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NCT02846532
The Purpose of this study is to characterize the single and multiple-dose pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/ PD) profiles after oral rivaroxaban therapy administered to pediatric participants 2 to 8 years of age with single ventricle physiology who have completed the Fontan procedure within 4 months prior to enrollment (Part A) and to evaluate the safety and efficacy of rivaroxaban, administered twice daily (exposure matched to rivaroxaban 10 milligram \[mg\] once daily in adults) compared to acetylsalicylic acid (ASA), given once daily (approximately 5 milligram per kilogram \[mg/kg\]) for thromboprophylaxis in pediatric participants 2 to 8 years of age with single ventricle physiology who have completed the Fontan procedure within 4 months prior to enrollment.
NCT05192850
Given the early literature available and its biological plausibility as an inhibitor of the mammalian target of rapamycin (mTOR) protein, it is hypothesized that women with endometrial cancer who take metformin for non-cancer related reasons have a lower cancer recurrence rate compared to women not taking metformin. The primary goal of this study is to determine whether metformin use is associated with a decrease in the rate of endometrial cancer recurrence. Secondary objectives are to assess whether women with endometrial cancer taking metformin have longer progression free survival and overall survival than those that do not take metformin.
NCT03153111
This is a study to evaluate whether macitentan is an effective and safe treatment for patients with heart failure with preserved ejection fraction (HFpEF) and pulmonary vascular disease. The primary objective is to evaluate whether macitentan 10 mg reduces N-terminal pro-brain natriuretic peptide (NT-pro-BNP) as compared to placebo in these patients.
NCT04092101
Prevalence of smoking among individuals with opioid use disorder (OUD) is six-fold that of the general US adult population. The mortality rate of opioid-dependent smokers is four times that of opioid-dependent nonsmokers, and their response to smoking cessation interventions is notoriously poor. A national policy of reducing the nicotine content of cigarettes has the potential to be an effective method of reducing tobacco use prevalence, dependence, and related adverse health outcomes. Controlled trials in the general smoker population have demonstrated that switching smokers to low nicotine content cigarettes results in reductions in cigarettes per day (CPD), dependence and tobacco toxicant exposure, with few adverse consequences. The investigators believe that the impact of reduced nicotine standards on use of combusted cigarettes in this population will be moderated considerably by other tobacco market conditions including (1) availability of alternative sources of non-combusted nicotine, and (2) whether these alternatives are available under conditions that optimize their appeal. The investigators hypothesize the same for other vulnerable populations as well, but achieving significant reductions in use of combusted cigarettes in smokers with OUD seems especially unlikely in the absence of readily available and appealing alternative sources of non-combusted nicotine. The goal of the proposed trial is to experimentally model whether increased availability and appeal of an alternative, non-combusted source of nicotine (e-cigarettes) will enhance the effectiveness of a reduced nicotine standard for cigarettes in smokers with OUD. Additionally, the investigators will test whether allowing participants to personalize the favor of the e-liquid alters any moderating effects their availability may have on tobacco cigarette smoking. Daily smokers who are receiving methadone or buprenorphine treatment will be recruited at University of Vermont and Johns Hopkins University. The investigators will study two research cigarettes referred to here as RC1 and RC2. One of these cigarettes will be a normal nicotine content cigarette and the other will be a reduced nicotine content cigarette. Investigators will study two e-cigarette conditions referred to here as EC1 and EC2. Both e-cigarette conditions will involve the same commercially available devices and same nicotine-containing e-liquid, but in one condition that e-liquid will be available only in tobacco flavor while in the other condition that e-liquid will be available in multiple flavors from which participants can choose based on personal taste preference. Participants will be assigned to one of the following four study conditions: (1) RC1 only; (2) RC2 only; (3) RC2 + EC1; (4) RC2 + EC2. Participants will be asked to use only their assigned study products for 16 weeks. Outcome measures include total CPD, cigarette demand assessed by behavioral economics-based purchase tasks, craving, withdrawal, psychiatric symptoms, breath carbon monoxide (CO), and biomarkers of tobacco toxicant exposure.
NCT04098068
This study will be looking at whether MK-3475 (pembrolizumab) is effective (anti-tumor activity) and safe in patients with MSI (Microsatellite Unstable) negative cancer with a mutator phenotype.
NCT03197688
The Opsumit Users registry (OPUS; NCT02126943) was developed to characterize the safety profile of Opsumit and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting. It is expected that the recruitment target of the OPUS registry cannot be achieved within the planned time period (5000 Opsumit new users by October 2018). The OrPHeUS study is designed to supplement the OPUS registry with retrospectively identified first-time Opsumit users in order to achieve the desired sample size.
NCT05547165
Patent Ductus Arteriosus is a developmental condition commonly observed among preterm infants. It is a condition where the opening between the two major blood vessels leading from the heart fail to close after birth. In the womb, the opening (ductus arteriosus) is the normal part of the circulatory system of the baby, but is expected to close at full term birth. If the opening is tiny, the condition can be self-limiting. If not, medications/surgery are options for treatment. There are two ways to treat patent ductus arteriosus - one is through closure of the opening with an FDA approved device called PICCOLO, the other is through supportive management (medications). No randomized controlled trials have been done previously to see if one of better than the other. Through our PIVOTAL study, the investigators aim to determine is one is indeed better than the other - if it is found that the percutaneous closure with PICCOLO is better, then it would immediately lead to a new standard of care. If not, then the investigators avoid an invasive costly procedure going forward.
NCT05458024
The main objective of this study is to determine whether the administration of a single dose of Vitamin D in the Emergency Department following a motor vehicle collision can improve musculoskeletal pain severity as well as reduce musculoskeletal pain outcome disparity between Blacks and White following a motor vehicle collision. This randomized controlled trial is a pilot study to determine feasibility and potential efficacy (response to study drug, ability to reduce racial disparity in pain outcomes). This data can be used to adequately power a larger randomized controlled trial to fully assess efficacy.
NCT04035226
The purpose of this study is to assess the safety and clinical response including overall response rate (ORR) of real-life standard-of-care (SOC) treatments under routine clinical practice, over a 24-month period, in patients with relapsed/refractory multiple myeloma (RRMM).
NCT05256771
Multi-center, three-arm, randomized, evaluator-blinded study of electrical muscle stimulation (EMS) and/or 1064 nm diode laser, pulsed electromagnetic field (PEMF) and vacuum assisted radio frequency (RF) using the Venus Bliss Max for fat reduction, body contouring and aesthetic improvement.
NCT04420754
The purpose of this study is to assess the safety and tolerability and determine the recommended Phase 2 dose of AIC100 Chimeric Antigen Receptor (CAR) T cells in patients with relapsed/refractory poorly differentiated thyroid cancer and anaplastic thyroid cancer, including newly diagnosed.
NCT03871829
The purpose of this study is to compare the efficacy (rate of very good partial response \[VGPR\] or better as best response as defined by the International Myeloma Working Group \[IMWG\] criteria) of daratumumab subcutaneous (Dara-SC) in combination with carfilzomib and dexamethasone (Kd) with the efficacy of Kd in participants with relapsed refractory multiple myeloma who were previously exposed to daratumumab to evaluate daratumumab retreatment.
NCT00740103
CNI-1493-CD05 is an open-label extension study of CNI-1493-CD04. In the CD05 study, patients are eligible for up to 5 courses of semapimod 60 mg IV x 3 days every 6 - 8 weeks. Primary objective is assessment of the efficacy of cumulative doses of semapimod measured by decrease in Crohn's Disease Activity Index (CDAI).
NCT05825898
Tricuspid regurgitation (TR) is a public health problem: moderate / severe TR are common, especially in ageing populations, and affect 4% of the population \>75 years old, totaling approximately 1.6 million in the US and 3 million in Europe. TR is associated with an increased risk of mortality and morbidity. Contrasting with TR prevalence and the magnitude of the problem, the vast majority of patients are medically treated with diuretics to relieve their symptoms and a curative surgical treatment for isolated severe TR is seldom performed. Reluctance to perform an ITVS can be explained in the one hand by the limited evidence that TR correction improves outcomes and on the other hand, ITVS is associated to high observed in-hospital mortality rates (≈ 10% remarkably consistent in most series across the literature). Severity of the clinical presentation is the main predictor of outcome after surgery. The TRI-SCORE, is a dedicated, simple and accurate risk score model to predict in-hospital mortality after ITVS that could guide the clinical decision-making process at the individual level. Excellent outcomes can be achieved when patients present with low TRI-SCORE. These results suggest adopting a more pro-active approach for TV interventions, and to intervene earlier in the course of the disease in patients with severe isolated TR, irrespective of TR mechanism / etiology, before the occurrence of advanced / irreversible consequences such as severe RV dilatation / dysfunction, renal and liver failure, and intractable heart failure. Recently transcatheter tricuspid valve interventions (TTVI) have emerged recently as a less invasive option to surgery to cure patients with TR. What is the best treatment between medical, surgical or transcatheter therapy to consider and the best timing for each patient are not clearly defined. The aim of the study is to compare outcome of patients with significant functional TR according to medical, transcatheter or surgical treatment after matching per TRISCORE.
NCT05782296
A clinical study designed to validate the safety and performance of the TrueLabor™ device in monitoring labor vs. current standard of care.
NCT03891524
The purpose of this study is to determine the efficacy of JNJ-70033093 in preventing total venous thromboembolism (VTE) events (proximal and/or distal deep vein thrombosis \[DVT\] \[asymptomatic confirmed by venography assessment or objectively confirmed symptomatic\], nonfatal pulmonary embolism \[PE\], or any death) during the treatment period.
NCT05576350
Ecological momentary interventions (EMI), which use phones to deliver messages to reduce alcohol use and related risk behaviors during or prior to drinking events, can help to address triggers in real-time. GPS tracking can determine when individuals visit places they have previously reported drinking or triggers to drink and then EMI messages can be delivered upon arrival to prevent risky alcohol use. A mobile app has been developed that uses GPS tracking to determine when individuals visit "risky" places and then delivers a survey asking what behaviors they engaged in while at the location. The goal of the proposed study is to use this app to enhance the Tracking and Reducing Alcohol Consumption (TRAC) intervention by delivering messages that encourage participants to employ strategies discussed during TRAC sessions when arriving at risky places. When they leave these places, they will complete a survey and breathalyzer reading in order to collect event-level self-report and biological data on alcohol use and HIV risk. If their breathalyzer result indicates alcohol use, they will receive harm reduction messaging. It is expected that combining TRAC with EMI ("TRAC-ER") will increase effectiveness by reinforcing topics discussed during these sessions, providing in-the-moment messaging to address triggers, and collecting real-time alcohol use data.
NCT03692715
This is a two arm, double blind RCT comparing the use of a single dose ciprofloxacin prior to SWL to saline alone. The multicenter trial will be conducted with a pragmatic emphasis including both high volume and low volume sites internationally.
NCT05403944
The objective of this study is to compare a novel 6-week strength training rehabilitation incorporating power exercises (STRIPE) program to a standard of care (SOC) program on short-term and long-term pain, subjective function, patellofemoral pain recurrence rates, and secondary outcomes (hip abduction and extension rate of torque development and single-leg squat kinematics). We hypothesize that participants with patellofemoral pain who complete the STRIPE program will have 1) decreased pain, 2) improved subjective function, 3) reduced patellofemoral pain recurrence rates, 4a) improved hip abduction/extension rate of torque development, and 4b) decreased hip adduction and pelvic drop during a single leg squat compared to participants who complete a SOC rehabilitation program.
NCT03153137
The primary objective is to assess the effect of macitentan 10 mg as compared to placebo on exercise capacity through cardiopulmonary exercise testing.