Articles: adult.
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Retrospective review of a prospective multicenter adult spinal deformity (ASD) study. ⋯ Level III-prognostic.
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Randomized Controlled Trial Multicenter Study
Sacral Neuromodulation Versus Conservative Treatment for Refractory Idiopathic Slow-transit Constipation: The Randomized Clinical No.2-Trial.
Assess the effectiveness of sacral neuromodulation (SNM) versus personalized conservative treatment (PCT) in patients with refractory idiopathic slow-transit constipation (STC). ⋯ SNM is a promising surgical treatment option in a homogeneous group of adults and adolescents with refractory idiopathic STC. No.2-Trial registered at ClinicalTrials.gov NCT02961582.
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Randomized Controlled Trial Multicenter Study
Efficacy and safety of eliapixant in diabetic neuropathic pain and prediction of placebo responders with an exploratory novel algorithm: results from the randomized controlled phase 2a PUCCINI study.
Phase 2a of the PUCCINI study was a placebo-controlled, double-blind, parallel-group, multicenter, proof-of-concept study evaluating the efficacy and safety of the selective P2X3 antagonist eliapixant in patients with diabetic neuropathic pain (DNP) ( ClinicalTrials.gov NCT04641273). Adults with type 1 or type 2 diabetes mellitus with painful distal symmetric sensorimotor neuropathy of >6 months' duration and neuropathic pain were enrolled and randomized 1:1 to 150 mg oral eliapixant twice daily or placebo for 8 weeks. The primary endpoint was change from baseline in weekly mean 24-hour average pain intensity score at week 8. ⋯ As the primary endpoint was not met, the PUCCINI study was terminated after completion of phase 2a and did not proceed to phase 2b. In conclusion, selective P2X3 antagonism in patients with DNP did not translate to any relevant improvement in different pain intensity outcomes compared with placebo. Funding: Bayer AG.
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Randomized Controlled Trial Multicenter Study
Comparison of the Efficacy of HSK3486 and Propofol for Induction of General Anesthesia in Adults: A Multicenter, Randomized, Double-Blind, Controlled, Phase 3 Noninferiority Trial.
Propofol is an intravenous anesthetic associated with hypotension, respiratory depression, and injection-site pain. HSK3486 injectable emulsion (ciprofol) is a 2,6-disubstituted phenol derivative with fast onset and quick, stable recovery. Previous studies support HSK3486 as an effective, safe anesthetic with substantially less injection-site pain than propofol. The primary objective of this study was to investigate the noninferiority of HSK3486 compared with propofol in successful general anesthesia induction. ⋯ The study met its primary objective and endpoint, demonstrating noninferiority of HSK3486 compared with propofol in successful anesthetic induction. Substantially less injection-site pain was associated with HSK3486 than with propofol.
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Multicenter Study
Practical Methods of Assessing Coronal Alignment and Outcomes in Adult Spinal Deformity Surgery: A Comparative Analysis.
Asymptomatic cohort: prospective, cross-sectional, multicenter. Symptomatic: retrospective, multisurgeon, single-center. ⋯ Preoperative OD-L5, ORB-L5, and C7-L5 lateral to pedicles were associated with worse preoperative ODI and higher intraoperative complexity. Postoperative OD-L5-L was associated with higher rates of proximal junctional kyphosis and pseudarthrosis. Postoperative CM, approximated by the cranial plumb line lateral to the L5 pedicles, was associated with sagittal plane complications.