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Zopiclone versus placebo for short-term treatment of insomnia in patients with advanced cancer—a double-blind, randomized placebo-controlled clinical multicenter phase IV trial
PurposeInsomnia is frequent in patients with advanced cancer, and a variety of pharmacological agents is used to treat this condition. Still, few...
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Qualified placebo for trials of herbal medicine treatment in rare diseases? A cross-sectional analysis
BackgroundWhile substantial placebos have been used in herbal medicine (HM) clinical trials for rare diseases, the use and quality of reporting of...
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A phase 2 randomized, placebo-controlled crossover trial to evaluate safety and efficacy of platelet-rich plasma injections for Peyronie’s disease: clinical trial update
Peyronie’s Disease (PD) is characterized by fibrotic plaques in the penile tunica albuginea, causing curvature and painful erections. Current...
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Inhibition of Receptor-Interacting Protein Kinase 1 in Chronic Plaque Psoriasis: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study
IntroductionReceptor-interacting protein kinase 1 (RIPK1), a key mediator of inflammation through necroptosis and proinflammatory cytokine...
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Daily intake of 30 mg duloxetine is effective in decreasing premature ejaculation severity: a prospective randomized placebo-controlled cross over clinical trial
BackgroundPremature ejaculation (PE) is considered to be the most common male sexual disorder affecting 20% to 66% of sexually active men. Most of...
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Accelerating drug development for amyotrophic lateral sclerosis: construction and application of a disease course model using historical placebo group data
BackgroundAmyotrophic lateral sclerosis (ALS) is an irreversible degenerative disease. Placebo-controlled randomized trials are currently the main...
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Additional Results from Two Randomized, Placebo-Controlled Trials of Stiripentol in Dravet Syndrome Highlight a Rapid Antiseizure Efficacy with Longer Seizure-Free Periods
IntroductionThe efficacy of stiripentol in Dravet syndrome children was evidenced in two randomized, double-blind, placebo-controlled, phase 3...
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Risk of seizures in neonates with hypoxic-ischemic encephalopathy receiving hypothermia plus erythropoietin or placebo
BackgroundAn ancillary study of the High-Dose Erythropoietin for Asphyxia and Encephalopathy (HEAL) trial for neonates with hypoxic-ischemic...
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Rivoceranib, a VEGFR-2 inhibitor, monotherapy in previously treated patients with advanced or metastatic gastric or gastroesophageal junction cancer (ANGEL study): an international, randomized, placebo-controlled, phase 3 trial
BackgroundRivoceranib is an oral, selective tyrosine kinase inhibitor of vascular endothelial growth factor receptor-2. ANGEL (NCT03042611) was a...
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Artificial intelligence approach for the analysis of placebo-controlled clinical trials in major depressive disorders accounting for individual propensity to respond to placebo
Treatment effect in clinical trials for major depressive disorders (RCT) can be viewed as the resultant of treatment specific and non-specific...
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Safety and efficacy of favipiravir in COVID-19 patients with pneumonia. A randomized, double-blind, placebo-controlled study (FAVID)
PurposeTo design a randomized clinical trial to assess the efficacy and safety of favipiravir in patients with COVID-19 disease with pneumonia.
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Re-evaluating the placebo response in recent canine dietary epilepsy trials
The placebo response is a common phenomenon. Limited evidence is available about its magnitude in canine epilepsy trials, even though it can...
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Supplementation of High-Strength Oral Probiotics Improves Immune Regulation and Preserves Beta Cells among Children with New-Onset Type 1 Diabetes Mellitus: A Randomised, Double-Blind Placebo Control Trial
ObjectivesTo investigate the mechanism of glycemic control in children with type 1 diabetes (T1D) following high-strength probiotics supplementation...
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Combined FOLFOX4 with all-trans retinoic acid versus FOLFOX4 with placebo in treatment of advanced hepatocellular carcinoma with extrahepatic metastasis: a randomized, double-blind comparative study
The majority of hepatocellular carcinoma (HCC) cases are diagnosed at an advanced stage. Currently, there are only a few therapeutic methods...
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Placebo effects in randomized trials of pharmacological and neurostimulation interventions for mental disorders: An umbrella review
There is a growing literature exploring the placebo response within specific mental disorders, but no overarching quantitative synthesis of this...
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Irritable bowel syndrome in children: the placebo response rate and influencing factors a meta-analysis
BackgroundIrritable bowel syndrome is common in children and exhibits a high placebo response. This study was to explore the placebo response rate...
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Metformin, placebo, and endocrine therapy discontinuation among participants in a randomized double-blind trial of metformin vs placebo in hormone receptor-positive early-stage breast cancer (CCTG MA32)
BackgroundThe MA32 study investigated whether 5 years of metformin (versus placebo) improves invasive disease-free survival in early-stage breast...
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Virologic Outcomes with Molnupiravir in Non-hospitalized Adult Patients with COVID-19 from the Randomized, Placebo-Controlled MOVe-OUT Trial
IntroductionThe randomized, placebo-controlled, double-blind MOVe-OUT trial demonstrated molnupiravir (800 mg every 12 h for 5 days) as safe and...
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Randomized, placebo-controlled, double-blinded study of prophylactic cranberries use in women with recurrent uncomplicated cystitis
BackgroundΤhe adherence of p-fimbriated Escherichia coli (E. coli) to urothelial cells leading to recurrent urinary tract infections (rUTIs) may be...
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Efficacy and Tolerability of Adjunctive Brivaracetam in Patients with Focal-Onset Seizures on Specific Concomitant Antiseizure Medications: Pooled Analysis of Double-Blind, Placebo-Controlled Trials
IntroductionThis article aimed to assess the efficacy and tolerability of adjunctive brivaracetam (BRV) in adults with focal-onset seizures on...
