Loading clinical trials...
Discover 17,868 clinical trials near Massachusetts. Find research studies in your area.
Browse by condition:
Showing 8601-8620 of 17,868 trials
NCT01307423
The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis who have not been previously treated with DMARDs. Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.
NCT05086835
Even when treated with methadone or buprenorphine maintenance, many people with opioid use disorder (OUD) continue to experience craving. Among both users of heroin and users of prescription opioids, mounting evidence shows that craving predicts return to use and undermines existing treatments for OUD, thus, the development of new interventions to reduce craving is a priority for addressing the opioid crisis (NIH HEAL Initiative Research Plan, 2019). Deficits in executive functioning, particularly working memory, are a central mechanism that undermines the ability to inhibit craving. Laboratory studies in non-clinical samples show that engaging in working memory tasks before or during a craving induction increases the ability to resist craving. This suggests that people with OUD may benefit from engaging in working memory tasks at the specific moment when craving occurs. Although previous research shows that working memory "training" does not improve clinical outcomes in OUD, these studies have not delivered training at the moment that craving actually occurs in daily life. Thus, engaging in working memory tasks at the moment that craving occurs could presumably help individuals with OUD to manage this persistent symptom, but this has not been tested. Further, studies using Ecological Momentary Assessment (EMA) methods show that people with OUD can accurately track moment-to-moment fluctuations in craving in their daily lives, suggesting that it may be feasible to deliver interventions for craving in the moment when craving is reported. This study will test the efficacy of embedding a mobile cognitive intervention into an EMA design in people with OUD. Using the NIH Stage Model of Intervention Development, Stage 1A of this project will optimize a working memory intervention based on iterative feedback from a sample of people with OUD (n = 20), in preparation for a Stage 1B trial using a randomized design. In this trial, participants with OUDs (n = 60) will complete a two-week EMA study in which they complete smartphone-based assessments of craving five times daily. When craving is reported, a mobile application containing the working memory intervention will activate. Half of the participants will complete the intervention, while half will complete a control task. At the conclusion of the trial, participants will be granted unrestricted access to the intervention during a feasibility phase. Outcomes include change in momentary craving, change in working memory performance, and feasibility and acceptability, including use of the intervention during follow-up. Substance use will also be assessed. This project supports the applicant's goal of leveraging cognitive mechanisms to conduct treatment development research for OUD. The applicant will receive training in the etiology and treatment of OUD, craving, mobile intervention development and human-centered design of interventions, and analysis of intensive longitudinal data. With its emphasis on modifying cognitive processes at the moment of craving, using mobile devices in patients' daily lives, this project has the potential to reveal new pathways for addressing a significant predictor of relapse in OUD.
NCT05097157
Subjects are to be enrolled in this clinical study if they are 18 - 55 years old. Up to 120 subjects will be enrolled at multiple study centers. Subjects may receive up to 5 treatments for a wide array of dermatologic conditions in which electrocoagulation and hemostasis is a viable mechanism for means of improvement.
NCT03265145
The primary objective of this pragmatic study is to compare the time to first moderate or severe COPD exacerbation in patients, not controlled on their current therapy, randomized to Stiolto Respimat versus triple therapy over 12 months of treatment The secondary objectives of this study include: 1. To compare the annual rate of moderate or severe COPD exacerbations for patients on Stiolto Respimat with patients on triple therapy. 2. To compare the time to first severe COPD exacerbation in both treatment arms. 3. To compare the annual rate of severe COPD exacerbations in both treatment arms. 4. To compare the proportion of patients with moderate or severe COPD exacerbations in both treatment arms.
NCT04350593
This is an international, multicenter, parallel-group, randomized, double-blind, placebo controlled, study in hospitalized adult patients with coronavirus disease 2019 (COVID-19) in the United States, Brazil, Mexico, Argentina, India, Canada, and United Kingdom. The study is evaluating the effect of dapagliflozin 10 milligrams versus placebo, given once daily for 30 days in addition to background local standard of care therapy, on reducing complications and all-cause mortality, or improving clinical recovery.
NCT03382574
This randomized pilot early phase I trial studies how well denosumab works in BRCA1/2 mutations carriers scheduled for risk-reducing salpingo-oophorectomy. Denosumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread.
NCT02777177
Bariatric surgery is a powerful tool for producing significant and durable weight loss. Yet, not all patients achieve initial weight loss success and many patients have weight regain as early as 1-2 years post-surgery. Suboptimal weight loss patterns not fully explained by surgical, demographic, and medical factors has led to greater emphasis on patient behaviors evidenced by clinical guidelines that focus on appropriate eating and physical activity. However, research to inform such guidelines typically has relied on imprecise measures or not been specific to bariatric surgery. There is also little understanding of mechanisms by which psychosocial factors influence outcomes. Thus, there is a need to: (a) measure behaviors and psychosocial factors thought to be related to surgical outcomes (particularly those emphasized in guidelines) using innovative strategies to maximize data quality, (b) determine which behaviors and psychosocial factors are related to outcomes, and (c) explore how psychosocial factors influence weight both directly and via influences on behavior. Our research team was the first to employ innovative mobile health (mHealth) technology within an Ecological Momentary Assessment (EMA) framework to measure adherence to recommended behaviors at 6 months post-surgery. The investigators propose to build on this work by using EMA to measure behavioral, psychosocial, and environmental factors over a longer period to understand how they predict success and risk after surgery. An NIH-funded multi-sensor PiLR HEALTH platform will integrate objective sensor data measuring behaviors and the environments in which they are performed with self-report information collected via smartphone in real-time and in patients' natural environment. Participants (N=100) recruited from 2 ASMBS-designated centers of excellence will complete a 10-day EMA protocol pre-surgery and at 3, 6, and 12 months post-surgery to assess recommended behaviors \[e.g., meal frequency, PA\], psychosocial indicators with the most prior evidence of an association with surgical outcomes (e.g., mood/depression), and key environmental factors (e.g., type/quality of the food environment). Participants will also be weighed at the above time points. Along with describing patterns in behaviors and their relation to weight loss, the investigators will test causal models to understand how complex systems of behavioral, psychosocial, and environmental factors affect weight loss, and to identify optimal targets for intervention. This project has the potential to build a much more sophisticated and valid understanding of who is and is not successful after bariatric surgery and why. This new understanding will directly contribute to improved (i.e., specific, consistent, and validated) guidelines for recommended pre and postoperative behaviors, which could lead to improved surgical outcomes. The enhanced understanding will also inform behavioral, psychosocial, and environmental targets for intervention that are mostly likely to improve surgical outcomes.
NCT03663335
The purpose of this study is to investigate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of three CFZ533 dose regimens in kidney transplant recipients. This study will allow assessment of the ability of CFZ533 to replace Calcineurin inhibitors (CNIs) in terms of anti-rejection efficacy, while providing better renal function with a better safety and tolerability profile. Results of this study will be used to inform the CFZ533 dose and regimen selection for investigation in later phases of clinical development.
NCT03600818
Primary Objective: To evaluate the efficacy of KEVZARA (sarilumab) in participants with polymyalgia rheumatica (PMR) as assessed by the proportion of participants with sustained remission for sarilumab with a shorter corticosteroid (CS) tapering regimen as compared to placebo with a longer CS tapering regimen. Secondary Objectives: * To demonstrate the efficacy of sarilumab in participants with PMR compared to placebo, in combination with a CS taper with regards to: * Clinical responses (such as components of sustained remission, disease remission rates, time to first disease flare) over time. * Cumulative CS (including prednisone) exposure. * To assess the safety (including immunogenicity) and tolerability of sarilumab in participants with PMR. * To measure sarilumab serum concentrations in participants with PMR. * To assess the effect of sarilumab in reducing glucocorticoid toxicity as measured by the composite glucocorticoid toxicity index (GTI) questionnaire.
NCT03245268
The International Balloon Pulmonary Angioplasty (BPA) Registry is a prospective, multi-center, long-term observational project. Scheduled to start data collection in Q4 2017, the registry will run for approximately four years with a follow-up time for each patient of at least two years. Its primary objective is to investigate the efficacy and safety of BPA intervention in patients with chronic thromboembolic pulmonary hypertension (CTEPH) not amenable to pulmonary endarterectomy (PEA).
NCT05080647
A randomized controlled trial comparing a group in which only child participants play Mightier video games for 8 weeks (Child Play group) to a group in which child and parent participants play Mightier video games for 8 weeks (Child and Parent Play group).
NCT01434290
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Given radiation therapy in different ways may kill more tumor cells. PURPOSE: This randomized phase II trial studies radiation therapy to see how well it works in treating patients with prostate cancer.
NCT03630770
This study evaluates whether adding a dietary supplement similar to coconut oil (MCT oil) to feedings in premature infants will reduce the amount of yeast (Candida) detectable in their stool. Infants who have Candida in their stool are eligible to participate. Half of the enrolled infants will have additional MCT oil added to their feedings and half will not.
NCT02625610
The purpose of this study was to demonstrate superiority of treatment with avelumab versus continuation of first-line chemotherapy.
NCT03951077
This study will assess the potential impact of elagolix on disordered pituitary and ovarian hormones in women with polycystic ovary syndrome (PCOS).
NCT03738423
The primary objective of the study is to assess the efficacy of REGN3500 monotherapy in Atopic dermatitis (AD), as well as understand the dose-response relationship, compared with placebo treatment, in adult patients with moderate-to-severe AD. Secondary objectives are to: * Assess the safety and tolerability of subcutaneous (SC) doses of REGN3500 monotherapy in adult patients with moderate-to-severe AD * Assess the Pharmacokinetics (PK) of REGN3500 in adult patients with moderate-to-severe AD * Assess the immunogenicity of REGN3500 in adult patients with moderate-to-severe AD
NCT03395704
This study is a Phase 2 multicenter, randomized, placebo controlled, single-blind study. The primary objective of the study is to compare the effect of weekly dosing of LJPC-401 (synthetic human hepcidin) versus placebo on transferrin saturation (TSAT) in an adult hereditary hemochromatosis patient population.
NCT03219164
The primary objective of this study is to evaluate the safety and efficacy of a 14-day course versus a 28-day course of aztreonam for inhalation solution (AZLI) in pediatric participants with new onset Pseudomonas aeruginosa respiratory tract infection or colonization.
NCT03540069
This research project will investigate the determinants of cervical cancer screening uptake and sustained utilization in this region and develop and evaluate a context-specific peer education behavioral intervention to improve uptake. Research supports the effectiveness of peer education in increasing cancer screening rates but, currently, no cervical cancer screening peer education program specific to rural Senegal exists. To inform the participatory development of this program, the investigators will assess barriers and facilitators of screening at multiple levels: individuals (women aged 30 to 59), households (family or principle social unit of at-risk women), and the community (immediate village or neighborhood with common amenities of at-risk women). We hypothesize that a peer education program that adapts to changing contexts over time and is targeted at a multi-level audience will result in early, widespread uptake and sustained use of the VIA cervical cancer screening program. Study findings will inform programmatic planning in Kedougou and the peer education curriculum we develop can serve as a template for maximizing early impact of new cervical cancer screening services implemented in other areas of rural Senegal. Our long-term goal is to inform national-level policy to guide the implementation of cervical cancer screening programs in other rural Senegal regions.
NCT03259269
This observational study will examine the safety and efficacy of bedaquiline and delamanid used (individually, not together) in routine, multidrug regimens for treatment of MDR-TB. The information gathered in this study will inform doctors how best to use these TB drugs in the future.
