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Filter by:This study will evaluate the safety, tolerability and pharmacokinetics (PK) of escalating single- and multiple-oral doses of IMM-H014 on fasted condition, and characterize PK of IMM-H014 on an empty stomach (fasted condition) and following a high fat, high calorie meal (fed condition) in a 2-period, 2-sequence manner. The study will be conducted in 3 parts (Ascending single dose, multiple dose and food effect). Participants will receive either IMM-H014 or placebo.
Frailty among patients undergoing surgery is strongly associated with an elevated risk of adverse perioperative outcomes, heightened incidence of postoperative complications, increased mortality rates, and prolonged hospital length of stay. Our focus centers on investigating the frailty index in the context of complications experienced by patients undergoing oncologic gynecology surgery. The principal objective of this research is to elucidate the extent to which residual neuromuscular blocking agents are linked to frailty.
The goal of this clinical trial is to evaluate the protective effect of metformin on nephrotoxicity of cisplatin in patients with bladder cancer. The main questions it aims to answer are: - To determine protective effect of metformin on structural and functional kidney injury caused by cisplatin in patients with bladder cancer. - To evaluate the safety of combining cisplatin and metformin on patients with bladder cancer
For the purposes of beta testing the first version of A4i-O, 15 individuals with OUD will use the platform for one month. From a design perspective this sample size is viewed as being sufficient to answer questions regarding app functionality and feasibility before moving to larger trials. Additionally, 15 individuals is a larger sample size than in the A4i pilot. This is an open label pilot with a primary objective of troubleshooting and providing early feedback on the beta version of the technology. To that end, 15 participants are anticipated to be sufficient to provide robust, early feedback. As with the focus groups, through sampling an effort will be made to secure a diverse group. Any individuals who might be declined in that effort at this stage (e.g., it is determined that no more male identifying participants are needed but they were interested) would be invited to take part in the subsequent RCT.
The purpose of this study is to evaluate the safety and effectiveness of tovinontrine compared to placebo to lower NT-proBNP in patients with chronic heart failure with reduced ejection fraction.
The purpose of this study is to evaluate the safety and effectiveness of tovinontrine compared to placebo to lower NT-proBNP in patients with chronic heart failure with preserved ejection fraction
We will sample intestinal microbiota using a microbiome sampling capsule in Healthy, Irritable Bowel Syndrome (IBS), and Functional Gastrointestinal Disease.
Acute respiratory distress syndrome (ARDS) is a heterogeneous syndrome with similar clinicopathological feathers caused by different etiologies. Respiratory supportive strategies is the main ARDS management, and the guidelines recommend low tidal volume to improve clinical outcomes. To be note, overdistension can still occur even if using a tidal volume as low as 6 ml/kg, given the heterogeneous nature of the syndrome. Therefore, adjusting tidal volume level to less than 6ml/kg may reduce ventilator-induced lung injury (VILI) and thus improve outcomes, especially in patients with severe lung injury. Prone position is also an important management in severe ARDS. Prone position can improve ventilation-perfusion (V/Q) matching and reduce the risk of VILI by recruiting dorsal collapsed alveoli. Meanwhile, prone position has also been shown to improve hemodynamics. Recent studies have showed that prone position did not reduce duration of venovenous extracorporeal membrane oxygenation (VV-ECMO) and 90-day mortality in patients with ARDS who receive VV-ECMO with ultra-low tidal volume ventilation. Therefore, the effect of PP on ventilation and lung blood flow in ARDS patients treated with VV-ECMO wiht ultra-low tidal volume ventilation remains unclear.
To evaluate the efficacy and safety of NRCT-101SR compared to placebo in subjects 13-17 years of age with ADHD
Objective: To investigate, through a controlled and randomized clinical trial, the effectiveness of using Melissa officinalis in different concentrations in the treatment of children and adolescents with probable sleep bruxism. Methodology: This is a randomized, triple-blind, crossover, and placebo-controlled clinical trial. The research participants will be children aged 5 to 10 years old and adolescents aged 11 to 16 years old who attend dental treatment at the FO/UFRJ Pediatric Dentistry Clinics. After approval by the Human Research Ethics Committee, children and adolescents will undergo homeopathic treatment with Melissa officinalis in different concentrations for possible sleep bruxism. In addition, research participants will undergo an assessment of TMJ, sleep, circadian cycle, quality of life, and quality of life related to oral health. The data will be tabulated and analyzed according to sex, age group, presence of possible sleep bruxism, presence or absence of TMD, circadian characteristics, presence or absence of sleep disorders, daytime and nighttime behavioral characteristics. The data will be tabulated and evaluated using SPSS 21.0. Absolute and relative frequency, odds ratio, correlation analysis and other relevant analyzes and statistical tests (p<0.05) will be carried out in accordance with the objectives proposed by the study