Publications by authors named "Keith Aqua"

Introduction: Self-dosing of off-the-shelf cannabidiol (CBD) for a myriad of health conditions is common in the USA. These CBD products are often mislabeled, suggesting that much less or much more CBD is being consumed than indicated on the label. This study examined the relationship between long-term self-dosing of CBD and (a) indications and, when a verified concentration of CBD is being consumed, (b) the daily CBD dosage, (c) the impact on general health and symptoms, and (d) over-the-counter (OTC) and prescription (Rx) drug usage.

View Article and Find Full Text PDF

Introduction: Previous research indicated that cannabidiol (CBD) may result in low levels of male total testosterone (TT), elevations in liver tests (LTs), and daytime drowsiness (DD). We investigated the prevalences of TT and LT in a large adult sample self-administering CBD and determined the effect self-dosing of CBD has on the severity of DD.

Methods: Adult participants (18-75 years of age) who self-dose CBD orally for a minimum of 30 days were recruited for this decentralized observational study from companies that offer CBD products.

View Article and Find Full Text PDF

Previous studies have suggested that prescribed cannabidiol (CBD) products may cause elevations in liver tests (LT). This study compared the prevalence of elevated LT in an adult population self-administering CBD with the normal and general adult population prevalences. Adults 18-75 years of age across the United States taking CBD orally for a minimum of 30 days were recruited from 12 individual CBD product companies in this decentralized, observational study and sent their standard CBD regimen from the company of their choice.

View Article and Find Full Text PDF

Purpose: The Kyleena Satisfaction Study (KYSS) aimed to assess satisfaction and continuation with levonorgestrel-releasing intrauterine system (LNG-IUS) 12 (Kyleena) in routine clinical practice and to evaluate factors that influence satisfaction.

Materials And Methods: This prospective, observational, multicentre, single-arm cohort study, with 1-year follow-up, was conducted in Belgium, Canada, Germany, Mexico, Norway, Sweden, Spain and the United States from 2017 to 2018. During routine counselling, women who independently selected to use LNG-IUS 12 were invited to participate in the study.

View Article and Find Full Text PDF

The Kyleena Satisfaction Study (KYSS) is a prospective, observational study conducted to assess satisfaction with LNG-IUS 12 (Kyleena) in clinical practice and aims to provide adequate information for counselling women on what to expect regarding insertion and satisfaction. Women deciding to use LNG-IUS 12 during routine counselling were informed of the study and provided informed consent. A baseline analysis was conducted to evaluate demographics, ease of insertion assessed by investigators, pain at insertion rated by women, additional interventions for insertion, and adverse events.

View Article and Find Full Text PDF

Background/purpose: Rapid hemostasis, an essential prerequisite of good surgical practice during surgical bleeding, including soft tissue open surgery, often requires adjunctive treatment. We evaluated the safety and hemostatic effectiveness of a human plasma-derived fibrin sealant (FS Grifols) in soft tissue open surgery.

Methods: Patients with moderate soft tissue bleeding during open, urologic, gynecologic or general surgery were studied.

View Article and Find Full Text PDF

Background And Objectives: This study evaluates the efficacy and safety of a sufentanil sublingual tablet system (SSTS) for the management of postoperative pain following open abdominal surgery.

Methods: At 13 hospital sites in the United States, patients following surgery with pain intensity of greater than 4 on an 11-point numerical rating scale were randomized to receive SSTS dispensing a 15-μg sufentanil tablet sublingually with a 20-minute lockout or an identical system dispensing a placebo tablet sublingually. Pain intensity scores were recorded at baseline and for up to 72 hours after starting study drug.

View Article and Find Full Text PDF

Hypothesis: Postoperative nausea and vomiting (PONV) are associated with a variety of complications. Neurokinin subtype 1 receptor antagonists have antiemetic activity in the postoperative setting, and the neurokinin subtype 1 receptor antagonist casopitant mesylate (GW679769) was well tolerated and effective at reducing the incidence of PONV in phase 1 and phase 2 trials.

Design: A multicenter, randomized, double-blind, parallel-group, phase 3 analysis was designed to evaluate the safety and efficacy of casopitant in combination with a single intravenous dose of the serotonin subtype 3 receptor antagonist ondansetron hydrochloride for the prevention of PONV in the perioperative setting.

View Article and Find Full Text PDF

Background: Patients are typically switched from parenteral opioids to oral opioids during the 24 to 48 hours after surgery. In June 2006, an oral immediate-release (IR) tablet formulation of oxymorphone was approved for the treatment of acute moderate to severe pain. Single doses of oxymorphone IR have been reported to provide significant pain relief after orthopedic surgery.

View Article and Find Full Text PDF

Transcervical hysteroscopic permanent sterilization is currently Federal Drug Administration (FDA) approved. The hysteroscopic approach obviates the need for general anesthesia and surgical incision. The device is a dynamically expanding micro-insert that, when placed in the proximal portion of the fallopian tube, generates a benign tissue response that results in anchoring of the device and subsequent occlusion of the tube.

View Article and Find Full Text PDF