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Filter by:This is a multisite randomized control proof-of-concept trial to evaluate the safety of Duramesh laparotomy closure in the trauma and emergency laparotomy setting. The study will be performed at University of Maryland Shock Trauma Center and Walter Reed National Military Medical Center. One hundred (100) patients will be randomized (2:1) to Duramesh laparotomy closure versus conventional suture closure. After the patient has been confirmed to be a candidate for the trial, randomization will be performed in the operating room upon completion of the index abdominal procedure. Duramesh will be provided for patients assigned to the Duramesh treatment arm. Patients will be followed for 1 year following laparotomy closure at follow-up intervals of 1 month, 3 months, 6 months, and 12 months.
Hepatic veno-occlusive disease/sinusoidal obstructive syndrome (VOD/SOS) is a potentially fatal complication of hematopoietic cell transplant (HCT). Historically VOD/SOS has been clinically diagnosed using the modified Seattle criteria or the Baltimore criteria. The modified Seattle Criteria define VOD/SOS diagnosis is made when two of the following three criteria are present in a patient within 21 days of transplantation: hyperbilirubinemia (total serum bilirubin > 2 mg/dL), hepatomegaly or right upper quadrant liver pain, and weight gain (> 2% of baseline) or ascites. Other conditions like graft versus host disease, sepsis syndrome (fever and hypotension), cardiac failure, or tumor infiltration) have to be excluded. This definition was from a well-designed retrospective cohort study on 255 adult and pediatric HCT patients in which the VOD/SOS incidence was 21%. McDonald et al followed up this work with a prospective cohort study of 355 patients noting an incidence of VOD/SOS of 54%. These seminal studies have had a major impact on the field by defining clinical diagnostic criteria. An alternative diagnostic criteria (Baltimore criteria) was proposed by Jones et al as a part of a well-designed retrospective review of 235 HCT patients finding a VOD/SOS incidence of 22%. Jones defined VOD/SOS as the presence of hyperbilirubinemia (total serum bilirubin > 2 mg/dL) along with at least 2 of 3 other findings: hepatomegaly, ascites, and weight gain (> 5% of baseline).
The American Heart Association guidelines for high blood pressure (BP) currently recommend using angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARBs) as first-line therapy for patients with chronic kidney disease (CKD) stage 3 or above. However, the prevalence of ACEi and ARB use in patients with CKD stage 4 or 5 is low, and current BP guidelines acknowledge the lack of solid evidence to support the benefit of using these agents in advanced CKD.This study seeks to conduct a pilot trial to determine the safety and feasibility of ACEi and/or ARB continuation (intervention) versus withdrawal (control) in patients with advanced CKD.
Prospective, monocentric, randomized phase II study evaluating Low-Level Laser Therapy (LLLT) as a treatment for the pain due to grade 2 oral mucositis in patients with upper aero-digestive tract cancer treated by radiotherapy or chemoradiotherapy. Patients with upper aero-digestive tract cancer receiving their first cervicofacial radiotherapy or chemoradiotherapy will be included in this study if they suffer from oral mucositis due to their treatment. The study procedure will consist in 5 applications of the LLLT that will be performed at three days intervals for a maximum duration of 15 days. Each patient will be followed until 3 days after the end of the study treatment, for a total duration of the study of 18 days.
In about 15% of adult concussion cases, symptoms last longer than 2 weeks and can largely impact the individual's ability to work, be physically active and participate in everyday life. These symptoms are often partially related to unresolved neck muscle tightness and other neck-related symptoms. Dry needling is a technique that uses acupuncture needles to release muscle knots, decrease neck muscle tightness and decrease neck pain. As far as the investigators are aware, there have been no studies looking at the effects of dry needling on symptoms of chronic concussion. This study will compare the effects of dry needling to traditional hands-on physiotherapy treatment of the neck for concussion-related symptoms. Participants with chronic concussion symptoms will receive either dry needling, hands-on manual physiotherapy or both. Concussion symptoms, symptom severity, neck range of motion and pain with pressure over neck muscles will be compared before and after treatment, and the day after treatment. The investigators expect that the greatest improvement in all of these will be seen in the group receiving both interventions, both immediately after treatment and the following day. If dry needling can immediately improve concussion symptoms, patients may better tolerate therapeutic exercise and experience quicker resolution of chronic symptoms.
The primary purpose of this study is to assess the effectiveness of TRELEGY ELLIPTA single inhaler triple therapy (SITT) (fluticasone furoate/umeclidinium bromide/vilanterol [FF/UMEC/VI]) relative to non-ELLIPTA multiple inhaler triple therapies (MITT) of inhaled corticosteroids/long-acting beta2-adrenergic receptor agonists/muscarinic receptor antagonists (ICS/LABA/LAMA) within a routine clinical practice setting. This is a non-randomized, interventional and self-controlled cohort study conducted to collect data in routine practice. This study will have two periods where in retrospective data will be collected in pre-switch period and prospective data will be collected in post-switch periods. Subjects will be switched from non-ELLIPTA MITT to TRELEGY ELLIPTA. The pre-switch period is of 52 weeks and post-switch period will be of 52 weeks. Additionally subjects will receive safety follow-up call at 26 weeks and 52 weeks for safety monitoring. Approximately 1300 subjects will be enrolled for this study. TRELEGY ELLIPTA is a registered trademark of the GlaxoSmithKline (GSK) group of companies.
This study will assess the effect of active postoperative temperature management and its effect on the cognitive function in patients following coronary artery bypass graft (CABG) surgery to determine if active postoperative temperature management to maintain normothermia reduces postoperative cognitive dysfunction (POCD) in this population. Additionally, the investigators will explore differences in temperature control variability by using temperature management wraps combined with acetaminophen vs. acetaminophen alone in a pilot arm.
Determine whether Mesh Suture achieves an acceptable safety and efficacy profile in load bearing internal tissue approximations. Mesh Suture has a novel design that permits tissue ingrowth and limits suture pull-through--items important for internal high-tension repairs
Conventionally, a relatively high level of fraction of inspired oxygen (FiO2) has been used for secure a margin of safety in patients undergoing cardiac surgery using cardiopulmonary bypass (CPB). Since the potential adverse effects of hyperoxemia (via reactive oxygen species, vasocontriction, perfusion heterogeneity, myocardiac injury, etc.), various studies on this topic has been performed. However, the results are conflicting and inconsistent, and the consensus about whether the use of additional oxygen supply in cardiac surgery using CPB has not been reached among practitioners yet.
The primary objective of this project is to compare the rate of postoperative voiding dysfunction in two voiding trials (the retrograde-fill technique versus the spontaneous-fill technique) after midurethral sling (MUS) procedures with tension-free vaginal tape (TVT) without any concomitant surgery.