Результаты поиска

Safety of retrograde cerebral perfusion under moderate hypothermia for hemiarch replacement.

OBJECTIVES: Aortic surgeries performed under moderate hypothermia require antegrade cerebral perfusion. The influence of retrograde cerebral perfusion under moderate hypothermic circulatory arrest remains unknown. To clarify this effect, this study aimed to compare the early outcomes of retrograde versus antegrade cerebral perfusion under moderate hypothermia for hemiarch replacement. METHODS: Between March 2009 and April 2020, 391 hemiarch replacements under moderate hypothermic circulatory arrest via median sternotomy were performed at our institution. Of these, 70 involved retrograde perfu

Safety study of allogeneic mesenchymal stem cell therapy in animal model.

Intravenous (IV) infusion of mesenchymal stem cells (MSCs) from nascent tissues like Wharton's Jelly of the umbilical cord is reported to offer therapeutic effects against chronic diseases. However, toxicological data essential for the clinical application of these cells are limited. Thus, this study aimed to determine the safety of IV infusion of Wharton's Jelly derived MSCs (WJ-MSCs) in rats. Fifteen male Sprague-Dawley rats were randomised into the control or treatment group. Each group received an equal volume of saline or WJ-MSC (10 × 106 cell/kg) respectively. The animals were evaluated …

Safety analysis of natural orifice specimen extraction surgery for colorectal cancer.

This study investigated the safety, feasibility, and clinical outcomes of natural orifice specimen extraction surgery (NOSES) by collecting clinical from patients who underwent complete laparoscopic radical resection for colorectal cancer versus those who underwent conventional laparoscopic radical resection for colorectal cancer. Patients with colorectal cancer were selected as the study sample and grouped according to the different surgical methods. A total of 182 patients were eligible for enrollment in the study, including 92 patients who underwent NOSES (NOSES group) and 90 patients who u…

High-Definition Liposculpture 18-Year Evolution: Patient Safety and Aesthetic Outcomes.

BACKGROUND: High-definition liposculpture (HDL) emerged as an innovative surgical technique that allowed plastic surgeons to achieve improved aesthetic results with a natural and athletic appearance using minimal incisions and with imperceptible scarring. Its targets are high aesthetic standards and patient safety. PURPOSE: This article summarizes the evolution of HDL by explaining upgrades to the original technique and comparing the complication rates among them. METHODS: The authors retrospectively reviewed records from four private medical centers (Evolution Medical Center, Santa Barbara …

Facial Gender-Affirming Surgery: Frontal Bossing Surgical Techniques, Outcomes and Safety.

BACKGROUND: Facial gender-affirming surgery (FGAS) is described as a set of surgical procedures done to feminize the soft tissue and the facial skeleton, allowing for transfeminine individuals to be recognizable as women to others. It is established in the literature that the most significant facial area for determination of gender is the forehead (Spiegel in Laryngoscope 121:250-261, 2011). This article describes the author's three main surgical techniques used in forehead feminization and reports on the results. METHODS: The type of surgery performed is based on the patient's anatomy. Type

Provocative Discography: Diagnostic Efficacy and Safety in Symptomatic Degenerative Disk Disease.

STUDY DESIGN: This was a retrospective cohort analysis. OBJECTIVE: The objective of this study was to report the efficacy and safety profile of provocative discography. SUMMARY OF BACKGROUND DATA: It is reported that the provocative discogram as a diagnostic test for symptomatic degenerative disk disease induces disk degeneration. MATERIALS AND METHODS: Discogram cases from 1998 to 2011 were identified. A matched control group with no discogram was identified. Both had pre-magnetic resonance imaging (MRI) and post-MRI with 5 years minimum between MRI studies. Statistics were generated by gr…

Preclinical safety profile of a liver-localized mitochondrial uncoupler: OPC-163493.

Mitochondrial uncouplers (mUncouplers) are known to exhibit a variety of toxic effects in animals. Here we report a safety profile of an mUncoupler, OPC-163493, recently synthesized at Otsuka Pharmaceutical Co, Ltd, and its development as a therapeutic agent for treating diabetes. To understand the acute and subchronic toxicity of OPC-163493, single and repeated oral dose studies in rats, dogs, and monkeys were performed. In the rat studies, rigor mortis and increased body temperatures were observed in the high dose group. Focal necrosis, fatty change, and granular eosinophilic cytoplasm of th…

Extended surveillance to assess safety of 9-valent human papillomavirus vaccine.

The safety of 9-valent HPV vaccine (9vHPV) has been established with regard to common and uncommon adverse events. However, investigation of rare and severe adverse events requires extended study periods to capture rare outcomes. This observational cohort study investigated the occurrence of three rare and serious adverse events following 9-valent human papillomavirus (9vHPV) vaccination compared to other vaccinations, in US individuals 9-26 years old, using electronic health record data from the Vaccine Safety Datalink (VSD). We searched for occurrences of Guillain-Barré syndrome (GBS), chron…

Long-Term Oncologic Safety of Nipple-Sparing Mastectomy With Immediate Reconstruction.

BACKGROUND: We assessed the long-term oncologic safety of nipple-sparing mastectomy (NSM) compared to skin-sparing mastectomy (SSM) for primary breast cancer patients with immediate reconstruction. PATIENTS AND METHODS: Data of stage 0-III primary breast cancer patients undergoing NSM (n = 190) or SSM (n = 729) from June 2006 to December 2012 were retrospectively collected. Nipple-tumor distance (NTD) was measured on pretreatment mammography, magnetic resonance imaging, or ultrasonography findings. NSM patients with NTD < 1 cm were excluded. Locoregional recurrence (LRR) rates were compared b…

Outpatient fractionated ICE protocol in relapsed/refractory lymphomas: Efficacy and safety.

METHODS: In this retrospective trial, we analyzed data of patients with relapsed/refractory lymphoma who received outpatient fractionated IC … a reasonable replacement for classic ICE regimen in many patients with lymphoma. It has a favorable safety profile. However, patients with primary refractory lymphomas need more effective regimens.

Percutaneous Ultrasound-guided Pigtail Catheter for Pleural Effusions: Efficacy and Safety.

OBJECTIVES: Small-bore pigtail catheters are now being used more frequently for draining pleural effusions. This study aimed to measure the efficacy, safety, and tolerability of these devices in different clinical conditions. METHODS: We retrospectively collected data from 141 patients with pleural effusions of various etiologies who underwent ultrasound-guided pigtail catheter insertion at Sultan Qaboos University Hospital, Muscat, Oman. RESULTS: The majority 109 (77.3%) of patients had exudates. The mean age was 50.0±18.6 years in patients with exudates and 67.3±15.5 in patients with trans…

REtrospective Multicenter INdian Study of Derivo Embolization Device (REMIND): Periprocedural Safety.

PURPOSE: The treatment of aneurysms with characteristics such as complex morphology, fusiform, blister-like, wide neck, or large size has be … to be less thrombogenic than conventional devices. We retrospectively evaluated the periprocedural safety and risks associated with the DED across 5 centers in India. MATERIALS AND METHODS: This is a multicentric, retrospective, observational study of DED, conducted at 5 high volume endovascular therapy centers in India from May 2018 to June 2020. Peri …

Safety of SF6(SonoVue®) Contrast Agent on Pharmacological Stress Echocardiogram.

BACKGROUND: In 2007, the United States Food and Drug Administration mandated safety reviews of commercially available echocardiographic contrast agents (ECA), following reports of death. During the past years, different studies have proven the safety of ECA, but there have been few studies on SonoVue®. OBJECTIVES: To evaluate the safety of SonoVue® during pharmacological stress echocardiography (PSE), by analyzing the incidence of allergic reactions and comparing groups regarding the appearance of arrhythmia, minor side effects and adverse events. METHODS: In this observational, prospective …

Safety profiles of new xanthine oxidase inhibitors: A post-marketing study.

INTRODUCTION: The development of new xanthine oxidase (XO) inhibitors, such as febuxostat and topiroxostat, could offer an alternative to treatment with allopurinol. The purpose of this study was to compare safety profiles of new XO inhibitors with allopurinol using a spontaneous reporting system database. MATERIALS AND METHODS: A retrospective pharmacovigilance disproportionality analysis was conducted using the Japanese Adverse Drug Event Report database. Adverse event reports submitted to the Pharmaceuticals and Medical Devices Agency were analyzed, and the reporting odds ratio (ROR) and 9…

Repeated talaporfin sodium photodynamic therapy for esophageal cancer: safety and efficacy.

BACKGROUND: Talaporfin sodium photodynamic therapy (tPDT) is an effective salvage treatment for local failure after chemoradiotherapy for esophageal cancer. Repeated tPDT could also be indicated for local recurrence or residue after the first salvage tPDT. However, the safety and efficacy of repeated tPDT have not been elucidated. METHODS: We reviewed 52 patients with esophageal cancer who were treated with the first tPDT at Kyoto University Hospital between October 2015 and April 2020. RESULTS: Among 52 patients, repeated tPDT after the first tPDT was indicated for 13 patients (25%), of whi…

Vibration Exposure Safety Guidelines for Surgeons Using Power-Assisted Liposuction (PAL).

BACKGROUND: As power-assisted liposuction (PAL) gains in popularity, plastic surgeons operating these devices experience occupational exposu … onditions and during 13 typical liposuction cases. Data were analyzed and compared with established safety limits of vibration exposure. RESULTS: The experiments demonstrated a mean vibration magnitude of typical liposuction surgeries to be 5.69 ± 0.77 m/s2 (range, 4.59-6.27 m/s2), which is significantly higher than the manufacturer declared value of 3. …

Telerehabilitation's Safety, Feasibility, and Exercise Uptake in Cancer Survivors: Process Evaluation.

BackgroundAccess to exercise for cancer survivors is poor despite global recognition of its benefits. Telerehabilitation may overcome barriers to exercise for cancer survivors but is not routinely offered.ObjectiveFollowing the rapid implementation of an exercise-based telerehabilitation program in response to COVID-19, a process evaluation was conducted to understand the impact on patients, staff, and the health service with the aim of informing future program development.MethodsA mixed methods evaluation was completed for a telerehabilitation program for cancer survivors admitted between Mar

Совпадение в полном тексте источника
… These discussions focused on areas of safety, acceptability, adoption, feasibility, fidelity, and costs ( Multimedia Appendix 2 ). … Overall, telerehabilitation was perceived as safe but staff acknowledged difficulty balancing safety needs with providing an adequate exercise prescription. Perception of safety was increased when patients used video. …

Characterization of Efficacy and Animal Safety across Four Caprine Disbudding Methodologies.

There is a strong industry demand for technically simple and highly efficacious alternatives to heat cautery disbudding in goat kids that can be performed as a stand-alone procedure without adjunct anesthesia, and that result in improved overall welfare through reduced acute pain, reduced tissues healing interval, and a consistent safety record. The objective of this study was to consider the net effect of disbudding techniques on goat welfare by examining vocalization frequency, long-term efficacy and animal safety associated with four alternative caprine disbudding methods against sham-disbu…