Articles: treatment.
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Randomized Controlled Trial Multicenter Study
Safety and efficacy of continuous subcutaneous levodopa-carbidopa infusion (ND0612) for Parkinson's disease with motor fluctuations (BouNDless): a phase 3, randomised, double-blind, double-dummy, multicentre trial.
Conventional oral levodopa therapy for the treatment of Parkinson's disease can be associated with variations in plasma concentrations. Levodopa infusion strategies might provide more consistent drug delivery and fewer motor fluctuations. We aimed to assess the safety and efficacy of a continuous 24 h/day subcutaneous infusion of ND0612 (a levodopa-carbidopa solution) compared with oral immediate-release levodopa-carbidopa for the treatment of motor fluctuations in people with Parkinson's disease. ⋯ NeuroDerm.
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Randomized Controlled Trial Multicenter Study Pragmatic Clinical Trial
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
Progressive Resistance Training or Neuromuscular Exercise for Hip Osteoarthritis : A Multicenter Cluster Randomized Controlled Trial.
Exercise is recommended as first-line treatment for patients with hip osteoarthritis (OA). However, randomized controlled trials providing evidence for the optimal exercise type are lacking. ⋯ Independent Research Fund Denmark.
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Randomized Controlled Trial
The novel rapid formulation of intravenous dantrolene (NPJ5008) versus standard dantrolene (DANTRIUM IV): A clinical part-randomised phase 1 study in healthy volunteers.
Delays in treating anaesthesia-induced malignant hyperthermia increase risks of complications and death. NPJ5008 is a novel formulation of the indicated treatment, dantrolene sodium, developed to shorten preparation and administration times compared with the reference formulation Dantrium®. The two formulations have been compared preclinically. ⋯ NPJ5008 showed comparable pharmacokinetic and safety profiles to Dantrium®, while reducing dantrolene dose preparation/administration times, potentially reducing patient complications/healthcare resourcing in malignant hyperthermia.
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Randomized Controlled Trial
Choice over placebo administration enhances open-label placebo hypoalgesia.
Many studies indicate that deceptively administered placebos can improve pain outcomes. However, the deception involved presents an ethical barrier to translation because it violates informed consent and patient autonomy. Open-label placebos (OLPs), inert treatments that are openly administered as placebos, have been proposed as an ethically acceptable alternative. ⋯ Of interest, there was no evidence for OLP hypoalgesia without choice relative to natural history. Furthermore, variability in pain intensity did not affect OLP hypoalgesia. The current findings present novel evidence that choice over treatment administration may be a cheap and effective strategy for boosting the efficacy of OLPs in the clinical care of pain.