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Discover 18,143 clinical trials near Colorado. Find research studies in your area.
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Showing 6321-6340 of 18,143 trials
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.
NCT04296890
This study is designed to evaluate the efficacy and safety of mirvetuximab soravtansine (MIRV) in participants with platinum-resistant high-grade serous epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of Folate Receptor-Alpha (FRα). Participants will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. All participants will receive single-agent MIRV at 6 mg/kg adjusted ideal body weight administered on Day 1 of every 3-week cycle.
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.
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.
NCT03931941
This is a prospective, multicenter, open-label Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least one recurrence of CDI after a primary episode and have completed at least one round of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Subjects may receive a second RBX2660 enema if they are deemed treatment failures following the initial enema per the protocol-specified treatment failure definition.
NCT05275205
This study is intended to assess safety, tolerability and biological activity of a repeat IVT injection of UBX1325 in patients with wet AMD.
NCT04528719
The primary objectives of this study are to evaluate the tolerability and reactogenicity of a single injection of up to 5 dose levels of mRNA-1345 in younger adults, women of child-bearing potential, and older adults including Japanese older adults; of 3 injections of the middle dose level of mRNA-1345 given 56 days apart in younger adults; of a booster injection of mRNA-1345 given approximately 12 and 24 months after the primary injection in older adults; and of 3 injections of 1 of 2 dose levels of mRNA-1345 given 56 days apart in children who are RSV-seropositive.
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.
NCT03934736
This is an open-label, single arm study design to evaluate HEPLISAV-B® in adults with ESRD who are initiating or undergoing hemodialysis.
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.
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®).
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).
NCT02338609
The primary objective of CRAD001M2305 was to report the long-term effects of everolimus treatment on height, weight and sexual development (using Tanner Stages) in children and adolescents with Tuberous Sclerosis Complex (TSC)-associated with Subependymal Giant Cell Astrocytoma (SEGA). The study monitored the growth and development of pediatric patients with TSC-associated SEGA, previously enrolled in CRAD001M2301 (NCT00789828) until they reach Tanner Stage V, or until age 16 for females or 17 for males whichever occurred first.
NCT05085964
PQ-421a-002 (Helia) is an open-label, extension study to evaluate the safety, tolerability and efficacy of QR 421a (ultevursen) administered via intravitreal (IVT) injection in one or both eyes, in subjects ≥ 12 years of age with RP due to mutations in exon 13 of the USH2A gene, for an anticipated period of 24 months, or until provision of continued treatment by other means is available, provided the subject's benefit-risk determination remains positive.
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.
NCT06404372
The clinical trial, sponsored by Sutura Medical Technology, Inc., is a pivotal, blinded, multi-center study assessing the safety and effectiveness of the Demetech Barbed PDO Suture, an absorbable Polydioxanone suture, for the temporary treatment of midface wrinkles. The trial will enroll 57 subjects across up to four sites, following them over a 12-month period to evaluate improvements in wrinkles based on the Lemperle Classification Facial Wrinkle Scale. Primary endpoints include assessing the rate of adverse events and a significant reduction in wrinkle severity at 6 months, with secondary endpoints focusing on longer-term results and patient satisfaction.
NCT03853317
Phase 2, single-arm study to evaluate combination therapy of avelumab, haNK and N-803 in patients with Merkel Cell Carcinoma who have progressed on or after checkpoint inhibitor therapy as assessed by ORR. Patients will receive treatment for a maximum of two years.
NCT02595866
This phase I trial studies the side effects of pembrolizumab in treating patients with human immunodeficiency virus (HIV) and malignant neoplasms that have come back (relapsed), do not respond to treatment (refractory), or have distributed over a large area in the body (disseminated). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
