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Placebo - Europe PMC

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Last Updated: 26 September 2022

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Efficacy of heterologous boosting against SARS-CoV-2 using a recombinant interferon-armed fusion protein vaccine (V-01): a randomized, double-blind and placebo-controlled phase III trial.

Following the decline of protection effectiveness after the second dose of COVID-19 vaccines was administered, including China-made inactivated vaccines, Waning of neutralizing titres and decline of protection efficiency was noted. In an activated vaccine-primed population, one dose of a recombinant SARS-CoV-2 fusion protein vaccine was tested, with the intention of restoring the immunity. Healthy people aged 18 years or older in Pakistan and Malaysia were tested in a random, double-blind, placebo-controlled phase III trial. Every eligible participant received one dose of Livzon Mabpharm Inc. or placebo within the 3-6 months following the two-dose primary regimen's two-dose primary regimen and being monitored for safety and effectiveness. In the V-01 group 14 days after the booster, a dramatic rise in neutralizing titres was determined. The heterologous vaccination with the V-01 vaccine was safe and effective, and it may have helped to promote heightened humoral immunity against the Omicron strain.

Source link: https://europepmc.org/article/MED/35686572


Shugan Jieyu capsule improve sleep and emotional disorder in coronavirus disease 2019 convalescence patients: a randomized, double-blind, placebo-controlled trial.

During Coronavirus disease 2019 convalescence, the aim was to determine the safety of the Shugan Jieyu capsule on improving sleep and emotional disorders. Methods We conducted a double-blind, placebo-controlled trial to recruit 200 COVID-19 convalescence patients and then divide the patients into two groups according to the experimental group and the control group. HAMA Total Scores, PHQ-15 Score, ISI Score from baseline in the experimental group and control group, respectively, showed statistically significant differences in the rate of decline as well as effectiveness in HAMD-17 scores, as well as effectiveness in HAMD-17 scores. During COVID-19 convalescence, Shugan Jieyu capsule could greatly enhance sleep and emotional disorders in patients.

Source link: https://europepmc.org/article/MED/36083489


Effect of intravenous almitrine on intubation or mortality in patients with COVID-19 acute hypoxemic respiratory failure: A multicentre, randomised, double-blind, placebo-controlled trial

Background Severe hypoxemia in patients with COVID-19 pneumonia can result from hypoxic pulmonary vasoconstriction, contributing to a ventilation/perfusion mismatch. Because almitrine improves V/Q, it may reduce the risk of mechanical ventilation in such patients. At day 7, our main aim was to determine the effect of almitrine on the need for MV. Methods In a randomised double-blind placebo controlled trial involving 15 ICUs, patients hospitalized with COVID-19 pneumonia, and patients of acute hypoxemic respiratory failure were randomly selected to receive 5 days of intravenous low-dose almitrine or placebo. The primary endpoint was achieved in 32 patients randomized to almitrine and in 37 patients randomized to placebo on day 7, a difference of u20134u00b73 percent. Interpretation In patients with COVID-19 acute respiratory failure, low-dose almitrine did not succeed in reducing the need for MV or death on day 7.

Source link: https://europepmc.org/article/MED/PMC9489996


Follow-up study of infants recruited to the randomised, placebo-controlled trial of azithromycin for the prevention of chronic lung disease of prematurity in preterm infants-study protocol for the AZTEC-FU study.

When compared to placebo, the AZTEC project has tested 799 infants born at a minimum of 30 weeks' gestation to see if a ten-day intravenous treatment with azithromycin improves survival without development of persistent lung disease of prematurity at 36 weeks' postmenstrual age. In the early neonatal period, infants who received azithromycin, neurodevelopmental, and growth results will be compared between infants who received azithromycin and those who were placebo. Survivors at 36 weeks' PMA from the main Azithromycin Therapy for Chronic Lung Disease of Prematurity study with parental permission will continue to be tested up to withdrawal from the neonatal unit and to 2 years of corrected age. The AZTEC-FU project will determine mortality and other important neonatal morbidities, including respiratory, neurodevelopmental, and growth effects.

Source link: https://europepmc.org/article/MED/36131325


A randomised placebo-controlled trial of the effectiveness of early metformin in addition to usual care in the reduction of gestational diabetes mellitus effects (EMERGE): study protocol.

Background Pregnancies affected by gestational diabetes mellitus are at a greater risk of adverse maternal and foetal outcomes. Metformin is safe in a select group of women with GDM, but in several studies, it is not first-line therapy due to a lack of long-term evidence on efficacy. The EMERGE trial will determine the success of metformin early in GDM's use. the time to insulin initiation and insulin administration are critical for infant birth and head circumference at delivery; gestational waist gain; neonatal height and head circumference; and quality of life determined by the EQ5D-5L scale; duration and length of life; and the value of life; infant birth and expiration are key outcomes; infant mortality; gestational weight gain; and quality of life are dependent on the EQ5D-5L scale. Discussion The EMERGE trial will determine the effectiveness and safety of metformin use in GDM both early and often.

Source link: https://europepmc.org/article/MED/36131291


Inhaled aviptadil for the possible treatment of COVID-19 in patients at high risk for ARDS: study protocol for a randomized, placebo-controlled, and multicenter trial.

Background: Despite the rapid introduction of new therapeutic agents in the implementation of COVID-19 and large-scale vaccination programs since the outbreak of the SARS-CoV-2 pandemic in early 2020, severe disease courses remain a threat, particularly to patients with risk factors. Because of its ability to influence the regulation of exaggerated pro-inflammatory proteins and orchestrate lung homeostasis, Aviptadil, a synthetic form of human vasoactive intestinal peptide, may be helpful to COVID-19 patients at high risk of developing ARDs. When applied intravenously, Aviptadil has been shown to dramatically improve the prognosis of ARDs in COVID-19. An inhaled application of aviptadil has the benefits of a higher concentration in the lung tissue, quick onset of activity, avoiding the hepatic first-pass metabolism, and the reduction of adverse effects. Inhaled aviptadil in patients hospitalized for COVID-19, which is at a high risk of developing ARDS, is the project's overall aim. Methods This multicenter, placebo-controlled, double-blinded, randomized trial of 132 adult patients hospitalized for COVID-19 and at risk of ARDS is being carried out in five European public hospitals. According to the World Health Organization's nine-level scale for clinical status, the primary endpoint is transition from hospitalization to clinical enhancement, which can be defined as either hospital discharge or the rise of at least two levels on the nine-level scale for clinical status. Inhaled aviptadil may have the ability to prevent ARDs in COVID-19 due to its unique immunomodulating properties also targeting the SARS-CoV-2 pathway.

Source link: https://europepmc.org/article/MED/36127739


Acipimox in Mitochondrial Myopathy (AIMM): study protocol for a randomised, double-blinded, placebo-controlled, adaptive design trial of the efficacy of acipimox in adult patients with mitochondrial myopathy.

Mitochondrial disease is a heterogenous group of rare, complex neurometabolic disorders. Despite their individual exceptionality, mitochondrial diseases collectively speak for the most common cause of inherited metabolic disorders in the United Kingdom; they affect 1 in every 4300 individuals, up to 15,000 adults in the United Kingdom, and 1 in every 15,000 adults. In patients with mitochondrial disease, myopathy is common and debilitating. Aim To investigate the success of a 12-week treatment with acipimox on the adenosine triphosphate content of skeletal muscle in patients with mitochondrial disease and myopathy. Methods AIMM is a single-centre, double blind, placebo-controlled, adaptive trial aimed at assessing the success of acipimox in patients with mitochondrial myopathy for 12 weeks. Eligible patients will be able to benefit from the trial investigational medicinal product, whether acipimox or matched placebo. In order to keep the treatment assignment's blinding, participants will also be given low dose aspirin as a non-investigational medical drug. From baseline to 12 weeks, the key outcome of the change in ATP content in skeletal muscle and secondary outcomes related to quality of life, perceived exhaustion, disease burden, leg coordination, and walking will be assessed. Discussion The AIMM trial will find out how acipimox modulates muscle ATP content and whether it can be repurposed as a new treatment for mitochondrial disease with myopathy.

Source link: https://europepmc.org/article/MED/36127727


Extraoral low-level laser therapy can decrease pain but not edema and trismus after surgical extraction of impacted mandibular third molars: a randomized, placebo-controlled clinical trial.

Background information This research was designed to determine the effects of an extraoral 940 nm low-level diode laser on pain, edema, and trismus after surgical removal of impacted mandibular third molars. At three points in the master muscle in contact mode immediately after surgical removal of third molar, the laser quadrant received 940 nm diode laser irradiation at three points. The third molar in the placebo quadrant was extracted after two weeks by the same surgeon using the same technique. The distance between the tragus and the chin point was measured before and immediately after surgery, and after 2 and 7 days, according to a doctor who was trying to determine edema. Conclusions The mean pain score in the first 7 days of the laser group was significantly lower in the first 7 days. Both groups edema and trismus were the same in both groups. Conclusion Following third molar extraction surgery, a single-session irradiation of 940 nm diode laser can safely reduce pain following third molar extraction surgery.

Source link: https://europepmc.org/article/MED/36127651


An Exploratory Machine Learning Approach to Identify Placebo Responders in Pharmacological Binge Eating Disorder Trials.

Randomized, placebo-controlled trials for binge eating disorder have shown highly variable, and often high, rates of short-term placebo response. Several quantitative based studies in patients with BED have inconsistently established which patient causes lead to an increase in placebo response. Placebo responders were defined as patients who experienced a greater than or equal increase in binge eating frequency at the study's end point. Gaussian Nau00efve Bayes algorithm produced the highest cross-validation accuracy, and was chosen as the final algorithm. According to Shapley's report, patients with low baseline BEF and anxiety status were significant moderators of placebo response. This is the first use of ML to determine placebo moderators in BED. The results of this investigation confirm previous findings of reduced baseline disease prevalence, and concludes that patients with no anxiety are more vulnerable to placebo response.

Source link: https://europepmc.org/article/MED/36126231


Effects of a novel weight-loss combination product containing orlistat and acarbose on obesity: A randomized, placebo-controlled trial.

Compared to placebo, the aim of this research was to investigate the effect of a novel, oral, and modified-release version of the lipase inhibitor orlistat and the glucosidase inhibitor acarbose on relative body weight after 26 weeks. The main end point was relative weight loss from baseline to week 26 in participants with at least one post-baseline weight measurement. EMP16-120/40 and -54 percent with EMP16-150/50, respectively, showed the mean estimated treatment difference to placebo in relative weight loss after 26 weeks in the intention-to-treat population, with EMP16-120/40 and -5. 42% with EMP16-150/50. EMP16 may be a promising option among other drugs for weight control among other drugs for improved weight management.

Source link: https://europepmc.org/article/MED/36123783

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions