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Discover 18,143 clinical trials near Colorado. Find research studies in your area.
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NCT02216214
The purpose of this study was to assess the efficacy, safety and tolerability of mirabegron versus placebo in the treatment of older adult subjects with OAB.
NCT06703749
The goal of this clinical trial is to investigate the effect of the BTL-899M device on muscular system function in adult subjects seeking treatment for improving their muscular system function in the lower extremities. The main question it aims to answer is: Whether the BTL-899M device is effective for muscular system function improvement 3 months posttreatment compared to the sham group, based on the dynamometer measurement. Researchers will compare a sham group to see if the device is effective. Participants will complete four treatment visits and two follow-up visits. Their strength will be recorded via a dynamometer.
NCT05180838
BioSticker data is remotely tracked and displayed in a report termed the BioReport for retrospective data analysis. Typically, the biosensor collects data on an interval of \~1 minute and this data is collated and reported remotely back to the BioReport every 6 hours. More importantly, for future applications of the BioSticker for early detection of FN, there are ongoing efforts to implement real time reporting and alarms using remote monitoring services that could alert the patient that they need to seek medical care. There are no known deleterious effects from the BioSticker and it is now being widely used and tested in diverse applications including detection and contact tracing of COVID and others.
NCT02409680
Available data suggest that low dose aspirin may be a safe, widely available and inexpensive intervention that may significantly reduce the risk of preterm birth. However, this possibility needs to be proven in a properly designed randomized controlled trial (RCT) with preterm birth as the primary outcome. Such a clinical trial in a racially, ethnically and geographically diverse population could best be accomplished by the established infrastructure of the Global Network for Women's and Children's Health Research (GN).
NCT02702492
This study will evaluate the safety, tolerability, and efficacy of oral KPT-9274 for the treatment of patients with advanced solid malignancies or non-Hodgkin's lymphoma (NHL).
NCT02864953
The primary objective of Part 1 of the study is to determine if BIIB093 improves functional outcome at Day 90 as measured by the modified Rankin Scale (mRS) when compared with placebo in participants with Large Hemispheric Infarction (LHI). The secondary objectives of Part 1 of the study are to determine if BIIB093 improves overall survival at Day 90 when compared with placebo, if BIIB093 improves functional outcome at Day 90 on the mRS dichotomized 0-4 vs. 5-6 when compared with placebo, if BIIB093 reduces midline shift at 72 hours (or at time of decompressive craniectomy \[DC\] or comfort measures only \[CMO\], if earlier) when compared with placebo, and to evaluate the safety and tolerability of BIIB093 in participants with LHI. The objectives of Part 2 of the study are to evaluate long-term disability following LHI, to evaluate long-term outcome measures of clinical function, quality of life, and healthcare utilization, and to assess the safety of BIIB093 in subjects with LHI during the follow-up period.
NCT03406611
Homocystinuria caused by Cystathionine Beta-Synthase (CBS) Deficiency is a rare autosomal-recessive metabolic condition characterized by an excess of homocysteine (Hcy) in the plasma, tissues and urine. It is due to reduced or absent activity of the CBS enzyme, and is also known as classical homocystinuria. The symptoms associated with homocystinuria are variable in severity and time of onset across patients. Some affected individuals may have mild signs of the disorder; others may have multi-systemic involvement including potentially life-threatening complications. Homocystinuria can affect many different organ systems of the body; the four most commonly involved are the eyes, central nervous system, skeleton, and the vascular system. The current approaches to treatment of homocystinuria patients include a highly restrictive diet and use of dietary supplements. Lifetime compliance with this diet is poor. Pegtibatinase (TVT-058) represents a novel therapeutic approach that incorporates the use of a modified version of the native, human CBS (hCBS) enzyme. The goal of treatment is to introduce the CBS enzyme into circulation, resulting in reduced Hcy levels, increased cystathionine (Cth) and cysteine (Cys) levels.
NCT02143401
This phase I trial studies the side effects and the best dose of navitoclax when given together with sorafenib tosylate in treating patients with solid tumors that have returned (relapsed) or do not respond to treatment (refractory). Navitoclax and sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
NCT03884608
The purpose of this registry is to prospectively assess outcomes of device-treated ventricular tachyarrhythmias and all-cause mortality in non-ischemic cardiomyopathy patients indicated for ICD or CRT-D implantation for the primary prevention of sudden cardiac death. Differences in outcomes will be evaluated by sex and by device type.
NCT03529045
Multicenter global post-market registry of subjects diagnosed with drug resistant epilepsy and treated with the VNS Therapy System.
NCT03514121
This is a multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of FPA150, an anti-B7H4 antibody alone or in combination with pembrolizumab an anti-PD1 antibody in patients with advanced solid tumors. The Phase 1a, open-label, cohort will identify a recommended dose of FPA150 to use for Phase 1a Combination (FPA150 and Pembrolizumab) Safety Lead-in and for Phase 1b monotherapy cohorts.
NCT03515837
The purpose of this study is to evaluate the efficacy and safety of pemetrexed plus platinum chemotherapy (carboplatin or cisplatin) with or without pembrolizumab (MK-3475; KEYTRUDA®) in the treatment of adults with the following types of tyrosine kinase inhibitor (TKI)-resistant, epidermal growth factor receptor (EGFR)-mutated, metastatic non-squamous non-small cell lung cancer (NSCLC) tumors: 1) TKI-failures (including osimertinib \[TAGRISSO®\] failure) with T790M-negative mutation tumors, 2) T790M-positive mutation tumors with prior exposure to osimertinib, and 3) first-line osimertinib failure regardless of T790M mutation status. The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy has superior efficacy compared to saline placebo plus chemotherapy in terms of: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review, and 2) Overall Survival (OS). This study will be considered to have met its success criteria if the combination of pembrolizumab plus chemotherapy is superior to saline placebo plus chemotherapy in terms of PFS or OS. Upon study completion, participants are discontinued and may be enrolled in a pembrolizumab extension study, if available.
NCT06610279
Feeling sick in the stomach (nausea) or throwing up (vomiting) are among the most common symptoms during treatment with medicines. It is hoped that a medicine called TAK-951 may help people to not feel sick in the stomach or throw up. The main aim of this study is to learn about side effects of TAK-951 when given as a single or multiple doses to healthy adults. Side effects are medical problems thought to be caused by the study treatment. Another aim is to learn how a healthy adult's body processes TAK-951 (this is called pharmacokinetics or PK). In this study, participants will receive either TAK-951 or placebo. The placebo looks like TAK-951 but does not have any medicine in it. Both TAK-951 and placebo will be given as an injection directly under the skin. This is called subcutaneous or subcutaneous (SC). The study will be conducted in 3 parts: * In Part 1, participants will be given one SC injection of either TAK-951 or placebo. * In Part 2, participants will receive up to three daily SC injections of either TAK-951 or placebo of the same dose * In Part 3, participants will receive one SC injection of either TAK-951 or placebo and another SC injection up to 1 week later. Participants will be checked for their health either 28 days after the last injection (Parts 1 and 2) or 14 days after the last injection (Part 3).
NCT05600114
A phase 2, multicenter, double-blind, parallel group, placebo-controlled, randomized clinical study, designed to compare the efficacy, safety, and tolerability of 2 dose levels of CBD and a matching placebo for the treatment of subjects with Social Anxiety Disorder (SAD).
NCT01231971
The purpose of this study is to build upon the information obtained in the original Alzheimer's Disease Neuroimaging Initiative (ADNI1) and ADNI-GO (Grand Opportunity; a study funded through an NIH grant under the American Recovery and Reinvestment Act), to examine how brain imaging technology can be used with other tests to measure the progression of mild cognitive impairment (MCI) and early Alzheimer's disease (AD). ADNI2 seeks to inform the neuroscience of AD. This information will aid in the early detection of AD, and in measuring the effectiveness of treatments in future clinical trials.
NCT03876457
SELECT 2 evaluates the efficacy and safety of endovascular thrombectomy compared to medical management alone in acute ischemic stroke patients due to a large vessel occlusion in the distal ICA and MCA M1 who have large core on either CT (ASPECTS: 3-5) or advanced perfusion imaging (\[rCBF\<30%\] on CTP or \[ADC\<620\] on MRI: ≥50cc) or both and are treated within 0-24 hours from last known well.
NCT05004181
This trial consisted of three parts, Part A, Part B, and Part C, and evaluated the safety and immunogenicity of a third (booster) injection of the multivalent vaccine BNT162b2 (B.1.1.7 + B.1.617.2), and the safety and immunogenicity of a third booster injection of the monovalent vaccine BNT162b2 (B.1.617.2) or BNT162b2 (B.1.1.7), in participants who had received two doses of the parent vaccine BNT162b2 at 30 µg, at least 6 months after the second dose of BNT162b2. It also evaluated the safety and immunogenicity of a three-dose regimen of BNT162b2 (B.1.1.7 + B.1.617.2) in participants who had not received prior Coronavirus Disease 2019 (COVID-19) vaccination. In addition, the safety and immunogenicity of BNT162b2 (B.1.1.529.1) or BNT162b2 given as a third or fourth vaccine dose to RNA COVID-19 vaccine-experienced participants with history of SARS-CoV-2 Omicron variant infection was evaluated and contrasted with the natural immune response reached after infection with the SARS-CoV-2 Omicron variant in RNA COVID-19 vaccine-experienced participants.
NCT03238755
In this study, investigators plan to test whether statins can preserve and/or improve diastolic function among asymptomatic persons with HIV who are on anti-retroviral therapy. Both myocardial fibrosis and myocardial steatosis are thought to contribute to diastolic dysfunction and eventually overt heart failure in HIV. HIV-positive participants will undergo cardiac MRI/MRS imaging studies for the evaluation of myocardial fibrosis and myocardial steatosis prior to initiation of statin or placebo therapy and then two years after initiation of statin or placebo therapy. Traditional markers of cardiovascular (CVD) risk, systemic immune activation/ inflammation, HIV-specific parameters (i.e. CD4 count), and markers of myocardial stretch/injury will be assessed in relation to cardiac MRI/MRS outcomes.
NCT04919499
This study is open to adults with diabetic macular ischemia who have received laser treatment. The main purpose of this study is to find out whether people with diabetic macular ischemia can tolerate a medicine called BI 765128. In this study, BI 765128 is given to people for the first time. The study has 2 parts. Part A tests 3 doses of BI 765128. Participants get either a low, medium or high dose of BI 765128 as a single injection into the eye. If participants tolerate it well, the highest dose will be used in part B. In part B, participants are put into 2 groups randomly, which means by chance. 1 group gets BI 765128 as injection into the eye. The other group gets sham injections. A sham injection means that it is not a real injection and contains no medicine. Participants cannot tell whether they get the real injection or a sham injection. In this part, participants receive study treatment once every month for 3 months. Participants in part A are in the study for about 4 months and visit the study site about 8 times. Participants in part B are in the study for about 5 months and visit the study site about 7 times. The doctors regularly check participants' health and take note of any unwanted effects.
NCT04564443
The purpose of this clinical investigation is to assess performance of the Medaxis Debritom+™ and to collect subject outcome data in the treatment of diabetic foot ulcers (DFU) vs Standard sharp debridement.