Are open‐Label Placebos Ethical? Informed Consent and Ethical Equivocations [PDF]
Bioethics, 2016 AbstractThe doctor‐patient relationship is built on an implicit covenant of trust, yet it was not until the post‐World War Two era that respect for patient autonomy emerged as an article of mainstream medical ethics. Unlike their medical forebears, physicians today are expected to furnish patients with adequate information about diagnoses, prognoses ...
Charlotte, Blease +2 more
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Oral Levosimendan in amyotrophic lateral sclerosis: a phase II multicentre, randomised, double-blind, placebo-controlled trial [PDF]
, 2019 Objective To evaluate the efficacy and safety of oral levosimendan in amyotrophic lateral sclerosis (ALS) patients. This phase 2, randomised, double-blind, placebo-controlled, crossover, 3-period study with 6 months open-label follow-up enrolled adults ...
Aho, Valtteri V +8 more
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Experiences with HPTN 067/ADAPT Study-Provided Open-Label PrEP Among Women in Cape Town: Facilitators and Barriers Within a Mutuality Framework. [PDF]
, 2017 Placebo-controlled trials of pre-exposure prophylaxis (PrEP) have reported challenges with study-product uptake and use, with the greatest challenges reported in studies with young women in sub-Saharan Africa.
Amico, K Rivet +8 more
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Placebos without deception: a randomized controlled trial in irritable bowel syndrome. [PDF]
PLoS ONE, 2010 Placebo treatment can significantly influence subjective symptoms. However, it is widely believed that response to placebo requires concealment or deception.
Ted J Kaptchuk +9 more
doaj +1 more source
Safety and Efficacy of Natalizumab in Japanese Patients with Relapsing-Remitting Multiple Sclerosis: Open-Label Extension Study of a Phase 2 Trial [PDF]
, 2016 Introduction The efficacy of natalizumab was evaluated in Japanese patients with relapsing-remitting multiple sclerosis (RRMS) in a 24-week, phase 2 bridging study.
Deb Steiner +11 more
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Cannabinoids in the treatment of epilepsy: current status and future prospects [PDF]
, 2020 Cannabidiol (CBD) is one of the prominent phytocannabinoids found in Cannabis sativa, differentiating from Δ9-tetrahydrocannabinol (THC) for its non-intoxicating profile and its antianxiety/antipsychotic effects.
Albini M. +6 more
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Open-label placebos for menopausal hot flushes: a randomized controlled trial [PDF]
Scientific Reports, 2020 AbstractThis study investigated the efficacy of an open-label placebo (OLP) treatment for menopausal hot flushes. Women with at least five moderate or severe hot flushes per day were allocated to receive four weeks of OLP for twice a day or no-treatment. Intention-to-treat analyses included n = 100 women.
Pan, Yiqi +5 more
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Maintenance N-acetyl cysteine treatment for bipolar disorder : a double-blind randomised placebo controlled trial [PDF]
, 2012 Background N-acetyl cysteine (NAC) is a glutathione precursor that has been shown to have antidepressant efficacy in a placebo-controlled trial. The current study aimed to investigate the maintenance effects of NAC following eight weeks of open-label ...
AC Leon +51 more
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Motor- and cognition-related safety of pimavanserin in patients with Parkinson's disease psychosis
Frontiers in Neurology, 2022 BackgroundPimavanserin, a selective 5-HT2A inverse agonist/antagonist, is the only treatment approved by the US Food and Drug Administration for hallucinations and delusions associated with Parkinson's disease (PD) psychosis.AimWe aimed to evaluate motor-
Victor Abler +5 more
doaj +1 more source
Statistical issues in trials of preexposure prophylaxis [PDF]
, 2015 Purpose of review We discuss selected statistical issues in the design and analysis of preexposure prophylaxis (PrEP) trials. The general principles may inform thinking for other interventions in HIV prevention.
Dunn, DT, Glidden, DV
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