomide, and look to establish a safe dose of this agent. The study will also look at the tumor's response to these drugs, but this is not the primary objective of this study. TPI 287 was shown to be effective in stopping tumor growth and was also shown to be safe in three different animal species. TPI 287 has been tested in humans in four clinical trials, and approximately 100 subjects with various types of cancers have received the drug. All of these subjects that have received TPI 287 have been adults. TPI 287 has not been tested in a pediatric population before this study. Temozolomide was tested in recurrent neuroblastoma and showed activity in a recently published study. Preclinical studies of TPI in combination with temozolomide have shown at minimum an additive effect. The ability of temozolomide and TPI 287 to be effective in combination is suggested by these two drugs showing even greater activity when used together.
NCT06470035
Trial title: A Randomized, Double Blind Sham Controlled Clinical Trial to Evaluate the Efficacy of Electrical Vestibular Nerve Stimulation (VeNS), Compared to a Sham Control for Treatment of Major Depressive Disorder (MDD) - Modius Mood Study The aim of this study: To better evaluate the efficacy of non-invasive electrical vestibular nerve stimulation (VeNS) as a method of treating major depressive disorder(MDD) , as compared to a sham control. Allocation: Randomized to either active device or control device usage. Endpoint classification: Efficacy Study Intervention Model: Parallel Assignment in 1:1 active to control allocation
NCT03710746
This project seeks to improve the effectiveness of a novel dissonance-based obesity prevention program that has reduced future BMI gain and overweight/obesity onset by (a) experimentally testing whether implementing it in single- versus mixed-sex groups, which should increase dissonance-induction that contributes to weight gain prevention effects, and (b) experimentally testing whether adding food response and attention training, which theoretically reduces valuation of and attention for high-calorie foods, increases weight gain prevention effects. This randomized trial would be the first to experimentally manipulate these two factors in an effort to produce superior weight gain prevention effects. A brief effective obesity prevention program that can be easily, inexpensively, and broadly implemented to late adolescents at risk for excess weight gain, as has been the case with another dissonance-based prevention program, could markedly reduce the prevalence of obesity and associated morbidity and mortality.
NCT04152863
This is a Phase 2 study to assess the efficacy, safety, and tolerability of gebasaxturev administered both intratumorally (ITu) and intravenously (IV) as combination therapy with pembrolizumab (MK-3475) versus pembrolizumab alone in anti-programmed cell death ligand 1 (anti-PD-L1)-treatment-naive participants with advanced/metastatic melanoma. The primary hypothesis of the study is that gebasaxturev administered either ITu or IV in combination with pembrolizumab results in a superior objective response rate (ORR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR), compared to pembrolizumab alone. This study will be terminated once all participants finish treatment with V937. Participants eligible to continue to receive pembrolizumab will be transferred to MK-3475-587 study.
NCT03841448
The purpose of this study is to evaluate the effect of cemdisiran on proteinuria in adults with immunoglobulin A nephropathy (IgAN), who excrete \>1 gram (gm) of protein per day despite standard of care, which includes treatment with angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB). These participants are at high risk for progression of kidney disease, which can result in end-stage renal failure.
