Active clinical trials for "Constriction, Pathologic"

Trial of ACURATE neo(TM) Aortic Bioprosthesis for Implantation using the ACURATE TA(TM) LP Transapical Delivery System in Patients with Severe Aortic Stenosis for evaluating the Safety and performance of the study device

The purpose of the study is to determine the best management of bile duct narrowing (stricture) due to inoperable tumors. The bile duct is a tube that carries bile formed in the liver to the small bowel to digest fats. Tumors around the bile duct can compress the duct causing pain, jaundice (yellow skin and eyes), itchy skin and fever.

Spinal stenosis is one of the most common causes of low back pain among older adults and can result in significant disability. Despite this, it still isn't known which treatments are most effective or what outcomes are most important to these older adults. Through a Patient Centered Outcomes Research Institute (PCORI) contract, the investigators are building on the existing infrastructure of an AHRQ-funded (ARRA CHOICE award) comparative effectiveness research (CER) trial of epidural steroid injections (ESI) for spinal stenosis (the LESS trial) to address several critical research questions. The proposed study will answer the following key questions. Do decision aids tailored to older adults with spinal stenosis change patient decision-making regarding subsequent treatments? Do patients respond differently at subsequent outcome assessments time-points after receiving tailored decision aids that contain their own individual outcome data from prior treatments? The investigators hypothesize that providing these individualized reports will allow patients to make more informed choices regarding subsequent treatments, leading to reduced use of ineffective treatments and improved outcomes overall.

The PREHAB study is a clinical trial where frail patients waiting for heart surgery are randomly chosen to either receive the current standard of care or to participate in an 8-week exercise/education program at a community-based cardiac rehabilitation facility. Patients can wait for elective heart surgery for as long as 3-4 months. During this time, individuals are often fearful of making things worse, causing them to stop being active and further deteriorate their physical condition. This wait period presents a potential opportunity for health care providers to engage the patient to take control of their self-managed care prior to surgery with the intent of improving post-surgical outcomes. Patients randomized to the PREHAB intervention group will participate in supervised exercise twice per week in a program designed to improve physical functioning and exercise capacity. The investigators hypothesize that the PREHAB program for frail elderly patients awaiting an elective cardiac surgery will reduce frailty, improve exercise capacity, improve physical activity behaviour, improve in-hospital outcomes, improve clinical outcomes 3 months and 1 year postoperatively, and improve overall quality of life.

Endoscopic retrograde biliary drainage with a self-expandable metal stent (SEMS) has been used as a principle palliative method of distal biliary obstruction in patients with pancreaticobiliary cancers. With potentially curative surgical resection being impossible, the maintenance of successful biliary drainage through patent stent has been regarded as the key to improve the quality of life and survival of patient, because it could prevent biliary infection or liver failure, and give patients opportunities for anti-cancer chemotherapy and/or radiotherapy. Although SEMSs have been reported to be superior to large bore plastic stents in terms of stent patency, they still have some controversial issues to resolve in relation to stent dysfunction and adverse event. It has been widely accepted that covered SEMSs designed to overcome the stent failure of uncovered SEMSs related to tumor ingrowth, have significant higher rate of stent migration as well as tumor overgrowth. Therefore covered SEMSs did not show the clear clinical excellence in the cumulative stent patency over uncovered SEMSs, despite some clinical results of randomized trials favor to covered SEMSs. From the perspective of adverse events such as pancreatitis and cholecystitis, conflicting results have been produced. It was initially assumed that covered SEMSs could cause the higher incidence of pancreatitis and cholecystitis attributed to occlusion of pancreatic duct and cystic duct by covering materials. However, no significant difference was found with regard to the incidence of pancreatitis and cholecystitis between covered and uncovered SEMSs in several randomized trials and meta-analysis. The aim of the current study is to compare the cumulative stent patency of partially covered and uncovered SEMS as a primary objective, and investigate overall patient survival, stent dysfunction-free patient survival, and incidence of adverse events including stent dysfunction as secondary objectives.

To evaluate the safety and efficacy of the Absorb BVS System compared to the XIENCE V Everolimus Eluting Coronary Stent System (EECSS) in the treatment of subjects with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.

Hypothesis: Topical application of Tranexamic acid into the surgical wound during spine surgery will decrease the overall blood loss post-operatively. This reduction in blood loss will reduce the need for transfusion. In addition it will also significantly reduce the cost of the surgical procedure. Specific Aim 1: The goal of this study is to quantitatively assess whether topical application of tranexamic acid placed into the surgical wound during lumbar spine surgery will decrease post-operative blood loss, thus lowering the need for blood transfusions. By reducing the number of transfusions participants can avoid the well-known complications associated with them. The investigators do not plan on measuring serum tranexamic acid levels. Several meta-analyses and level I studies have shown that intravenous (IV) administration of tranexamic acid is effective in reducing postoperative blood loss and the need for transfusion.

This is a prospective, multi-center, single-arm, open-label clinical trial. Clinical follow-up will be performed at 30 days. Follow-up by phone will be performed at 6 months, and 1 year after the procedure. Study Objective is to further assess the safety and efficacy of long (38 mm) Ridaforolimus Eluting Stent - EluNIR.

Treatment options for lumbar spinal stenosis include surgical and non-surgical approaches. For most people, the decision depends on how bothered they are by their symptoms and how they feel about having surgery. Since individuals with the same clinical presentation may feel differently about their symptoms and how they view the benefits and harms of their options, there is no agreed upon "best"treatment. It has been shown that, for "preference-sensitive" decisions like this one, decision aids (tools that pair balanced, evidence-based information regarding treatment options with values clarification) improve patients'knowledge and realistic expectations, lower decisional conflict, increase patient involvement in decision making, decrease the number of undecided, and increase agreement between values and choice.1 The Spine Center, in collaboration with the Center for Shared Decision Making (CSDM) at Dartmouth Hitchcock Medical Center (DHMC), has been providing patients with decision aids (DAs) for several years. Hypothesis: Patients identified as having low literacy and/or high decisional conflict after viewing a video decision aid will show greater resolution of their decisional conflict, higher decision self-efficacy and less decision regret if a coaching intervention is paired with a video decision aid. Decision support in the form of coaching develops patients'skills in preparing for a consultation and deliberating about their options.2 A study of women with abnormal uterine bleeding showed that pairing coaching with a DA helped patients clarify their values and preferences, reduced costs, and increased long term satisfaction.3 The investigators plan to assess the impact of coaching in patients with lumbar spinal stenosis who are referred to the CSDM for a video decision aid about their treatment options. The investigators are also interested to learn whether screening for low literacy and high decisional conflict can identify a subgroup of patients who are more likely to benefit from coaching.

The investigators are evaluating the use of a SpyBite biopsy forceps for tissue diagnosis when compared to standard biopsy techniques.