9 results match your criteria: "Department of Clinical and Medical Affairs[Affiliation]"

Introduction: There is an unmet need for high-quality data for Robot-assisted partial nephrectomy (RAPN) in the Indian population. Indian study group on partial nephrectomy (ISGPN) is a consortium of Indian centers contributing to the partial nephrectomy (PN) database. The current study is a descriptive analysis of perioperative and functional outcomes following RAPN.

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Background: Vagus nerve stimulation (VNS) at low frequencies (≤30 Hz) has been an established treatment for drug-resistant epilepsy (DRE) for over 25 years.

Objective: To examine the initial safety and efficacy performance of an investigational, high-frequency (≥250 Hz) VNS paradigm herein called "Microburst VNS" (μVNS). μVNS consists of short, high-frequency bursts of electrical pulses believed to preferentially modulate certain brain regions.

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In a real‐world database of metastatic colorectal cancer (mCRC) in the United States, comprehensive genomic profiling (CGP) using plasma‐based next‐generation sequencing identified potentially actionable profiles for approximately one‐third of the patients with both the first test and again with a second test after disease progression, with around 60% of all patients tested receiving therapy consistent with the CGP results at each line of treatment. This suggests a role for CGP prior to more than one line of mCRC treatment.

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Introduction: Incontinence impacts the quality-of-life of people suffering from the disease. However, there is limited information on the prevalence of incontinence due to the stigma, lack of awareness, and underdiagnosis.

Objective: This study aims to conduct a systematic review and meta-analysis of overactive bladder (OAB) and nonobstructive urinary retention (NOUR).

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Introduction: There are standard treatment guidelines for the surgical management of rectal cancer, that are advocated by recognized physician societies. But, owing to disparities in access and affordability of various treatment options, there remains an unmet need for personalizing these international guidelines to Indian settings.

Methods: Clinical Robotic Surgery Association (CRSA) set up the Indian rectal cancer expert group, with a pre-defined selection criterion and comprised of the leading surgical oncologists and gastrointestinal surgeons managing rectal cancer in India.

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Background: Historically, intraosseous (IO) vascular access devices cleared to market by the US FDA have been restricted to 24-h use. An observational study was conducted to determine the safety of IO access for a period up to 48 h in adult volunteers.

Methods: A 2-arm randomized, stratified, parallel assignment, prospective interventional study was conducted at ICON Early Phase Services in San Antonio, Texas, United States.

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Machine Learning Approaches to Analyzing Adverse Events Following Durable LVAD Implantation.

Ann Thorac Surg

September 2021

Heinz College of Information Systems and Public Policy, Carnegie Mellon University, Pittsburgh, Pennsylvania.

Background: This study employed machine learning approaches to analyze sequences of adverse events (AEs) after left ventricular assist device (LVAD) implantation.

Methods: Data on patients implanted with the HeartWare HVAD durable LVAD were extracted from the ENDURANCE and ENDURANCE Supplemental clinical trials, with follow-up through 5 years. Major AEs included device malfunction, major bleeding, major infection, neurological dysfunction, renal dysfunction, respiratory dysfunction, and right heart failure (RHF).

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HVAD: The ENDURANCE Supplemental Trial.

JACC Heart Fail

September 2018

Divisions of Cardiovascular Medicine and Cardiothoracic Surgery, University of Michigan, Ann Arbor, Michigan.

Objectives: The aim of this study was to prospectively evaluate the impact of blood pressure management on stroke rates in patients receiving the HeartWare HVAD System.

Background: The ENDURANCE trial demonstrated noninferiority of the HeartWare HVAD System versus control (HeartMate II) in patients with advanced heart failure ineligible for heart transplantation. However, stroke was more common in HVAD subjects.

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