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Discover 18,161 clinical trials near Denver, Colorado. Find research studies in your area.
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Showing 9601-9620 of 18,161 trials
NCT02685631
This research registry studies Yttrium Y 90 resin microspheres in collecting data from patients with liver cancer not capable of being removed by surgery (unresectable) for the radiation-emitting Selective Internal Radiation-Spheres (SIR-spheres) in non-resectable (RESIN) liver tumor registry. The information generated will help doctors better understand treatment patterns involving Y90 therapy, gain additional insights in the long-term outcomes for patients, as well as guide future research for using Y90 therapy, especially for those conditions where data is currently very limited or lacking.
NCT02116608
This study plans to learn more about the different ways used to treat tracheostomy granulomas. Investigators want to see which standard of care method (steroid application, silver nitrate, or betadine) is more successful in treating tracheostomy granulomas.
NCT02544321
Type 1 diabetes (T1D) continues to be a disease plagued by hyperglycemia, insulin resistance (IR), and increased cardiovascular disease (CVD) despite advances in insulin delivery and glucose monitoring. Therefore new approaches are needed. Bromocriptine (BC), a dopamine (DA) agonist, has long been widely used for treating Parkinson's disease and prolactinoma. Its recent approval in a quick release formulation, BCQR, for type 2 diabetes (T2D) is an exciting development, representing a novel mechanism for improving IR. BCQR has not been studied in T1D, but it's mechanism of action, mechanistic studies, and preliminary data support the proposed study of possible benefits of BCQR on insulin action, glycemic control, and the vasculature in T1D. This study has received an exemption from the FDA to study BCQR in adults with T1D and an IND approval (131360) to study BCQR in adolescents with T1D. This is a random-order, double-blind, placebo-controlled study of a 4 week intervention. Outcomes will include fasting and postprandial glucose, glycemic variability, insulin dosing, hypoglycemia frequency and awareness, sleep quality, and metabolic hormone levels.
NCT03987191
This randomized controlled, two arms, investigator initiated, intervention study is aimed to examine an investigational approach in contrast to the clinical standard of 1:1 dose basal insulin conversion in an attempt to lower the incidence and/or duration of hyperglycemia after transition from insulin pump to multiple daily injections in adults with type 1 diabetes.
NCT02903511
This study is being done to determine if treatment with metformin, a drug widely used for the treatment of diabetes type 2, is safe and well tolerated by individuals with Autosomal Dominant Polycystic Kidney Disease (ADPKD) who are not diabetic and who have slightly decreased kidney function. The study will also evaluate the effects of metformin on kidney growth and kidney function.
NCT05038033
Project ASSET will explore the preliminary efficacy of interpersonal therapy, when compared with cognitive behavioral therapy, for reducing anxiety symptoms, preventing excess weight gain, and reducing cardio-metabolic risk in adolescent girls with above-average weight and elevated anxiety. As a pilot for a larger multi-site study, this trial will also test multi-site feasibility, acceptability, and intervention fidelity.
NCT02513797
This study is a prospective, multicenter, randomized (2:1) controlled study to evaluate the safety and effectiveness of the LARIAT System to percutaneously isolate and ligate the Left Atrial Appendage from the left atrium as an adjunct to planned pulmonary vein isolation (PVI) catheter ablation in the treatment of subjects with symptomatic persistent or longstanding persistent atrial fibrillation. This study will be conducted in two stages: * Limited Early Stage (Stage 1): up to 250 subjects at up to 65 sites. (COMPLETED, transitioned to Stage 2) * Pivotal Stage/ Phase III (Stage 2): up to 600 subjects at up to 65 sites. (COMPLETED) All subjects from both stages will be included in the primary analysis.
NCT02477800
The primary objective of the study is to evaluate the efficacy of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with early AD. Secondary objectives are to assess the effect of monthly doses of aducanumab as compared with placebo on clinical progression as measured by Mini-Mental State Examination (MMSE), AD Assessment Scale-Cognitive Subscale (13 items) \[ADAS-Cog 13\], and AD Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) \[ADCS-ADL-MCI\].
NCT02626000
The primary objective of this study was to evaluate the safety, as assessed by incidence of dose limiting toxicity (DLT), of talimogene laherparepvec in combination with pembrolizumab in adults with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).
NCT03631732
The primary objective of this study is to evaluate the efficacy of switching from a regimen of 2 nucleos(t)Ide reverse transcriptase inhibitors (NRTIs) and a third agent to a fixed dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing their baseline regimen in HIV-1 infected, virologically suppressed African American participants.
NCT03261960
The objective of this study is to compare the safety and efficacy of BLI4700 bowel preparation to an FDA-approved bowel preparation as 2-day, split-dose bowel preparations prior to colonoscopy in adult patients.
NCT03297398
This study will evaluate the safety and effectiveness of different doses of OPK-88004 compared to placebo on serum PSA compared to placebo in men with benign prostatic hyperplasia (BPH).
NCT03257839
The SoftVue™ is a whole breast ultrasound system with an automated scanning curvilinear ring-array transducer that employs UST. It is currently cleared under FDA 510(k) K123209 and K142517 for use as both a B-mode ultrasonic breast imaging system and color imaging of transmission data (sound speed and attenuation). SoftVue™ is not intended to be used as a replacement for screening mammography. SoftVue uses non-ionizing ultrasound energy to generate tomographic image volumes of the whole breast. While the patient lays prone on a padded table with one breast comfortably submerged in a bath of warm water, a ring-shaped transducer, 22 cm in diameter, encircles the breast and pulses low-frequency sound waves through the water and into the breast tissue. More than 2000 elements in the curvilinear transducer's 360 degree array emit and receive ultrasound signals to analyze echoes from the breast anatomy in all directions, from the chest wall to the nipple. Not only does SoftVue capture data from the reflection of the sound waves off of tissue boundaries and structures within the breast, but because the transducer surrounds the whole breast, SoftVue also captures signals that are transmitted through the breast. This additional transmission data enhances the visualization of the anatomic structure of the breast tissue and is not currently available in any other commercially marketed breast ultrasound device. This prospective, multicenter, multi-arm, clinical case collection program is IRB-approved and will be conducted in compliance with Good Clinical Practice, the Declaration of Helsinki and all applicable regulatory requirements. Arm 1 aims to collectively enroll up to 17,500 women at a total of up to 8 clinical sites. The design of this protocol is strictly limited to case collection; all investigational and statistical plans for future analyses will be prepared and registered separately, if they are applicable to the requirements of FDAAA 801. Arm 1 is limited to the cohort of asymptomatic women, with heterogeneously or extremely dense breast parenchyma (BI-RADS breast composition category c or d). Matched triads of 2D digital mammography (FFDM), 3D digital mammography (DBT), and SoftVue automated whole breast ultrasound (SV)exams, from the same patient, with demographic information and clinical outcome data, will be collected during the same screening imaging episode. Ultrasound characteristics for all types of lesions, whether they are benign or malignant, will be collected, as well as objective and subjective breast density composition data. The exams and clinical data accumulated in this prospective case collection (PCC) protocol will populate a database from which future investigations may be designed for peer reviewed publication, development of user training curriculums, building teaching case, and creating new marketing materials for SoftVue.A subset of exams will be sampled from Arm 1 for use in ROC Reader Study (protocol DMT-2015.002), which will be separately registered and is designed to evaluate the safety and efficacy of a new screening indication for use of SoftVue™ as an adjunct to screening mammography. The results of this ROC Reader Study will be submitted to the FDA for their consideration of a PMA application for SoftVue.
NCT01346969
The study will investigate the efficacy of various doses and regimens of EXC 001 in reducing skin scarring in subjects undergoing revision of scars from prior surgery. The study will also evaluate the safety and tolerability of EXC 001 and placebo.
NCT00171730
Acromegaly is a rare, serious condition characterized by chronic hypersecretion of growth hormone (GH), generally caused by a GH-secreting pituitary adenoma. The study assessed the long-term safety and efficacy of pasireotide in participants with acromegaly.
NCT02423343
The main purpose of this study is to evaluate the safety, tolerability, and efficacy of the study drug known as galunisertib in combination with nivolumab in participants with advanced refractory solid tumors and in recurrent or refractory non-small cell lung cancer (NSCLC) or hepatocellular carcinoma (HCC).
NCT01723020
First in human, open-label, sequential dose escalation and expansion study of AMG 232 in subjects with advanced solid tumors or multiple myeloma
NCT00066859
RATIONALE: Antidepressants such as sertraline and the herb hypericum perforatum (St. John's wort) may be effective in treating mild to moderate depression. It is not yet known which treatment is more effective in improving depression in patients who have cancer. PURPOSE: This randomized phase III trial is studying how well sertraline works compared to St. John's wort in treating mild to moderate depression in patients with solid tumors.
NCT04658017
To evaluate the feasibility of performing combined hemodialysis with the GARNET device in chronic hemodialysis patients with a blood stream infection (BSI), and measure clinical performance and safety endpoints.
NCT03758885
The primary objective of this study is to confirm the efficacy of a single oral 900 mg dose of nolasiban versus placebo to increase the ongoing clinical pregnancy rate at 10 weeks post-embryo transfer (ET) day.
