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NCT00847613
This study is designed to provide safety and efficacy data to support the development of CP-690,550 in patients with moderate to severe rheumatoid arthritis on background of methotrexate.
NCT03568331
This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the United States in subjects with atopic dermatitis.
NCT02981407
The purpose of this study is to compare two red blood cell transfusion strategies (liberal and restrictive) for patients who have had an acute myocardial infarction and are anemic.
NCT04390113
Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC).
NCT06215014
The goal of this intervention is to compare the blood pressure response of young females and males to a single bout of static handgrip exercise before and after static handgrip training (4 weeks). The main questions this study aims to answer are: * Are the lowering blood pressure effects of static handgrip exercise training different between young females and males? * Which factors explain the lowering blood pressure effects of static handgrip training and possible differences between sexes? Is it an improved blood vessel dilation? Is it a reduced stiffening of blood vessels? Is it a reduced fight or flight response resulting in a lower heart rate and blood pumped by the heart into the vessels? All the above? * Which factors regulate blood pressure response during and immediately after a single bout of static handgrip exercise? All participants will be asked to: * Visit the laboratory to perform static handgrip exercise - first visit; * Participants will be randomized (like flipping a coin) to static handgrip exercise training or to a non-exercising phase, with each phase lasting four weeks. Participants will also complete the other condition (handgrip or no handgrip) after completing the first four-week condition * Return to the laboratory after the completion of both static handgrip training and no training to perform the static handgrip exercise of the first visit. The investigators will compare participants' blood pressure response to a single bout static of handgrip exercise after training to their own blood pressure response to the same bout of exercise after the non-training period.
NCT03118752
The investigators will complete a pragmatic randomized trial (N=260 randomized participants) of the 26-week blended collaborative care (CC) intervention compared to enhanced usual care (eUC) in patients admitted for acute coronary syndrome (ACS) or heart failure (HF) found to have current depression, generalized anxiety disorder (GAD), or panic disorder (PD). The CC intervention will use a novel three-pronged approach to these high-risk patients. Care managers will provide centralized care coordination and specific interventions targeting: (1) the psychiatric disorders, (2) cardiac health behaviors, and (3) the cardiac illness. The primary study outcome will be physical function at 26 weeks, measured by the Duke Activity Status Index (DASI), given links between function and new cardiac events. The investigators will also examine effects on numerous other outcomes important to patients and healthcare systems. Specific Aim 1 \[patient-centered outcomes-primary aim\]: To compare between-group differences in the CC and eUC conditions on improvements in physical function, health-related quality of life, mental health, patient satisfaction, and other key patient-reported outcomes at 26 and 52 weeks. Specific Aim 2 \[adherence and medical outcomes\]: To compare between-group differences on health behaviors (physical activity, diet, smoking, medication adherence) and major adverse cardiac events. Specific Aim 3 \[cost\]: To compare healthcare costs between groups and assess the cost-effectiveness of CC. Hypotheses: The investigators expect this bolstered CC program to be associated with superior improvements in physical function, health-related quality of life, patient satisfaction, and adherence at 26 weeks, with promising effects on major adverse cardiac events. The investigators likewise expect the intervention to be cost-effective (\<$10,000/quality-adjusted life year) over the study period.
NCT02952222
The primary aim of this study is to compare the propofol requirements of children who receive propofol with that of children who receive dexmedetomidine prior to propofol, for sedation for upper and lower endoscopic procedures.
NCT04535609
This is a randomized, double-blind, placebo-controlled, parallel group, multi-centre, study designed to investigate the efficacy and safety of REN001 administered once daily over a 24-week period to patients with PMM.
NCT04140695
NCT02628899
To assess the safety and feasibility of Transcatheter Aortic Valve Replacement (TAVR) with commercially available bioprostheses in patients with severe, symptomatic aortic stenosis (AS) who are low-risk (STS score ≤3%) for surgical aortic valve replacement (SAVR).
NCT02507687
This study will evaluate the intraocular pressure (IOP)-lowering effect and safety of bimatoprost SR compared with selective laser trabeculoplasty in patients with open-angle glaucoma or ocular hypertension who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy (e.g., due to intolerance or nonadherence).
NCT03371082
Primary Objective: •To evaluate equivalence of Gan \& Lee Insulin Glargine Injection and Lantus® in terms of immunogenicity Secondary Objective: Immunogenicity: • To evaluate the percentage of subjects with negative anti-insulin antibodies (AIAs) at baseline who develop confirmed positive AIA up to Week 26, the percentage of baseline in AIA titers between treatment groups, the percentage of subjects with confirmed positive AIA who develop any anti-insulin neutralizing antibodies up to visit Week 26, and percentage of subjects who develop confirmed positive AIA up to visit Week 26 of Gan \& Lee Insulin Glargine Injection in comparison with that of Lantus®. Safety: •To evaluate the safety of Gan \& Lee Insulin Glargine Injection in comparison with that of Lantus®. Efficacy: •To evaluate the efficacy of Gan \& Lee Insulin Glargine Injection in comparison with that of Lantus®.
NCT04657016
This is a study of tirzepatide in participants with obesity. The purpose of this study is to learn more about how tirzepatide maintains body weight or adds to weight loss after an intensive lifestyle modification program. The study will last about 2 years (29 visits).
NCT03779841
This was a multi-center, randomized, double-blind, placebo-controlled, parallel group, dose-ranging study to evaluate the efficacy and safety of botulinum toxin type A (AGN-151607) injections into the epicardial fat pads, foci of ganglionic plexi, to prevent Post-Operative Atrial Fibrillation (POAF) in patients undergoing open-chest cardiac surgery.
NCT03515811
The objectives of this prospective, two-arm, multicenter post-market study is to confirm safety and performance through the incidence of subjects reporting serious adverse device effects (ADEs) up to and including 30 days following use of Signia™ Stapling System with Endo GIA™ with Tri-Staple™ Technology and Tri-Staple™ 2.0 Intelligent Reloads in subjects undergoing indicated abdominal or thoracic procedures for resection, transection and creation of anastomosis per the IFU.
NCT02908100
This is a study to evaluate the safety and efficacy of GDC-0853 in combination with standard of care therapy in participants with moderate to severe active systemic lupus erythematosus (SLE).
NCT03674307
The Canadian Australasian Randomized Trial of Screening Kidney Transplant Candidates for Coronary Artery Disease (CARSK) will test the hypothesis that eliminating the regular use of non-invasive screening tests for CAD AFTER waitlist activation is not inferior to regular (i.e., annual) screening for CAD during wait-listing for the prevention of Major Adverse Cardiac Events. Secondary analyses will assess the impact of screening on the rate of transplantation, and the relative cost-effectiveness of screening.
NCT02946463
The primary purpose of this study was to assess the noninferiority of ravulizumab compared to eculizumab in adult participants with PNH who had never been treated with a complement inhibitor (treatment-naïve).
NCT03969225
A functioning vascular access provides a lifeline for patients requiring haemodialysis but vascular access dysfunction remains one of the leading causes of excessive morbidity, mortality and healthcare costs in this group. Despite increasing numbers of vascular access trials, successful interventions to improve vascular access function have been sparse and compromised by highly variable, often selectively reported outcome measures of limited relevance to patients and health professionals. Through engagement of all relevant stakeholders including patients and caregivers, vascular access function, defined by the need for interventions to enable and maintain the use of a vascular access for haemodialysis, has been identified as one of the most critically important outcome measures for trials in haemodialysis. This prospective, multi-centre, multinational validation study aims to assess the accuracy and feasibility of measuring vascular access function part of routine clinical practice and across different clinical settings to ensure successful global implementation of this core outcome measure in future trials in haemodialysis.
NCT04345900
To assess the duration of severe neutropenia (DSN) in treatment Cycle 1 in patients treated with docetaxel (75 mg/m2) + plinabulin (5, 10, or 20 mg/m2) or with docetaxel (75 mg/m2) + pegfilgrastim (6 mg). Neutrophils count was to be assessed at baseline (prior to Cycle 1 docetaxel dose) and during Cycle 1 on Days 1, 2, 6, 7, 8, 9, 10, and 15 (pre-dose on dosing days; times equivalent to pre dose on other days).