About 31,588 results


Sep 30th, 2022 - The objective of this multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the CAPTURER in a NON-SELECTED, Real World population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device regulation requirements for post-market clinical follow-up.

Use of Autologous Concentrated Bone Marrow Aspirate in Preventing Wound Complications in Below Knee Amputation (BKA)

Sep 30th, 2022 - Patients scheduled for amputation will receive bone marrow cells concentrated via the MarrowStim device (cBMA) injected IM at 25 sites in the leg proximal to the amputation in the index limb to prevent ischemic wound complications after surgery. cBMA will be injected into the anterior tibialis muscle below the point of amputation in an area approximately 3cm^2 x 2cm^2 for analytical purposes. P...

A Clinical and Histological Analysis of Mesenchymal Stem Cells in Amputation

Sep 30th, 2022 - This is a phase I single center open label trial study that will enroll twenty-six (26) patients requiring semi-elective lower extremity major amputation within a 30 day period for non-infectious complications related to critical limb ischemia (CLI). After enrollment patients will be scheduled for amputation 7 days after MSC administration. The investigational treatment uses allogeneic bone mar...

ELUVIA™ Drug-eluting Stent Versus Zilver® PTX® Stent

Sep 30th, 2022 - Atherosclerosis is a systemic disease that has become increasingly recognized in the expanding elderly population as a significant cause of morbidity and mortality. Atherosclerosis in the vessels of the lower extremities can cause a variety of symptoms ranging from intermittent claudication to ischemic rest pain and critical ischemia with major tissue loss. Typically, femoropopliteal lesions ha...

Look AHEAD: Action for Health in Diabetes

Sep 30th, 2022 - Look AHEAD is examining, in overweight volunteers with type 2 diabetes, the long-term effects of an intensive lifestyle intervention program designed to achieve and maintain weight loss by decreased caloric intake and increased physical activity. This program will be compared to a control condition involving a program of diabetes support and education. The primary hypothesis is that the inciden...

Adaptive Efficacy and Safety Study of Glenzocimab Used as an add-on Therapy on Top of Standard of Care un the 4.5 Hours Following an Acute Ischemic Stroke

Sep 30th, 2022 - A randomized, double blind, multicenter, multinational, placebo controlled, parallel group, single dose, adaptive phase II/III study. The study will be conducted in 3 consecutive parts, each separated from the preceding one by an interim analysis to allow the Independent Data Monitoring Committee (IDMC) to issue recommendations on study conduct, potential early termination or protocol adjustmen...

Ketorolac-an Option for Post Operative Pain Management After Elective Cardiac Surgery.

Sep 30th, 2022 - DATA COLLECTION: Computer randomization was done for the numbers 1 to 60, having 50% probability of being in either of two groups: Ketorolac (treatment) or Paracetamol (control). After randomizing each number into either group, which ever patient (consenting and meeting the inclusion criteria) came, was allotted these numbers consecutively, as they presented for elective cardiac surgery. Thus r...

Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA

Sep 30th, 2022 - Cardiac rehabilitation (CR) decreases mortality and both CR and pulmonary rehabilitation (PR) improve function, quality of life, and decrease readmission rates. Despite their proven efficacy, both programs are grossly underutilized, with fewer than 20% of eligible persons participating. Patients with heart and lung disease living in rural communities have even lower rates of participation. The ...

Prevail Drug Balloon Study

Sep 30th, 2022 - Procedural strategy, adjuvant medical therapy and antiplatelet regime were left to the discretion of individual operators and their routine clinical practice. In brief, lesion preparation with predilatation using an uncoated balloon with or without the use of adjunctive therapy such as atherectomy or intracoronary lithotripsy to achieve residual diameter stenosis of less than 30% will be requir...

Safety and Efficacy After Selective Intra-arterial Thrombolysis for Central Retinal Artery Occlusion

Sep 30th, 2022 - Central retinal artery occlusion (CRAO) is an ophthalmic emergency which leads to devastating visual function defects and poor prognosis. Though traditional conservative treatments are widely used, none of them is proved to be effective. The respective responses of brain and retinal tissues to acute ischemia share many features is the rationale for therapeutic thrombolysis in CRAO. Intravenous ...

Efficacy and Safety of Head Acupuncture After Mechanical Thrombectomy for Acute Ischemic Stroke

Sep 30th, 2022 - Control group: Mechanical thrombectomy followed by the guideline recommended treatment for acute ischemic stroke; Experimental group: After mechanical thrombectomy, head acupuncture and the treatment regimen recommended by the guideline for acute ischemic stroke were administered

SCOPE-CLI: Shifting Care and Outcomes for Patients With Endangered Limbs

Sep 29th, 2022 - An estimated 8 million individuals in America are affected by peripheral arterial disease (PAD). One of its extreme expressions is Critical Limb Ischemia (CLI). It is one of the most severe vascular conditions associated with devastating outcomes, including poorly healing wounds, extreme pain, and a high amputation risk. It is also one of the deadliest conditions, with 6-month and 5-year mortal...

Role of Sympathetic Activation in Ischemia Reperfusion Injury

Sep 29th, 2022 - This is a randomized single blind study where subjects will be allocated to undergo one of the 4 protocols. Participants will be given placebo or 0.2mg of Moxonidine to take orally 20 minutes prior to the first endothelial function measurement. This medication acts by reducing the activity of nerves believed to be involved in the conditioning process. The placebo pill, designed to have no effec...

Compressive Elastic Dressing Versus TR Band

Sep 29th, 2022 - Radial approach is widely established in cardiac diagnostic and therapeutic treatments. It has been shown to decrease bleeding, vascular problems, and mortality rates when compared to the femoral approach. It also offers better comfort to patients through early mobility and lowers hospital expenses. Previously, there were no specific devices for radial artery hemostasis. Many different types of...

EVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction

Sep 29th, 2022 - The primary objective of this study is to evaluate the effectiveness of early treatment with evolocumab plus routine lipid management vs routine lipid management alone when administered in the acute setting to reduce myocardial infarction, ischemic stroke, arterial revascularization, and all-cause death in subjects hospitalized for an acute myocardial infarction (non-ST-segment elevation myocar...

Mitochondrial Health and Hemodynamic Instability Related to Renal Replacement Therapy in Critically Ill Patients

Sep 29th, 2022 - BACKGROUND: Acute kidney injury (AKI) that requires renal replacement therapy (RRT) affects 2% of all hospitalized patients and 15% of those admitted to ICU. Non-recovery of kidney function and consequent long-term dialysis-dependence, has a profoundly negative impact on patients' health and quality of life. While RRT is life-saving treatment for severe AKI, hemodynamic instability related to R...

The Reducing Exercise Sensitivity With Exposure Training (RESET) Study

Sep 29th, 2022 - Fear of exercise may be prominent among acute coronary syndrome (ACS) survivors due to the presence of physical disease states that can exacerbate uncertainty about bodily sensations. For instance, patients may perceive physical sensations experienced during exercise (e.g., increased heart rate, shortness of breath, fatigue) as dangerous, intolerable, or similar to sensations experienced or att...

Early Discovery of Ischemia After Replantation Surgery of the Extremities

Sep 29th, 2022 - This is an open, prospective, interventional, single-center clinical investigation designed to examine the feasibility and safety of the IscAlert™ device in patients scheduled for extremity replant surgery. Sixty patients will be enrolled to undergo the procedures using a total of 400 devices depending on the injuries. IscAlert is 0.8 mm in diameter and in vitro testing, shows stable and accura...

Phase Ib/IIa Clinical Study of ApTOLL for the Treatment of Acute Ischemic Stroke

Sep 29th, 2022 - This is a prospective, multicenter, double-blind, randomized, placebo-controlled, Phase Ib/IIa clinical study to assess the administration of ApTOLL together with endovascular therapy in acute ischemic stroke (AIS) patients with confirmed Large Vessel Occlusion (LVO) who are candidates to receive reperfusion therapies including endovascular treatment with or without i.v. rt-PA (recombinant tiss...

The Benefit of Bermekimab in Patients With Systemic Sclerosis

Sep 29th, 2022 - Systemic sclerosis (SSc also known as scleroderma) is a devastating chronic immune-mediated inflammatory syndrome that is characterized by progressive organ dysfunction. The most common affected systems are the skin, the gastrointestinal tract, the lungs and the heart. Capillary endothelium is involved leading to ischemia and digital necrosis. Patients develop an interstitial lung disease (ILD)...