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Discover 15,316 clinical trials near Massachusetts. Find research studies in your area.
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NCT05489588
This study is a prospective, non-randomized, multicenter, single-arm, clinical study to evaluate the performance, safety and efficacy of the GORE® VIABAHN® FORTEGRA Venous Stent (formerly known as GORE® VIAFORT Vascular Stent) for treatment of symptomatic iliofemoral venous obstruction.
NCT05738330
The SMaRRT-HD trial is a cluster randomized trial of symptom monitoring with supported clinician follow-up using the SMaRRT-HD electronic patient reported outcome measure (ePROM) system versus Usual Care. Approximately 2400 patients at up to 36 geographically and racially diverse US hemodialysis clinics will be enrolled. The primary trial hypothesis is that regular symptom patient reported outcome measure (PROM) administration with supported clinician follow-up in dialysis care will reduce suffering and improve outcomes by prompting treatment of unrecognized symptoms, and enhancing patient-care team communication. Clinics randomized to the SMaRRT-HD group will adopt the use of SMaRRT-HD for 12 months. SMaRRT-HD is a symptom monitoring system that includes 1) tablet-based symptom reporting using a PROM and 2) supported clinician follow-up consisting of symptom alerts, guidances for symptom management, and symptom tracking reports that are shared with patients. Dialysis clinics randomized to Usual Care will not adopt SMaRRT-HD or any other trial-driven procedures. Usual Care clinics will monitor symptoms through clinical care interactions with participants and by administering a Health Related Quality of Life survey that includes questions about symptoms.
NCT06878976
This is a Phase 3, multi-center, open-label study to evaluate the long-term safety and efficacy of solriamfetol in the treatment of binge eating disorder (BED) in adults.
NCT05627440
Severe skeletal wasting and catabolic weight loss are highly common among patients with heart failure with reduced ejection fraction (HFrEF). This prospective randomized controlled trial will compare changes in the muscle mass in the arms and the legs (appendicular lean mass) in patients with HFrEF randomized between 3 groups of no, low- or high-dose protein supplementation. The dietary protein supplementation will be Ensure(R) products manufactured by Abbott Nutrition. The Investigators hypothesize that skeletal muscle wasting in HFrEF is promoted by neurohumoral activation of catabolic metabolism (such as GDF-15 and ActRII pathways) and can be at least partially reversed by increased dietary protein intake. It is anticipated that this study will determine whether dietary protein supplementation helps to prevent muscle wasting and will advance understanding of the GDF-15 and ActRII muscle wasting pathways.
NCT05514535
This study compares semaglutide, together with a lower dose of insulin glargine, to a higher dose of insulin glargine in participants with type 2 diabetes. The study looks at how well the study medicines control blood glucose levels. Participants will either get semaglutide together with a lower dose of insulin glargine or a higher dose of insulin glargine. The study will last for about 47 weeks (approximately 11 months). Participants will have 9 clinic visits, 15 phone/video calls and 1 home visit. Participants will be asked to wear a sensor that measures their blood sugar all the time in 2 periods of 10 days during the study.
NCT04271540
Psoriasis, a common chronic inflammatory skin disease affecting approximately 2% of the population, is associated with increased cardiovascular (CV) risk. Despite the implication of inflammation in this excess risk, it remains unclear whether reducing inflammation reduces the risk of cardiac events. This study proposes to test whether Tildrakizumab, an FDA approved therapy for psoriasis that blocks IL-23 and the Th17 pathway of inflammation, improves coronary vascular function and coronary flow reserve, as measured by noninvasive imaging with cardiac positron emission tomography. In so doing, improvement in coronary vasoreactivity, endothelial function, and tissue perfusion may have beneficial effects on myocardial mechanics, left ventricular deformation and function and, ultimately, symptoms and prognosis. This research may offer novel insights into the contributors of CV risk in psoriasis and provide data to support the development of strategies to prevent cardiovascular events in psoriatic disease.
NCT06568367
SUSTAIN (Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder) is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel- group trial to assess the efficacy and safety of solriamfetol in adults with excessive sleepiness associated with shift work disorder (SWD).
NCT06565052
The purpose of this study is to determine the feasibility of a prehabilitation program for participants diagnosed with rectal cancer undergoing neoadjuvant chemotherapy and/or radiation, followed by surgical resection. The names of the groups in this research study are: * Group A: Prehabilitation program * Group B: Usual Care
NCT06331403
The primary goal of this protocol is to conduct an open pilot to collect initial quantitative and qualitative feedback on the intervention that the investigators are developing. To do so, the investigators will deliver a newly-developed intervention to up to 2 consecutive groups of female colorectal and anal cancer survivors (n = up to 10 per group, total N = up to 20). Participants will provide feedback regarding intervention acceptability, feasibility, and perceived benefit. To inform plans for ongoing program refinement, the investigators will elicit specific feedback about study assessment tools, recruitment procedures, and group factors. Given the early-stage, open pilot nature of this protocol, the investigators will not set strict criteria to establish feasibility and acceptability but will rather interpret each of these outcomes holistically. Qualitative feedback collected in post-intervention exit interviews will also support understanding of feasibility and acceptability. As a secondary aim, the investigators will explore the preliminary effects of the intervention on psychosocial measures of satisfaction with sexuality and impact of functional limitations, coping abilities, acceptance of body image changes, loneliness, and anticipated stigma. As noted above, the investigators will not set specific criteria to establish preliminary efficacy, nor will they consider statistical significance as an indicator of the study's efficacy for these outcomes. Instead, the investigators will consider pre-post intervention effect sizes to consider the need for refinement of study procedures/measurement in a future larger trial. In future, larger-scale, work, the investigators intend to conduct a larger randomized pilot trial to assess intervention acceptability, feasibility, as well as preliminary efficacy on essential outcomes related to sexual well-being.
NCT04107649
Total knee replacement (TKR) is a common and costly procedure widely used to relieve pain and improve function in patients with symptomatic advanced knee osteoarthritis (OA). As of 2013, the annual incidence of TKR was over 680,000 surgeries and annual costs exceeded $11 billion. Growing evidence suggests that while pain and functional status improve following TKR, physical activity (PA) typically does not surpass pre-TKR levels. Engagement in PA can meaningfully improve quality of life (QoL), pain, and function. Given the large investment in TKR, the effectiveness and cost-effectiveness of TKR could be substantially increased if TKR recipients became more physically active. The Knee Arthroplasty Activity Trial (KArAT) is a randomized controlled trial and participants will be randomly assigned to one of three arms. Participants across all arms will receive usual post-operative care for TKR surgery. Participants in the first arm will complete basic study activities, such as responding to surveys and attending two in-person clinic visits. Participants in the second arm will do the same and also receive a wrist-based physical activity tracker intervention. Participants in the third arm will receive a telephonic active coaching (motivational interviewing) and financial incentives (for reaching physical activity goals) (TAC(MI)+FI) based intervention, as well as a wrist-based physical activity tracker intervention. The second and third arms will be eligible to receive lottery-based financial rewards for wearing a wrist-worn activity tracker for twenty-four months during the study.
NCT03368157
The purpose of the study is to develop a detailed pregnancy registry of patients with Multiple Sclerosis in the New England states. Women with a diagnosis of MS that are either pregnant or actively planning to become pregnant are eligible to participate. The study will solely take place through phone interviews. One of the study coordinator at the Partners MS Center will contact the participant for an intake phone interview where general information about the individual, their pregnancy and their MS will be collected. Thereafter the coordinator will contact the participant every 3 months for 20 minutes follow up interviews. After birth, the coordinator will collect information on the growth and development of the participant's baby. Pediatric interviews will be conducted at 2, 4, 6, 9, 12, 18, 24, 36 months. Information from the participant's neurologist and obstetrician, as well as information from the baby's pediatrician, will be made available to the study staff at regular intervals throughout the duration of the study. Through this study, the investigators hope to learn more about the effects of MS on pregnancy and pediatric development, and about the effects of pregnancy on the course of MS.
NCT03284957
Primary Objectives: Dose Escalation: * To assess the incidence rate of dose-limiting toxicity (DLT) and to determine the maximum tolerated dose (MTD) as well as the recommended dose (RD) of amcenestrant administered as monotherapy and in combination with palbociclib * To assess the incidence rate of DLT and determine the RD of everolimus or abemaciclib in combination with the selected amcenestrant dose for the combination therapy Safety Run-In: \- To confirm the RD of amcenestrant in combination with alpelisib Dose Expansion: * Antitumor activity using objective response rate (ORR) * Overall safety profile of amcenestrant administered in combination with palbociclib, alpelisib, everolimus, and abemaciclib Secondary Objectives: * Overall safety profile of amcenestrant monotherapy and in combination * Pharmacokinetic (PK) profile of amcenestrant administered as monotherapy or in combination and PK profile of palbociclib, alpelisib, everolimus and abemaciclib * Antitumor activity using ORR, the clinical benefit rate (CBR) and progression free survival (PFS) * Time to first tumor response * Residual ER availability with positron emission tomography (PET) scan \[(18)F\] fluoroestradiol (18F-FES) uptake with increasing doses of amcenestrant * Food effect on PK of amcenestrant * Potential induction/inhibition effect of amcenestrant on cytochrome P450 (CYP) 3A using 4b-OH cholesterol
NCT05131984
The primary aim of this project is to determine whether there are differences in access to, efficacy and tolerability of Ocrelizumab in men and women of different racial and ethnic origins and socio-economic backgrounds with RRMS and PPMS in two large academic MS Centers with a high volume of patients on Ocrelizumab. The study is a retrospective analysis of multiple sclerosis patients cared for at Brigham and Women's Hospital and Boston Medical Center who were treated with Ocrelizumab during the 4 year study period.
NCT01081262
This randomized phase III trial studies carboplatin given together with paclitaxel with or without bevacizumab to see how well it works compared with oxaliplatin given together with capecitabine with or without bevacizumab as first-line therapy in treating patients with newly diagnosed stage II-IV, or recurrent (has come back) stage I epithelial ovarian or fallopian tube cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel, oxaliplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, may block tumor growth in different ways by targeting certain cells. It is not yet known which regimen of combination chemotherapy given together with or without bevacizumab is more effective in treating epithelial ovarian cancer or fallopian tube cancer.
NCT05730725
The purpose of this study is to evaluate clinical effectiveness and safety of BMS-986322 in participants with moderate-to-severe psoriasis.
NCT01286272
This randomized phase II trial studies how well ofatumumab and bendamustine hydrochloride with or without bortezomib works in treating patients with untreated follicular non-Hodgkin lymphoma. Monoclonal antibodies, such as ofatumumab, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Bortezomib may also stop the growth of cancer cells by blocking blood flow to the tumor. It is not yet known whether ofatumumab and bendamustine hydrochloride are more effective with bortezomib in treating patients with follicular non-Hodgkin lymphoma.
NCT05299606
This is a prospective, multicenter, single-arm study on transbronchial microwave ablation using the NEUWAVE FLEX Microwave Ablation System and Accessories on oligometastatic tumors in the peripheral lung, guided by the Auris MONARCH Platform for visualization and access while using cone beam CT (computed tomography) to confirm probe tip placement and final ablation zone. The primary endpoint is Technique Efficacy, assessed 30-days post-ablation via CT imaging.
NCT03945162
This is a phase II, open-label, single-arm, multi-center Study conducted in Canada and the United States. Patients with Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS") (with or without resected papillary disease (Ta, T1)) that are considered Bacillus Calmette-Guerin ("BCG")-Unresponsive or who are intolerant to BCG therapy. BCG-Unresponsive is at least one of the following: At least five of six doses of an initial induction course plus at least two of three doses of maintenance therapy; or, at least five of six doses of an initial induction course plus at least two of six doses of a second induction course. Patients experiencing disease relapse within 12 months after finishing the second course of BCG therapy are considered BCG-Unresponsive. The Study will consist of 90 patients who will undergo one (1) Study Procedure, with up to two (2) additional re-induction Study Procedures based on patient response.
NCT03528694
This is a randomized, open-label, multi-center, global, phase III study to determine the efficacy and safety of Durvalumab + BCG combination therapy in the treatment of patients with non-muscle-invasive bladder cancer
NCT06841679
This is a multi-national, open-label, randomized, seamless phase II/III clinical study of UTD2 combined with fluoropyrimidine- and platinum-containing therapy to evaluate the efficacy and safety in patients with locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma untreated with systemic treatment in advanced setting.