Background: An estimated 185,000 patients per year undergo an extremity amputation in the United States (over 500 amputations/day). Prolonged postoperative opioid use, defined as the presence of a filled opioid prescription between 90 and 180 days following the operative amputation procedure, affects nearly 50% of amputees. Moreover, the use of preoperative benzodiazepines, muscle relaxants, anticonvulsants, and antidepressants is strongly linked to prolonged opioid use suggesting new therapeutic strategies are needed.
View Article and Find Full Text PDFBackground: Chronic venous insufficiency is characterized by inadequate venous return from the lower extremities, which may arise from intravenous obstruction after deep vein thrombosis or from extrinsic venous compression. The purpose of this study was to determine the safety and effectiveness of a dedicated endovenous stent for symptomatic iliofemoral venous obstruction.
Methods: The VIRTUS trial (VIRTUS Safety and Efficacy of the Veniti Vici Venous Stent System [Veniti, Inc] When Used to Treat Clinically Significant Chronic Non-Malignant Obstruction of the Iliofemoral Venous Segment) was a prospective, international, single-arm, pivotal study of endovenous stent placement in patients with symptomatic iliofemoral venous obstruction.
Objective To evaluate the efficacy and tolerability of single pulse transcranial magnetic stimulation (sTMS) for the preventive treatment of migraine. Background sTMS was originally developed for the acute treatment of migraine with aura. Open label experience has suggested a preventive benefit.
View Article and Find Full Text PDFIntroduction: Wide-necked bifurcation aneurysms (WNBAs) present unique technical challenges for both endovascular and surgical treatments which aim to achieve complete occlusion of the aneurysm without compromising the patency of the incorporated regional parent vessels. We present a meta-analysis of traditional therapies for WNBAs to provide critical benchmarks for safety and effectiveness.
Methods: Following a systematic search of the literature and the application of pre-specified appropriateness criteria, 43 (including 2794 aneurysms treated) and 65 (including 5366 patients treated) references with sufficient detail were identified to include in a meta-analysis of efficacy and safety, respectively.
The potential clinical utility of a novel quantitative electroencephalographic (EEG)-based Brain Function Index (BFI) as a measure of the presence and severity of functional brain injury was studied as part of an independent prospective validation trial. The BFI was derived using quantitative EEG (QEEG) features associated with functional brain impairment reflecting current consensus on the physiology of concussive injury. Seven hundred and twenty adult patients (18-85 years of age) evaluated within 72 h of sustaining a closed head injury were enrolled at 11 U.
View Article and Find Full Text PDFObjectives: A brain electrical activity biomarker for identifying traumatic brain injury (TBI) in emergency department (ED) patients presenting with high Glasgow Coma Scale (GCS) after sustaining a head injury has shown promise for objective, rapid triage. The main objective of this study was to prospectively evaluate the efficacy of an automated classification algorithm to determine the likelihood of being computed tomography (CT) positive, in high-functioning TBI patients in the acute state.
Methods: Adult patients admitted to the ED for evaluation within 72 hours of sustaining a closed head injury with GCS 12 to 15 were candidates for study.
Background And Objectives: Low level laser (light) therapy (LLLT) has been demonstrated to promote hair growth in males. A double-blind randomized controlled trial was undertaken to define the safety and physiologic effects of LLLT on females with androgenic alopecia.
Methods: Forty-seven females (18-60 years old, Fitzpatrick I-IV, and Ludwig-Savin Baldness Scale I-2, I-3, I-4, II-1, II-2 baldness patterns) were recruited.
Background And Objectives: Low level laser therapy (LLLT) has been used to promote hair growth. A double-blind randomized controlled trial was undertaken to define the safety and physiologic effects of LLLT on males with androgenic alopecia.
Methods: Forty-four males (18-48 yo, Fitzpatrick I-IV, Hamilton-Norwood IIa-V) were recruited.
Study Design: A prospective, randomized, blinded, multicenter clinical study.
Objective: To evaluate carboxymethylcellulose/polyethylene oxide gel (Oxiplex) in improving clinical outcomes in subjects having predominant leg pain and elevated low back pain undergoing first-time lumbar discectomy for disk herniation.
Summary Of Background Data: Clinical studies in the United States and Italy found that Oxiplex reduced leg pain after decompression surgery.
Study Design: Prospective, randomized, blinded clinical trial.
Objective: To evaluate effectiveness of Oxiplex gel for reduction of pain and associated symptoms after lumbar discectomy.
Summary Of Background Data: Oxiplex gel (carboxymethylcellulose, polyethylene oxide, and calcium) is used during discectomy to coat the surgical site for reduction of pain and symptoms after lumbar discectomy.
Background: Cardiac contractility modulation (CCM) signals are nonexcitatory electrical signals delivered during the absolute refractory period intended to improve contraction. We previously tested the safety and efficacy of CCM in 428 NYHA functional class III/IV heart failure patients with EF ≤35% and narrow QRS randomized to optimal medical treatment (OMT) plus CCM (n = 215) versus OMT alone (n = 213) and found no significant effect on ventilatory anaerobic threshold (VAT), the study's primary end point. In the present analysis, we sought to identify if there was a subgroup of patients who showed a response to CCM.
View Article and Find Full Text PDFBackground: Cardiac contractility modulation (CCM) delivers nonexcitatory electrical signals to the heart during the absolute refractory period intended to improve contraction.
Methods: We tested CCM in 428 New York Heart Association class III or IV, narrow QRS heart failure patients with ejection fraction (EF) ≤ 35% randomized to optimal medical therapy (OMT) plus CCM (n = 215) versus OMT alone (n = 213). Efficacy was assessed by ventilatory anaerobic threshold (VAT), primary end point, peak Vo₂ (pVo₂), and Minnesota Living with Heart Failure Questionnaire (MLWFQ) at 6 months.
Background: Endobronchial valves that allow air to escape from a pulmonary lobe but not enter it can induce a reduction in lobar volume that may thereby improve lung function and exercise tolerance in patients with pulmonary hyperinflation related to advanced emphysema.
Methods: We compared the safety and efficacy of endobronchial-valve therapy in patients with heterogeneous emphysema versus standard medical care. Efficacy end points were percent changes in the forced expiratory volume in 1 second (FEV1) and the 6-minute walk test on intention-to-treat analysis.
Study Objectives: To determine if vestibular stimulation is an effective therapy for transient insomnia in a sleep phase advance model.
Design: Multi-site, double-blind, randomized, parallel-group, sham-controlled trial
Setting: This study was carried out at 6 sites in the United States.
Participants: 198 healthy normal sleepers.