Publications by authors named "Bramante C"

Objective: To assess the absence of diabetic foot examination in Brazil and how ethnicity affected this outcome.

Design: This is an analysis of a nationwide survey held in Brazil in 2019. Participants with diabetes and that were 15 years of age or older were eligible for inclusion in the analysis.

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  • A study was conducted to evaluate the effectiveness of montelukast versus a placebo in helping outpatients with mild to moderate COVID-19 recover from symptoms more quickly.
  • The trial included 1,250 participants over 30 years old with confirmed COVID-19 symptoms for less than a week, who were randomly assigned to receive either montelukast or a placebo for 14 days.
  • Results showed no significant difference in recovery time between the montelukast and placebo groups, with both groups having a median recovery time of 10 days and no reported deaths.
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The number and complexity of obesity treatments has increased rapidly in recent years. This is driven by the approval of new anti-obesity medications (AOMs) that produce larger degrees of weight loss than previously approved AOMs. Unfortunately, access to these highly effective therapies and to integrated team-based obesity care is limited by intra-/interpersonal patient, institutional/practitioner, community, and policy factors.

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Coronavirus disease 2019 (COVID-19) and its associated severity have been linked to uncontrolled inflammation and may be associated with changes in the microbiome of mucosal sites including the gastrointestinal tract and oral cavity. These sites play an important role in host-microbe homeostasis, and disruption of epithelial barrier integrity during COVID-19 may potentially lead to exacerbated inflammation and immune dysfunction. Outcomes in COVID-19 are highly disparate, ranging from asymptomatic to fatal, and the impact of microbial dysbiosis on disease severity is unclear.

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Objective: Studies show metformin use before and during SARS-CoV-2 infection reduces severe COVID-19 and postacute sequelae of SARS-CoV-2 (PASC) in adults. Our objective was to describe the incidence of PASC and possible associations with prevalent metformin use in adults with type 2 diabetes mellitus (T2DM).

Research Design And Methods: This is a retrospective cohort analysis using the National COVID Cohort Collaborative (N3C) and Patient-Centered Clinical Research Network (PCORnet) electronic health record (EHR) databases with an active comparator design that examined metformin-exposed individuals versus nonmetformin-exposed individuals who were taking other diabetes medications.

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Objective: The coronavirus 2019 (COVID-19) pandemic has evolved over time by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant, disease severity, treatment, and prevention. There is evidence of an elevated risk of incident diabetes after COVID-19; our objective was to evaluate whether this association is consistent across time and with contemporary viral variants.

Research Design And Methods: We conducted a retrospective cohort study using National COVID Cohort Collaborative (N3C) data to evaluate incident diabetes risk among COVID-positive adults compared with COVID-negative patients or control patients with acute respiratory illness (ARI).

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  • This study focuses on decentralized methods for recruiting participants in a COVID-19 treatment trial, evaluating their effectiveness and efficiency.
  • Five primary recruitment strategies are analyzed: search engine ads, paid ads through national and regional testing companies, electronic health record messaging, and word of mouth.
  • The study compares these methods based on patient demographics, recruitment efficiency, and associated costs.
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  • A study investigated the prevalence of vestibular disorders in patients with COVID-19 compared to those without the virus using data from the National COVID Cohort Collaborative database.
  • Results showed that individuals with COVID-19 were significantly more likely to experience vestibular disorders, with the highest risk associated with the omicron 23A variant (OR of 8.80).
  • The findings underscore the need for further research on the long-term effects of vestibular disorders in COVID-19 patients and implications for patient counseling.
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Importance: Adolescent severe obesity is usually not effectively treated with traditional lifestyle modification therapy. Meal replacement therapy (MRT) shows short-term efficacy for body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) reduction in adolescents, and financial incentives (FIs) may be an appropriate adjunct intervention to enhance long-term efficacy.

Objective: To evaluate the effect of MRT plus FIs vs MRT alone on BMI, body fat, and cardiometabolic risk factors in adolescents with severe obesity.

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Background: Observed activity of metformin in reducing the risk of severe COVID-19 suggests a potential use of the anti-hyperglycemic in the prevention of post-acute sequelae of SARS-CoV-2 infection (PASC). We assessed the 3-month and 6-month risk of PASC among patients with type 2 diabetes mellitus (T2DM) comparing metformin users to sulfonylureas (SU) or dipeptidyl peptidase-4 inhibitors (DPP4i) users.

Methods: We used de-identified patient level electronic health record data from the National Covid Cohort Collaborative (N3C) between October 2021 and April 2023.

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  • - The study aimed to determine the effectiveness of montelukast, a medication, versus a placebo in helping outpatients with mild to moderate COVID-19 recover from their symptoms more quickly.
  • - Conducted as part of the ACTIV-6 trial, 1250 participants aged 30 and older were enrolled from across 104 U.S. sites, receiving either montelukast or a placebo for 14 days.
  • - Results showed no significant difference in recovery times between those taking montelukast and those taking the placebo, with both groups having a median recovery time of 10 days and minimal hospitalizations or adverse events reported.
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The limitations of the explanatory clinical trial framework include the high expense of implementing explanatory trials, restrictive entry criteria for participants, and redundant logistical processes. These limitations can result in slow evidence generation that is not responsive to population health needs, yielding evidence that is not generalizable. Clinically integrated trials, which integrate clinical research into routine care, represent a potential solution to this challenge and an opportunity to support learning health systems.

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  • - Metformin shows antiviral properties against SARS-CoV-2 by inhibiting protein translation through the mechanistic target of rapamycin pathway, leading to significant reductions in hospitalizations, emergency visits, and long COVID risk in the COVID-OUT trial.
  • - The COVID-OUT trial involved 999 participants and compared metformin, fluvoxamine, and ivermectin; it found a 3.6-fold reduction in viral load with metformin compared to placebo, and reduced rates of detectable viral load and viral rebound.
  • - The results indicate that metformin effectively lowers SARS-CoV-2 viral load, potentially explaining its clinical effectiveness, while neither ivermectin nor fluvoxamine showed significant benefits over placebo.
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Introduction: The aim of this study was to assess the effectiveness of filling removal material from the apical third of curved mesial root canals of mandibular molars. Reciprocating instrumentation followed by additional rotary instrumentation with instruments made of alloys with different heat treatments was evaluated.

Materials And Methods: Thirty-six mesial roots of mandibular molars were divided into two groups: Group Class IV consisted of 16 roots with two independent canals, and Group Class II consisted of 20 roots with two canals that merged into one at their apical level.

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Background: Severe obesity is a complex, chronic disease affecting nearly 9% of adolescents in the U.S. Although the current mainstay of treatment is lifestyle therapy, pediatric clinical practice guidelines recommend the addition of adjunct anti-obesity medication (AOM), such as phentermine and topiramate.

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The COVID-19 pandemic accelerated the development of decentralized clinical trials (DCT). DCT's are an important and pragmatic method for assessing health outcomes yet comprise only a minority of clinical trials, and few published methodologies exist. In this report, we detail the operational components of COVID-OUT, a decentralized, multicenter, quadruple-blinded, randomized trial that rapidly delivered study drugs nation-wide.

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Importance: Obesity affects approximately 42% of US adults and is associated with increased rates of type 2 diabetes, hypertension, cardiovascular disease, sleep disorders, osteoarthritis, and premature death.

Observations: A body mass index (BMI) of 25 or greater is commonly used to define overweight, and a BMI of 30 or greater to define obesity, with lower thresholds for Asian populations (BMI ≥25-27.5), although use of BMI alone is not recommended to determine individual risk.

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  • * This study aimed to develop and validate a new baseline proteomic signature, analyzing over 7000 proteins from patients to predict the severity of COVID-19 during infection.
  • * The findings indicated that 4110 proteins showed significant differences between mild and severe cases, with a promising predictive accuracy, identifying five key proteins and age as indicators for disease severity.
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Importance: The effect of higher-dose fluvoxamine in reducing symptom duration among outpatients with mild to moderate COVID-19 remains uncertain.

Objective: To assess the effectiveness of fluvoxamine, 100 mg twice daily, compared with placebo, for treating mild to moderate COVID-19.

Design, Setting, And Participants: The ACTIV-6 platform randomized clinical trial aims to evaluate repurposed medications for mild to moderate COVID-19.

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Objectives: To test and validate a new protocol for contamination of dentinal tubules using () by confocal laser scanning microscopy (CLSM), in addition to evaluating the effectiveness of conventional endodontic irrigants such as sodium hypochlorite (NaOCl) and chlorhexidine (CLX) on this biofilm.

Material And Methods: Thirty lower premolars were contaminated with (ATCC 51190) for 7 days under anaerobic conditions using the proposed new model The specimens were divided into a control group and experimental groups, according to the irrigants: NaOCl 2.5% and CLX 2%.

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Background: Observational and preclinical data suggest metformin may prevent severe coronavirus disease 2019 (COVID-19) outcomes.

Purpose: We conducted a systematic review of randomized, placebo-controlled clinical trials of metformin treatment for COVID-19 to determine whether metformin affects clinical or laboratory outcomes in individuals infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and present a structured summary of preclinical data.

Study Selection: Two independent reviewers searched PubMed, Scopus, Cochrane COVID-19 Study Register, and ClinicalTrials.

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Current antiviral treatment options for SARS-CoV-2 infections are not available globally, cannot be used with many medications, and are limited to virus-specific targets. Biophysical modeling of SARS-CoV-2 replication predicted that protein translation is an especially attractive target for antiviral therapy. Literature review identified metformin, widely known as a treatment for diabetes, as a potential suppressor of protein translation via targeting of the host mTor pathway.

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Background: Post-COVID-19 condition (also known as long COVID) is an emerging chronic illness potentially affecting millions of people. We aimed to evaluate whether outpatient COVID-19 treatment with metformin, ivermectin, or fluvoxamine soon after SARS-CoV-2 infection could reduce the risk of long COVID.

Methods: We conducted a decentralised, randomised, quadruple-blind, parallel-group, phase 3 trial (COVID-OUT) at six sites in the USA.

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