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The placebo and nocebo effects in functional urology
A placebo is an inert substance normally used in clinical trials for comparison with an active substance. However, a placebo has been shown to have...
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A phase IIb randomized placebo-controlled trial testing the effect of MAG-EPA long-chain omega-3 fatty acid dietary supplement on prostate cancer proliferation
BackgroundHigh prostate eicosapentaenoic fatty acid (EPA) levels were associated with a significant reduction of upgrading to grade group (GG) ≥ 2...
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Recipient factors in faecal microbiota transplantation: one stool does not fit all
Faecal microbiota transplantation (FMT) is a promising therapy for chronic diseases associated with gut microbiota alterations. FMT cures 90% of...
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Phase II randomized, double blind, placebo controlled, clinical trial of safety and immunogenicity of an inactivated SARS-CoV-2 vaccine FAKHRAVAC in adults aged 18–70 years
BackgroundThe FAKHRAVAC®, an inactivated SARS-CoV-2 vaccine, was assessed for safety and immunogenicity in a phase II trial.
MethodsWe did a phase...
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Molnupiravir for the treatment of COVID-19 in immunocompromised participants: efficacy, safety, and virology results from the phase 3 randomized, placebo-controlled MOVe-OUT trial
PurposeImmunocompromised patients have a potentially increased risk for progression to severe COVID-19 and prolonged replication of SARS-CoV-2. This...
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Efficacy and Safety of RBX2660 in PUNCH CD3, a Phase III, Randomized, Double-Blind, Placebo-Controlled Trial with a Bayesian Primary Analysis for the Prevention of Recurrent Clostridioides difficile Infection
BackgroundRecurrent Clostridioides difficile infection, associated with dysbiosis of gut microbiota, has substantial disease burden in the USA....
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Potential of FX06 to prevent disease progression in hospitalized non-intubated COVID-19 patients — the randomized, EU-wide, placebo-controlled, phase II study design of IXION
BackgroundMore than 2.7 million hospitalizations of COVID-19-infected patients have occurred in Europe alone since the outbreak of the coronavirus in...
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A multicenter randomized placebo-controlled trial of intravenous thyroxine for heart-eligible brain-dead organ donors
BackgroundBrain death frequently induces hemodynamic instability and cardiac stunning. Impairments in cardiac performance are major contributors to...
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Effect of fecal microbiota transplantation on primary hypertension and the underlying mechanism of gut microbiome restoration: protocol of a randomized, blinded, placebo-controlled study
BackgroundHypertension is currently the leading modifiable cause of global morbidity and mortality, leading to substantial health and financial...
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The effect of intra-vaginal oxytocin on sexual function in breastfeeding mothers: a randomized triple-blind placebo-controlled trial
BackgroundConsidering the importance of sexual function, high prevalence of sexual dysfunction (especially dyspareunia caused by atrophic vaginitis)...
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Investigating the efficacy of baricitinib in new onset type 1 diabetes mellitus (BANDIT)—study protocol for a phase 2, randomized, placebo controlled trial
BackgroundType 1 diabetes (T1D) places an extraordinary burden on individuals and their families, as well as on the healthcare system. Despite recent...
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Double-blind placebo-controlled randomized trial of N-acetylcysteine infusion following live donor liver transplantation
BackgroundThe role of N -acetylcysteine (NAC) in improving outcomes following live donor liver transplantation (LDLT) is not well established. We...
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The effects of polyunsaturated fatty acid (PUFA) administration on the microbiome-gut-brain axis in adolescents with anorexia nervosa (the MiGBAN study): study protocol for a longitudinal, double-blind, randomized, placebo-controlled trial
BackgroundAnorexia nervosa (AN) is a severe psychiatric disease that often takes a chronic course due to insufficient treatment options. Emerging...
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The Design and Rationale of a Phase 2b, Randomized, Double-Blinded, and Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Lomecel-B in Older Adults with Frailty
BackgroundFrailty in older adults is a rapidly growing unmet medical need. It is an aging-related syndrome characterized by physical decline leading...
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Efficacy and safety of Suxiao Jiuxin Pill in the treatment of stable angina (Qi stagnation and blood stasis syndrome): study protocol of a randomized, double-blind, placebo-controlled, multi-center clinical trial
BackgroundCoronary heart disease (CHD) has become one of the biggest health problems in the world. Stable angina is a common clinical type of CHD...
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Sunitinib-related high-grade proteinuria and allograft dysfunction in a kidney recipient: a rare case report
BackgroundSunitinib-induced high-grade proteinuria and irreversible renal allograft dysfunction are rare conditions. Here, we present a patient who...
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The PROMOTe study: targeting the gut microbiome with prebiotics to overcome age-related anabolic resistance: protocol for a double-blinded, randomised, placebo-controlled trial
BackgroundLoss of skeletal muscle mass and strength occurs with increasing age and is associated with loss of function, disability, and the...
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Alcohol and Placebo: The Role of Expectations and Social Influence
The placebo effect is frequently present in our lives when an expectation, associated with any psychoactive material, leads to subjective and...
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Testosterone eliminates strategic prosocial behavior through impacting choice consistency in healthy males
Humans are strategically more prosocial when their actions are being watched by others than when they act alone. Using a psychopharmacogenetic...
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SER-109 (VOWST™): A Review in the Prevention of Recurrent Clostridioides difficile Infection
SER-109 (VOWST ™ ; fecal microbiota spores, live-brpk) is a live biotherapeutic product indicated to prevent the recurrence of Clostridioides difficile ...
